Home NDC 16864-061 Triple 3x Max Diaper Rash
Product NDC 16864-061
11-digit product format 168640061
Labeler code 16864
Product ID 16864-061_51d0a7c7-f1fa-2e15-e063-6394a90a678b
Type HUMAN OTC DRUG
Nonproprietary name ZINC OXIDE
Dosage form OINTMENT
Route TOPICAL
Labeler Advantice Health, LLC
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-05-15
Substance ZINC OXIDE
Active strength 40 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 Triple 3x Max Diaper Rash
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 40 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 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 16864-061-01 Triple 3x Max Diaper Rash 1 in 1 CARTON OINTMENT 1 5 16864-061-01 Triple 3x Max Diaper Rash 57 g in 1 TUBE OINTMENT 57 5 16864-061-02 Triple 3x Max Diaper Rash 170 g in 1 TUBE OINTMENT 170 5 16864-061-03 Triple 3x Max Diaper Rash 284 g in 1 JAR OINTMENT 284 5 16864-061-04 Triple 3x Max Diaper Rash 340 g in 1 JAR OINTMENT 340 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 16864-061 TRIPLE 3X MAX DIAPER RASH (ZINC OXIDE) OINTMENT [ADVANTICE HEALTH, LLC] 3 Current NDC, 5 package rows 20250511_e554046b-cd0a-4a6e-8f24-2e610c697432.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 51 of 68 · 1,350 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 16864-061-01 16864006101 1 TUBE in 1 CARTON (16864-061-01) / 57 g in 1 TUBE 1 tube 2024-05-15 No No Current 16864-061-02 16864006102 170 g in 1 TUBE (16864-061-02) 170 g 2024-10-15 No No Current 16864-061-03 16864006103 284 g in 1 JAR (16864-061-03) 284 g 2025-12-01 No No Current 16864-061-04 16864006104 340 g in 1 JAR (16864-061-04) 340 g 2024-05-15 No No Current