Nizoral Anti-Dandruff Shampoo Ketoconazole 1% Clean Fresh Scent 7 fl oz: version 1
Saved 2026-09-27 04:30 by @benjaminsen (bot): Added Nizoral Anti-Dandruff Shampoo (ketoconazole 1%, 7 fl oz / 200 mL, US), barcode 0053076192407, from the wanted list. Identity is confirmed by the DailyMed 7 oz carton artwork, which prints 0 53076 19240 7, and by the Amazon.com listing B00AINMFAC, which prints this UPC. The drug facts, the full inactive-ingredient list, NDC 55505-196-40, NDA020310 and the 2022 marketing start come from DailyMed SPL version 8 (published 2026-09-18). The carton gives "Made in Canada" as the origin and names Kramer Laboratories, Inc. (Bridgewater, NJ) as distributor. The 2018 acquisition from Janssen and the 2019 Arcadia Consumer Healthcare rename come from the PR Newswire releases. The US market is evidenced by Amazon.com (prints the barcode; buy box unavailable, offers from USD 16.88), Walmart (USD 16.88, derived) and Target (derived). New stubs: brand/nizoral, company/kramer-laboratories, company/arcadia-consumer-healthcare, and ingredients ketoconazole, cocamide MEA, glycol distearate, hydrochloric acid, polyquaternium-7, sodium cocoyl sarcosinate and sodium laureth sulfate. Tetrasodium EDTA maps to the existing sodium-edetate page (the SPL names it Edetate Sodium, UNII MP1J8420LU). Gaps: the Canadian manufacturer is not named; the 0053076 prefix is not written as a company prefix (its length is not established and the OFF block has an unrelated Asda record); a second UPC (053076191400) on the Amazon listing is unexplained; there is no reusable photo. . This is the current version.
Source of v1
# Nizoral Anti-Dandruff Shampoo Ketoconazole 1% Clean Fresh Scent 7 fl oz <!--product-->
## Identity <!--identity-->
gtin: 00053076192407
name: Nizoral Anti-Dandruff Shampoo Ketoconazole 1% Clean Fresh Scent 7 fl oz
default_observation: us-carton-2022
summary: US over-the-counter anti-dandruff shampoo with 1% ketoconazole in a 200 mL bottle and carton, distributed by Kramer Laboratories.
brand: brand/nizoral
category: category/10000368
net_content: 7 fl_oz
country_of_sale: US
country_of_origin: CA
pack_format: bottle in carton
status: active
<!--/identity-->
## Relations <!--relations-->
| role | target | market | from | until | ended | status | source | note |
| ------------------- | --------------------------- | ------ | ---------- | ----- | ----- | ------- | ---------------- | ------------------------------------------------------------------------------------------------------------ |
| distributed_by | company/kramer-laboratories | US | | | | printed | ^dailymed-carton | "Distributed by: Kramer Laboratories, Inc., Bridgewater, NJ 08807 USA" on the carton side panel. |
| brand_owner_at_sale | company/kramer-laboratories | US | 2018-06-25 | | | sourced | ^prn-2018 | Kramer bought the Nizoral brand for North America and Latin America from Janssen Pharmaceutica NV. |
| gs1_prefix_owner | company/kramer-laboratories | | | | | derived | ^dailymed-carton | prefix 0053076; the distributor printed on the carton, which also labels Kaopectate packs in the same block. |
<!--/relations-->
## Markets <!--markets-->
| country | status | source | note | observed | condition | origin | price |
| ------- | ------- | ---------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ---------- | --------- | ------ | --------- |
| US | printed | ^dailymed-carton | Carton names a US distributor (Bridgewater, NJ) and a US drug facts panel; NDC 55505-196-40 in the DailyMed listing. | 2026-09-18 | | CA | |
| US | sourced | ^amazon-us | Amazon.com listing ASIN B00AINMFAC prints UPC 053076191400 and 053076192407; the buy box read "Currently unavailable" and the size selector showed 4 new offers from USD 16.88. | 2026-09-27 | new | | |
| US | derived | ^walmart-us | Walmart.com item 131537114 matches name, 7 fl oz size and single pack; the page prints no barcode. | 2026-09-27 | new | | USD 16.88 |
