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 81 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
UnguentinePHENOL, ZINC OXIDEOakhurst Company327038a1-b825-1199-e063-6394a90a7f5f2025-04-10WarningsExact identifier
application number: M003
Northside Hospital Grey Amenity KitSODIUM MONOFLUOROPHOSPATEASP Global, LLCa3cc89df-be1b-4d9a-8ba3-8578853254222025-04-09WarningsExact identifier
application number: M003
Isopropyl alcohol 70 percentISOPROPYL ALCOHOLTOP CARE (Topco Associates LLC)afe23634-27a4-46cf-b428-8fa3a274712c2025-04-09WarningsExact identifier
application number: M003
Isopropyl Alcohol 91 percentISOPROPYL ALCOHOLTOP CARE (Topco Associates LLC)3c70ba1c-b12f-4a98-b993-1179ebe3e0702025-04-09WarningsExact identifier
application number: M003
Band Aid Antiseptic CleansingBENZALKONIUM CHLORIDEKenvue Brands LLCd3190050-d646-5957-e053-2995a90ad5212025-04-08WarningsExact identifier
application number: M003
mart Care Assorted Hand Sanitizer 0.94oz-Sweet Pea 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.322b90e8-be38-7237-e063-6394a90a488f2025-04-07WarningsExact identifier
application number: M003
Meijer Hydrating Hand Sanitizer 1oz - WatermelonALCOHOLShenzhen Lantern Scicence Co.,Ltd.322c0bdd-4dc5-52e7-e063-6294a90a13802025-04-07WarningsExact identifier
application number: M003
Meijer Hydrating Hand Sanitizer 1oz - BerryALCOHOLShenzhen Lantern Scicence Co.,Ltd.322c56b0-7eb6-c33a-e063-6394a90a15fb2025-04-07WarningsExact identifier
application number: M003
Meijer Hydrating Hand Sanitizer 1oz - VanillaALCOHOLShenzhen Lantern Scicence Co.,Ltd.322ce179-c528-0f62-e063-6394a90ac5602025-04-07WarningsExact identifier
application number: M003
MEDI-FIRST First Aid AntisepticHYDROGEN PEROXIDEUltra Distributors Incb6f7b346-3d6b-5953-e053-2995a90a878f2025-04-07WarningsExact identifier
application number: M003
MEDI-FIRST First Aid AntisepticISOPROPYL ALCOHOLUltra Distributors Incb6c88941-9982-3a37-e053-2995a90a8a5a2025-04-07WarningsExact identifier
application number: M003
Walgreens Max Strength Burn GelBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDEWalgreens Co.25a1e89b-bafd-4770-e063-6294a90a14d22025-04-07WarningsExact identifier
application number: M003
Eye WashWATERCMC Group Inc.6158a1f5-a6bc-4a3e-9d1d-0a310d9dc5612025-04-02WarningsExact identifier
application number: M003
Standard ANSI First AidWATER, BENZALKONIUM CHLORIDE, ISOPROPYL ALCOHOL, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, LIDOCAINE HYDROCHLORIDECMC Group, Inc.e1ef74bf-8895-4200-a411-f726dcdaa9452025-04-02WarningsExact identifier
application number: M003
Clear DefenseETHYL ALCOHOLMelaleuca, Inc.a2178a68-780e-e69b-e053-2a95a90ab7d62025-04-02WarningsExact identifier
application number: M003
Large ANSI First Aid KitWATER, BENZALKONIUM CHLORIDE, ISOPROPYL ALCOHOL, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, LIDOCAINE HYDROCHLORIDECMC Group, Inc.fa8578c2-a0bc-4e2e-a4f9-d48debfff3782025-04-02WarningsExact identifier
application number: M003
ETHYL ALCOHOLALCOHOLASP Global LLC67a4b949-ce8a-4841-a965-fcc94165135c2025-04-02WarningsExact identifier
application number: M003
Sanitizing Hand MistETHYL ALCOHOLALO New York LLC31baefe1-2521-9ef3-e063-6294a90a450e2025-04-01WarningsExact identifier
application number: M003
DeconimoHAND SANITIZING WIPESIMAGINE AMAZON LLC311c670d-8f87-b746-e063-6294a90afd5e2025-04-01WarningsExact identifier
application number: M003
Meijer Antibacterial Foaming Hand Wash0.13% BENZALKONIUM CHLORIDE SOLUTIONMeijer, Inc.1eb6b603-ef96-dfda-e063-6294a90ae4682025-03-31WarningsExact 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