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

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 Identifiers#

Field, Values table
FieldValues
Unii3K9958V90M
Rxcui581662

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

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 ml2024-06-25NoNoHistorical
83318-605-14833180605143785 mL in 1 BOTTLE, PLASTIC3785 mlHistorical