FDA.reportPublic FDA data

NEXXGEN 91% RUBBING ALCOHOL

Product NDC
83629-016
11-digit product format
836290016
Labeler code
83629
Product ID
83629-016_c2e182f3-9602-4082-8637-69007f8b8710
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
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
609267da-3ee6-4bd3-aecf-610d9047774cAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83629-016-12NEXXGEN 91% RUBBING ALCOHOL355 mL in 1 BOTTLE, PLASTICLIQUID3553
83629-016-16NEXXGEN 91% RUBBING ALCOHOL473 mL in 1 BOTTLE, PLASTICLIQUID4733
83629-016-32NEXXGEN 91% RUBBING ALCOHOL946 mL in 1 BOTTLE, PLASTICLIQUID9463

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83629-016NEXXGEN 91% RUBBING ALCOHOL (ISOPROPYL ALCOHOL) LIQUID [A & A NEXXGEN LLC]3Current NDC, 3 package rows20241212_609267da-3ee6-4bd3-aecf-610d9047774c.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 97 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
First Aid Only Sting Relief PadBENZOCAINE, ISOPROPYL ALCOHOLAcme United Corporationd71047f6-1353-c758-e053-2995a90a962c2024-11-26WarningsExact identifier
application number: M003
First Aid Only Alcohol Antiseptic PadISOPROPYL ALCOHOLAcme United Coporationa01fec1b-1339-40b9-e053-2995a90aeda52024-11-23WarningsExact identifier
application number: M003
Med-Nap Sterile Alcohol Prep PadsISOPROPYL ALCOHOLAcme United Corporationc6eff57b-d537-69c8-e053-2a95a90adc3a2024-11-23WarningsExact identifier
application number: M003
First Aid Only Alcohol AntisepticISOPROPYL ALCOHOLAcme United Corporationa810e723-ad0c-8c71-e053-2995a90a0acc2024-11-23WarningsExact identifier
application number: M003
Universal 50% Rubbing AlcoholISOPROPYL ALCOHOLUniversal Distribution Center LLC0dcc9bd2-aea5-4c27-9956-47d56221726b2024-11-22WarningsExact identifier
application number: M003
Universal 70% Rubbing Alcohol with Wintergreen and GlycerinISOPROPYL ALCOHOLUniversal Distribution Center LLC9a9d42ad-79d5-4acc-b5d9-cb7468961d472024-11-22WarningsExact identifier
application number: M003
Universal 50% Rubbing Alcohol with Wintergreen and GlycerinISOPROPYL ALCOHOLUniversal Distribution Center LLC044a6287-f568-4cfa-a813-7fc0e6ffc3522024-11-22WarningsExact identifier
application number: M003
NEXXGEN 70% RUBBING ALCOHOLISOPROPYL ALCOHOLA & A Nexxgen LLCce73ac48-c5af-4a35-950c-62ff0232aa302024-11-22WarningsExact identifier
application number: M003
Universal 70% Rubbing AlcoholISOPROPYL ALCOHOLUniversal Distribution Center LLCd8b9b0e7-2cb8-4fc5-af55-790e64d6cfe82024-11-22WarningsExact identifier
application number: M003
Alcohol sterileISOPROPYL ALCOHOLCardinal Health, Incbb7c530f-5d80-4158-b715-09c1c837299d2024-11-21WarningsExact identifier
application number: M003
Alcohol sterileISOPROPYL ALCOHOLCardinal Health 200 LLC10135db9-f614-4511-96ac-faa6a02a1b612024-11-21WarningsExact identifier
application number: M003
BZK Antiseptic Swabsticks 4 TripleBENZALKONIUM CHLORIDEChangzhou Maokang Medical Products Co., Ltdd9f35c14-2f5a-4e1a-bc2b-a7e1631342132024-11-21WarningsExact identifier
application number: M003
Povidone-lodine Swabsticks TriplePOVIDONE-IODINEChangzhou Maokang Medical Products Co., Ltd74e70ea9-640b-4295-a40f-56f65fca13002024-11-21WarningsExact identifier
application number: M003
MK Alcohol Prep Pads MediumISOPROPYL ALCOHOLChangzhou Maokang Medical Products Co., Ltd37f10b1f-b73c-4d71-91c2-1252f3d9d4ce2024-11-21WarningsExact identifier
application number: M003
BZK Antiseptic ToweletteBENZALKONIUM CHLORIDEChangzhou Maokang Medical Products Co., Ltd1936d749-bf38-a433-e063-6294a90aba8c2024-11-21WarningsExact identifier
application number: M003
Maokang 10 Povidone IodinePOVIDONE-IODINEChangzhou Maokang Medical Products Co., Ltd7c17ce40-0358-44ff-aa60-53711666914b2024-11-21WarningsExact identifier
application number: M003
MK Alcohol Prep Pads MediumISOPROPYL ALCOHOLChangzhou Maokang Medical Products Co., Ltd11390854-9e72-40a2-9c89-3c29a585dced2024-11-21WarningsExact identifier
application number: M003
Instant Hand Sanitizeing WipeISOPROPANOL AND COMPOUND DOUBLE-STRANDED QUATERNARY AMMONIUM SALTSShandong Yayun Sanitary Products Co., Ltd.aa0dc01a-2c6b-7402-e053-2a95a90af6a22024-11-21WarningsExact identifier
application number: M003
Dynarex Povidone Iodine Prep SolutionPOVIDONE IODINE PREP SOLUTIONDynarex Corporation6bb4d55b-2be7-3549-e053-2a91aa0a2bb02024-11-20WarningsExact identifier
application number: M003
Dynarex Povidone Iodine Surgical ScrubPOVIDONE IODINE SURGICAL SCRUB SOLUTIONDynarex Corporation6f053e55-cbf6-9072-e053-2991aa0a2edd2024-11-20WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
582901isopropyl alcohol 91 % Topical SolutionPSN609267da-3ee6-4bd3-aecf-610d9047774c3
582901isopropyl alcohol 0.91 ML/ML Topical SolutionSCD609267da-3ee6-4bd3-aecf-610d9047774c3
582901isopropyl alcohol 91 % Topical SolutionSY609267da-3ee6-4bd3-aecf-610d9047774c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83629-016-1283629001612355 mL in 1 BOTTLE, PLASTIC (83629-016-12) 355 ml2023-08-01NoNoCurrent
83629-016-1683629001616473 mL in 1 BOTTLE, PLASTIC (83629-016-16) 473 ml2023-08-01NoNoCurrent
83629-016-3283629001632946 mL in 1 BOTTLE, PLASTIC (83629-016-32) 946 ml2023-08-01NoNoCurrent