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 109 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RevitaDERM Wound CareBENZALKONIUM CHLORIDEBlaine Labs Inc.9254dada-4e32-43a0-892b-c488d68e23e72023-12-21WarningsExact identifier
application number: M003
NUMSTAT Antiseptic and Pain Relieving Prep PadALCOHOL, MENTHOL, AND BENZOCAINE PREP PADSpectra Medical Devices, LLC07d20040-9dd9-0aba-e063-6294a90ab7cf2023-12-20WarningsExact identifier
application number: M003
Health Mart IodidesALCOHOLStrategic Sourcing Services LLC8d9f2112-c678-4559-b567-9d6d287c5fa32023-12-20WarningsExact identifier
application number: M003
Health Mart Iodine Tincture MildIODINE AND SODIUM IODIDE AND ALCOHOLStrategic Sourcing Services LLC72eeb3e6-c0a1-4b18-87f1-8db06f9bd1112023-12-20WarningsExact identifier
application number: M003
Health Mart Hydrogen Peroxide 3 PercentHYDROGEN PEROXIDEStrategic Sourcing Services LLCcbe02fa1-c167-4b77-8f63-817362090e192023-12-20WarningsExact identifier
application number: M003
Health Mart Isopropyl Alcohol 91 PercentISOPROPYL ALCOHOLStrategic Sourcing Services LLCfbd2aa69-b1c7-4a28-9642-a436ae09faaf2023-12-20WarningsExact identifier
application number: M003
Quality Choice Povidone IodinePOVIDONE IODINE 10%Chain Drug Market Association9fa49a3c-ad09-4d35-8cd9-e1a0f2da0d2d2023-12-20WarningsExact identifier
application number: M003
Quality Choice Iodine Tincture MildIODINE AND SODIUM IODIDE AND ALCOHOLChain Drug Market Association55c970ed-13a9-4ea2-a8cb-aaf14d3a214d2023-12-20WarningsExact identifier
application number: M003
Quality Choice Iodides TinctureETHYL ALCOHOLChain Drug Market Association71aedfd5-e81f-4b69-b163-527ff1ce30b12023-12-20WarningsExact identifier
application number: M003
Quality Choice MerthiolateBENZALKONIUM CHLORIDEChain Drug Market Association5b7303b9-b8c4-4e7c-876f-70ed764430552023-12-20WarningsExact identifier
application number: M003
Premier Value Povidone IodinePOVIDONE IODINE 10%Chain Drug Consortium5cc9d782-5f7e-27d9-e053-2991aa0a24282023-12-20WarningsExact identifier
application number: M003
Harris Teeter Iodine Tincture MildIODINE AND SODIUM IODIDE AND ALCOHOLHarris Teeter, LLC5c88d7cb-2917-54e9-e053-2991aa0a0bd92023-12-20WarningsExact identifier
application number: M003
CVS IodineIODINE, SODIUM IODIDE AND ALCOHOLCVS Pharmacyb11db4e5-6a6d-4d4a-b980-600692b541762023-12-20WarningsExact identifier
application number: M003
CVS Povidone-IodinePOVIDONE IODINECVS Pharmacy402d571f-e1e8-43fd-9e7b-05aab18379052023-12-20WarningsExact identifier
application number: M003
Sanitizing wipes with aloe Grapefruit GroveALCOHOLThe Honest Companyfaa3690b-ce0d-43d4-9e5c-f2ce77daabe72023-12-19WarningsExact identifier
application number: M003
Sanitizing Wipes Fragrance FreeALCOHOLThe Honest Company0ce3e7ee-aa50-16bc-e063-6294a90a527d2023-12-19WarningsExact identifier
application number: M003
sunmark Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLStrategic Sourcing Services LLC46da2750-37d1-4ed1-baf3-1fd4266175672023-12-19WarningsExact identifier
application number: M003
Sunmark IodineIODINE, SODIUM IODIDE, ALCOHOLStrategic Sourcing Services LLCe8dae2d6-58b1-4c4e-a4c1-371db055b7ae2023-12-19WarningsExact identifier
application number: M003
Sunmark Isopropyl Alcohol 70 Percent With Wintergreen OilISOPROPYL ALCOHOLStrategic Sourcing Services LLC515dd733-1b44-4df0-928f-a3b202b5f9c22023-12-19WarningsExact identifier
application number: M003
Sunmark Isopropyl Alcohol 91 PercentISOPROPYL ALCOHOLStrategic Sourcing Services LLC92afb1ce-6a9e-456e-b3ee-e8a8d93ebc5e2023-12-19WarningsExact 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