Home NDC 36800-370-16 Advanced
Product NDC 36800-370
Requested package NDC 36800-370-16
11-digit product format 368000370
Labeler code 36800
Product ID 36800-370_4ab94790-1ffa-d62a-e063-6294a90a1688
Type HUMAN OTC DRUG
Nonproprietary name Ethyl Alcohol
Dosage form GEL
Route TOPICAL
Labeler Topco Associates LLC
Application 505G(a)(3)
Marketing category OTC MONOGRAPH DRUG
Marketing start 2012-09-27
Substance ALCOHOL
Active strength 70 mL/100mL
NDC exclude flag No
Listing certified through 2027-12-31
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 Advanced
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ALCOHOL 70 mL/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 3K9958V90M Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 581662 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 36800-370-16 Advanced 59 mL in 1 BOTTLE, PUMP GEL 59 18 36800-370-34 Advanced 236 mL in 1 BOTTLE, PUMP GEL 236 18 36800-370-45 Advanced 946 mL in 1 BOTTLE, PUMP GEL 946 18
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 36800-370 ADVANCED (ETHYL ALCOHOL) GEL [TOPCO ASSOC. LLC] 16 Current NDC, Legacy NDC, 3 package rows 20240802_faaa3452-ef1e-47db-9978-5105de69d981.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 1 of 1 · 1 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 36800-370-16 36800037016 59 mL in 1 BOTTLE, PUMP (36800-370-16) 59 ml 2012-09-27 0000-00-00 No No Current