Home NDC 80489-005 ANTI-ITCH
Product NDC 80489-005
11-digit product format 804890005
Labeler code 80489
Product ID 80489-005_2b51fa9d-b2ae-c4bf-e063-6294a90a3105
Type HUMAN OTC DRUG
Nonproprietary name ZINC ACETATE , DIPHENHYDRAMINE
Dosage form CREAM
Route TOPICAL
Labeler OL PHARMA TECH, LLC
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-01-01
Substance DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE
Active strength 1; .1 g/100g; g/100g
Pharmacologic classes Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
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 ANTI-ITCH
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIPHENHYDRAMINE HYDROCHLORIDE 1 g/100g ZINC ACETATE .1 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination TC2D6JAD40 Internal UNII lookup FM5526K07A Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1292313 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 80489-005-01 ANTI-ITCH 28.3 g in 1 TUBE CREAM 28.3 4 80489-005-01 ANTI-ITCH 1 in 1 CARTON CREAM 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80489-005 ANTI-ITCH (ZINC ACETATE , DIPHENHYDRAMINE) CREAM [OL PHARMA TECH, LLC] 4 Current NDC, Legacy NDC, 2 package rows 20250112_b79d3096-c609-e710-e053-2995a90a8da2.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 57 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 80489-005-01 80489000501 1 TUBE in 1 CARTON (80489-005-01) / 28.3 g in 1 TUBE 1 tube 2021-01-01 0000-00-00 No No Current