Home NDC 80489-444 OLP diaper Rash cream A and D
Product NDC 80489-444
11-digit product format 804890444
Labeler code 80489
Product ID 80489-444_2b51e8c1-17f5-573d-e063-6294a90a2f58
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 2022-02-01
Substance ZINC OXIDE
Active strength 10 g/100g
Pharmacologic classes Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
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 OLP diaper Rash cream A and D
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 10 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 248279 Internal RxNorm 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 80489-444-01 OLP diaper Rash cream A and D 1 in 1 CARTON CREAM 1 8 80489-444-01 OLP diaper Rash cream A and D 20 g in 1 TUBE CREAM 20 8 80489-444-02 OLP diaper Rash cream A and D 45 g in 1 TUBE CREAM 45 8 80489-444-02 OLP diaper Rash cream A and D 1 in 1 CARTON CREAM 1 8 80489-444-03 OLP diaper Rash cream A and D 49.6 g in 1 TUBE CREAM 49.6 8 80489-444-03 OLP diaper Rash cream A and D 1 in 1 CARTON CREAM 1 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80489-444 OLP DIAPER RASH CREAM A AND D (ZINC OXIDE) CREAM [OL PHARMA TECH, LLC DRS PHARMACY] 8 Current NDC, Legacy NDC, 6 package rows 20250112_d6faa4d9-751c-a1b6-e053-2a95a90aee5b.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 28 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 Marketing end Sample Exclude flag Status 80489-444-01 80489044401 1 TUBE in 1 CARTON (80489-444-01) / 20 g in 1 TUBE 1 tube 2022-02-01 0000-00-00 No No Current 80489-444-02 80489044402 1 TUBE in 1 CARTON (80489-444-02) / 45 g in 1 TUBE 1 tube 2022-02-01 No No Current 80489-444-03 80489044403 1 TUBE in 1 CARTON (80489-444-03) / 49.6 g in 1 TUBE 1 tube 2022-02-01 No No Current