Home NDC 57337-151 Diaper Rash Cream 2.5oz
Product NDC 57337-151
11-digit product format 573370151
Labeler code 57337
Product ID 57337-151_0ba98cdf-489f-dc2a-e063-6294a90adb38
Type HUMAN OTC DRUG
Nonproprietary name Zinc Oxide
Dosage form CREAM
Route TOPICAL
Labeler Rejoice International 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 57337-151-01 Diaper Rash Cream 2.5oz 71 g in 1 TUBE CREAM 71 1 57337-151-01 Diaper Rash Cream 2.5oz 1 in 1 BOX CREAM 1 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 57337-151 DIAPER RASH CREAM 2.5OZ (ZINC OXIDE) CREAM [REJOICE INTERNATIONAL CORP.] 1 Current NDC, 2 package rows 20231204_0ba98cdf-489e-dc2a-e063-6294a90adb38.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 53 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 57337-151-01 57337015101 1 TUBE in 1 BOX (57337-151-01) / 71 g in 1 TUBE 1 tube 2023-12-04 No No Current