American Crew Anti-Dandruff plus Sebum Control

Product NDC
42743-4700
11-digit product format
427434700
Labeler code
42743
Product ID
42743-4700_605ebeb6-c4ad-4c3e-8a6d-e15b63041dda
Type
HUMAN OTC DRUG
Nonproprietary name
Pyrithione Zinc
Dosage form
SHAMPOO
Route
CUTANEOUS
Labeler
Colomer USA, Ltd.
Application
part358H
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2013-08-31
Marketing end
0000-00-00
Substance
PYRITHIONE ZINC
Active strength
10 mg/mL
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct42743-4700IInactivated by FDA2026-10-16
excluded packagepackage42743-470042743-4700-1IInactivated by FDA2026-10-16

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 44 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage42743-4700-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage42743-4700-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage42743-4700-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage42743-4700-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage42743-4700-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage42743-4700-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage42743-4700-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage42743-4700-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage42743-4700-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage42743-4700-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage42743-4700-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage42743-4700-1557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage42743-4700-18af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage42743-4700-1834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage42743-4700-11332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage42743-4700-1fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage42743-4700-186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage42743-4700-1bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage42743-4700-18dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage42743-4700-1e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage42743-4700-19bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage42743-4700-1110d247fa046…a55b01930146…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42743-4700-12019-11-27C16284748780-19855e2a2-4788-60a7-e053-dbdaa90a05bdAmerican Crew ® Anti-Dandruff + Sebum Control Shampoo

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42743-4700-1American Crew Anti-Dandruff plus Sebum Control250 mL in 1 BOTTLESHAMPOO2502

