Home NDC 69367-188 Zinc Oxide
Product NDC 69367-188
11-digit product format 693670188
Labeler code 69367
Product ID 69367-188_f9d7570e-1da1-4050-b2f1-72aeeb7359e3
Type HUMAN OTC DRUG
Nonproprietary name Zinc Oxide
Dosage form CREAM
Route TOPICAL
Labeler Westminster Pharmaceuticals, LLC
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-07-29
Substance ZINC OXIDE
Active strength 22 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
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 22 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 1734937 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 69367-188-04 Zinc Oxide 113 g in 1 TUBE CREAM 113 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69367-188 ZINC OXIDE CREAM [WESTMINSTER PHARMACEUTICALS, LLC] 7 Current NDC, Legacy NDC, 1 package rows 20240129_7e045b3a-f33b-4faa-ab9b-2baec6ff7924.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 Marketing end Sample Exclude flag Status 69367-188-04 69367018804 113 g in 1 TUBE (69367-188-04) 113 g 2021-07-29 0000-00-00 No No Current