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 48 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Freshnap Plus - 80% Ethyl Alcohol ToweletteALCOHOL TOWELETTEKARI-OUT LLCf4ae66e3-323b-5e2e-e053-2995a90acf422025-12-27WarningsExact identifier
application number: M003
GuardelleBENZALKONIUM CHLORIDESocial Medical Supply LLC8793e3be-7409-4f71-9397-abbeacd27cf82025-12-22WarningsExact identifier
application number: M003
CareALL First Aid Burn CreamBENZALKONIUM CHLORIDE, LIDOCAINE HCLNew World Imports, Inc69eef888-0044-485c-96a1-247ed12048582025-12-22WarningsExact identifier
application number: M003
Hand Sanitizer Pear Blossom TeaALCOHOL SOLUTIONNoshinku46927edb-f8be-f0b9-e063-6294a90a8e562025-12-22WarningsExact identifier
application number: M003
Hand Sanitizer Santal BlancALCOHOL SOLUTIONNoshinku4692c807-268e-6477-e063-6394a90aac0a2025-12-22WarningsExact identifier
application number: M003
Hand Sanitizer Vanilla CremeALCOHOL SOLUTIONNoshinku4692e68c-2bc8-83f8-e063-6294a90a84e42025-12-22WarningsExact identifier
application number: M003
Alcohol sanitizer wipesALCOHOL/PURIFIED WATERSHANDONG HENGFA HYGIENIC PRODUCTS CO., LTD.ab9634bd-4226-2f73-e053-2995a90a802f2025-12-19WarningsExact identifier
application number: M003
Sanitizing WipesBENZALKONIUM CHLORIDEWipes LLC9e9a76d9-23e0-4d3a-9903-8bf7aba54aa32025-12-19WarningsExact identifier
application number: M003
Hand SanitizerBENZALKONIUM CHLORIDEDGH Pharma, Inc.afeccd10-c7e5-6193-e053-2995a90a9a5a2025-12-18WarningsExact identifier
application number: M003
Hand SanitizerBENZALKONIUM CHLORIDEDGH Pharma, Inc.ae4311f8-fc40-38a7-e053-2a95a90ae8292025-12-18WarningsExact identifier
application number: M003
AlcoholALCOHOLDynarex Corporation88c5dcbe-185f-4966-b98b-25d50299e8df2025-12-18WarningsExact identifier
application number: M003
Povidone IodinePOVIDONE-IODINETwinMed LLCfc8cb10c-4973-c0bd-e053-6394a90a6fdb2025-12-18WarningsExact identifier
application number: M003
Povidone IodinePOVIDONE-IODINETwinMed LLCfcf27cbf-9535-1356-e053-6394a90a03622025-12-18WarningsExact identifier
application number: M003
Povidone IodinePOVIDONE-IODINETwinMed LLCfcf30b3a-c25b-7aaf-e053-6394a90affda2025-12-18WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Black RaspberryETHYL ALCOHOL 70% V/VZhejiang Guoyao Jingyue Aerosol Co., Ltd.462ab5e8-029a-fe9d-e063-6294a90ac14d2025-12-17WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Clementine BurstETHYL ALCOHOL 70% V/VZhejiang Guoyao Jingyue Aerosol Co., Ltd.462ad5ba-253f-2a30-e063-6294a90a261d2025-12-17WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Honeydew TartETHYL ALCOHOL 70% V/VZhejiang Guoyao Jingyue Aerosol Co., Ltd.462af072-6709-546f-e063-6294a90aacc82025-12-17WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Pear BlossomETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC462b1d38-c7fa-992f-e063-6294a90ab78f2025-12-17WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Black RaspberryETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC462b2d3f-67b0-c393-e063-6294a90a208a2025-12-17WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Clementine BurstETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC462b36d0-0a1f-bda8-e063-6294a90a57922025-12-17WarningsExact 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