Home NDC 83318-605-08 Plus Brasept Alcocol Gel
Product NDC 83318-605
Requested package NDC 83318-605-08
11-digit product format 833180605
Labeler code 83318
Product ID 83318-605_440c5ac8-dc18-6db4-e063-6294a90a6f19
Type HUMAN OTC DRUG
Nonproprietary name ALCOHOL
Dosage form GEL
Route TOPICAL
Labeler NEWDROP NORTH AMERICA LLC
Application 505G(a)(3)
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-03-24
Substance ALCOHOL
Active strength .7 mL/mL
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 Plus Brasept Alcocol Gel
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ALCOHOL .7 mL/mL
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 83318-605-08 Plus Brasept Alcocol Gel 208200 mL in 1 DRUM GEL 208200 4 83318-605-14 Plus Brasept Alcocol Gel 3785 mL in 1 BOTTLE, PLASTIC GEL 3785 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83318-605 PLUS BRASEPT ALCOCOL GEL (ALCOHOL) GEL [NEWDROP NORTH AMERICA LLC] 3 Current NDC, 2 package rows 20240628_f791c99c-5879-9ba2-e053-6394a90ad3c7.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 Sample Exclude flag Status 83318-605-08 83318060508 208200 mL in 1 DRUM (83318-605-08) 208200 ml 2024-06-25 No No Current