Home NDC 78691-031 Biopure Alcohol Cotton Swabs
Product NDC 78691-031
11-digit product format 786910031
Labeler code 78691
Product ID 78691-031_4d1bd566-3634-f769-e063-6394a90a06ed
Type HUMAN OTC DRUG
Nonproprietary name Isopropyl Alcohol, Cotton Swab
Dosage form SWAB
Route TOPICAL
Labeler QUEST USA CORP
Application M003
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-08-15
Substance ISOPROPYL ALCOHOL
Active strength .15 mL/mL
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 Biopure Alcohol Cotton Swabs
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ISOPROPYL ALCOHOL .15 mL/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination ND2M416302 Internal UNII 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 78691-031-00 Biopure Alcohol Cotton Swabs 1 mL in 1 APPLICATOR SWAB 1 2 78691-031-00 Biopure Alcohol Cotton Swabs 15 in 1 BOX SWAB 15 2
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 99 of 114 · 2,277 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 78691-031-00 78691003100 15 APPLICATOR in 1 BOX (78691-031-00) / 1 mL in 1 APPLICATOR 15 applicator 2025-08-15 No No Current