Home NDC 11509-5101 Vagisil Anti-Itch Creme Maximum Strength Sensitive Skin Formula
Product NDC 11509-5101
11-digit product format 115095101
Labeler code 11509
Product ID 11509-5101_6bda1a43-d565-4da6-9c24-bdd05ada4cc2
Type HUMAN OTC DRUG
Nonproprietary name Hydrocortisone Acetate
Dosage form CREAM
Route TOPICAL
Labeler Combe Incorporated
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2016-01-30
Substance HYDROCORTISONE ACETATE
Active strength 280 mg/28g
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 Vagisil Anti-Itch Creme Maximum Strength Sensitive Skin Formula
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HYDROCORTISONE ACETATE 280 mg/28g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 3X7931PO74 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1039349 Internal RxNorm lookup 1039353 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 11509-5101-1 Vagisil Anti-Itch Creme Maximum Strength Sensitive Skin Formula 28 g in 1 CARTON CREAM 28 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 11509-5101 VAGISIL ANTI-ITCH CREME MAXIMUM STRENGTH SENSITIVE SKIN FORMULA (HYDROCORTISONE ACETATE) CREAM [COMBE INCORPORATED] 3 Current NDC, Legacy NDC, 1 package rows 20200421_9b69fa24-02dd-43e4-a81f-9a37968d7099.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 18 of 153 · 3,057 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 11509-5101-1 11509510101 28 g in 1 CARTON (11509-5101-1) 28 g 2016-01-30 0000-00-00 No No Current