Home NDC 16864-041 multipurpose
Product NDC 16864-041
11-digit product format 168640041
Labeler code 16864
Product ID 16864-041_4d63eb8d-9dec-031c-e063-6294a90a74ca
Type HUMAN OTC DRUG
Nonproprietary name Zinc Oxide Skin Protectant
Dosage form OINTMENT
Route TOPICAL
Labeler Advantice Health, LLC
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-09-16
Substance ZINC OXIDE
Active strength 12.8 g/100g
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 multipurpose
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 12.8 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 637168 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 16864-041-01 multipurpose 1 in 1 CARTON OINTMENT 1 2 16864-041-01 multipurpose 56 g in 1 TUBE OINTMENT 56 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 16864-041 MULTIPURPOSE (ZINC OXIDE SKIN PROTECTANT) OINTMENT [ADVANTICE HEALTH, LLC] 1 Current NDC, 2 package rows 20241215_291563cc-7491-ce41-e063-6394a90ac6c1.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 · 1,350 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 16864-041-01 16864004101 1 TUBE in 1 CARTON (16864-041-01) / 56 g in 1 TUBE 1 tube 2024-09-16 No No Current