Home NDC 85453-101 Dr. Maxs Diaper
Product NDC 85453-101
11-digit product format 854530101
Labeler code 85453
Product ID 85453-101_31bfa962-5e3c-c5d2-e063-6294a90ac177
Type HUMAN OTC DRUG
Nonproprietary name Zinc Oxide
Dosage form OINTMENT
Route TOPICAL
Labeler Dr. Max�s LLC
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-04-04
Substance ZINC OXIDE
Active strength 12 g/100g
NDC exclude flag No
Listing certified through 2026-12-31
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 Dr. Maxs Diaper
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 12 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 199852 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 85453-101-11 Dr. Maxs Diaper 94 g in 1 CYLINDER OINTMENT 94 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 85453-101 DR. MAXS DIAPER (ZINC OXIDE) OINTMENT [DR. MAX’S LLC] 1 Current NDC, 1 package rows 20250406_31bfa962-5e3b-c5d2-e063-6294a90ac177.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 53 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 Sample Exclude flag Status 85453-101-11 85453010111 94 g in 1 CYLINDER (85453-101-11) 94 g 2025-04-04 No No Current