FDA.reportPublic FDA data

Isopropyl Rubbing Alcohol

Product NDC
0404-0002
11-digit product format
004040002
Labeler code
0404
Product ID
0404-0002_47e65223-4673-2b48-e063-6394a90a7e6d
Type
HUMAN OTC DRUG
Nonproprietary name
Isopropyl Alcohol
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Henry Schein Inc.
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-06-01
Substance
ISOPROPYL ALCOHOL
Active strength
700 mg/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
Isopropyl Rubbing Alcohol
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ISOPROPYL ALCOHOL700 mg/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 RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
808520Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
eeaf255e-497b-4672-bebc-4d3fcba904c7Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0404-0002-01Isopropyl Rubbing Alcohol3785 mL in 1 BOTTLE, PLASTICSOLUTION378512
0404-0002-16Isopropyl Rubbing Alcohol473 mL in 1 BOTTLE, PLASTICSOLUTION47312
0404-0002-32Isopropyl Rubbing Alcohol946 mL in 1 BOTTLE, PLASTICSOLUTION94612

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Isopropyl AlcoholACTIVE INGREDIENTND2M416302ISOPROPYL RUBBING ALCOHOL (ISOPROPYL ALCOHOL) SOLUTION [HENRY SCHEIN INC.]1
Isopropyl AlcoholACTIVE MOIETYND2M416302ISOPROPYL RUBBING ALCOHOL (ISOPROPYL ALCOHOL) SOLUTION [HENRY SCHEIN INC.]1
WaterINACTIVE INGREDIENT059QF0KO0RISOPROPYL RUBBING ALCOHOL (ISOPROPYL ALCOHOL) SOLUTION [HENRY SCHEIN INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0404-0002ISOPROPYL RUBBING ALCOHOL (ISOPROPYL ALCOHOL) SOLUTION [HENRY SCHEIN INC.]11Current NDC, Legacy NDC, 3 package rows20241116_eeaf255e-497b-4672-bebc-4d3fcba904c7.zip

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 60 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Smart Care Luxury Hand Sanitizer Cashmere CharALCOHOLShenzhen Lantern Scicence Co.,Ltd.41938c11-391c-0a55-e063-6394a90ad4512025-10-20WarningsExact identifier
application number: M003
Smart Care Luxury Hand Sanitizer Tea and TimberALCOHOLShenzhen Lantern Scicence Co.,Ltd.4193d08a-bc54-ef3b-e063-6294a90a06082025-10-20WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Coastal CoconutETHYL ALCOHOL 70% V/VZhejiang Guoyao Jingyue Aerosol Co., Ltd.41940273-689d-0f44-e063-6294a90a957f2025-10-20WarningsExact identifier
application number: M003
Smart Care Luxury Hand Sanitizer Vanilla VerdantALCOHOLShenzhen Lantern Scicence Co.,Ltd.41942841-faa9-114e-e063-6294a90a0e582025-10-20WarningsExact identifier
application number: M003
Smart Care Luxury Hand Sanitizer Zen and ZestALCOHOLShenzhen Lantern Scicence Co.,Ltd.419441a8-a6df-e15d-e063-6294a90a02ae2025-10-20WarningsExact identifier
application number: M003
CVS Alcohol PrepISOPROPYL ALCOHOLCVS Pharmacy7abc66f2-faf6-421c-9c3c-b69f5a5872462025-10-20WarningsExact identifier
application number: M003
Gentian VioletGENTIAN VIOLETWorld Perfumes Inc419cc9a2-bfde-a516-e063-6294a90a065c2025-10-20WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Lavender DriftETHYL ALCOHOL 70% V/VZhejiang Guoyao Jingyue Aerosol Co., Ltd.41a2d051-4920-76ee-e063-6294a90a5d3c2025-10-20WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Peach NectarETHYL ALCOHOL 70% V/VZhejiang Guoyao Jingyue Aerosol Co., Ltd.41a36bb3-a648-3b5b-e063-6394a90aa4df2025-10-20WarningsExact identifier
application number: M003
PROHEAL ALCOHOL XXL PREP PADSISOPROPYL ALCOHOLClick Industries LLCec81be59-94a5-4675-9047-e3e82d7ad7612025-10-20WarningsExact identifier
application number: M003
ALCOHOL PREP PADISOPROPYL ALCOHOLGuangdong Comfort Medical Products Co., Ltd.3a2dea43-8123-3fb7-e063-6294a90a5e502025-10-19WarningsExact identifier
application number: M003
ANTISEPTIC WIPEBENZALKONIUM CHLORIDEGuangdong Comfort Medical Products Co., Ltd.3a40a31d-4032-71ba-e063-6294a90a48dc2025-10-19WarningsExact identifier
application number: M003
ANTIBACTERIAL BANDAGESBENZALKONIUM CHLORIDEGuangdong Comfort Medical Products Co., Ltd.6e43b8b3-2d49-8f76-e053-2a91aa0affb02025-10-19WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Soft BerryETHYL ALCOHOL 70% V/VZhejiang Guoyao Jingyue Aerosol Co., Ltd.418fed84-d4ab-7352-e063-6294a90a6dab2025-10-19WarningsExact identifier
application number: M003
BZK CLEANSERBENZALKONIUM CHLORIDEGeri-Gentle Corporation415eb5fb-5f88-d2dd-e063-6394a90abe5d2025-10-17WarningsExact identifier
application number: M003
Medline Alcohol Prep Sterile, LargeISOPROPYL ALCOHOLMedline Industries, LPc9fae7b6-2f4b-490b-9b17-a7297e7380692025-10-16WarningsExact identifier
application number: M003
Medline Alcohol Prep Sterile, MediumISOPROPYL ALCOHOLMedline Industries, LP9a8584e1-b422-4b77-8464-4e022d578fad2025-10-16WarningsExact identifier
application number: M003
Signature Select Pain RelievingLIDOCAINE HCL, BENZALKONIUM CHLORIDESafeway/Albartsons3cab1b0c-4ffd-9c01-e063-6294a90ad15d2025-10-16WarningsExact identifier
application number: M003
Medline Alcohol PrepISOPROPYL ALCOHOLMedline Industries, LPb43c0bff-82f8-c18d-e053-2995a90a87162025-10-16WarningsExact identifier
application number: M003
MedlineBENZALKONIUM CHLORIDE, LIDOCAIN HYDROCHLORIDEMedline Industries, LPb1059e68-b240-056c-e053-2995a90a61b22025-10-16WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
808520isopropyl alcohol 70 % Topical SolutionPSNeeaf255e-497b-4672-bebc-4d3fcba904c712
808520isopropyl alcohol 0.7 ML/ML Topical SolutionSCDeeaf255e-497b-4672-bebc-4d3fcba904c712
808520isopropyl alcohol 70 % Topical SolutionSYeeaf255e-497b-4672-bebc-4d3fcba904c712

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0404-0002-01004040002013785 mL in 1 BOTTLE, PLASTIC (0404-0002-01) 3785 ml2014-06-010000-00-00NoNoCurrent
0404-0002-1600404000216473 mL in 1 BOTTLE, PLASTIC (0404-0002-16) 473 ml2014-06-010000-00-00NoNoCurrent
0404-0002-3200404000232946 mL in 1 BOTTLE, PLASTIC (0404-0002-32) 946 ml2014-06-010000-00-00NoNoCurrent