Home NDC 16864-031-01 TriplePaste Adult Care Rash Treatment
Product NDC 16864-031
Requested package NDC 16864-031-01
11-digit product format 168640031
Labeler code 16864
Product ID 16864-031_4d63cb6f-d54c-bd29-e063-6294a90aa895
Type HUMAN OTC DRUG
Nonproprietary name Zinc Oxide
Dosage form PASTE
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 TriplePaste Adult Care Rash Treatment
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 16864-031-01 TriplePaste Adult Care Rash Treatment 227 g in 1 JAR PASTE 227 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 16864-031 TRIPLEPASTE ADULT CARE RASH TREATMENT (ZINC OXIDE) PASTE [ADVANTICE HEALTH, LLC] 1 Current NDC, 1 package rows 20250511_2cf0575c-8d3d-1f16-e063-6294a90a629d.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 52 of 68 · 1,346 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 16864-031-01 16864003101 227 g in 1 JAR (16864-031-01) 227 g 2021-05-15 No No Current