FDA.reportPublic FDA data

Tazza

Product NDC
76370-0013
Requested package NDC
76370-0013-0
11-digit product format
763700013
Labeler code
76370
Product ID
76370-0013_df4d0107-c35a-7bcf-e053-2a95a90ae832
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium Chloride
Dosage form
CLOTH
Route
TOPICAL
Labeler
Tazza Brands East Inc.
Application
part333E
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2021-06-09
Marketing end
0000-00-00
Substance
BENZALKONIUM CHLORIDE
Active strength
0 g/100mL
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage76370-001376370-0013-0IInactivated by FDA2026-10-05

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76370-0013-0Tazza1700 in 1 POUCHCLOTH17003
76370-0013-0Tazza1.3 mL in 1 APPLICATORCLOTH1.33

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76370-0013TAZZA (BENZALKONIUM CHLORIDE) CLOTH [TAZZA BRANDS EAST INC.]3Legacy NDC, 2 package rows20240120_c4574172-9898-5aa6-e053-2995a90a0557.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSNc4574172-9898-5aa6-e053-2995a90a05573
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCDc4574172-9898-5aa6-e053-2995a90a05573
1038558benzalkonium chloride 0.13 % Topical ClothSYc4574172-9898-5aa6-e053-2995a90a05573
1038558benzalkonium chloride 0.13 % Topical SwabSYc4574172-9898-5aa6-e053-2995a90a05573
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSYc4574172-9898-5aa6-e053-2995a90a05573
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSYc4574172-9898-5aa6-e053-2995a90a05573
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSYc4574172-9898-5aa6-e053-2995a90a05573

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76370-0013-0763700013001700 APPLICATOR in 1 POUCH (76370-0013-0) > 1.3 mL in 1 APPLICATOR1700 applicator2021-06-090000-00-00NoNoCurrent