Home NDC 69452-450 zinc oxide 20%
Product NDC 69452-450
11-digit product format 694520450
Labeler code 69452
Product ID 69452-450_1549491b-a7b0-2b4a-e063-6294a90a9196
Type HUMAN OTC DRUG
Nonproprietary name zinc oxide 20%
Dosage form OINTMENT
Route TOPICAL
Labeler Bionpharma Inc
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-04-01
Substance ZINC OXIDE
Active strength 20 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 zinc oxide 20%
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 20 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 198911 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 69452-450-58 zinc oxide 20% 425 g in 1 JAR OINTMENT 425 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69452-450 ZINC OXIDE 20% OINTMENT [BIONPHARMA INC] 1 Current NDC, 1 package rows 20240420_1549500a-0941-0fba-e063-6394a90a564e.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 28 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 69452-450-58 69452045058 425 g in 1 JAR (69452-450-58) 425 g 2024-04-18 No No Current