FDA.reportPublic FDA data

Isopropyl Alcohol with Wintergreen 70%

Product NDC
10565-006
11-digit product format
105650006
Labeler code
10565
Product ID
10565-006_48337b0f-9b82-7607-e063-6394a90a1d15
Type
HUMAN OTC DRUG
Nonproprietary name
Isopropyl Alcohol with Wintergreen 70%
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Hydrox Laboratories
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-06-11
Substance
ISOPROPYL ALCOHOL
Active strength
70 mL/100mL
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 Alcohol with Wintergreen 70%
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ISOPROPYL ALCOHOL70 mL/100mL

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
5845f723-8866-4738-bec6-621041899f57Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10565-006-04Isopropyl Alcohol with Wintergreen 70%118 mL in 1 BOTTLE, PLASTICSOLUTION11811
10565-006-08Isopropyl Alcohol with Wintergreen 70%237 mL in 1 BOTTLE, PLASTICSOLUTION23711
10565-006-16Isopropyl Alcohol with Wintergreen 70%473 mL in 1 BOTTLE, PLASTICSOLUTION47311
10565-006-32Isopropyl Alcohol with Wintergreen 70%946 mL in 1 BOTTLE, PLASTICSOLUTION94611
10565-006-99Isopropyl Alcohol with Wintergreen 70%3785 mL in 1 BOTTLE, PLASTICSOLUTION378511

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10565-006ISOPROPYL ALCOHOL WITH WINTERGREEN 70% SOLUTION [HYDROX LABORATORIES]10Current NDC, Legacy NDC, 5 package rows20231027_5845f723-8866-4738-bec6-621041899f57.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 31 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
70%ISOPROPYL ALCOHOLUnited Natural Foods, Inc. dba UNFId39bc652-442d-4d91-9eba-a496636b95332026-02-26Warnings, Adverse reactionsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLUnited Natural Foods, Inc. dba UNFIf6be70d5-763c-42d8-9b4e-a55e84c747852026-02-26Warnings, Adverse reactionsExact identifier
application number: M003
RubbingETHYL ALCOHOLUnited Natural Foods, Inc. dba UNFIcd03611f-879a-4888-8d45-f8bdfd82529c2026-02-26Warnings, Adverse reactionsExact identifier
application number: M003
Lightning X POVIDONE IODINE WIPEPOVIDONE IODINE WIPEChangzhou Maokang Medical Products Co., Ltd.04be4c2f-742b-7058-e063-6394a90a460d2026-02-25WarningsExact identifier
application number: M003
70% Isopropyl Rubbing AlcoholISOPROPYL RUBBING ALCOHOLBetter Living Brands, LLC4817df03-05a2-4e85-bec2-a06f9d57d0b82026-02-24Warnings, Adverse reactionsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLBetter Living Brands, LLC4031ea5d-cba4-44f5-9a81-0cab2367d97e2026-02-24Warnings, Adverse reactionsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDEBetter Living Brands, LLC1b2decdf-58be-4ab9-a481-6c78bd91faf02026-02-24Warnings, Adverse reactionsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLBetter Living Brands, LLC6391432a-a5b8-4528-88a6-862bc2062f682026-02-24Warnings, Adverse reactionsExact identifier
application number: M003
First Aid AntisepticPOVIDONE-IODINEFamily Dollar Stores, Inc58157bc5-54ea-49f8-9f17-f0eeb57323952026-02-24Warnings, Adverse reactionsExact identifier
application number: M003
IsopropylISOPROPYL ALCOHOLH E B25fea857-9ed8-49e7-b892-b24f639f83ca2026-02-24Warnings, Adverse reactionsExact identifier
application number: M003
70%ISOPROPYL ALCOHOLH E B403e52e8-bac1-460a-81ef-bac5a7b5de102026-02-24Warnings, Adverse reactionsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLH E B28cd16f5-61c5-4943-9dd6-a9864fa358062026-02-24Warnings, Adverse reactionsExact identifier
application number: M003
50% Isopropyl AlcoholISOPROPYL ALCOHOLH E B0ed762dd-9432-45b4-9e75-c24fb28ff9562026-02-24Warnings, Adverse reactionsExact identifier
application number: M003
Sunvine 70 Isopropyl Alcohol First Aid AntisepticISOPROPYL ALCOHOLMac Innovations, LLC8435ef45-5d2c-4bbb-b9e0-0b00c1ec8c762026-02-24WarningsExact identifier
application number: M003
Alcohol Prep PadsISOPROPYL ALCOHOLALCOVE BRANDS4bad1fee-b4fe-c518-e063-6294a90a03182026-02-24WarningsExact identifier
application number: M003
First Aid AntisepticPOVIDONE-IODINEBetter Living Brands, LLC3ce6e6af-b513-ed9f-e063-6394a90a4ce72026-02-23Warnings, Adverse reactionsExact identifier
application number: M003
Scent Theory Hand Sanitizers Cherry Pop, Ocean Splash, Juicy PearALCOHOLScent Theory Products LLC4b865d82-71c3-1023-e063-6294a90ac7742026-02-23WarningsExact identifier
application number: M003
Hydrogen Peroxide 3%HYDROGEN PEROXIDE 3%4 Visions LLC4b87254a-8dc5-3873-e063-6394a90a3f3b2026-02-23WarningsExact identifier
application number: M003
Isopropyl Rubbing AlcoholISOPROPYL ALCOHOL4 Visions LLC4b87d4cc-163e-1432-e063-6294a90af4832026-02-23WarningsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOL4 Visions LLC4b88008f-fe78-4b7e-e063-6294a90ab9ae2026-02-23WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
808520isopropyl alcohol 70 % Topical SolutionPSN5845f723-8866-4738-bec6-621041899f5711
808520isopropyl alcohol 0.7 ML/ML Topical SolutionSCD5845f723-8866-4738-bec6-621041899f5711
808520isopropyl alcohol 70 % Topical SolutionSY5845f723-8866-4738-bec6-621041899f5711

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10565-006-0410565000604118 mL in 1 BOTTLE, PLASTIC (10565-006-04) 118 ml2019-06-110000-00-00NoNoCurrent
10565-006-0810565000608237 mL in 1 BOTTLE, PLASTIC (10565-006-08) 237 ml2019-06-170000-00-00NoNoCurrent
10565-006-1610565000616473 mL in 1 BOTTLE, PLASTIC (10565-006-16) 473 ml2019-06-170000-00-00NoNoCurrent
10565-006-3210565000632946 mL in 1 BOTTLE, PLASTIC (10565-006-32) 946 ml2019-06-170000-00-00NoNoCurrent
10565-006-99105650006993785 mL in 1 BOTTLE, PLASTIC (10565-006-99) 3785 ml2019-06-170000-00-00NoNoCurrent