Home NDC 82038-007 Protectif Untinted
Product NDC 82038-007
11-digit product format 820380007
Labeler code 82038
Product ID 82038-007_1acd3232-7d83-8f27-e063-6294a90a0fb4
Type HUMAN OTC DRUG
Nonproprietary name Zinc Oxide and Titanium Dioxide
Dosage form CREAM
Route TOPICAL
Labeler Derma Research Group Inc.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-05-17
Substance TITANIUM DIOXIDE; ZINC OXIDE
Active strength 6.5; 8.6 g/100g; 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 Protectif Untinted
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TITANIUM DIOXIDE 6.5 g/100g ZINC OXIDE 8.6 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 15FIX9V2JP Internal UNII lookup SOI2LOH54Z 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 82038-007-01 Protectif Untinted 100 g in 1 BOTTLE, PUMP CREAM 100 1 82038-007-02 Protectif Untinted 1 in 1 CARTON CREAM 1 1 82038-007-03 Protectif Untinted 30 g in 1 BOTTLE, PUMP CREAM 30 1 82038-007-04 Protectif Untinted 1 in 1 CARTON CREAM 1 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 82038-007 PROTECTIF UNTINTED (ZINC OXIDE AND TITANIUM DIOXIDE) CREAM [DERMA RESEARCH GROUP INC.] 1 Current NDC, 4 package rows 20240615_1acd3f09-87f2-75e4-e063-6394a90a0cd9.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 82038-007-01 82038000701 100 g in 1 BOTTLE, PUMP 100 g Historical 82038-007-02 82038000702 1 BOTTLE, PUMP in 1 CARTON (82038-007-02) / 100 g in 1 BOTTLE, PUMP (82038-007-01) 2024-05-17 No No Current 82038-007-03 82038000703 30 g in 1 BOTTLE, PUMP 30 g Historical 82038-007-04 82038000704 1 BOTTLE, PUMP in 1 CARTON (82038-007-04) / 30 g in 1 BOTTLE, PUMP (82038-007-03) 2024-05-17 No No Current