FDA.reportPublic FDA data

Benzethonium chloride Plus Dyclonine hydrochloride

Product NDC
63868-045
11-digit product format
638680045
Labeler code
63868
Product ID
63868-045_c7907a41-165f-de3f-e053-2995a90a4fbc
Type
HUMAN OTC DRUG
Nonproprietary name
Liquid Bandage
Dosage form
LIQUID
Route
TOPICAL
Labeler
Chain Drug Marketing Association
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2017-12-19
Marketing end
0000-00-00
Substance
BENZETHONIUM CHLORIDE; DYCLONINE HYDROCHLORIDE
Active strength
0 mg/9mL; mg/9mL
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

Additional Listing Data#

Finished product
Yes
Brand name base
Benzethonium chloride Plus Dyclonine hydrochloride

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZETHONIUM CHLORIDE.2 mg/9mL
DYCLONINE HYDROCHLORIDE.75 mg/9mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiPH41D05744, ZEC193879Q

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1da7d10e-498b-41dd-970f-0f5bd7432f39Product name120190228

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-045-03Benzethonium chloride Plus Dyclonine hydrochloride9 mL in 1 BOTTLE, WITH APPLICATORLIQUID96

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-045BENZETHONIUM CHLORIDE PLUS DYCLONINE HYDROCHLORIDE (LIQUID BANDAGE) LIQUID [CHAIN DRUG MARKETING ASSOCIATION]6Legacy NDC, 1 package rows20241213_2419c9f9-3e15-4d0e-b422-a6110281fd1d.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63868-045-03638680045039 mL in 1 BOTTLE, WITH APPLICATOR (63868-045-03) 9 ml2017-12-190000-00-00NoNoCurrent