FDA.reportPublic FDA data

Antibacterial

Product NDC
71788-017
Requested package NDC
71788-017-10
11-digit product format
717880017
Labeler code
71788
Product ID
71788-017_d21c108f-9cc2-46c9-e053-2995a90a2e7e
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium Chloride
Dosage form
LIQUID
Route
TOPICAL
Labeler
Protect U Guard LLC
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2021-12-02
Marketing end
0000-00-00
Substance
BENZALKONIUM CHLORIDE
Active strength
0 g/100mL
NDC exclude flag
No
Listing certified through
2022-12-31
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 packagepackage71788-01771788-017-10IInactivated by FDA2026-10-05

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71788-017-102026-01-29C16284748780-149896155-c00f-586f-e063-e6dba90add90d21c108f-9cc1-46c9-e053-2995a90a2e7e
71788-017-502026-01-29C16284748780-149896155-c00f-586f-e063-e6dba90add90d21c108f-9cc1-46c9-e053-2995a90a2e7e
71788-017-702026-01-29C16284748780-149896155-c00f-586f-e063-e6dba90add90d21c108f-9cc1-46c9-e053-2995a90a2e7e

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71788-017-10Antibacterial4 in 1 CARTONLIQUID43
71788-017-20Antibacterial1000 mL in 1 BOTTLE, PUMPLIQUID10003
71788-017-50Antibacterial12 in 1 CARTONLIQUID123
71788-017-60Antibacterial530 mL in 1 BOTTLE, PUMPLIQUID5303
71788-017-70Antibacterial24 in 1 CARTONLIQUID243
71788-017-80Antibacterial100 mL in 1 BOTTLE, PUMPLIQUID1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71788-017ANTIBACTERIAL LAVENDER SCENT (BENZALKONIUM CHLORIDE) LIQUID ANTIBACTERIAL LEMON SCENT (BENZALKONIUM CHLORIDE) LIQUID ANTIBACTERIAL WATERMELON SCENT (BENZALKONIUM CHLORIDE) LIQUID ANTIBACTERIAL (BENZALKONIUM CHLORIDE) LIQUID ANTIBACTERIAL COTTON SCENT (BENZALKONIUM CHLORIDE) LIQUID [PROTECT U GUARD LLC]3Legacy NDC, 6 package rows20250101_d21c108f-9cc1-46c9-e053-2995a90a2e7e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1233282benzalkonium chloride 0.1 % Medicated Liquid SoapPSNd21c108f-9cc1-46c9-e053-2995a90a2e7e3
1233282benzalkonium chloride 1 MG/ML Medicated Liquid SoapSCDd21c108f-9cc1-46c9-e053-2995a90a2e7e3
1233282benzalkonium chloride 0.1 % Medicated Liquid SoapSYd21c108f-9cc1-46c9-e053-2995a90a2e7e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71788-017-10717880017104 BOTTLE, PUMP in 1 CARTON (71788-017-10) > 1000 mL in 1 BOTTLE, PUMP (71788-017-20) 2021-12-020000-00-00NoNoCurrent