Home NDC 58503-202-01 Diaper Rash Cream 5.6oz
Product NDC 58503-202
Requested package NDC 58503-202-01
11-digit product format 585030202
Labeler code 58503
Product ID 58503-202_21d20881-602e-a826-e063-6394a90afb45
Type HUMAN OTC DRUG
Nonproprietary name Zinc Oxide
Dosage form CREAM
Route TOPICAL
Labeler China Ningbo Shangge Cosmetics Technology Corp.
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-09-03
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 5.6oz
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 58503-202-01 Diaper Rash Cream 5.6oz 160 g in 1 BOTTLE CREAM 160 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58503-202 DIAPER RASH CREAM 15OZ (ZINC OXIDE) CREAM DIAPER RASH CREAM 5.6OZ (ZINC OXIDE) CREAM [CHINA NINGBO SHANGGE COSMETICS TECHNOLOGY CORP.] 3 Current NDC, 1 package rows 20240912_21a7c4ce-1360-931c-e063-6294a90aa66d.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 58 of 68 · 1,350 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 58503-202-01 58503020201 160 g in 1 BOTTLE (58503-202-01) 160 g 2024-09-03 No No Current