FDA.reportPublic FDA data

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
IngredientStrength
ISOPROPYL ALCOHOL.15 mL/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ND2M416302Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3a60362b-b397-da15-e063-6394a90a45ffAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78691-031-00Biopure Alcohol Cotton Swabs1 mL in 1 APPLICATORSWAB12
78691-031-00Biopure Alcohol Cotton Swabs15 in 1 BOXSWAB152

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 107 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hand sanitizer 8oz with aloe veraETHYL ALCOHOL 70%V/VZhejiang Guoyao Jingyue Aerosol Co., Ltd.0fbd6962-59e6-7230-e063-6394a90afd8e2024-01-24WarningsExact identifier
application number: M003
Cold Sore Treatment, 24-7 Life by 7-ElevenBENZALKONIUM CHLORIDELil' Drug Store Products, Inc.0f4fb868-1462-f88e-e063-6394a90a69e42024-01-19WarningsExact identifier
application number: M003
Medi-First Burn with LidocaineBENZALKONIUM CHLORIDE, LIDOCAINEUnifirst First Aid Corporationbd46efc8-0b36-0931-e053-2a95a90adb6f2024-01-17WarningsExact identifier
application number: M003
Green Guard AntisepticBENZALKONIUM CHLORIDEUnifirst First Aid Corporationbc914c36-e0f0-18c5-e053-2a95a90a894e2024-01-17WarningsExact identifier
application number: M003
Medi-First Hydrogen PeroxideHYDROGEN PEROXIDEUnifirst First Aid Corporationbca2b641-7fbc-5462-e053-2995a90ae2b42024-01-17WarningsExact identifier
application number: M003
Medi-First Isopropyl Alcohol 70%ISOPROPYL ALCOHOLUnifirst First Aid Corporationdbeac2f5-b897-5e71-e053-2995a90a75492024-01-17WarningsExact identifier
application number: M003
Green Guard Hydrogen PeroxideHYDROGEN PEROXIDEUnifirst First Aid Corporationbca4545e-d477-270a-e053-2995a90a0ed62024-01-17WarningsExact identifier
application number: M003
MyMedic Calendula GelCALENDULA OFFICINALIS FLOWERNantong Health & Beyond Hygienic Products Inc.0f0aa235-ac35-ac91-e063-6394a90a73fc2024-01-16WarningsExact identifier
application number: M003
MyMedic Oral Pain Relief GelBENZOCAINENantong Health & Beyond Hygienic Products Inc.0f0b6157-ec18-13ef-e063-6294a90a2e0c2024-01-16WarningsExact identifier
application number: M003
MyMedic Super SanitizerETHYL ALCOHOLNantong Health & Beyond Hygienic Products Inc.0f0c535d-8ff3-4799-e063-6394a90a70632024-01-16WarningsExact identifier
application number: M003
MyMedic Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATENantong Health & Beyond Hygienic Products Inc.0f0d1ba7-fe9c-8e0b-e063-6394a90a30812024-01-16WarningsExact identifier
application number: M003
White PetrolatumWHITE PETROLATUMNantong Health & Beyond Hygienic Products Inc.0f0d6ff0-ff30-aaf8-e063-6394a90a27162024-01-16WarningsExact identifier
application number: M003
Thompson Hand SanitizerETHYL ALCOHOLThompsondeada606-8a82-9eeb-e053-2a95a90a9e6d2024-01-16WarningsExact identifier
application number: M003
MyMedic Arnica GelARNICA MONTANANantong Health & Beyond Hygienic Products Inc.0ef8760d-27c0-7ece-e063-6294a90a68732024-01-15WarningsExact identifier
application number: M003
American Safety First Aid AntispeticHYDROGEN PEROXIDEOrazen Incea2fbdfe-1932-9fb4-e053-2a95a90a35632024-01-15WarningsExact identifier
application number: M003
First Aid AntispeticBENZALKONIUM CHLORIDEOrazen Incea2debcb-892c-339f-e053-2a95a90a4b182024-01-15WarningsExact identifier
application number: M003
Ever Ready First AidBENZALKONIUM CHLORIDE, LIDOCAINE HCIEver Ready First Aide53f3bf5-25c0-2b86-e053-2a95a90a010f2024-01-15WarningsExact identifier
application number: M003
FIRST SHIELD First Aid AntisepticBENZALKONIUM CHLORIDEEver Ready First Aide013ef0a-ef3d-7af5-e053-2a95a90a54d32024-01-15WarningsExact identifier
application number: M003
Latalia Hand Sanitizer 80 Alcohol AntisepticALCOHOLINTERNATIONAL CONSUMER PRODUCTS (PVT.) LTDae55fab3-3177-383e-e053-2995a90a17a02024-01-10WarningsExact identifier
application number: M003
Latalia Sanitizing WipeALCOHOLINTERNATIONAL CONSUMER PRODUCTS (PVT.) LTDae564635-898e-fbf6-e053-2995a90a81192024-01-10WarningsExact identifier
application number: M003

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
78691-031-007869100310015 APPLICATOR in 1 BOX (78691-031-00) / 1 mL in 1 APPLICATOR15 applicator2025-08-15NoNoCurrent