Head and Shoulders

Product NDC
51769-133
11-digit product format
517690133
Labeler code
51769
Product ID
51769-133_6c83ea07-49b7-4448-ba47-bc80062868f6
Type
HUMAN OTC DRUG
Nonproprietary name
Pyrithione Zinc
Dosage form
LOTION/SHAMPOO
Route
TOPICAL
Labeler
ALL NATURAL DYNAMICS
Application
part358H
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2013-01-24
Marketing end
0000-00-00
Substance
PYRITHIONE ZINC
Active strength
0 g/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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct51769-133IInactivated by FDA2026-10-05
excluded packagepackage51769-13351769-133-40IInactivated by FDA2026-10-05
excluded packagepackage51769-13351769-133-70IInactivated by FDA2026-10-05

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 2 · 66 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 packagepackage51769-133-40d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage51769-133-70d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage51769-133-40f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage51769-133-70f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage51769-133-402ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage51769-133-702ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage51769-133-40a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage51769-133-70a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage51769-133-40cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage51769-133-70cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage51769-133-40cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage51769-133-70cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage51769-133-40302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage51769-133-70302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage51769-133-40ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage51769-133-70ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage51769-133-400efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage51769-133-700efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage51769-133-40ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage51769-133-70ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage51769-133-40367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage51769-133-70367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage51769-133-40557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage51769-133-70557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage51769-133-408af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage51769-133-708af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage51769-133-40834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage51769-133-70834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage51769-133-401332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage51769-133-701332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage51769-133-40fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage51769-133-70fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage51769-133-4086f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage51769-133-7086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage51769-133-40bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage51769-133-70bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage51769-133-408dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage51769-133-708dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage51769-133-40e2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage51769-133-70e2bbac7714bc…27bdfed8d636…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51769-133-402019-11-27C16284748780-19855d018-e801-cd31-e053-dbdaa90ab51aHead & Shoulders menthol fresh
51769-133-702019-11-27C16284748780-19855d018-e801-cd31-e053-dbdaa90ab51aHead & Shoulders menthol fresh

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51769-133-40Head and Shouldersmenthol fresh400 mL in 1 BOTTLE, PLASTICLOTION/SHAMPOO4001
51769-133-70Head and Shouldersmenthol fresh700 mL in 1 BOTTLE, PLASTICLOTION/SHAMPOO7001

