Home NDC 52412-285 Balmex Diaper Rash
Product NDC 52412-285
11-digit product format 524120285
Labeler code 52412
Product ID 52412-285_29577ef9-f215-1dc6-e063-6394a90a44ab
Type HUMAN OTC DRUG
Nonproprietary name Zinc Oxide 11.3%
Dosage form CREAM
Route TOPICAL
Labeler Randob Labs, LTD
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-04-19
Substance ZINC OXIDE
Active strength 11.3 g/100g
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 Balmex Diaper Rash
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 11.3 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 630923 Internal RxNorm lookup 967558 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52412-285 BALMEX DIAPER RASH (ZINC OXIDE 11.3%) CREAM [RANDOB LABS, LTD] 3 Current NDC, 8 package rows 20241217_f7f7a89d-d4e0-9faa-e053-6294a90aaf7b.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 55 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 52412-285-02 52412028502 1 TUBE in 1 CARTON (52412-285-02) / 56 g in 1 TUBE 1 tube 2021-04-19 No No Current 52412-285-03 52412028503 1 TUBE in 1 CARTON (52412-285-03) / 85 g in 1 TUBE 1 tube 2023-04-04 No No Current 52412-285-04 52412028504 1 TUBE in 1 CARTON (52412-285-04) / 113 g in 1 TUBE 1 tube 2021-04-19 No No Current 52412-285-12 52412028512 340 g in 1 JAR (52412-285-12) 340 g 2021-04-19 No No Current 52412-285-16 52412028516 453 g in 1 JAR (52412-285-16) 453 g 2021-04-19 No No Current