FDA.reportPublic FDA data

70% Isopropyl Rubbing Alcohol

Product NDC
36800-589
11-digit product format
368000589
Labeler code
36800
Product ID
36800-589_4a927c4d-6260-1540-e063-6294a90a1b83
Type
HUMAN OTC DRUG
Nonproprietary name
Isopropyl Rubbing Alcohol
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Topco Associates LLC
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-08-28
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
70% Isopropyl Rubbing Alcohol
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
9fbded5f-8dc1-4134-a711-48d1a581d874Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-589-1470% Isopropyl Rubbing Alcohol162.7 mL in 1 CANSOLUTION162.723
36800-589-4370% Isopropyl Rubbing Alcohol473 mL in 1 BOTTLE, PLASTICSOLUTION47323
36800-589-4570% Isopropyl Rubbing Alcohol946 mL in 1 BOTTLE, PLASTICSOLUTION94623
36800-589-7270% Isopropyl Rubbing Alcohol295 mL in 1 BOTTLE, SPRAYSOLUTION29523

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ISOPROPYL ALCOHOLACTIVE INGREDIENTND2M41630270% ISOPROPYL RUBBING ALCOHOL (ISOPROPYL RUBBING ALCOHOL) SOLUTION [TOPCO ASSOCIATES LLC]2
ISOPROPYL ALCOHOLACTIVE MOIETYND2M41630270% ISOPROPYL RUBBING ALCOHOL (ISOPROPYL RUBBING ALCOHOL) SOLUTION [TOPCO ASSOCIATES LLC]2
WATERINACTIVE INGREDIENT059QF0KO0R70% ISOPROPYL RUBBING ALCOHOL (ISOPROPYL RUBBING ALCOHOL) SOLUTION [TOPCO ASSOCIATES LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-58970% ISOPROPYL RUBBING ALCOHOL (ISOPROPYL RUBBING ALCOHOL) SOLUTION [TOPCO ASSOCIATES LLC]21Current NDC, Legacy NDC, 4 package rows20240802_9fbded5f-8dc1-4134-a711-48d1a581d874.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 104 of 114 · 2,275 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Safly BZK Antiseptic ToweletteBENZALKONIUM CHLORIDEJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.5cd9043e-daf2-43eb-9568-54775fc4f84a2024-05-15WarningsExact identifier
application number: M003
Noshinku Bergamot Hand SanitizerALCOHOLNoshinku53fea81e-4482-6fae-e054-00144ff8d46c2024-05-14WarningsExact identifier
application number: M003
Noshinku Eucalyptus Hand SanitizerALCOHOLNoshinku9dcb8b51-d1bb-4305-a5ff-8cc8bdcdc4c02024-05-14WarningsExact identifier
application number: M003
Noshinku Lavender Hand SanitizerALCOHOLNoshinkua57e44b2-f5fa-4c3c-a59c-aa73bfbb66cf2024-05-14WarningsExact identifier
application number: M003
LEADER 2% Mild Iodine TinctureIODINE AND SODIUM IODIDE AND ALCOHOL LIQUIDCardinal Health, 110 dba Leader7f810b92-60f6-2f72-e053-2991aa0ab9732024-05-13WarningsExact identifier
application number: M003
Leader Decolorized IodineALCOHOL LIQUIDCardinal Health, 110 dba Leader822f6f28-956f-dd82-e053-2991aa0ae7522024-05-13WarningsExact identifier
application number: M003
Inverness Ear CareBENZALKONIUM CHLORIDEThe Richline Group, Inc.180a2995-334c-2e93-e063-6294a90aecf72024-05-09WarningsExact identifier
application number: M003
Helzberg Diamonds Ear CareBENZALKONIUM CHLORIDEThe Richline Group, Inc.180a3776-0edd-26f3-e063-6294a90a740d2024-05-09WarningsExact identifier
application number: M003
Ulta Beauty Ear CareBENZALKONIUM CHLORIDEThe Richline Group, Inc.180a37f4-8718-3e40-e063-6294a90acaad2024-05-09WarningsExact identifier
application number: M003
Guardian VaginalBENZALKONIUM CHLORIDEEastern Century Pharmaceuticals1605ba44-02b7-4c72-9fec-89a5aa962b442024-04-24WarningsExact identifier
application number: M003
Inverness Hygienic Ear Care AntisepticBENZALKONIUM CHLORIDEThe Richline Group, Inc.0ccd72e7-16a2-47c7-9ce6-dffb63a0344b2024-04-18WarningsExact identifier
application number: M003
Lovisa Piercing Care SolutionBENZALKONIUM CHLORIDEThe Richline Group, Inc.74f46b81-cc5b-4e3f-a36e-0bd86d370c222024-04-18WarningsExact identifier
application number: M003
CliniClean BZK Cleansing Contains Benzalkonium ChlorideBENZALKONIUM CHLORIDEHR HealthCareb6916466-0931-408f-a430-0797a449c32e2024-04-18WarningsExact identifier
application number: M003
Handy Solutions First Aid KitBENZALKONIUM CHLORIDENavajo Manufacturing Company Inc.130237ff-3db4-1288-e063-6394a90ab1af2024-04-16WarningsExact identifier
application number: M003
BZKBENZALKONIUM CHLORIDEHenry Schein Inc.ff877b63-fa58-4770-a882-694eda33203b2024-04-02WarningsExact identifier
application number: M003
First Aid Antiseptic Pain Relieving Benzalkonium Chloride Lidocaine HydrochlorideBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDEM-star (Hubei) Health&Care Products Co., Ltd.8e1f35ff-d4e6-4940-ad8f-dce2b73e595d2024-04-01WarningsExact identifier
application number: M003
Antiseptic Towelette TOALLITAS ANTISEPTICASBENZALKONIUM CHLORIDEM-star (Hubei) Health&Care Products Co., Ltd.b267e186-cf7a-458f-9c28-a48a8554af402024-04-01WarningsExact identifier
application number: M003
Antiseptic Povidone Iodine Prep PadPOVIDONE-IODINEM-star (Hubei) Health&Care Products Co., Ltd.fc76c1f3-b48e-4276-890d-5b8e5a894e622024-04-01WarningsExact identifier
application number: M003
Novex Hand SanitizerBENZALKONIUM CHLORIDENatural Essentials, Inc.8b53dde5-c9f6-41c4-8ddb-bf0bf67008d32024-03-20WarningsExact identifier
application number: M003
AntisepticBENZALKONIUM CHLORIDE 0.13%Trifecta Pharmaceuticals USA, LLC.13f1c70f-3b44-8eef-e063-6294a90af6342024-03-18WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
808520isopropyl alcohol 70 % Topical SolutionPSN9fbded5f-8dc1-4134-a711-48d1a581d87423
808520isopropyl alcohol 0.7 ML/ML Topical SolutionSCD9fbded5f-8dc1-4134-a711-48d1a581d87423
808520isopropyl alcohol 70 % Topical SolutionSY9fbded5f-8dc1-4134-a711-48d1a581d87423

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-589-1436800058914162.7 mL in 1 CAN (36800-589-14) 162.7 ml2021-12-200000-00-00NoNoCurrent
36800-589-4336800058943473 mL in 1 BOTTLE, PLASTIC (36800-589-43) 473 ml2015-08-28NoNoCurrent
36800-589-4536800058945946 mL in 1 BOTTLE, PLASTIC (36800-589-45) 946 ml2015-08-280000-00-00NoNoCurrent
36800-589-7236800058972295 mL in 1 BOTTLE, SPRAY (36800-589-72) 295 ml2015-08-280000-00-00NoNoCurrent