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_53d7df48-ed33-ad29-e063-6394a90a41e1
Type
HUMAN OTC DRUG
Nonproprietary name
Liquid Bandage
Dosage form
LIQUID
Route
TOPICAL
Labeler
Chain Drug Marketing Association
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-12-19
Marketing end
2027-02-28
Substance
BENZETHONIUM CHLORIDE; DYCLONINE HYDROCHLORIDE
Active strength
.2; .75 mg/9mL; mg/9mL
NDC exclude flag
No
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
Benzethonium chloride Plus Dyclonine hydrochloride

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
PH41D05744Internal UNII lookup
ZEC193879QInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2419c9f9-3e15-4d0e-b422-a6110281fd1dAvailable on FDA.report

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]6Current NDC, Legacy NDC, 1 package rows20241213_2419c9f9-3e15-4d0e-b422-a6110281fd1d.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 103 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dermal Wound CleanserBENZETHONIUM CHLORIDESmith & Nephew Medical Ltd.18704cd5-1ecf-4e8c-9897-7e45394e68c82024-07-15WarningsExact identifier
application number: M003
Novex Anti-Bacterial Hand Sanitizer WipeBENZALKONIUM CHLORIDEJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.7832a0be-a8ce-4b56-a9bb-a375b97df2872024-07-10WarningsExact identifier
application number: M003
Callington Anti-Bacterial Hand Sanitizer WipeBENZALKONIUM CHLORIDEJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.00ca48ca-893d-4a3f-ad90-119522664e082024-07-10WarningsExact identifier
application number: M003
Assorted Licensed Hand Sanitizer Grape 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.1c9095ad-ce19-3666-e063-6394a90ae22d2024-07-09WarningsExact identifier
application number: M003
AMORAY 70% ETHYL ALCOHOL HAND SANITIZER FRESH CITRUSETHYL ALCOHOLMY IMPORTS USA LLC1ccb78ed-36f9-a7d2-e063-6394a90a64772024-07-09WarningsExact identifier
application number: M003
AMORAY 70% ETHYL ALCOHOL HAND SANITIZER LAVENDERETHYL ALCOHOLMY IMPORTS USA LLC1ccb9671-1970-39f9-e063-6294a90ac0792024-07-09WarningsExact identifier
application number: M003
AMORAY 70% ETHYL ALCOHOL HAND SANITIZER STRAWBERRYETHYL ALCOHOLMY IMPORTS USA LLC1ccbc68e-2b6b-768c-e063-6294a90a643b2024-07-09WarningsExact identifier
application number: M003
AMORAY 70% ETHYL ALCOHOL HAND SANITIZER ORIGINALETHYL ALCOHOLMY IMPORTS USA LLC1ccbbc55-3f7d-76d1-e063-6294a90a55902024-07-09WarningsExact identifier
application number: M003
AMORAY 70% ETHYL ALCOHOL HAND SANITIZER LAVENDERETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.1cb701f7-61c8-e5f4-e063-6294a90a0c3c2024-07-08WarningsExact identifier
application number: M003
AMORAY 70% ETHYL ALCOHOL HAND SANITIZER ORIGINALETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.1cb77267-73ad-efd2-e063-6294a90a43f72024-07-08WarningsExact identifier
application number: M003
AMORAY 70% ETHYL ALCOHOL HAND SANITIZER STRAWBERRYETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.1cb7d6ca-ef7e-5225-e063-6294a90aa6922024-07-08WarningsExact identifier
application number: M003
Assorted Licensed Hand Sanitizer Sweet pea 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.1cc8a756-852f-6cf8-e063-6394a90a57e62024-07-08WarningsExact identifier
application number: M003
Assorted Licensed Hand Sanitizer Vanilla 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.1cc90b2f-450f-1deb-e063-6394a90a64802024-07-08WarningsExact identifier
application number: M003
AMORAY 70% ETHYL ALCOHOL HAND SANITIZER FRESH CITRUSETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.1cb4316d-c8c6-3fa2-e063-6394a90a23d22024-07-07WarningsExact identifier
application number: M003
Antibacterial Hand SanitizerALCOHOLCosmuses Cosmetics (Ningbo) Co., Ltdf531053d-82e4-7613-e053-2995a90a349f2024-07-02WarningsExact identifier
application number: M003
Antibacterial Hand SanitizerALCOHOLCosmuses Cosmetics (Ningbo) Co., Ltd1ae5c268-1834-4ac2-931e-bb7fd0088cd22024-07-02WarningsExact identifier
application number: M003
Quality ChoiceISOPROPYL ALCOHOLChain Drug Marketing Association Inc1262c5d7-63ef-f1c1-e063-6294a90a1f0f2024-07-02WarningsExact identifier
application number: M003
Genuine First Aid Antiseptic ToweletteBENZALKONIUM CHLORIDEGFA Production (Xiamen) Co., Ltd.dfff78d2-e23c-40b2-8a49-8f4140bb0df62024-06-25WarningsExact identifier
application number: M003
Walgreens 3 Hydrogen Peroxide WipesHYDROGEN PEROXIDEWalgreen Company03c497cc-c8b1-43b7-86ba-f9f9fc7432bf2024-06-18WarningsExact identifier
application number: M003
AntimicrobialBODY CLEANSERMcKesson8ff06cea-3427-5b40-e053-2995a90a06342024-06-17WarningsExact identifier
application number: M003

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 ml2017-12-192027-02-28NoNoCurrent