Diaper Rash

Product NDC
63940-226
11-digit product format
639400226
Labeler code
63940
Product ID
63940-226_27edb300-b392-4094-87ff-348e2869abc0
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
Harmon Stores Inc
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2013-02-15
Marketing end
0000-00-00
Substance
ZINC OXIDE
Active strength
130 mg/g
NDC exclude flag
No
Listing certified through
2020-12-31
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 productproduct63940-226DDiscontinued by firm2026-11-10
excluded packagepackage63940-22663940-226-26DDiscontinued by firm2026-11-10

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 · 24 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 packagepackage63940-226-26d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63940-226-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63940-226-262ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63940-226-26a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63940-226-26cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63940-226-26cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63940-226-26302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63940-226-26ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63940-226-260efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63940-226-26ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63940-226-26367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63940-226-26557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZDIAPER RASH (ZINC OXIDE) CREAM [HARMON STORES INC]1
ZINC OXIDEACTIVE MOIETYSOI2LOH54ZDIAPER RASH (ZINC OXIDE) CREAM [HARMON STORES INC]1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0DIAPER RASH (ZINC OXIDE) CREAM [HARMON STORES INC]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XDIAPER RASH (ZINC OXIDE) CREAM [HARMON STORES INC]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1ODIAPER RASH (ZINC OXIDE) CREAM [HARMON STORES INC]1
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3PDIAPER RASH (ZINC OXIDE) CREAM [HARMON STORES INC]1
MAGNESIUM SULFATEINACTIVE INGREDIENTDE08037SABDIAPER RASH (ZINC OXIDE) CREAM [HARMON STORES INC]1
MICROCRYSTALLINE WAXINACTIVE INGREDIENTXOF597Q3KYDIAPER RASH (ZINC OXIDE) CREAM [HARMON STORES INC]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPDIAPER RASH (ZINC OXIDE) CREAM [HARMON STORES INC]1
PEG-30 DIPOLYHYDROXYSTEARATEINACTIVE INGREDIENT9713Q0S7FODIAPER RASH (ZINC OXIDE) CREAM [HARMON STORES INC]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UDIAPER RASH (ZINC OXIDE) CREAM [HARMON STORES INC]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TDIAPER RASH (ZINC OXIDE) CREAM [HARMON STORES INC]1
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TDIAPER RASH (ZINC OXIDE) CREAM [HARMON STORES INC]1
SORBITAN SESQUIOLEATEINACTIVE INGREDIENT0W8RRI5W5ADIAPER RASH (ZINC OXIDE) CREAM [HARMON STORES INC]1
WATERINACTIVE INGREDIENT059QF0KO0RDIAPER RASH (ZINC OXIDE) CREAM [HARMON STORES INC]1
YELLOW WAXINACTIVE INGREDIENT2ZA36H0S2VDIAPER RASH (ZINC OXIDE) CREAM [HARMON STORES INC]1