FDA.reportPublic FDA data

Isopropyl Rubbing Alcohol 70% with Wintergreen

Product NDC
52000-053
11-digit product format
520000053
Labeler code
52000
Product ID
52000-053_758fade3-1fc0-4cca-a8a5-c048a7c3a0f1
Type
HUMAN OTC DRUG
Nonproprietary name
Isopropyl Alcohol
Dosage form
LIQUID
Route
TOPICAL
Labeler
Universal Distribution Center LLC
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-05-20
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 Rubbing Alcohol 70% with Wintergreen
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
3dcdc1cc-ece8-4b47-a236-ee57c375bb99Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52000-053-01Isopropyl Rubbing Alcohol 70% with Wintergreen118 mL in 1 BOTTLE, PLASTICLIQUID1182
52000-053-02Isopropyl Rubbing Alcohol 70% with Wintergreen177 mL in 1 BOTTLE, PLASTICLIQUID1772
52000-053-03Isopropyl Rubbing Alcohol 70% with Wintergreen237 mL in 1 BOTTLE, PLASTICLIQUID2372
52000-053-04Isopropyl Rubbing Alcohol 70% with Wintergreen296 mL in 1 BOTTLE, PLASTICLIQUID2962
52000-053-05Isopropyl Rubbing Alcohol 70% with Wintergreen355 mL in 1 BOTTLE, PLASTICLIQUID3552
52000-053-06Isopropyl Rubbing Alcohol 70% with Wintergreen414 mL in 1 BOTTLE, PLASTICLIQUID4142
52000-053-07Isopropyl Rubbing Alcohol 70% with Wintergreen473 mL in 1 BOTTLE, PLASTICLIQUID4732

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52000-053ISOPROPYL RUBBING ALCOHOL 70% WITH WINTERGREEN (ISOPROPYL ALCOHOL) LIQUID [UNIVERSAL DISTRIBUTION CENTER LLC]2Current NDC, Legacy NDC, 7 package rows20241212_3dcdc1cc-ece8-4b47-a236-ee57c375bb99.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
808520isopropyl alcohol 70 % Topical SolutionPSN3dcdc1cc-ece8-4b47-a236-ee57c375bb992
808520isopropyl alcohol 0.7 ML/ML Topical SolutionSCD3dcdc1cc-ece8-4b47-a236-ee57c375bb992
808520isopropyl alcohol 70 % Topical SolutionSY3dcdc1cc-ece8-4b47-a236-ee57c375bb992

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52000-053-0152000005301118 mL in 1 BOTTLE, PLASTIC (52000-053-01) 118 ml2020-05-200000-00-00NoNoCurrent
52000-053-0252000005302177 mL in 1 BOTTLE, PLASTIC (52000-053-02) 177 ml2020-05-200000-00-00NoNoCurrent
52000-053-0352000005303237 mL in 1 BOTTLE, PLASTIC (52000-053-03) 237 ml2020-05-200000-00-00NoNoCurrent
52000-053-0452000005304296 mL in 1 BOTTLE, PLASTIC (52000-053-04) 296 ml2020-05-200000-00-00NoNoCurrent
52000-053-0552000005305355 mL in 1 BOTTLE, PLASTIC (52000-053-05) 355 ml2020-05-200000-00-00NoNoCurrent
52000-053-0652000005306414 mL in 1 BOTTLE, PLASTIC (52000-053-06) 414 ml2020-05-200000-00-00NoNoCurrent
52000-053-0752000005307473 mL in 1 BOTTLE, PLASTIC (52000-053-07) 473 ml2020-05-200000-00-00NoNoCurrent