FDA.reportPublic FDA data

ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN

Product NDC
52862-023
11-digit product format
528620023
Labeler code
52862
Product ID
52862-023_29a2950e-791c-ae41-e063-6294a90a3fd2
Type
HUMAN OTC DRUG
Nonproprietary name
Isopropyl Alcohol
Dosage form
LIQUID
Route
TOPICAL
Labeler
Home Smart Products
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% WITH WINTERGREEN
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
ce735a5f-0502-44ca-b2d6-db97ad0c01cbAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52862-023-03ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN119 mL in 1 BOTTLE, PLASTICLIQUID1193
52862-023-04ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN178 mL in 1 BOTTLE, PLASTICLIQUID1783
52862-023-06ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN237 mL in 1 BOTTLE, PLASTICLIQUID2373
52862-023-09ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN295 mL in 1 BOTTLE, PLASTICLIQUID2953
52862-023-10ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN354 mL in 1 BOTTLE, PLASTICLIQUID3543
52862-023-11ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN414 mL in 1 BOTTLE, PLASTICLIQUID4143
52862-023-12ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN473 mL in 1 BOTTLE, PLASTICLIQUID4733

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52862-023ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN (ISOPROPYL ALCOHOL) LIQUID [HOME SMART PRODUCTS]3Current NDC, Legacy NDC, 7 package rows20241222_ce735a5f-0502-44ca-b2d6-db97ad0c01cb.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 89 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Antibiotic ApplicationBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATECMC Group, Inc.da436c35-a98f-4df7-9d23-885564734cef2025-01-13WarningsExact identifier
application number: M003
Burn TreatmentBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDECMC Group Inc.9dd56b66-48c0-4bcf-a9a8-ba2f1e11ce402025-01-13WarningsExact identifier
application number: M003
Hand SanitizerALCOHOLCMC Group Inc.dcca50e6-0935-401d-a23e-be4d1231dde92025-01-13WarningsExact identifier
application number: M003
Refill 2BENZALKONIUM CHLORIDE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATECMC Group, Inc.45dde3f0-546c-4ec5-beb0-c3d0432f49832025-01-13WarningsExact identifier
application number: M003
Refill 3BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDECMC Group Inc.e5cb395f-5037-4b0e-9c9d-2d78b5b01b252025-01-13WarningsExact identifier
application number: M003
Refill 4ISOPROPYL ALCOHOLCMC Group Inc.6f4a4538-7522-4bcf-b3cf-8dea60438a4d2025-01-13WarningsExact identifier
application number: M003
Refill 6ALCOHOL, WATERCMC Group, Inc.7849ae59-5484-4b86-a0b9-ec9b93d9afe02025-01-13WarningsExact identifier
application number: M003
EVR Povidone lodine WipePOVIDONE LODINEChangzhou Maokang Medical Products Co., Ltd.2b57e301-74e0-e1db-e063-6294a90a6c182025-01-10WarningsExact identifier
application number: M003
EVR Sting Relief WipeBENZOCAINE, ISOPROPYL ALCOHOLChangzhou Maokang Medical Products Co., Ltd.2b584d09-916c-00f8-e063-6294a90adbcf2025-01-10WarningsExact identifier
application number: M003
Medzah Ditek Alcohol Prep PadsISOPROPYL ALCOHOLMedzah Industries4e6e5b6b-147c-4e7c-9b8c-6a3116c4bdac2025-01-10WarningsExact identifier
application number: M003
Alcohol Prep Pad-LargeISOPROPYL ALCOHOLGlobal Biomedical Technologies, LLC93d00515-e93f-48a3-b66b-7d933e734e542025-01-10WarningsExact identifier
application number: M003
DERMADIVE ULTRACARE - TETRAIDBENZALKONIUM CHLORIDEReleaf Technologies LLC025c0b33-73ca-334b-e063-6394a90ad6682025-01-09WarningsExact identifier
application number: M003
Drs. pharmacy triple antibioticBACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE OINTMENTOL PHARMA TECH, LLCbb730976-0045-c0ae-e053-2a95a90af34e2025-01-09WarningsExact identifier
application number: M003
Drs. Antibiotic BacitracinBACITRACINOL PHARMA TECH, LLCc26493c4-0bc1-5fdc-e053-2995a90a81e62025-01-09WarningsExact identifier
application number: M003
Drs. Pharmacy Triple Antibiotic PlusBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, LIDOCAINEOL PHARMA TECH, LLC Drs PHARMACYd037bfb8-0d8c-4eda-e053-2995a90ae1f22025-01-09WarningsExact identifier
application number: M003
BACTINE MAXBACTINE MAX WOUND WASHWellSpring Pharmaceutical Corporation39b26c28-93e0-41a9-8018-f73525ebc0152025-01-08WarningsExact identifier
application number: M003
sterilePOVIDONE-IODINEAsia Dynamics Inc., d/b/a ADI Medical0658a0c8-f5ec-b380-e063-6394a90afff52025-01-08WarningsExact identifier
application number: M003
Betadine Surgical ScrubPOVIDONE-IODINEAtlantis Consumer Healthcare, Inc.1ad39e11-ea1e-44a4-8224-93f8135436c22025-01-06WarningsExact identifier
application number: M003
First Aid AntisepticBENZALKONIUM CHLORIDEWater-Jel Technologies2b3cb958-c0c4-47fd-8338-7c7821135f2b2025-01-06WarningsExact identifier
application number: M003
Instant Hand SanitizerALCOHOLWater-Jel Technologies54e62104-8076-41db-afe5-6dc5c3563acc2025-01-06WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
616456isopropyl alcohol 50 % Topical SolutionPSNce735a5f-0502-44ca-b2d6-db97ad0c01cb3
616456isopropyl alcohol 0.5 ML/ML Topical SolutionSCDce735a5f-0502-44ca-b2d6-db97ad0c01cb3
616456isopropyl alcohol 50 % Topical SolutionSYce735a5f-0502-44ca-b2d6-db97ad0c01cb3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52862-023-0352862002303119 mL in 1 BOTTLE, PLASTIC (52862-023-03) 119 ml2020-06-180000-00-00NoNoCurrent
52862-023-0452862002304178 mL in 1 BOTTLE, PLASTIC (52862-023-04) 178 ml2020-06-180000-00-00NoNoCurrent
52862-023-0652862002306237 mL in 1 BOTTLE, PLASTIC (52862-023-06) 237 ml2020-06-180000-00-00NoNoCurrent
52862-023-0952862002309295 mL in 1 BOTTLE, PLASTIC (52862-023-09) 295 ml2020-06-180000-00-00NoNoCurrent
52862-023-1052862002310354 mL in 1 BOTTLE, PLASTIC (52862-023-10) 354 ml2020-06-180000-00-00NoNoCurrent
52862-023-1152862002311414 mL in 1 BOTTLE, PLASTIC (52862-023-11) 414 ml2020-06-180000-00-00NoNoCurrent
52862-023-1252862002312473 mL in 1 BOTTLE, PLASTIC (52862-023-12) 473 ml2020-06-180000-00-00NoNoCurrent