Antibacterial

Product NDC
71020-003
Requested package NDC
71020-003-32
11-digit product format
710200003
Labeler code
71020
Product ID
71020-003_513c9c2a-c06a-afb2-e063-6394a90a2f67
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium Chloride
Dosage form
LIQUID
Route
TOPICAL
Labeler
Sante Manufcaturing Inc
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-10-08
Substance
BENZALKONIUM CHLORIDE
Active strength
1.3 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
Antibacterial
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE1.3 mg/mL

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
3e5c5148-3196-2899-e054-00144ff8d46cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71020-003-32Antibacterial947 mL in 1 BOTTLE, PLASTICLIQUID9476

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71020-003ANTIBACTERIAL (BENZALKONIUM CHLORIDE) LIQUID [SANTE MANUFCATURING INC]5Current NDC, Legacy NDC, 1 package rows20250109_3e5c5148-3196-2899-e054-00144ff8d46c.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
AntibacterialBENZALKONIUM CHLORIDESante Manufcaturing Inc3e5c5148-3196-2899-e054-00144ff8d46c2026-05-07WarningsExact identifier
ndc (package): 71020-003-32
ndc (product): 71020-003
ndc11 (package): 71020000332

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapPSN3e5c5148-3196-2899-e054-00144ff8d46c6
1046593benzalkonium chloride 1.3 MG/ML Medicated Liquid SoapSCD3e5c5148-3196-2899-e054-00144ff8d46c6
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapSY3e5c5148-3196-2899-e054-00144ff8d46c6
1046593benzalkonium chloride 1.33 MG/ML Medicated Liquid SoapSY3e5c5148-3196-2899-e054-00144ff8d46c6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71020-003-3271020000332947 mL in 1 BOTTLE, PLASTIC (71020-003-32) 947 ml2016-10-080000-00-00NoNoCurrent