FDA.reportPublic FDA data

Tazza

Product NDC
76370-0001
Requested package NDC
76370-0001-4
11-digit product format
763700001
Labeler code
76370
Product ID
76370-0001_461a0228-8ecc-8b76-e063-6294a90ac4e0
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium Chloride
Dosage form
CLOTH
Route
TOPICAL
Labeler
Tazza Brands East Inc.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-11-01
Substance
BENZALKONIUM CHLORIDE
Active strength
.13 g/100mL
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
Tazza
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE.13 g/100mL

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
1038558Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
585eea15-4d92-4f24-be59-83511736ae1aAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76370-0001-0Tazza1.3 mL in 1 APPLICATORCLOTH1.323
76370-0001-0Tazza180 in 1 CANISTERCLOTH18023
76370-0001-1Tazza250 in 1 CANISTERCLOTH25023
76370-0001-1Tazza1.3 mL in 1 APPLICATORCLOTH1.323
76370-0001-2Tazza1500 in 1 CANISTERCLOTH150023
76370-0001-2Tazza1.3 mL in 1 APPLICATORCLOTH1.323
76370-0001-3Tazza1200 in 1 CANISTERCLOTH120023
76370-0001-3Tazza1.3 mL in 1 APPLICATORCLOTH1.323
76370-0001-4Tazza1.3 mL in 1 APPLICATORCLOTH1.323
76370-0001-4Tazza240 in 1 CANISTERCLOTH24023
76370-0001-5Tazza1.3 mL in 1 APPLICATORCLOTH1.323
76370-0001-5Tazza160 in 1 POUCHCLOTH16023
76370-0001-6Tazza1.3 mL in 1 APPLICATORCLOTH1.323
76370-0001-6Tazza80 in 1 POUCHCLOTH8023
76370-0001-7Tazza20 in 1 POUCHCLOTH2023
76370-0001-7Tazza1.3 mL in 1 APPLICATORCLOTH1.323
76370-0001-8Tazza100 in 1 POUCHCLOTH10023
76370-0001-8Tazza1.3 mL in 1 APPLICATORCLOTH1.323
76370-0001-9Tazza1.3 mL in 1 APPLICATORCLOTH1.323
76370-0001-9Tazza50 in 1 POUCHCLOTH5023

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZALKONIUM CHLORIDEACTIVE INGREDIENTF5UM2KM3W7TAZZA (BENZALKONIUM CHLORIDE) CLOTH [TERRABOOST MEDIA LLC]4
BENZALKONIUMACTIVE MOIETY7N6JUD5X6YTAZZA (BENZALKONIUM CHLORIDE) CLOTH [TERRABOOST MEDIA LLC]4
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XTAZZA (BENZALKONIUM CHLORIDE) CLOTH [TERRABOOST MEDIA LLC]4
GLYCERININACTIVE INGREDIENTPDC6A3C0OXTAZZA (BENZALKONIUM CHLORIDE) CLOTH [TERRABOOST MEDIA LLC]4
OLETH-2INACTIVE INGREDIENT7L6R1SQ6M0TAZZA (BENZALKONIUM CHLORIDE) CLOTH [TERRABOOST MEDIA LLC]4
WATERINACTIVE INGREDIENT059QF0KO0RTAZZA (BENZALKONIUM CHLORIDE) CLOTH [TERRABOOST MEDIA LLC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76370-0001TAZZA (BENZALKONIUM CHLORIDE) CLOTH [TAZZA BRANDS EAST INC.]21Current NDC, Legacy NDC, 20 package rows20241206_585eea15-4d92-4f24-be59-83511736ae1a.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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TazzaBENZALKONIUM CHLORIDETazza Brands East Inc.585eea15-4d92-4f24-be59-83511736ae1a2025-12-17WarningsExact identifier
ndc (package): 76370-0001-4
ndc (product): 76370-0001
ndc11 (package): 76370000104

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSN585eea15-4d92-4f24-be59-83511736ae1a23
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCD585eea15-4d92-4f24-be59-83511736ae1a23
1038558benzalkonium chloride 0.13 % Topical ClothSY585eea15-4d92-4f24-be59-83511736ae1a23
1038558benzalkonium chloride 0.13 % Topical SwabSY585eea15-4d92-4f24-be59-83511736ae1a23
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSY585eea15-4d92-4f24-be59-83511736ae1a23
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSY585eea15-4d92-4f24-be59-83511736ae1a23
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSY585eea15-4d92-4f24-be59-83511736ae1a23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76370-0001-476370000104240 APPLICATOR in 1 CANISTER (76370-0001-4) / 1.3 mL in 1 APPLICATOR240 applicator2013-11-010000-00-00NoNoCurrent