Home NDC 80489-103 ANTI-ITCH FEMININE CARE
Product NDC 80489-103
11-digit product format 804890103
Labeler code 80489
Product ID 80489-103_2b51e47c-1642-8a83-e063-6394a90abe5b
Type HUMAN OTC DRUG
Nonproprietary name HYDROCORTISONE 0.5%
Dosage form CREAM
Route TOPICAL
Labeler OL PHARMA TECH, LLC Drs PHARMACY
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-02-01
Substance HYDROCORTISONE
Active strength 5 mg/g
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [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 FEMININE CARE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HYDROCORTISONE 5 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination WI4X0X7BPJ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198707 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 80489-103-01 ANTI-ITCH FEMININE CARE 1 in 1 CARTON CREAM 1 10 80489-103-01 ANTI-ITCH FEMININE CARE 20 g in 1 TUBE CREAM 20 10 80489-103-02 ANTI-ITCH FEMININE CARE 1 in 1 CARTON CREAM 1 10 80489-103-02 ANTI-ITCH FEMININE CARE 30 g in 1 TUBE CREAM 30 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80489-103 ANTI-ITCH FEMININE CARE (HYDROCORTISONE 0.5%) CREAM [OL PHARMA TECH, LLC DRS PHARMACY] 10 Current NDC, Legacy NDC, 4 package rows 20250112_d6fa5ff3-ebdc-222d-e053-2a95a90a88d5.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 8 of 49 · 973 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 80489-103-01 80489010301 1 TUBE in 1 CARTON (80489-103-01) / 20 g in 1 TUBE 1 tube 2022-02-01 0000-00-00 No No Current 80489-103-02 80489010302 1 TUBE in 1 CARTON (80489-103-02) / 30 g in 1 TUBE 1 tube 2022-02-01 No No Current