Home NDC 16864-021 Triple Diaper Rash
Product NDC 16864-021
11-digit product format 168640021
Labeler code 16864
Product ID 16864-021_4d63f2a2-f114-d739-e063-6394a90a2d27
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 2021-05-15
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 Triple Diaper Rash
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 637168 Internal RxNorm lookup 729935 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 16864-021-01 Triple Diaper Rash 1 in 1 CARTON OINTMENT 1 6 16864-021-01 Triple Diaper Rash 57 g in 1 TUBE OINTMENT 57 6 16864-021-02 Triple Diaper Rash 1 in 1 CARTON OINTMENT 1 6 16864-021-02 Triple Diaper Rash 85 g in 1 TUBE OINTMENT 85 6 16864-021-03 Triple Diaper Rash 227 g in 1 JAR OINTMENT 227 6 16864-021-04 Triple Diaper Rash 283 g in 1 JAR OINTMENT 283 6 16864-021-05 Triple Diaper Rash 454 g in 1 JAR OINTMENT 454 6 16864-021-06 Triple Diaper Rash 1 in 1 CARTON OINTMENT 1 6 16864-021-06 Triple Diaper Rash 11.5 g in 1 TUBE OINTMENT 11.5 6 16864-021-07 Triple Diaper Rash 6 g in 1 PACKET OINTMENT 6 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 16864-021 TRIPLE DIAPER RASH (ZINC OXIDE) OINTMENT [ADVANTICE HEALTH, LLC] 5 Current NDC, Legacy NDC, 10 package rows 20241011_d457c58d-8239-41c4-999e-d0ba237e3945.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 57 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 16864-021-01 16864002101 1 TUBE in 1 CARTON (16864-021-01) / 57 g in 1 TUBE 1 tube 2021-05-15 0000-00-00 No No Current 16864-021-02 16864002102 1 TUBE in 1 CARTON (16864-021-02) / 85 g in 1 TUBE 1 tube 2021-05-15 0000-00-00 No No Current 16864-021-03 16864002103 227 g in 1 JAR (16864-021-03) 227 g 2021-05-15 0000-00-00 No No Current 16864-021-04 16864002104 283 g in 1 JAR (16864-021-04) 283 g 2021-05-15 0000-00-00 No No Current 16864-021-05 16864002105 454 g in 1 JAR (16864-021-05) 454 g 2021-05-15 0000-00-00 No No Current 16864-021-06 16864002106 1 TUBE in 1 CARTON (16864-021-06) / 11.5 g in 1 TUBE 1 tube 2021-05-15 0000-00-00 No No Current 16864-021-07 16864002107 6 g in 1 PACKET (16864-021-07) 6 g 2024-05-01 Yes No Current