FDA.reportPublic FDA data

Isopropyl Alcohol 50%

Product NDC
10565-003
11-digit product format
105650003
Labeler code
10565
Product ID
10565-003_4833395f-8efc-471c-e063-6394a90a175e
Type
HUMAN OTC DRUG
Nonproprietary name
Isopropyl Alcohol 50%
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
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 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
930bb3a3-5ca3-414c-b4fb-c71ee17fc746Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10565-003-04Isopropyl Alcohol 50%118 mL in 1 BOTTLE, PLASTICSOLUTION11814
10565-003-08Isopropyl Alcohol 50%237 mL in 1 BOTTLE, PLASTICSOLUTION23714
10565-003-16Isopropyl Alcohol 50%473 mL in 1 BOTTLE, PLASTICSOLUTION47314
10565-003-32Isopropyl Alcohol 50%946 mL in 1 BOTTLE, PLASTICSOLUTION94614
10565-003-99Isopropyl Alcohol 50%3785 mL in 1 BOTTLE, PLASTICSOLUTION378514

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10565-003ISOPROPYL ALCOHOL 50% SOLUTION [HYDROX LABORATORIES]13Current NDC, Legacy NDC, 5 package rows20231027_930bb3a3-5ca3-414c-b4fb-c71ee17fc746.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 82 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Walgreens Max Strength Burn GelBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDEWalgreens Co.25a1e89b-bafd-4770-e063-6294a90a14d22025-04-07WarningsExact identifier
application number: M003
Eye WashWATERCMC Group Inc.6158a1f5-a6bc-4a3e-9d1d-0a310d9dc5612025-04-02WarningsExact identifier
application number: M003
Standard ANSI First AidWATER, BENZALKONIUM CHLORIDE, ISOPROPYL ALCOHOL, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, LIDOCAINE HYDROCHLORIDECMC Group, Inc.e1ef74bf-8895-4200-a411-f726dcdaa9452025-04-02WarningsExact identifier
application number: M003
Clear DefenseETHYL ALCOHOLMelaleuca, Inc.a2178a68-780e-e69b-e053-2a95a90ab7d62025-04-02WarningsExact identifier
application number: M003
Large ANSI First Aid KitWATER, BENZALKONIUM CHLORIDE, ISOPROPYL ALCOHOL, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, LIDOCAINE HYDROCHLORIDECMC Group, Inc.fa8578c2-a0bc-4e2e-a4f9-d48debfff3782025-04-02WarningsExact identifier
application number: M003
ETHYL ALCOHOLALCOHOLASP Global LLC67a4b949-ce8a-4841-a965-fcc94165135c2025-04-02WarningsExact identifier
application number: M003
Sanitizing Hand MistETHYL ALCOHOLALO New York LLC31baefe1-2521-9ef3-e063-6294a90a450e2025-04-01WarningsExact identifier
application number: M003
DeconimoHAND SANITIZING WIPESIMAGINE AMAZON LLC311c670d-8f87-b746-e063-6294a90afd5e2025-04-01WarningsExact identifier
application number: M003
Meijer Antibacterial Foaming Hand Wash0.13% BENZALKONIUM CHLORIDE SOLUTIONMeijer, Inc.1eb6b603-ef96-dfda-e063-6294a90ae4682025-03-31WarningsExact identifier
application number: M003
Beautifier Life Hand Sanitizer Mist OceanALCOHOLShenzhen Lantern Scicence Co.,Ltd.31628598-f7b8-111b-e063-6394a90a3de22025-03-28WarningsExact identifier
application number: M003
Beautifier Life Hand Sanitizer Mist WatermelonALCOHOLShenzhen Lantern Scicence Co.,Ltd.31633195-d964-278b-e063-6294a90ad42d2025-03-28WarningsExact identifier
application number: M003
Beautifier Life Hand Sanitizer Mist CucumberALCOHOLShenzhen Lantern Scicence Co.,Ltd.31642cc2-c3f6-891d-e063-6294a90a28582025-03-28WarningsExact identifier
application number: M003
MeijerBENZALKONIUM CHLORIDEMeijer1e69a1b6-1b2b-8db7-e063-6294a90a78e92025-03-28WarningsExact identifier
application number: M003
Berberex Wound GelBENZETHONIUM CHLORIDE, ALLANTOINCosco International, Inc.5dd97e65-bfb3-468e-a2b1-e56d30da99df2025-03-28WarningsExact identifier
application number: M003
ANTIBACTERIAL BANDAGESBENZALKONIUM CHLORIDEGuangdong Comfort Medical Products Co., Ltd.da241df2-6153-05e4-e053-2a95a90a09842025-03-26WarningsExact identifier
application number: M003
Caring Mill Hand Advanced SanitizerETHYL ALCOHOL 70%Veridian Healthcare312e0fde-8b5b-1296-e063-6294a90a4f262025-03-25WarningsExact identifier
application number: M003
HAND SANITIZING WIPESHAND SANITIZING WIPESIMAGINE AMAZON LLC30a373d6-59cd-fc74-e063-6394a90a9a9a2025-03-24WarningsExact identifier
application number: M003
Klean-Them Hand Sanitizing TowelsBENZALKONIUM CHLORIDERite-Kem, Inc.30dedeee-aadd-6436-e063-6394a90a0cde2025-03-21WarningsExact identifier
application number: M003
SaniiswabISOPROPYL ALCOHOLPOLLEY MED LLC303b1ad5-a104-3479-e063-6294a90abcde2025-03-20WarningsExact identifier
application number: M003
XTRA Squeeze Antibacterial Hand Juicy OrangeBENZALKONIUM CHLORIDEMY IMPORTS USA LLC304ab556-36d8-5fba-e063-6394a90a234a2025-03-19WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
616456isopropyl alcohol 50 % Topical SolutionPSN930bb3a3-5ca3-414c-b4fb-c71ee17fc74614
616456isopropyl alcohol 0.5 ML/ML Topical SolutionSCD930bb3a3-5ca3-414c-b4fb-c71ee17fc74614
616456isopropyl alcohol 50 % Topical SolutionSY930bb3a3-5ca3-414c-b4fb-c71ee17fc74614

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10565-003-0410565000304118 mL in 1 BOTTLE, PLASTIC (10565-003-04) 118 ml2019-06-110000-00-00NoNoCurrent
10565-003-0810565000308237 mL in 1 BOTTLE, PLASTIC (10565-003-08) 237 ml2019-06-110000-00-00NoNoCurrent
10565-003-1610565000316473 mL in 1 BOTTLE, PLASTIC (10565-003-16) 473 ml2019-06-110000-00-00NoNoCurrent
10565-003-3210565000332946 mL in 1 BOTTLE, PLASTIC (10565-003-32) 946 ml2019-06-110000-00-00NoNoCurrent
10565-003-99105650003993785 mL in 1 BOTTLE, PLASTIC (10565-003-99) 3785 ml2019-06-110000-00-00NoNoCurrent