FDA.reportPublic FDA data

Hy-G-Clenz

Product NDC
59764-004
11-digit product format
597640004
Labeler code
59764
Product ID
59764-004_ba2f88bd-5358-485b-9ece-257f3aa08e73
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium Chloride
Dosage form
LIQUID
Route
TOPICAL
Labeler
Micronova Manufacturing, Inc.
Application
M
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-12-19
Substance
BENZALKONIUM CHLORIDE
Active strength
13 kg/100kg
NDC exclude flag
No
Listing certified through
2026-12-31
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
Hy-G-Clenz
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE13 kg/100kg

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
F5UM2KM3W7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1046593Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ce96634e-1ce8-4244-b317-8e1da249de83Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59764-004-13Hy-G-Clenz3.80564 kg in 1 BOTTLE, PLASTICLIQUID3.805647

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59764-004HY-G-CLENZ (BENZALKONIUM CHLORIDE) LIQUID [MICRONOVA MANUFACTURING, INC.]6Current NDC, Legacy NDC, 1 package rows20250108_ce96634e-1ce8-4244-b317-8e1da249de83.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 6 of 6 · 111 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MAX relief juniorACETAMINOPHENATLANTIC BIOLOGICALS CORP.396903dc-ae2d-4bf4-b1fd-0017b84abef92024-02-28WarningsExact identifier
application number: M
MAX relief juniorACETAMINOPHENATLANTIC BIOLOGICALS CORP.44730cbd-5b98-49bd-b3b8-6fecb0ccd1532024-02-28WarningsExact identifier
application number: M
HYDROCORTISONEHYDROCORTISONE ACETATEHART Health779f945f-ab69-40de-8d86-ab76debc5c7c2024-02-16WarningsExact identifier
application number: M
First Aid and BurnBENZALKONIUM CHLORIDE, LIDOCAINEHART Healthf5746bba-9d7f-4691-b466-14985473bf142024-02-16WarningsExact identifier
application number: M
IBUPROFENIBUPROFENHART Health1c1374e1-890f-48ab-8f93-e84da9d5bf842024-01-25WarningsExact identifier
application number: M
Hand SanitizerANTISEPTIC GELHART Healthf07daf29-d0db-4cf8-8baf-d175c2b2ef502024-01-25WarningsExact identifier
application number: M
Hydrogen PeroxideHYDROGEN PEROXIDEHART Health0346a322-8f6e-405a-8d17-8bc6ce5105a32024-01-24WarningsExact identifier
application number: M
AlcoholISOPROPYL ALCOHOLNorMed441b915a-287f-4734-b4d9-730b3d95e04c2024-01-24WarningsExact identifier
application number: M
Sooth-a-StingBENZOCAINEHART Healthbd7229b6-813a-4149-bfe2-fe682f270ff42024-01-18WarningsExact identifier
application number: M
First AidBENZALKONIUM CHLORIDE, BENZOCAINEHART Healtha6d258ed-6d6d-42f0-9994-6c2c4c3d0f4a2024-01-18WarningsExact identifier
application number: M
TRIBIOTICBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEHART Healthd8f175f9-f526-4c73-a171-49309ca16cb02024-01-18Warnings, Adverse reactionsExact identifier
application number: M

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapPSNce96634e-1ce8-4244-b317-8e1da249de837
1046593benzalkonium chloride 1.3 MG/ML Medicated Liquid SoapSCDce96634e-1ce8-4244-b317-8e1da249de837
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapSYce96634e-1ce8-4244-b317-8e1da249de837
1046593benzalkonium chloride 1.33 MG/ML Medicated Liquid SoapSYce96634e-1ce8-4244-b317-8e1da249de837

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59764-004-13597640004133.80564 kg in 1 BOTTLE, PLASTIC (59764-004-13) 3.80564 kg2022-12-190000-00-00NoNoCurrent