Home NDC 54031-020 Max Mineral
Product NDC 54031-020
11-digit product format 540310020
Labeler code 54031
Product ID 54031-020_0a2095ac-5703-39ba-e063-6294a90aa1c9
Type HUMAN OTC DRUG
Nonproprietary name Titanium Dioxide, Zinc Oxide
Dosage form CREAM
Route TOPICAL
Labeler Peter Thomas Roth Labs, LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-02-15
Substance ZINC OXIDE; TITANIUM DIOXIDE
Active strength 9.271756; .9276575 g/48.19g; g/48.19g
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 Max Mineral
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 9.271756 g/48.19g TITANIUM DIOXIDE .9276575 g/48.19g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination SOI2LOH54Z Internal UNII lookup 15FIX9V2JP Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 54031-020-01 Max Mineral 48.19 g in 1 TUBE CREAM 48.19 3 54031-020-02 Max Mineral 48.19 g in 1 CARTON CREAM 48.19 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54031-020 MAX MINERAL (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [PETER THOMAS ROTH LABS, LLC] 3 Current NDC, 2 package rows 20231115_0980992c-6488-2fa1-e063-6294a90a41ea.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 26 of 357 · 7,139 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 54031-020-01 54031002001 48.19 g in 1 TUBE (54031-020-01) 48.19 g 2021-02-15 No No Current 54031-020-02 54031002002 48.19 g in 1 CARTON (54031-020-02) 48.19 g 2021-02-15 No No Current