FDA.reportPublic FDA data

Benzethonium chloride and Dyclonine hydrochloride

Product NDC
83324-232
11-digit product format
833240232
Labeler code
83324
Product ID
83324-232_53d7a1c1-cad4-780c-e063-6394a90aa094
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
2025-04-17
Substance
BENZETHONIUM CHLORIDE; DYCLONINE HYDROCHLORIDE
Active strength
2; 7.5 mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
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 and Dyclonine hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZETHONIUM CHLORIDE2 mg/mL
DYCLONINE HYDROCHLORIDE7.5 mg/mL

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 RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1048366Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
34062b23-52aa-99ae-e063-6294a90ae73fAvailable 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
83324-232-03Benzethonium chloride and Dyclonine hydrochloride9 mL in 1 BOTTLE, WITH APPLICATORLIQUID93
83324-232-03Benzethonium chloride and Dyclonine hydrochloride1 in 1 CARTONLIQUID13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83324-232BENZETHONIUM CHLORIDE AND DYCLONINE HYDROCHLORIDE (LIQUID BANDAGE) LIQUID [CHAIN DRUG MARKETING ASSOCIATION]1Current NDC, 2 package rows20250504_34062b23-52aa-99ae-e063-6294a90ae73f.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 104 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SwabsISOPROPYL ALCOHOLMcKesson4650c945-8e38-5ad9-e054-00144ff8d46c2024-06-07WarningsExact identifier
application number: M003
HAND SANITIZER COCONUT BREEZEALCOHOLSCENT THEORY PRODUCTS LLC1a5152b3-d674-f69a-e063-6394a90a6cac2024-06-07WarningsExact identifier
application number: M003
HAND SANITIZER REBEL CHERRYALCOHOLSCENT THEORY PRODUCTS LLC1a503858-4d2f-8e32-e063-6294a90ade972024-06-07WarningsExact identifier
application number: M003
Antiseptic WipeBENZALKONIUM CHLORIDEJianerkang Medical Co., Ltd1a3c5fc9-70cc-e857-e063-6294a90a34242024-06-06WarningsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDEWildman Business Group1f95b277-e40c-4a17-e063-6294a90a11272024-06-01WarningsExact identifier
application number: M003
Hand SanitizerALCOHOLJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.dbfdecf0-a961-4cc5-bf87-ae30bbc302dd2024-05-31WarningsExact identifier
application number: M003
hand sanitizer 01ALCOHOLCosmuses Cosmetics (Ningbo) Co., Ltd.19a6c3c6-4b27-9011-e063-6394a90ae5122024-05-30WarningsExact identifier
application number: M003
antibacterial hand sanitizer gel 01ALCOHOLCosmuses Cosmetics (Ningbo) Co., Ltd.19a7b2fc-239c-b53c-e063-6394a90a09062024-05-30WarningsExact identifier
application number: M003
MyMedic HydrocortisoneHYDROCORTISONENantong Health & Beyond Hygienic Products Inc.197fc623-2fb9-184c-e063-6394a90a41042024-05-28WarningsExact identifier
application number: M003
Nourishing Hand Sanitizer LimonALCOHOLNoshinkud70fba7a-513f-0341-e053-2a95a90add862024-05-15WarningsExact identifier
application number: M003
Nourishing Hand Sanitizer VetiverALCOHOLNoshinkud70fb84c-fdbc-6ba8-e053-2995a90ab5292024-05-15WarningsExact identifier
application number: M003
Safly BZK Antiseptic ToweletteBENZALKONIUM CHLORIDEJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.5cd9043e-daf2-43eb-9568-54775fc4f84a2024-05-15WarningsExact identifier
application number: M003
Noshinku Bergamot Hand SanitizerALCOHOLNoshinku53fea81e-4482-6fae-e054-00144ff8d46c2024-05-14WarningsExact identifier
application number: M003
Noshinku Eucalyptus Hand SanitizerALCOHOLNoshinku9dcb8b51-d1bb-4305-a5ff-8cc8bdcdc4c02024-05-14WarningsExact identifier
application number: M003
Noshinku Lavender Hand SanitizerALCOHOLNoshinkua57e44b2-f5fa-4c3c-a59c-aa73bfbb66cf2024-05-14WarningsExact identifier
application number: M003
LEADER 2% Mild Iodine TinctureIODINE AND SODIUM IODIDE AND ALCOHOL LIQUIDCardinal Health, 110 dba Leader7f810b92-60f6-2f72-e053-2991aa0ab9732024-05-13WarningsExact identifier
application number: M003
Leader Decolorized IodineALCOHOL LIQUIDCardinal Health, 110 dba Leader822f6f28-956f-dd82-e053-2991aa0ae7522024-05-13WarningsExact identifier
application number: M003
Inverness Ear CareBENZALKONIUM CHLORIDEThe Richline Group, Inc.180a2995-334c-2e93-e063-6294a90aecf72024-05-09WarningsExact identifier
application number: M003
Helzberg Diamonds Ear CareBENZALKONIUM CHLORIDEThe Richline Group, Inc.180a3776-0edd-26f3-e063-6294a90a740d2024-05-09WarningsExact identifier
application number: M003
Ulta Beauty Ear CareBENZALKONIUM CHLORIDEThe Richline Group, Inc.180a37f4-8718-3e40-e063-6294a90acaad2024-05-09WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1048366benzethonium Cl 0.2 % / dyclonine HCl 0.75 % Topical SolutionPSN34062b23-52aa-99ae-e063-6294a90ae73f3
1048366benzethonium chloride 2 MG/ML / dyclonine hydrochloride 7.5 MG/ML Topical SolutionSCD34062b23-52aa-99ae-e063-6294a90ae73f3
1048366benzethonium Cl 0.2 % / dyclonine HCl 0.75 % Topical SolutionSY34062b23-52aa-99ae-e063-6294a90ae73f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
83324-232-03833240232031 BOTTLE, WITH APPLICATOR in 1 CARTON (83324-232-03) / 9 mL in 1 BOTTLE, WITH APPLICATOR2025-04-25NoNoCurrent