FDA.reportPublic FDA data

Isopropyl Rubbing Alcohol 50%

Product NDC
51628-4232
11-digit product format
516284232
Labeler code
51628
Product ID
51628-4232_29880318-13b3-2d0b-e063-6294a90a9263
Type
HUMAN OTC DRUG
Nonproprietary name
Isopropyl Alcohol
Dosage form
LIQUID
Route
TOPICAL
Labeler
MY IMPORTS LLC
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-06-18
Substance
ISOPROPYL ALCOHOL
Active strength
50 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 Rubbing Alcohol 50%
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ISOPROPYL ALCOHOL50 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
616456Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d4d72406-067d-1f67-e053-2995a90a1a9fAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51628-4232-1Isopropyl Rubbing Alcohol 50%355 mL in 1 BOTTLE, PLASTICLIQUID3554
51628-4232-2Isopropyl Rubbing Alcohol 50%473 mL in 1 BOTTLE, PLASTICLIQUID4734
51628-4232-3Isopropyl Rubbing Alcohol 50%946 mL in 1 BOTTLE, PLASTICLIQUID9464

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51628-4232ISOPROPYL RUBBING ALCOHOL 50% (ISOPROPYL ALCOHOL) LIQUID [MY IMPORTS LLC]4Current NDC, Legacy NDC, 3 package rows20241220_d4d72406-067d-1f67-e053-2995a90a1a9f.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 105 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
Burn CreamBENZALKONIUM CHLORIDE, LIDOCAINE HCITrifecta Pharmaceuticals USA LLC1308ce91-2858-310a-e063-6394a90a68102024-03-06WarningsExact identifier
application number: M003
Instant Hand Sanitizer - Cocoa ButterETHYL ALCOHOLRejoice International, Inc.97dee45e-53be-4b37-a427-fc24388c0e052024-02-28WarningsExact identifier
application number: M003
Instant Hand Sanitizer Aloe VeraETHYL ALCOHOLRejoice International, Inc.1e28454c-f5d8-4d6e-91f9-bc4501b027c12024-02-28WarningsExact identifier
application number: M003
Instant Hand Sanitizer - ClearETHYL ALCOHOLRejoice International, Inc.f0e637d9-d61e-466d-9e05-f906639dbaca2024-02-28WarningsExact identifier
application number: M003
Instant Hand SanitizerETHYL ALCOHOLRejoice International, Inc.07b163e4-8f67-44e7-b5ef-f237023080e02024-02-28WarningsExact identifier
application number: M003
Instant Hand Sanitizer - Ice ClearETHYL ALCOHOLRejoice International, Inc.605ec88a-2f4c-4716-8522-eb2748b433982024-02-28WarningsExact identifier
application number: M003
Instant Hand Sanitizer - OriginalETHYL ALCOHOLRejoice International, Inc.bb9cc886-275e-4996-99dc-529f928b49052024-02-28WarningsExact identifier
application number: M003
Liquid Hand CleanseTRICLOSANRejoice International, Inc.23ff5450-8308-41c0-9052-1ac4c4433d6c2024-02-28WarningsExact identifier
application number: M003
XtraCare Antibacterial Hand Cleanse OriginalTRICLOSANRejoice International, Inc.b5ce6663-fe82-4da1-923e-acea293d7a002024-02-28WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
616456isopropyl alcohol 50 % Topical SolutionPSNd4d72406-067d-1f67-e053-2995a90a1a9f4
616456isopropyl alcohol 0.5 ML/ML Topical SolutionSCDd4d72406-067d-1f67-e053-2995a90a1a9f4
616456isopropyl alcohol 50 % Topical SolutionSYd4d72406-067d-1f67-e053-2995a90a1a9f4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51628-4232-151628423201355 mL in 1 BOTTLE, PLASTIC (51628-4232-1) 355 ml2020-06-180000-00-00NoNoCurrent
51628-4232-251628423202473 mL in 1 BOTTLE, PLASTIC (51628-4232-2) 473 ml2020-06-180000-00-00NoNoCurrent
51628-4232-351628423203946 mL in 1 BOTTLE, PLASTIC (51628-4232-3) 946 ml2020-06-180000-00-00NoNoCurrent