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Pyrithione ZincACTIVE INGREDIENTR953O2RHZ5AMERICAN CREW ANTI-DANDRUFF PLUS SEBUM CONTROL (PYRITHIONE ZINC) SHAMPOO [COLOMER USA, LTD.]2
Pyrithione ZincACTIVE MOIETYR953O2RHZ5AMERICAN CREW ANTI-DANDRUFF PLUS SEBUM CONTROL (PYRITHIONE ZINC) SHAMPOO [COLOMER USA, LTD.]2
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KXAMERICAN CREW ANTI-DANDRUFF PLUS SEBUM CONTROL (PYRITHIONE ZINC) SHAMPOO [COLOMER USA, LTD.]2
DI-PPG-2 MYRETH-10 ADIPATEINACTIVE INGREDIENT4IN301M0KJAMERICAN CREW ANTI-DANDRUFF PLUS SEBUM CONTROL (PYRITHIONE ZINC) SHAMPOO [COLOMER USA, LTD.]2
ETHYLPARABENINACTIVE INGREDIENT14255EXE39AMERICAN CREW ANTI-DANDRUFF PLUS SEBUM CONTROL (PYRITHIONE ZINC) SHAMPOO [COLOMER USA, LTD.]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXAMERICAN CREW ANTI-DANDRUFF PLUS SEBUM CONTROL (PYRITHIONE ZINC) SHAMPOO [COLOMER USA, LTD.]2
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)INACTIVE INGREDIENTR33S7TK2EPAMERICAN CREW ANTI-DANDRUFF PLUS SEBUM CONTROL (PYRITHIONE ZINC) SHAMPOO [COLOMER USA, LTD.]2
LIMONENE, (+)-INACTIVE INGREDIENTGFD7C86Q1WAMERICAN CREW ANTI-DANDRUFF PLUS SEBUM CONTROL (PYRITHIONE ZINC) SHAMPOO [COLOMER USA, LTD.]2
METHYLCHLOROISOTHIAZOLINONEINACTIVE INGREDIENTDEL7T5QRPNAMERICAN CREW ANTI-DANDRUFF PLUS SEBUM CONTROL (PYRITHIONE ZINC) SHAMPOO [COLOMER USA, LTD.]2
METHYLISOTHIAZOLINONEINACTIVE INGREDIENT229D0E1QFAAMERICAN CREW ANTI-DANDRUFF PLUS SEBUM CONTROL (PYRITHIONE ZINC) SHAMPOO [COLOMER USA, LTD.]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TAMERICAN CREW ANTI-DANDRUFF PLUS SEBUM CONTROL (PYRITHIONE ZINC) SHAMPOO [COLOMER USA, LTD.]2
PEG-12 DIMETHICONE (300 CST)INACTIVE INGREDIENTZEL54N6W95AMERICAN CREW ANTI-DANDRUFF PLUS SEBUM CONTROL (PYRITHIONE ZINC) SHAMPOO [COLOMER USA, LTD.]2
PEPPERMINT OILINACTIVE INGREDIENTAV092KU4JHAMERICAN CREW ANTI-DANDRUFF PLUS SEBUM CONTROL (PYRITHIONE ZINC) SHAMPOO [COLOMER USA, LTD.]2
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TAMERICAN CREW ANTI-DANDRUFF PLUS SEBUM CONTROL (PYRITHIONE ZINC) SHAMPOO [COLOMER USA, LTD.]2
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW)INACTIVE INGREDIENT0L414VCS5YAMERICAN CREW ANTI-DANDRUFF PLUS SEBUM CONTROL (PYRITHIONE ZINC) SHAMPOO [COLOMER USA, LTD.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3AMERICAN CREW ANTI-DANDRUFF PLUS SEBUM CONTROL (PYRITHIONE ZINC) SHAMPOO [COLOMER USA, LTD.]2
ROSEMARYINACTIVE INGREDIENTIJ67X351P9AMERICAN CREW ANTI-DANDRUFF PLUS SEBUM CONTROL (PYRITHIONE ZINC) SHAMPOO [COLOMER USA, LTD.]2
SAGEINACTIVE INGREDIENT065C5D077JAMERICAN CREW ANTI-DANDRUFF PLUS SEBUM CONTROL (PYRITHIONE ZINC) SHAMPOO [COLOMER USA, LTD.]2
SODIUM ACETATEINACTIVE INGREDIENT4550K0SC9BAMERICAN CREW ANTI-DANDRUFF PLUS SEBUM CONTROL (PYRITHIONE ZINC) SHAMPOO [COLOMER USA, LTD.]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XAMERICAN CREW ANTI-DANDRUFF PLUS SEBUM CONTROL (PYRITHIONE ZINC) SHAMPOO [COLOMER USA, LTD.]2
SODIUM LAURETH-3 SULFATEINACTIVE INGREDIENTBPV390UAP0AMERICAN CREW ANTI-DANDRUFF PLUS SEBUM CONTROL (PYRITHIONE ZINC) SHAMPOO [COLOMER USA, LTD.]2
TEA TREE OILINACTIVE INGREDIENTVIF565UC2GAMERICAN CREW ANTI-DANDRUFF PLUS SEBUM CONTROL (PYRITHIONE ZINC) SHAMPOO [COLOMER USA, LTD.]2
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKAMERICAN CREW ANTI-DANDRUFF PLUS SEBUM CONTROL (PYRITHIONE ZINC) SHAMPOO [COLOMER USA, LTD.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42743-4700AMERICAN CREW ANTI-DANDRUFF PLUS SEBUM CONTROL (PYRITHIONE ZINC) SHAMPOO [COLOMER USA, LTD.]2Legacy NDC, 1 package rows20140612_7e62cb98-d03d-4091-824b-7406583d871f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
209884zinc pyrithione 1 % Medicated ShampooPSN7e62cb98-d03d-4091-824b-7406583d871f2
209884zinc pyrithione 10 MG/ML Medicated ShampooSCD7e62cb98-d03d-4091-824b-7406583d871f2
209884zinc pyrithione 1 % Medicated ConditionerSY7e62cb98-d03d-4091-824b-7406583d871f2
209884zinc pyrithione 1 % Medicated ShampooSY7e62cb98-d03d-4091-824b-7406583d871f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
42743-4700-142743470001250 mL in 1 BOTTLE250 mlHistorical