| US | derived | ^target-us | Target listing A-15603485 matches name, Clean Fresh Scent and 7 fl oz; the page shows no barcode or price in its text. | 2026-09-27 | new | | |
<!--/markets-->
## Aliases <!--aliases-->
| name | type | locale | from | until |
| -------------------------------------- | ------ | ------ | ---- | ----- |
| Nizoral A-D Anti-Dandruff Shampoo 7 oz | name | en | | |
| Nizoral ketoconazole shampoo | search | en | | |
<!--/aliases-->
## Ingredients <!--ingredients-->
| ingredient | role | kind | note | percent | basis | market | from | until | source | id | observation | parent_id | position | printed_name | state |
| ------------------------------------ | ----------------- | ----- | -------------------------------------------------------- | ------- | ----- | ------ | ---- | ----- | --------- | ----------------- | -------------- | --------- | -------- | ----------------------------- | ----- |
| ingredient/ketoconazole | active ingredient | label | Purpose: anti-dandruff shampoo; SPL gives 10 mg in 1 mL. | 1 | w/w | | | | ^dailymed | keto | us-carton-2022 | | 1 | Ketoconazole | known |
| ingredient/benzyl-alcohol | inactive | label | | | | | | | ^dailymed | benzyl-alcohol | us-carton-2022 | | 2 | benzyl alcohol | known |
| ingredient/butylated-hydroxytoluene | inactive | label | | | | | | | ^dailymed | bht | us-carton-2022 | | 3 | BHT | known |
| ingredient/brilliant-blue-fcf | inactive | label | SPL: FD&C Blue No. 1. | | | | | | ^dailymed | blue-1 | us-carton-2022 | | 4 | blue 1 | known |
| ingredient/citric-acid | inactive | label | | | | | | | ^dailymed | citric-acid | us-carton-2022 | | 5 | citric acid | known |
| ingredient/cocamide-mea | inactive | label | | | | | | | ^dailymed | cocamide-mea | us-carton-2022 | | 6 | cocamide MEA | known |
| ingredient/fragrance | inactive | label | | | | | | | ^dailymed | fragrance | us-carton-2022 | | 7 | fragrance | known |
| ingredient/glycol-distearate | inactive | label | | | | | | | ^dailymed | glycol-distearate | us-carton-2022 | | 8 | glycol distearate | known |
| ingredient/hydrochloric-acid | inactive | label | | | | | | | ^dailymed | hcl | us-carton-2022 | | 9 | hydrochloric acid | known |
| ingredient/hypromellose | inactive | label | SPL: Hypromellose, unspecified. | | | | | | ^dailymed | hpmc | us-carton-2022 | | 10 | hydroxypropyl methylcellulose | known |
| ingredient/polyquaternium-7 | inactive | label | | | | | | | ^dailymed | pq7 | us-carton-2022 | | 11 | polyquaternium-7 | known |
| ingredient/sodium-benzoate | inactive | label | | | | | | | ^dailymed | sodium-benzoate | us-carton-2022 | | 12 | sodium benzoate | known |
| ingredient/salt | inactive | label | | | | | | | ^dailymed | sodium-chloride | us-carton-2022 | | 13 | sodium chloride | known |
| ingredient/sodium-cocoyl-sarcosinate | inactive | label | | | | | | | ^dailymed | scs | us-carton-2022 | | 14 | sodium cocoyl sarcosinate | known |
| ingredient/sodium-hydroxide | inactive | label | | | | | | | ^dailymed | sodium-hydroxide | us-carton-2022 | | 15 | sodium hydroxide | known |
| ingredient/sodium-laureth-sulfate | inactive | label | SPL: Sodium Laureth-3 Sulfate. | | | | | | ^dailymed | sles | us-carton-2022 | | 16 | sodium laureth sulfate | known |
| ingredient/sodium-edetate | inactive | label | SPL: Edetate Sodium (UNII MP1J8420LU). | | | | | | ^dailymed | edta | us-carton-2022 | | 17 | tetrasodium EDTA | known |
| ingredient/water | inactive | label | | | | | | | ^dailymed | water | us-carton-2022 | | 18 | water | known |
<!--/ingredients-->
## Specifications <!--specifications-->
| property | value | unit | source | note | observation | key | numeric_value | mode | state | method | qualifier |
