Home NDC 69968-0768 Desitin Maximum Strength Zinc Oxide Diaper Rash
Product NDC 69968-0768
11-digit product format 699680768
Labeler code 69968
Product ID 69968-0768_26dcf123-a428-28f4-e063-6394a90a7575
Type HUMAN OTC DRUG
Nonproprietary name Zinc Oxide
Dosage form PASTE
Route TOPICAL
Labeler Kenvue Brands LLC
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-07-15
Substance ZINC OXIDE
Active strength 400 mg/g
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 69968-0768-1 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 69968-0768-1 367a005e9d99…383a685ebd0f…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Desitin Maximum Strength Zinc Oxide Diaper Rash
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 400 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination SOI2LOH54Z Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1094560 Internal RxNorm lookup 1797059 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69968-0768-1 Desitin Maximum Strength Zinc Oxide Diaper Rash 28 g in 1 TUBE PASTE 28 2 69968-0768-1 Desitin Maximum Strength Zinc Oxide Diaper Rash 1 in 1 CARTON PASTE 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69968-0768 DESITIN MAXIMUM STRENGTH ZINC OXIDE DIAPER RASH (ZINC OXIDE) PASTE [KENVUE BRANDS LLC] 2 Current NDC, 2 package rows 20241127_1d5f0207-26f9-2b19-e063-6294a90a6468.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 66 of 68 · 1,357 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 69968-0768-1 69968076801 1 TUBE in 1 CARTON (69968-0768-1) / 28 g in 1 TUBE 1 tube 2024-07-15 No No Current