Antisepation

Product NDC
61619-717
Requested package NDC
61619-717-07
11-digit product format
616190717
Labeler code
61619
Product ID
61619-717_d3d2f9a2-7dfb-745a-e053-2a95a90a6a3d
Type
HUMAN OTC DRUG
Nonproprietary name
Benzethonium Chloride
Dosage form
LOTION
Route
CUTANEOUS
Labeler
A-Cute Derm, Incorporated
Application
part333E
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2016-02-05
Marketing end
0000-00-00
Substance
BENZETHONIUM CHLORIDE
Active strength
2 mg/mL
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61619-717-07Antisepation29.6 mL in 1 BOTTLE, PLASTICLOTION29.68
61619-717-10Antisepation1 in 1 BOXLOTION18
61619-717-12Antisepation946.4 mL in 1 BOTTLE, PLASTICLOTION946.48
61619-717-14Antisepation118.294 mL in 1 BOTTLE, PLASTICLOTION118.2948
61619-717-18Antisepation236.6 mL in 1 BOTTLE, PLASTICLOTION236.68
61619-717-28Antisepation3800 mL in 1 BOTTLE, PLASTICLOTION38008

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZETHONIUM CHLORIDEACTIVE INGREDIENTPH41D05744ANTISEPATION ANTIMICROBIAL CLEANSING GEL (BENZETHONIUM CHLORIDE) GEL [A-CUTE DERM, INCORPORATED]1
BENZETHONIUMACTIVE MOIETY1VU15B70BPANTISEPATION ANTIMICROBIAL CLEANSING GEL (BENZETHONIUM CHLORIDE) GEL [A-CUTE DERM, INCORPORATED]1
AMMONIUM LAURYL SULFATEINACTIVE INGREDIENTQ7AO2R1M0BANTISEPATION ANTIMICROBIAL CLEANSING GEL (BENZETHONIUM CHLORIDE) GEL [A-CUTE DERM, INCORPORATED]1
DIAZOLIDINYL UREAINACTIVE INGREDIENTH5RIZ3MPW4ANTISEPATION ANTIMICROBIAL CLEANSING GEL (BENZETHONIUM CHLORIDE) GEL [A-CUTE DERM, INCORPORATED]1
HYDROXYPROPYL BIS-HYDROXYETHYLDIMONIUM CHLORIDEINACTIVE INGREDIENT1EO3O1X7HGANTISEPATION ANTIMICROBIAL CLEANSING GEL (BENZETHONIUM CHLORIDE) GEL [A-CUTE DERM, INCORPORATED]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOANTISEPATION ANTIMICROBIAL CLEANSING GEL (BENZETHONIUM CHLORIDE) GEL [A-CUTE DERM, INCORPORATED]1
IODOPROPYNYL BUTYLCARBAMATEINACTIVE INGREDIENT603P14DHEBANTISEPATION ANTIMICROBIAL CLEANSING GEL (BENZETHONIUM CHLORIDE) GEL [A-CUTE DERM, INCORPORATED]1
LAURAMIDOPROPYL BETAINEINACTIVE INGREDIENT23D6XVI233ANTISEPATION ANTIMICROBIAL CLEANSING GEL (BENZETHONIUM CHLORIDE) GEL [A-CUTE DERM, INCORPORATED]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TANTISEPATION ANTIMICROBIAL CLEANSING GEL (BENZETHONIUM CHLORIDE) GEL [A-CUTE DERM, INCORPORATED]1
PEG-4 LAURATEINACTIVE INGREDIENTAYF4VM3N1ZANTISEPATION ANTIMICROBIAL CLEANSING GEL (BENZETHONIUM CHLORIDE) GEL [A-CUTE DERM, INCORPORATED]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ANTISEPATION ANTIMICROBIAL CLEANSING GEL (BENZETHONIUM CHLORIDE) GEL [A-CUTE DERM, INCORPORATED]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHANTISEPATION ANTIMICROBIAL CLEANSING GEL (BENZETHONIUM CHLORIDE) GEL [A-CUTE DERM, INCORPORATED]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XANTISEPATION ANTIMICROBIAL CLEANSING GEL (BENZETHONIUM CHLORIDE) GEL [A-CUTE DERM, INCORPORATED]1
WATERINACTIVE INGREDIENT059QF0KO0RANTISEPATION ANTIMICROBIAL CLEANSING GEL (BENZETHONIUM CHLORIDE) GEL [A-CUTE DERM, INCORPORATED]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61619-717ANTISEPATION (BENZETHONIUM CHLORIDE) LOTION [A-CUTE DERM, INCORPORATED]8Legacy NDC, 6 package rows20211224_0ef1322d-57e8-44be-a74d-a28dd9811c4e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1243889benzethonium chloride 0.2 % Medicated Liquid SoapPSN0ef1322d-57e8-44be-a74d-a28dd9811c4e8
1243889benzethonium chloride 2 MG/ML Medicated Liquid SoapSCD0ef1322d-57e8-44be-a74d-a28dd9811c4e8
1243889benzethonium chloride 0.2 % Medicated Liquid SoapSY0ef1322d-57e8-44be-a74d-a28dd9811c4e8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61619-717-076161907170729.6 mL in 1 BOTTLE, PLASTIC (61619-717-07) 29.6 ml2016-02-050000-00-00NoNoCurrent