| ------------------ | --------------------------------------------------------------------------------------------------------------------------------------- | ---- | --------- | --------------------------------------------------------------------- | -------------- | --------------- | ------------- | ---- | ----- | ------ | --------- |
| Dosage form | shampoo | | ^dailymed | Route of administration: topical. | us-carton-2022 | | | | | | |
| Strength | 1 % w/w ketoconazole (10 mg in 1 mL) | | ^dailymed | | us-carton-2022 | | | | | | |
| NDC package code | 55505-196-40 | | ^dailymed | 200 mL in 1 bottle, 1 bottle in 1 carton; marketing start 2022-06-16. | us-carton-2022 | | | | | | |
| Marketing category | NDA020310 (New Drug Application), human OTC drug | | ^dailymed | | us-carton-2022 | supply_category | | | | | |
| Directions | adults and children 12 years and over: use every 3-4 days for up to 8 weeks or as directed by a doctor; children under 12: ask a doctor | | ^dailymed | | us-carton-2022 | | | | | | |
| Storage | 20 °C to 25 °C (68 °F to 77 °F) | | ^dailymed | | us-carton-2022 | | | | | | |
<!--/specifications-->
## Observations <!--observations-->
| id | label | kind | market | language | valid_from | valid_until | observed | status | ingredients_text | ingredients_declaration | ingredients_exempt_basis | source | note | net_content | pack_quantity | piece_count | pack_format | model_number |
| -------------- | --------------------------------------------- | ----- | ------ | -------- | ---------- | ----------- | ---------- | --------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ----------------------- | ------------------------ | --------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ----------- | ------------- | ----------- | ---------------- | ------------ |
| us-carton-2022 | US 7 fl oz carton, © 2022 Kramer Laboratories | label | US | en | 2022-06-16 | | 2026-09-18 | supported | Active ingredient: Ketoconazole 1% w/w (anti-dandruff shampoo). Inactive ingredients: benzyl alcohol, BHT, blue 1, citric acid, cocamide MEA, fragrance, glycol distearate, hydrochloric acid, hydroxypropyl methylcellulose, polyquaternium-7, sodium benzoate, sodium chloride, sodium cocoyl sarcosinate, sodium hydroxide, sodium laureth sulfate, tetrasodium EDTA, water | listed | | ^dailymed | Drug facts panel as shown in DailyMed SPL version 8 and the 7 oz carton artwork, which prints barcode 0 53076 19240 7; valid_from is the marketing start date of NDC 55505-196-40. | 7 fl_oz | 1 | | bottle in carton | |
<!--/observations-->
## Label claims <!--claims-->
| observation | claim | kind | source | note |
| -------------- | ----------------------------------------------------------------------- | ----- | ---------------- | -------------------------------------------------- |
| us-carton-2022 | Clinically proven to control flaking, scaling and itching from dandruff | label | ^dailymed-carton | Front panel. |
| us-carton-2022 | The only over-the-counter anti-dandruff shampoo that has Ketoconazole | label | ^dailymed-carton | Side panel "How Does Nizoral Anti-Dandruff Work?". |
<!--/claims-->
## Research gaps <!--research_gaps-->
| observation | domain | state | detail | source |
| -------------- | ------------- | ------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ---------------- |
| us-carton-2022 | relationships | unknown | The carton says "Made in Canada" and names only the distributor; the Canadian manufacturer is not named. | ^dailymed-carton |
| | relationships | unknown | Prefix 0053076 is not written to Kramer's gs1_prefixes: no fetched source names the holder, its length is not established, and the Open Food Facts block under 0053076 also holds a record titled "Asda Straight to Wok Noodles" next to Kaopectate packs. | |
| | identity | unknown | The Amazon.com listing prints a second UPC, 053076191400, beside this one; no source says whether it is an earlier barcode of the same article. | ^amazon-us |
