Antimicrobial cleansing gel

Product NDC
61619-104
Requested package NDC
61619-104-01
11-digit product format
616190104
Labeler code
61619
Product ID
61619-104_c1200e4e-c4f3-9067-e053-2a95a90af509
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
2020-02-20
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.

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61619-104-01Antimicrobial cleansing gel29.57 mL in 1 BOTTLE, PLASTICLOTION29.575
61619-104-04Antimicrobial cleansing gel118.29 mL in 1 BOTTLE, PLASTICLOTION118.295
61619-104-08Antimicrobial cleansing gel236.59 mL in 1 BOTTLE, PLASTICLOTION236.595
61619-104-09Antimicrobial cleansing gel1 in 1 BOXLOTION15
61619-104-32Antimicrobial cleansing gel946.35 mL in 1 BOTTLE, PLASTICLOTION946.355

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61619-104ANTIMICROBIAL CLEANSING GEL (BENZETHONIUM CHLORIDE) LOTION [A-CUTE DERM, INCORPORATED]5Legacy NDC, 5 package rows20210430_9eefba02-85ae-c966-e053-2995a90a27a3.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61619-104-016161901040129.57 mL in 1 BOTTLE, PLASTIC (61619-104-01) 29.57 ml2020-02-200000-00-00NoNoCurrent