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 86 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
XtraCare Cucumber MelonETHYL ALCOHOLRejoice International021fa2a0-d2ea-4699-a3d8-3c0af18c5aa32025-02-12WarningsExact identifier
application number: M003
XtraCare Lavender ChamomileETHYL ALCOHOLRejoice International6e611e87-1835-49f8-aa52-b724bd2515272025-02-12WarningsExact identifier
application number: M003
XtraCare Sweet Pea BlossomETHYL ALCOHOLRejoice International1a5408f2-910c-4c6a-b6b3-c1304dd1cdf02025-02-12WarningsExact identifier
application number: M003
XtraCare Warm VanillaETHYL ALCOHOLRejoice International46e7b4fa-3722-4487-9325-f8552ea92acf2025-02-12WarningsExact identifier
application number: M003
Instant Hand Sanitizer 2oz Bonus packETHYL ALCOHOLRejoice International Inc.5b209df6-d896-170c-e053-2a91aa0a52a82025-02-12WarningsExact identifier
application number: M003
Hand Sanitizer w/ Carabiner (Strawberry Scented) 2oz Bonus packETHYL ALCOHOLRejoice International Inc.6e62eb50-ebb8-361e-e053-2991aa0aba6f2025-02-12WarningsExact identifier
application number: M003
Hand Sanitizer w/ Carabiner (Lemon Scented) 2oz Bonus packETHYL ALCOHOLRejoice International Inc.6e6585a3-61e1-30ec-e053-2a91aa0a60392025-02-12WarningsExact identifier
application number: M003
Smart Care Assorted Licensed Sanitizer Spider Man 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.2dedab76-3f5a-febf-e063-6394a90a69932025-02-12WarningsExact identifier
application number: M003
Hand Sanitizer w/ Carabiner (Watermelon Scented) 2oz Bonus packETHYL ALCOHOLRejoice International Inc.6e65856c-0e14-1ab6-e053-2991aa0a3f3e2025-02-12WarningsExact identifier
application number: M003
Smart Care Assorted Licensed Sanitizer Barbie 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.2dfd2ffd-a85a-f63e-e063-6294a90a6a5e2025-02-12WarningsExact identifier
application number: M003
Smart Care Assorted Licensed Sanitizer Crayola 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.2dfd4acb-451b-12d3-e063-6294a90a48732025-02-12WarningsExact identifier
application number: M003
Smart Care Assorted Licensed Sanitizer Hot Wheels 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.2dfdd225-24f4-6d57-e063-6394a90a8a242025-02-12WarningsExact identifier
application number: M003
Smart Care Cucumber Melon Hand Sanitizer 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.2dfe0ac7-99d5-aac3-e063-6294a90a31b32025-02-12WarningsExact identifier
application number: M003
Isopropyl alcohol 70 percentISOPROPYL ALCOHOLGood Sense (Geiss, Destin & Dunn, Inc.)ac66be77-d358-44ea-8904-88186a7c2bbb2025-02-07WarningsExact identifier
application number: M003
Rubbing Alcohol 70 Percent IsopropylISOPROPYL ALCOHOLHarris Teeter, LLC4196dd97-9041-4712-8196-02237a3b0cb22025-02-07WarningsExact identifier
application number: M003
Isopropyl alcohol 91 percentISOPROPYL ALCOHOLHarris Teeter, LLC1b044f47-45e1-40a3-81b0-2717ed425f162025-02-07WarningsExact identifier
application number: M003
Instant Hand SanitizerETHYL ALCOHOLRejoice International Corp.4e042f5b-3f0c-1830-e054-00144ff88e882025-02-06WarningsExact identifier
application number: M003
Instant Hand SanitizerETHYL ALCOHOLRejoice International Corp.4e04fa70-c25d-4499-e054-00144ff8d46c2025-02-06WarningsExact identifier
application number: M003
Instant Hand SanitizerETHYL ALCOHOLRejoice International Corp.4e05cceb-b8f3-48f7-e054-00144ff88e882025-02-06WarningsExact identifier
application number: M003
Hand Sanitizer 1.8 oz AntisepticETHYL ALCOHOLREJOICE INTERNATIONAL CORP.a0313f20-11dc-6c7d-e053-2a95a90a60f12025-02-06WarningsExact 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