| | images | unknown | No front photo under a reusable licence was found; the DailyMed carton artwork carries no licence statement. | ^dailymed-carton |
<!--/research_gaps-->
## Research <!--research-->
structure_version: 2
reviewed_on: 2026-09-27
<!--/research-->
## References <!--references-->
| ref | url | title | accessed | publisher | kind | published | record_id | locator | licence | attribution | upstream |
| --------------- | ------------------------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------- | ---------- | --------------------------------- | ------------ | ---------- | ------------------------------------ | ------------------------------------------------- | ------- | ----------- | -------- |
| dailymed | https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a17b7424-ee7e-4fcc-b6b3-0904932ae319 | DailyMed: NIZORAL (ketoconazole) shampoo, Kramer Laboratories | 2026-09-27 | U.S. National Library of Medicine | registry | 2026-09-18 | a17b7424-ee7e-4fcc-b6b3-0904932ae319 | SPL version 8: drug facts, packaging, ingredients | | | |
| dailymed-carton | https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=a17b7424-ee7e-4fcc-b6b3-0904932ae319&name=7ozcarton.jpg | DailyMed: Nizoral 7 fl oz carton artwork | 2026-09-27 | U.S. National Library of Medicine | pack | 2026-09-18 | 7ozcarton.jpg | Full carton flat, barcode panel | | | |
| amazon-us | https://www.amazon.com/dp/B00AINMFAC | Amazon.com: Nizoral Anti-Dandruff Shampoo with 1% Ketoconazole, Fresh Scent, 7 Fl Oz | 2026-09-27 | Amazon.com | retailer | | B00AINMFAC | Product information | | | |
| walmart-us | https://www.walmart.com/ip/Nizoral-A-D-Anti-Dandruff-Shampoo-7-Oz/131537114 | Walmart.com: Nizoral Anti-Dandruff Shampoo with 1% Ketoconazole, Fresh Scent, 7 Fl Oz | 2026-09-27 | Walmart | retailer | | 131537114 | | | | |
| target-us | https://www.target.com/p/nizoral-anti-dandruff-shampoo-with-1-ketoconazole-clean-fresh-scent-7-fl-oz/-/A-15603485 | Target: Nizoral Anti Dandruff Shampoo with 1% Ketoconazole, Clean Fresh Scent - 7 fl oz | 2026-09-27 | Target | retailer | | A-15603485 | | | | |
| prn-2018 | https://www.prnewswire.com/news-releases/kramer-laboratories-to-acquire-nizoral-from-janssen-pharmaceutica-nv-300671438.html | Kramer Laboratories to Acquire Nizoral from Janssen Pharmaceutica NV | 2026-09-27 | PR Newswire | publication | 2018-06-25 | | | | | |
| prn-2019 | https://www.prnewswire.com/news-releases/kramer-laboratories-announces-new-corporate-identity-as-arcadia-consumer-healthcare-300933311.html | Kramer Laboratories Announces New Corporate Identity as Arcadia Consumer Healthcare | 2026-09-27 | PR Newswire | publication | 2019-10-08 | | | | | |
| nizoral-com | https://nizoral.com/ | Nizoral Anti-Dandruff Shampoo - Ketoconazole 1% | 2026-09-27 | Kramer Laboratories | manufacturer | | | | | | |
<!--/references-->
## About <!--about-->
Nizoral Anti-Dandruff is an over-the-counter shampoo containing 1% ketoconazole, sold in the United States in a 7 fl oz (200 mL) bottle packed in a carton.[^dailymed] It is labelled to control the flaking, scaling and itching associated with dandruff, and its maker describes it as the only over-the-counter anti-dandruff shampoo with ketoconazole.[^nizoral-com] The carton, which carries this barcode, says it was made in Canada and is distributed by Kramer Laboratories, Inc. of Bridgewater, New Jersey.[^dailymed-carton] The FDA listing files it under NDA020310 as package code 55505-196-40, marketed since 16 June 2022.[^dailymed] It is sold at Amazon, Walmart and Target in the US.[^amazon-us][^walmart-us]
Kramer Laboratories acquired Nizoral for North America and Latin America from Janssen Pharmaceutica, a Johnson & Johnson company, in June 2018.[^prn-2018] In October 2019 the company adopted the corporate name Arcadia Consumer Healthcare, Inc., keeping Kramer Laboratories, Inc. as a subsidiary under which its products continue to be sold.[^prn-2019]
<!--/about-->