Home NDC 77338-164-01 Diaper Rash Cream 40% ZINC
Product NDC 77338-164
Requested package NDC 77338-164-01
11-digit product format 773380164
Labeler code 77338
Product ID 77338-164_16da8bcf-3e86-f435-e063-6294a90a7c8c
Type HUMAN OTC DRUG
Nonproprietary name Zinc Oxide
Dosage form CREAM
Route TOPICAL
Labeler ASTONEA LABS PRIVATE LIMITED
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-03-06
Substance ZINC OXIDE
Active strength 40 g/100g
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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 Diaper Rash Cream 40% ZINC
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 40 g/100g
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1305337 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 77338-164-01 Diaper Rash Cream 40% ZINC 57 g in 1 TUBE CREAM 57 1 77338-164-01 Diaper Rash Cream 40% ZINC 1 in 1 BOX CREAM 1 1 77338-164-02 Diaper Rash Cream 40% ZINC 71 g in 1 TUBE CREAM 71 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 77338-164 DIAPER RASH CREAM 40% ZINC (ZINC OXIDE) CREAM [ASTONEA LABS PRIVATE LIMITED] 1 Current NDC, 3 package rows 20240426_16da985a-6210-ec82-e063-6294a90a132d.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 56 of 68 · 1,343 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 77338-164-01 77338016401 1 TUBE in 1 BOX (77338-164-01) / 57 g in 1 TUBE 1 tube 2024-03-06 No No Current