Home NDC 11509-5035 VAGISIL Anti-Itch Medicated Wipes Maximum Strength
Product NDC 11509-5035
11-digit product format 115095035
Labeler code 11509
Product ID 11509-5035_d52bff6a-9386-4ff7-a2ff-bef4a6ad07f8
Type HUMAN OTC DRUG
Nonproprietary name pramoxine hydrochloride
Dosage form CLOTH
Route TOPICAL
Labeler Combe Incorporated
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2005-06-28
Substance PRAMOXINE HYDROCHLORIDE
Active strength 10 mg/g
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 Medicated Wipes Maximum Strength
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PRAMOXINE HYDROCHLORIDE 10 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 88AYB867L5 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1039541 Internal RxNorm lookup 1039550 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 11509-5035-1 VAGISIL Anti-Itch Medicated Wipes Maximum Strength 4.5 g in 1 PACKET CLOTH 4.5 9 11509-5035-1 VAGISIL Anti-Itch Medicated Wipes Maximum Strength 12 in 1 CARTON CLOTH 12 9
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 11509-5035 VAGISIL ANTI-ITCH MEDICATED WIPES MAXIMUM STRENGTH (PRAMOXINE HYDROCHLORIDE) CLOTH [COMBE INCORPORATED] 9 Current NDC, Legacy NDC, 2 package rows 20241211_b848f53d-8aea-4efe-aa2c-009d5121fc33.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 11509-5035-1 11509503501 12 PACKET in 1 CARTON (11509-5035-1) / 4.5 g in 1 PACKET 12 packet 2005-06-28 0000-00-00 No No Current