Plus Brasept Alcocol Gel

Product NDC
83318-605
11-digit product format
833180605
Labeler code
83318
Product ID
83318-605_440c5ac8-dc18-6db4-e063-6294a90a6f19
Type
HUMAN OTC DRUG
Nonproprietary name
ALCOHOL
Dosage form
GEL
Route
TOPICAL
Labeler
NEWDROP NORTH AMERICA LLC
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-03-24
Substance
ALCOHOL
Active strength
.7 mL/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage83318-60583318-605-14DDiscontinued by firm2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 1 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage83318-60583318-605-14DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

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
Plus Brasept Alcocol Gel
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALCOHOL.7 mL/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3K9958V90MInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
581662Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f791c99c-5879-9ba2-e053-6394a90ad3c7Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83318-605-08Plus Brasept Alcocol Gel208200 mL in 1 DRUMGEL2082004
83318-605-14Plus Brasept Alcocol Gel3785 mL in 1 BOTTLE, PLASTICGEL37854

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83318-605PLUS BRASEPT ALCOCOL GEL (ALCOHOL) GEL [NEWDROP NORTH AMERICA LLC]3Current NDC, 2 package rows20240628_f791c99c-5879-9ba2-e053-6394a90ad3c7.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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Plus Brasept Alcocol GelALCOHOLNEWDROP NORTH AMERICA LLCf791c99c-5879-9ba2-e053-6394a90ad3c72025-11-20WarningsExact identifier
ndc (product): 83318-605

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581662ethanol 70 % Topical GelPSNf791c99c-5879-9ba2-e053-6394a90ad3c74
581662ethanol 0.7 ML/ML Topical GelSCDf791c99c-5879-9ba2-e053-6394a90ad3c74
581662ethanol 70 % Topical GelSYf791c99c-5879-9ba2-e053-6394a90ad3c74
581662ethyl alcohol 70 % Topical GelSYf791c99c-5879-9ba2-e053-6394a90ad3c74

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83318-605-0883318060508208200 mL in 1 DRUM (83318-605-08) 208200 ml2024-06-25NoNoCurrent
83318-605-14833180605143785 mL in 1 BOTTLE, PLASTIC3785 mlHistorical