Advanced

Product NDC
36800-370
11-digit product format
368000370
Labeler code
36800
Product ID
36800-370_4ab94790-1ffa-d62a-e063-6294a90a1688
Type
HUMAN OTC DRUG
Nonproprietary name
Ethyl Alcohol
Dosage form
GEL
Route
TOPICAL
Labeler
Topco Associates LLC
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-09-27
Substance
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
Advanced
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALCOHOL70 mL/100mL

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
faaa3452-ef1e-47db-9978-5105de69d981Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-370-16Advanced59 mL in 1 BOTTLE, PUMPGEL5918
36800-370-34Advanced236 mL in 1 BOTTLE, PUMPGEL23618
36800-370-45Advanced946 mL in 1 BOTTLE, PUMPGEL94618

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALCOHOLACTIVE INGREDIENT3K9958V90MADVANCED (ETHYL ALCOHOL) GEL [TOPCO ASSOC. LLC]1
ALCOHOLACTIVE MOIETY3K9958V90MADVANCED (ETHYL ALCOHOL) GEL [TOPCO ASSOC. LLC]1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0ADVANCED (ETHYL ALCOHOL) GEL [TOPCO ASSOC. LLC]1
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENT71DD5V995LADVANCED (ETHYL ALCOHOL) GEL [TOPCO ASSOC. LLC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXADVANCED (ETHYL ALCOHOL) GEL [TOPCO ASSOC. LLC]1
GLYCERYL CAPRYLATE/CAPRATEINACTIVE INGREDIENTG7515SW10NADVANCED (ETHYL ALCOHOL) GEL [TOPCO ASSOC. LLC]1
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSADVANCED (ETHYL ALCOHOL) GEL [TOPCO ASSOC. LLC]1
SULISOBENZONEINACTIVE INGREDIENT1W6L629B4KADVANCED (ETHYL ALCOHOL) GEL [TOPCO ASSOC. LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RADVANCED (ETHYL ALCOHOL) GEL [TOPCO ASSOC. LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-370ADVANCED (ETHYL ALCOHOL) GEL [TOPCO ASSOC. LLC]16Current NDC, Legacy NDC, 3 package rows20240802_faaa3452-ef1e-47db-9978-5105de69d981.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
AdvancedETHYL ALCOHOLTopco Associates LLCfaaa3452-ef1e-47db-9978-5105de69d9812026-02-13Warnings, Adverse reactionsExact identifier
ndc (product): 36800-370

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581662ethanol 70 % Topical GelPSNfaaa3452-ef1e-47db-9978-5105de69d98118
581662ethanol 0.7 ML/ML Topical GelSCDfaaa3452-ef1e-47db-9978-5105de69d98118
581662ethanol 70 % Topical GelSYfaaa3452-ef1e-47db-9978-5105de69d98118
581662ethyl alcohol 70 % Topical GelSYfaaa3452-ef1e-47db-9978-5105de69d98118

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-370-163680003701659 mL in 1 BOTTLE, PUMP (36800-370-16) 59 ml2012-09-270000-00-00NoNoCurrent
36800-370-3436800037034236 mL in 1 BOTTLE, PUMP (36800-370-34) 236 ml2012-09-270000-00-00NoNoCurrent
36800-370-4536800037045946 mL in 1 BOTTLE, PUMP (36800-370-45) 946 ml2012-09-270000-00-00NoNoCurrent