Home NDC 11509-5103 VAGISIL Anti-Itch Creme Regular Strength
Product NDC 11509-5103
11-digit product format 115095103
Labeler code 11509
Product ID 11509-5103_c557751a-53ba-467c-8bf8-2ef3c03c07b7
Type HUMAN OTC DRUG
Nonproprietary name Benzocaine and Resorcinol
Dosage form CREAM
Route TOPICAL
Labeler Combe Incorporated
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2016-01-01
Substance BENZOCAINE; RESORCINOL
Active strength 50; 20 mg/g; mg/g
Pharmacologic classes Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [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 Regular Strength
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZOCAINE 50 mg/g RESORCINOL 20 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination U3RSY48JW5 Internal UNII lookup YUL4LO94HK Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 243587 Internal RxNorm lookup 849742 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 11509-5103-1 VAGISIL Anti-Itch Creme Regular Strength 28 g in 1 TUBE CREAM 28 4 11509-5103-1 VAGISIL Anti-Itch Creme Regular Strength 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 11509-5103 VAGISIL ANTI-ITCH CREME REGULAR STRENGTH (BENZOCAINE AND RESORCINOL) CREAM [COMBE INCORPORATED] 4 Current NDC, Legacy NDC, 2 package rows 20241211_dd303ff8-0deb-4292-bfd8-5bda91f86d51.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 152 · 3,029 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 11509-5103-1 11509510301 1 TUBE in 1 CARTON (11509-5103-1) / 28 g in 1 TUBE 1 tube 2016-01-01 0000-00-00 No No Current