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Pyrithione ZincACTIVE INGREDIENTR953O2RHZ5HEAD AND SHOULDERS MENTHOL FRESH (PYRITHIONE ZINC) LOTION/SHAMPOO [ALL NATURAL DYNAMICS]1
PYRITHIONE ZINCACTIVE MOIETYR953O2RHZ5HEAD AND SHOULDERS MENTHOL FRESH (PYRITHIONE ZINC) LOTION/SHAMPOO [ALL NATURAL DYNAMICS]1
cocamidopropyl betaineINACTIVE INGREDIENT5OCF3O11KXHEAD AND SHOULDERS MENTHOL FRESH (PYRITHIONE ZINC) LOTION/SHAMPOO [ALL NATURAL DYNAMICS]1
D&C red no. 33INACTIVE INGREDIENT9DBA0SBB0LHEAD AND SHOULDERS MENTHOL FRESH (PYRITHIONE ZINC) LOTION/SHAMPOO [ALL NATURAL DYNAMICS]1
dimethiconeINACTIVE INGREDIENT92RU3N3Y1OHEAD AND SHOULDERS MENTHOL FRESH (PYRITHIONE ZINC) LOTION/SHAMPOO [ALL NATURAL DYNAMICS]1
FD&C blue no. 1INACTIVE INGREDIENTH3R47K3TBDHEAD AND SHOULDERS MENTHOL FRESH (PYRITHIONE ZINC) LOTION/SHAMPOO [ALL NATURAL DYNAMICS]1
glycol distearateINACTIVE INGREDIENT13W7MDN21WHEAD AND SHOULDERS MENTHOL FRESH (PYRITHIONE ZINC) LOTION/SHAMPOO [ALL NATURAL DYNAMICS]1
magnesium carbonate hydroxideINACTIVE INGREDIENTYQO029V1L4HEAD AND SHOULDERS MENTHOL FRESH (PYRITHIONE ZINC) LOTION/SHAMPOO [ALL NATURAL DYNAMICS]1
methylchloroisothiazolinoneINACTIVE INGREDIENTDEL7T5QRPNHEAD AND SHOULDERS MENTHOL FRESH (PYRITHIONE ZINC) LOTION/SHAMPOO [ALL NATURAL DYNAMICS]1
methylisothiazolinoneINACTIVE INGREDIENT229D0E1QFAHEAD AND SHOULDERS MENTHOL FRESH (PYRITHIONE ZINC) LOTION/SHAMPOO [ALL NATURAL DYNAMICS]1
pyrithione zincINACTIVE INGREDIENTR953O2RHZ5HEAD AND SHOULDERS MENTHOL FRESH (PYRITHIONE ZINC) LOTION/SHAMPOO [ALL NATURAL DYNAMICS]1
sodium benzoateINACTIVE INGREDIENTOJ245FE5EUHEAD AND SHOULDERS MENTHOL FRESH (PYRITHIONE ZINC) LOTION/SHAMPOO [ALL NATURAL DYNAMICS]1
sodium chlorideINACTIVE INGREDIENT451W47IQ8XHEAD AND SHOULDERS MENTHOL FRESH (PYRITHIONE ZINC) LOTION/SHAMPOO [ALL NATURAL DYNAMICS]1
sodium laureth sulfateINACTIVE INGREDIENTBPV390UAP0HEAD AND SHOULDERS MENTHOL FRESH (PYRITHIONE ZINC) LOTION/SHAMPOO [ALL NATURAL DYNAMICS]1
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JHEAD AND SHOULDERS MENTHOL FRESH (PYRITHIONE ZINC) LOTION/SHAMPOO [ALL NATURAL DYNAMICS]1
sodium xylenesulfonateINACTIVE INGREDIENTG4LZF950URHEAD AND SHOULDERS MENTHOL FRESH (PYRITHIONE ZINC) LOTION/SHAMPOO [ALL NATURAL DYNAMICS]1
waterINACTIVE INGREDIENT059QF0KO0RHEAD AND SHOULDERS MENTHOL FRESH (PYRITHIONE ZINC) LOTION/SHAMPOO [ALL NATURAL DYNAMICS]1
zinc carbonateINACTIVE INGREDIENTEQR32Y7H0MHEAD AND SHOULDERS MENTHOL FRESH (PYRITHIONE ZINC) LOTION/SHAMPOO [ALL NATURAL DYNAMICS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51769-133HEAD AND SHOULDERS MENTHOL FRESH (PYRITHIONE ZINC) LOTION/SHAMPOO [ALL NATURAL DYNAMICS]1Legacy NDC, 2 package rows20130125_ffa115c5-c7b8-489a-b939-0004d36860fd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1043244head & shoulders 1 % Medicated ShampooPSNffa115c5-c7b8-489a-b939-0004d36860fd1
209884zinc pyrithione 1 % Medicated ShampooPSNffa115c5-c7b8-489a-b939-0004d36860fd1
1043244zinc pyrithione 10 MG/ML Medicated Shampoo [Head & Shoulders]SBDffa115c5-c7b8-489a-b939-0004d36860fd1
209884zinc pyrithione 10 MG/ML Medicated ShampooSCDffa115c5-c7b8-489a-b939-0004d36860fd1
1043244Head & Shoulders 1 % Medicated ShampooSYffa115c5-c7b8-489a-b939-0004d36860fd1
1043244Head & Shoulders 10 MG/ML Medicated ShampooSYffa115c5-c7b8-489a-b939-0004d36860fd1
209884zinc pyrithione 1 % Medicated ConditionerSYffa115c5-c7b8-489a-b939-0004d36860fd1
209884zinc pyrithione 1 % Medicated ShampooSYffa115c5-c7b8-489a-b939-0004d36860fd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
51769-133-4051769013340400 mL in 1 BOTTLE, PLASTIC400 mlHistorical
51769-133-7051769013370700 mL in 1 BOTTLE, PLASTIC700 mlHistorical