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 92 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
germstarCitrusETHYL ALCOHOLSoaptronic, LLC779abef7-53ff-47c3-b7e6-27570eb055b32024-12-19WarningsExact identifier
application number: M003
germstarGelETHYL ALCOHOLSoaptronic, LLCb5fd6c3c-d452-74e6-e053-2995a90a90902024-12-19WarningsExact identifier
application number: M003
Isopropyl alcohol 91 percentISOPROPYL ALCOHOLJell Pharmaceuticals Pvt. Ltd.cd98812b-017a-2cd2-e053-2a95a90a38ce2024-12-18WarningsExact identifier
application number: M003
Isopropyl Rubbing Alcohol 50%ISOPROPYL ALCOHOLMY IMPORTS LLCd4d72406-067d-1f67-e053-2995a90a1a9f2024-12-18WarningsExact identifier
application number: M003
AMORAY 70% ISOPROPYL RUBBING ALCOHOLISOPROPYL ALCOHOLMY IMPORT USA INC7114b527-106b-4629-867c-63dba13635a22024-12-18WarningsExact identifier
application number: M003
AMERICAN REDCROSS 70% ISOPROPYL RUBBING ALCOHOL WITH WINTERGREENISOPROPYL ALCOHOLMY IMPORTS USA LLCd4d7e7f8-7c8a-2b51-e053-2995a90a63d02024-12-18WarningsExact identifier
application number: M003
ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREENISOPROPYL ALCOHOLMy Imports USA, LLCd4d77ec3-4930-74f0-e053-2a95a90a962a2024-12-18WarningsExact identifier
application number: M003
91% Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLMY IMPORTS USA LLCd4d7adaf-c0fd-82fa-e053-2995a90ab9f62024-12-18WarningsExact identifier
application number: M003
ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREENISOPROPYL ALCOHOLMY IMPORTS USA, LLCde47bf08-f64e-781d-e053-2a95a90ab08f2024-12-18WarningsExact identifier
application number: M003
AMERICAN REDCROSS 91% ISOPROPYL RUBBING ALCOHOL WITH WINTERGREENISOPROPYL ALCOHOLMY IMPORTS USA LLCd4d80ae4-3fba-4605-e053-2a95a90a21192024-12-18WarningsExact identifier
application number: M003
American Red Cross 50% Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLMY IMPORTS USA LLCde47a879-9cd0-5fbb-e053-2a95a90a1fba2024-12-18WarningsExact identifier
application number: M003
RUBBING ALCOHOLALCOHOLINTERNATIONAL GENERAL TRADING CORPbd5ee961-1d64-0d9d-e053-2a95a90a60102024-12-18WarningsExact identifier
application number: M003
70% Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLSZY Holdings, LLC dba EverReady First Aid1e39b0f4-66d1-47ac-aed6-d6ac019888ce2024-12-18WarningsExact identifier
application number: M003
RUBBING ALCOHOLALCOHOLINTERNATIONAL GENERAL TRADING CORPbd5eb0df-cd2d-691c-e053-2995a90a25112024-12-18WarningsExact identifier
application number: M003
Isopropyl Rubbing Alcohol 70%ISOPROPYL ALCOHOLFirst Aid Research Corp.7d1c0382-31b3-48d0-a514-c5cc45a2299e2024-12-18WarningsExact identifier
application number: M003
First Aid Only First Aid-BurnBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDEAcme United Corporationf31a44ff-e4ac-de1e-e053-2a95a90ab0362024-12-18WarningsExact identifier
application number: M003
Hand Sanitizer (Lavender Rosemary)HAND SANITIZER SPRAYTubby Todd2992a52a-21a9-18be-e063-6294a90a834d2024-12-18WarningsExact identifier
application number: M003
CVS Decolorized IodineALCOHOLCVS Pharmacyd9f1a1aa-f402-4c0d-96e8-eeb5eb5cfacd2024-12-18WarningsExact identifier
application number: M003
De La Cruz Decolorized IodineETHYL ALCOHOLDLC Laboratories, Inc.5d8f6aaa-0b87-1166-e053-2991aa0a297f2024-12-18WarningsExact identifier
application number: M003
Humco Povidone IodinePOVIDONE IODINE 10%Humco Holding Group, Inc.1e078022-f32c-48bd-8add-f83aebcc58122024-12-18WarningsExact 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