Home NDC 76348-825 Baby Mantra Diaper Cream
Product NDC 76348-825
11-digit product format 763480825
Labeler code 76348
Product ID 76348-825_32c47a66-a98d-817a-e063-6294a90ac7a3
Type HUMAN OTC DRUG
Nonproprietary name Zinc Oxide 10%
Dosage form OINTMENT
Route TOPICAL
Labeler Renu Laboratories, LLC
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-01-03
Substance ZINC OXIDE
Active strength 10 g/100mL
NDC exclude flag No
Listing certified through 2026-12-31
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 Baby Mantra Diaper Cream
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 10 g/100mL
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 199099 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 76348-825-34 Baby Mantra Diaper Cream 100 mL in 1 TUBE OINTMENT 100 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76348-825 BABY MANTRA DIAPER CREAM (ZINC OXIDE 10%) OINTMENT [RENU LABORATORIES, LLC] 2 Current NDC, 1 package rows 20250416_0427bbc9-f4c0-0eb6-e063-6294a90a7199.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 52 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 76348-825-34 76348082534 100 mL in 1 TUBE (76348-825-34) 100 ml 2024-01-03 No No Current