Home NDC 63941-318 Diaper Rash
Product NDC 63941-318
11-digit product format 639410318
Labeler code 63941
Product ID 63941-318_b7b8182a-b978-17af-e053-2995a90a1777
Type HUMAN OTC DRUG
Nonproprietary name Zinc Oxide
Dosage form CREAM
Route TOPICAL
Labeler Valu Merchandisers, Co.
Application part347
Marketing category OTC MONOGRAPH FINAL
Marketing start 2012-01-30
Marketing end 0000-00-00
Substance ZINC OXIDE
Active strength 400 mg/g
NDC exclude flag No
Listing certified through 2021-12-31
Current FDA listing Historical FDA.report record 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 · 20 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 63941-318-04 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 63941-318-04 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 63941-318-04 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 63941-318-04 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 63941-318-04 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 63941-318-04 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 63941-318-04 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 63941-318-04 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 63941-318-04 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 63941-318-04 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63941-318-04 Diaper Rash 1 in 1 BOX CREAM 1 7 63941-318-04 Diaper Rash 113 g in 1 TUBE CREAM 113 7
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ZINC OXIDE ACTIVE INGREDIENT SOI2LOH54Z DIAPER RASH (ZINC OXIDE) CREAM [VALU MERCHANDISERS, CO.] 1 ZINC OXIDE ACTIVE MOIETY SOI2LOH54Z DIAPER RASH (ZINC OXIDE) CREAM [VALU MERCHANDISERS, CO.] 1 BUTYLATED HYDROXYTOLUENE INACTIVE INGREDIENT 1P9D0Z171K DIAPER RASH (ZINC OXIDE) CREAM [VALU MERCHANDISERS, CO.] 1 LANOLIN INACTIVE INGREDIENT 7EV65EAW6H DIAPER RASH (ZINC OXIDE) CREAM [VALU MERCHANDISERS, CO.] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T DIAPER RASH (ZINC OXIDE) CREAM [VALU MERCHANDISERS, CO.] 1 PETROLATUM INACTIVE INGREDIENT 4T6H12BN9U DIAPER RASH (ZINC OXIDE) CREAM [VALU MERCHANDISERS, CO.] 1 SQUALENE INACTIVE INGREDIENT 7QWM220FJH DIAPER RASH (ZINC OXIDE) CREAM [VALU MERCHANDISERS, CO.] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U DIAPER RASH (ZINC OXIDE) CREAM [VALU MERCHANDISERS, CO.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R DIAPER RASH (ZINC OXIDE) CREAM [VALU MERCHANDISERS, CO.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63941-318 DIAPER RASH (ZINC OXIDE) CREAM [VALU MERCHANDISERS, CO.] 7 Legacy NDC, 2 package rows 20230209_98f90168-7d06-4a80-9f6a-dc26bf2aa877.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63941-318-04 63941031804 1 TUBE in 1 BOX (63941-318-04) > 113 g in 1 TUBE 1 tube 2012-01-30 0000-00-00 No No Current