Home NDC 58503-170-01 Diaper Rash Cream 2.5oz
Product NDC 58503-170
Requested package NDC 58503-170-01
11-digit product format 585030170
Labeler code 58503
Product ID 58503-170_0baaab8c-1135-394f-e063-6394a90afa07
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 2023-12-04
Substance ZINC OXIDE
Active strength .4 g/g
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 2.5oz
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE .4 g/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 · 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 58503-170-01 Diaper Rash Cream 2.5oz 1 in 1 BOX CREAM 1 1 58503-170-01 Diaper Rash Cream 2.5oz 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 58503-170 DIAPER RASH CREAM 2.5OZ (ZINC OXIDE) CREAM [CHINA NINGBO SHANGGE COSMETICS TECHNOLOGY CORP.] 1 Current NDC, 2 package rows 20231205_0baa8a14-8655-d77c-e063-6294a90ab8aa.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 · 1,346 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 58503-170-01 58503017001 1 TUBE in 1 BOX (58503-170-01) / 71 g in 1 TUBE 1 tube 2023-12-04 No No Current