Home NDC 80489-576 Drs. DIAPER RASH MAXIMUM STRENGTH
Product NDC 80489-576
11-digit product format 804890576
Labeler code 80489
Product ID 80489-576_56368fba-54cb-5ca0-e063-6394a90a8abf
Type HUMAN OTC DRUG
Nonproprietary name Zinc Oxide
Dosage form CREAM
Route TOPICAL
Labeler OL PHARMA TECH, LLC Drs PHARMACY
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-10-07
Substance ZINC OXIDE; DIMETHICONE
Active strength 10; 1 g/100g; g/100g
Pharmacologic classes Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Skin Barrier Activity [PE]
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 Drs. DIAPER RASH MAXIMUM STRENGTH
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 10 g/100g DIMETHICONE 1 g/100g
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 92RU3N3Y1O Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 686403 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 80489-576-01 Drs. DIAPER RASH MAXIMUM STRENGTH 20 g in 1 TUBE CREAM 20 1 80489-576-01 Drs. DIAPER RASH MAXIMUM STRENGTH 1 in 1 CARTON CREAM 1 1 80489-576-02 Drs. DIAPER RASH MAXIMUM STRENGTH 1 in 1 CARTON CREAM 1 1 80489-576-02 Drs. DIAPER RASH MAXIMUM STRENGTH 45 g in 1 TUBE CREAM 45 1 80489-576-03 Drs. DIAPER RASH MAXIMUM STRENGTH 1 in 1 CARTON CREAM 1 1 80489-576-03 Drs. DIAPER RASH MAXIMUM STRENGTH 49.6 g in 1 TUBE CREAM 49.6 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80489-576 DRS. DIAPER RASH MAXIMUM STRENGTH (ZINC OXIDE) CREAM [OL PHARMA TECH, LLC DRS PHARMACY] 1 Current NDC, 6 package rows 20240417_161ba174-1b13-83cd-e063-6394a90af19c.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 80489-576-01 80489057601 1 TUBE in 1 CARTON (80489-576-01) / 20 g in 1 TUBE 1 tube 2022-02-01 No No Current 80489-576-02 80489057602 1 TUBE in 1 CARTON (80489-576-02) / 45 g in 1 TUBE 1 tube 2022-02-01 No No Current 80489-576-03 80489057603 1 TUBE in 1 CARTON (80489-576-03) / 49.6 g in 1 TUBE 1 tube 2024-04-13 No No Current