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 88 of 151 · 3,010 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Hilook Blue Gel Anesthetic LIDOCAINE Guangdong Aimu Biological Technology Co., Ltd 1b9db681-a297-5aa9-e063-6394a90a80ea 2025-06-25 Warnings Exact identifier application number: M017 Hilook Numbing Cream LIDOCAINE Guangdong Aimu Biological Technology Co., Ltd 1b9f1a4c-ca0b-d820-e063-6394a90a3239 2025-06-25 Warnings Exact identifier application number: M017 Lidocaine Knee Pain Relief Gel-Patch LIDOCAINE Guangzhou Zhupuyou E-commerce Co., Ltd 384c1ff8-80bd-86cb-e063-6394a90a2d65 2025-06-24 Warnings Exact identifier application number: M017 Aroamas Cot Nicotine Transdermal Patches Kit NICOTINE TRANSDERMAL PATCHES PCHEERY LLC 38576022-9413-c9af-e063-6294a90afd46 2025-06-24 Warnings Exact identifier application number: M017 NERVE REVERSE PAIN RELIEF MENTHOL Pogue Medical Services da97bcc6-5aa8-48e2-a2c2-c937745bf6d3 2025-06-23 Warnings Exact identifier application number: M017 Medterra Pain Relief Menthol Roll-On MENTHOL Respect Manufacturing Corporation 05a6067a-287a-52d4-e063-6394a90a2c4e 2025-06-23 Warnings Exact identifier application number: M017 Medterra Pain Relief 500mg Hemp Menthol Cream MENTHOL Respect Manufacturing Corporation 06c4640a-ee42-5d1a-e063-6394a90ad254 2025-06-23 Warnings Exact identifier application number: M017 Medterra Pain Relief 1000mg Hemp Menthol Cream MENTHOL Respect Manufacturing Corporation 06e944e8-71f6-9fe9-e063-6294a90a8c37 2025-06-23 Warnings Exact identifier application number: M017 Procure gel MENTHOL TWIN MED, LLC e69c0b68-d408-9fd2-e053-2a95a90ac934 2025-06-20 Warnings Exact identifier application number: M017 A Health Itch Relief Gel ITCH RELIEF GEL Bionpharma, Inc. 38040732-48c9-3533-e063-6394a90af10a 2025-06-20 Warnings Exact identifier application number: M017 SCHOELIF Numbing Cream NUMBING CREAM Guangzhou Qiexiran Cosmetics Co., Ltd. 37eaabb7-884e-0bd5-e063-6294a90ae063 2025-06-19 Warnings Exact identifier application number: M017 Re-Lieved Lidocaine Patch LIDOCAINE PATCH 4% Transfer Technology 37ee539c-df7e-511d-e063-6394a90a4469 2025-06-19 Warnings Exact identifier application number: M017 Re-Lieved Lidocaine Patch LIDOCAINE PATCH 4% Transfer Technology 37eef80a-556f-b090-e063-6294a90a151b 2025-06-19 Warnings Exact identifier application number: M017 Re-Lieved Lidocaine Patch LIDOCAINE PATCH 4% Transfer Technology 37ef02d4-2ff5-cb23-e063-6294a90a68af 2025-06-19 Warnings Exact identifier application number: M017 Post-Treatment Repair Cream HYDROCORTISONE Vi Medical Products Inc. ab8885a9-0778-28ff-e053-2995a90a2e12 2025-06-19 Warnings Exact identifier application number: M017 MyDerm LIDOCAINE Inspec Solutions LLC. 82d075d1-c92e-2097-e053-2991aa0ab131 2025-06-18 Warnings Exact identifier application number: M017 Walgreens Extra Small Lidocaine LIDOCAINE Walgreen Co. dc838e47-d234-4ba5-9449-f645e99be923 2025-06-18 Warnings Exact identifier application number: M017 CLn Body Moisturizer COLLOIDAL OAT MOISTURIZER TopMD Skin Care, Inc. 2de3d68d-a540-d456-e063-6394a90a4b57 2025-06-18 Warnings Exact identifier application number: M017 Aloe UP SPF 30 Mineral ZINC OXIDE, TITANIUM DIOXIDE Aloe Care International, LLC 35967b33-bdfb-ee3c-e063-6294a90a75f6 2025-06-18 Warnings Exact identifier application number: M017 Aloe Up SPF 50 Mineral ZINC OXIDE, TITANIUM DIOXIDE Aloe Care International, LLC 35b9dcfa-05f3-3d7b-e063-6394a90a18f1 2025-06-18 Warnings Exact identifier application number: M017
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