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 25 of 68 · 1,357 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Kenkoderm Eczema Honey Soothing Body KENKODERM ECZEMA HONEY SOOTHING BODY LOTION Guangzhou Ariel Biotech Co., Ltd. 4865c697-05fc-eac8-e063-6294a90ae541 2026-01-14 Warnings Exact identifier application number: M016 Gold Bond Medicated eczema relief COLLOIDAL OATMEAL Chattem, Inc. 52744c77-278f-40b1-a356-14ae4366389b 2026-01-14 Warnings Exact identifier application number: M016 Water Drench Hyaluronic Healing Balm DIMETHICONE Peter Thomas Roth Labs, LLC 3f789176-1d80-d146-e063-6294a90a948a 2026-01-13 Warnings Exact identifier application number: M016 DERMEDIAL Anti-Itch OATMEAL, ZINC OXIDE Saje Natural Business Inc 385dd757-740b-8324-e063-6294a90afeee 2026-01-13 Warnings Exact identifier application number: M016 Sweet cheeks ZINC OXIDE Saje Natural Business Inc. 5fc6486e-8604-5c7b-e053-2991aa0a8d14 2026-01-13 Warnings Exact identifier application number: M016 Teevodar ALLANTOIN PEER PHARM LTD. 57a1b6d1-9439-462b-aeb9-ef806e572eaf 2026-01-12 Warnings Exact identifier application number: M016 Botao Baby Diaper Rash Cream ZINC OXIDE Peer Pharm Ltd. df60a70e-e6c0-41b3-e053-2995a90af176 2026-01-12 Warnings Exact identifier application number: M016 ECZEMA HAND RELIEF COLLOIDAL OATMEAL Skinfix, Inc. 0389bab7-04fb-7cfc-e063-6394a90a22d8 2026-01-12 Warnings Exact identifier application number: M016 SKINFIX HAND REPAIR OATMEAL Skinfix, Inc. 1b65fc81-1b9e-4260-829a-332cf6891d02 2026-01-12 Warnings Exact identifier application number: M016 ECZEMA INTENSIVE DAILY RELIEF BODY COLLOIDAL OATMEAL CREAM Skinfix, Inc. 0be3c631-bc9b-00a9-e063-6394a90abcbb 2026-01-12 Warnings Exact identifier application number: M016 Sarna COLLOIDAL OATMEAL Crown Laboratories, Inc. 2d6b1872-9f4d-9eb3-e063-6394a90ab675 2026-01-12 Warnings Exact identifier application number: M016 XIMONTH Nail Repairs Patches GLYCERIN Shantou Ximonth Biotechnology Co., Ltd. 47f1a711-5d6f-c023-e063-6294a90aa801 2026-01-09 Warnings Exact identifier application number: M016 Endit zinc oxide skin protection ZINC OXIDE EndIt Laboratories, Inc. e60bb0da-3349-f8f9-e053-2a95a90a9051 2026-01-09 Warnings Exact identifier application number: M016 Endit Zinc Oxide Skin Protectant ZINC OXIDE Endit Laboratories, Inc. 55b3aa07-871d-421b-b76a-c2d359d6003f 2026-01-09 Warnings Exact identifier application number: M016 Flanders Buttocks WHITE PETROLATUM, ZINC OXIDE Flanders Inc 32371159-c76d-41b0-e054-00144ff88e88 2026-01-09 Warnings Exact identifier application number: M016 Pure Petrolatum Jelly PETROLATUM MY IMPORTS USA LLC 47da77ea-ab4e-fc3c-e063-6394a90a27b7 2026-01-08 Warnings Exact identifier application number: M016 Z-Bum DIAPER RASH CREAM GM Pharmaceuticals, Inc 2a36f396-3a30-3f3f-e054-00144ff8d46c 2026-01-08 Warnings Exact identifier application number: M016 Daily VLotion DIMETHICONE Kindra 1cc4b804-6483-68fd-e063-6294a90a38e4 2026-01-08 Warnings Exact identifier application number: M016 V Relief Serum DIMETHICONE Kindra 1cd8a9e9-ac88-1799-e063-6294a90a3278 2026-01-08 Warnings Exact identifier application number: M016 DR SMITHS DIAPER ZINC OXIDE Mission Pharmacal 7705b182-acf7-4195-9996-7d9fcdfbf055 2026-01-08 Warnings Exact identifier application number: M016
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