FDA.reportPublic FDA data

NEXXGEN 91% RUBBING ALCOHOL with Wintergreen

Product NDC
83629-018
11-digit product format
836290018
Labeler code
83629
Product ID
83629-018_8c0dd90b-81f4-474b-a3f3-3532dc5d1652
Type
HUMAN OTC DRUG
Nonproprietary name
Isopropyl alcohol
Dosage form
LIQUID
Route
TOPICAL
Labeler
A & A Nexxgen LLC
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-08-01
Substance
ISOPROPYL ALCOHOL
Active strength
91 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
NEXXGEN 91% RUBBING ALCOHOL with Wintergreen
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ISOPROPYL ALCOHOL91 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
582901Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
12b8c85a-da0c-47a1-9531-c9f2858c4f31Available 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
83629-018-12NEXXGEN 91% RUBBING ALCOHOL with Wintergreen355 mL in 1 BOTTLE, PLASTICLIQUID3553
83629-018-16NEXXGEN 91% RUBBING ALCOHOL with Wintergreen473 mL in 1 BOTTLE, PLASTICLIQUID4733
83629-018-32NEXXGEN 91% RUBBING ALCOHOL with Wintergreen946 mL in 1 BOTTLE, PLASTICLIQUID9463

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83629-018NEXXGEN 91% RUBBING ALCOHOL WITH WINTERGREEN (ISOPROPYL ALCOHOL) LIQUID [A & A NEXXGEN LLC]3Current NDC, 3 package rows20241212_12b8c85a-da0c-47a1-9531-c9f2858c4f31.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 35 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hand Sanitizer Cherry PopALCOHOLScent Theory Products LLC4a18b475-fd3b-10a3-e063-6294a90a4f472026-02-05WarningsExact identifier
application number: M003
Hand Sanitizer Ocean SplashALCOHOLScent Theory Products LLC4a18d7b2-94ca-7924-e063-6394a90af3d12026-02-05WarningsExact identifier
application number: M003
Hand Sanitizer Banana CremeALCOHOLScent Theory Products LLC4a18e8e0-43e3-70d8-e063-6294a90adf4b2026-02-05WarningsExact identifier
application number: M003
Hand Sanitizer Juicy PearALCOHOLScent Theory Products LLC4a18e8e0-43e5-70d8-e063-6294a90adf4b2026-02-05WarningsExact identifier
application number: M003
Hand Sanitizer Pink MelonALCOHOLScent Theory Products LLC4a18ec9c-d466-63c1-e063-6294a90a11222026-02-05WarningsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLPharmacy Value Alliance, LLC528011d7-8c6d-4940-bee1-52b39acef40d2026-02-05Warnings, Adverse reactionsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLPublix Super Markets, Inc.14aecc7b-c68a-4cb9-863f-475e204f66a52026-02-05WarningsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDEPublix Super Markets, Inc.250d12ba-524e-4283-ad98-b7318f414ee02026-02-05WarningsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLPublix Super Markets, Inc.b3b5324b-ee2c-4f87-9bb9-81d3d85f73ee2026-02-05WarningsExact identifier
application number: M003
Hand Sanitizer 8 oz. Vitamin E 70 v/vETHYL ALCOHOLNingbo Rejoice Internationala26a6f97-7166-0a40-e053-2a95a90a4b682026-02-05WarningsExact identifier
application number: M003
Hand Sanitizer Vitamin E and Aloe VeraETHYL ALCOHOLNingbo Rejoice Internationala26a4676-6eae-088a-e053-2a95a90a7c1a2026-02-05WarningsExact identifier
application number: M003
Isopropyl alcohol 50 percentISOPROPYL ALCOHOLEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)b1b52183-3296-48b2-b3d3-821c141b0bea2026-02-05WarningsExact identifier
application number: M003
Isopropyl alcohol 50 percentISOPROPYL ALCOHOLEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)ee67fb96-fa2c-4542-8fdb-f2ccd885ee532026-02-05WarningsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLDyad Medical Sourcing, LLCb5c9e222-10eb-4cea-af70-213a77fcc8652026-02-04Warnings, Adverse reactionsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLGoBrands, Inc.0fb3db50-4132-07dc-e063-6294a90a81682026-02-04Warnings, Adverse reactionsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDEGoBrands, Inc.0fa3615b-4181-1bd8-e063-6294a90ad1292026-02-04Warnings, Adverse reactionsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDEGreenbrier International, Incce4e301b-af91-4fa0-a64c-4b235a5ff07d2026-02-04Warnings, Adverse reactionsExact identifier
application number: M003
Terramed Just Think Comfort Armor Antibacterial Cleansing BarBENZALKONIUM CHLORIDERida LLC68e59a77-6a0c-42e2-a6a9-1353470d2e082026-02-04WarningsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLGrocery Outlet, Inc.3dff8c83-7c33-7bca-e063-6394a90a675f2026-02-04Warnings, Adverse reactionsExact identifier
application number: M003
Isopropyl alcoholISOPROPYL ALCOHOLGrocery Outlet, Inc.3dffba95-71c4-a2b0-e063-6394a90aaeb32026-02-04Warnings, Adverse reactionsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
582901isopropyl alcohol 91 % Topical SolutionPSN12b8c85a-da0c-47a1-9531-c9f2858c4f313
582901isopropyl alcohol 0.91 ML/ML Topical SolutionSCD12b8c85a-da0c-47a1-9531-c9f2858c4f313
582901isopropyl alcohol 91 % Topical SolutionSY12b8c85a-da0c-47a1-9531-c9f2858c4f313

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83629-018-1283629001812355 mL in 1 BOTTLE, PLASTIC (83629-018-12) 355 ml2023-08-01NoNoCurrent
83629-018-1683629001816473 mL in 1 BOTTLE, PLASTIC (83629-018-16) 473 ml2023-08-01NoNoCurrent
83629-018-3283629001832946 mL in 1 BOTTLE, PLASTIC (83629-018-32) 946 ml2023-08-01NoNoCurrent