FDA.reportPublic FDA data

Complete

Product NDC
63900-101
Requested package NDC
63900-101-02
11-digit product format
639000101
Labeler code
63900
Product ID
63900-101_41ed3320-484f-c859-e063-6294a90a3cb5
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium chloride
Dosage form
SOAP
Route
TOPICAL
Labeler
Simoniz Saniclean, LLC
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-10-13
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
Complete
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
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
41ed32ea-5a3b-fa50-e063-6394a90a20c4Available 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
63900-101-01Complete3785 mL in 1 BOTTLE, PLASTICSOAP37851
63900-101-02Complete4 in 1 BOXSOAP41

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
CompleteBENZALKONIUM CHLORIDESimoniz Saniclean, LLC41ed32ea-5a3b-fa50-e063-6394a90a20c42025-10-27WarningsExact identifier
ndc (package): 63900-101-02
ndc (product): 63900-101
ndc11 (package): 63900010102

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapPSN41ed32ea-5a3b-fa50-e063-6394a90a20c41
1046593benzalkonium chloride 1.3 MG/ML Medicated Liquid SoapSCD41ed32ea-5a3b-fa50-e063-6394a90a20c41
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapSY41ed32ea-5a3b-fa50-e063-6394a90a20c41
1046593benzalkonium chloride 1.33 MG/ML Medicated Liquid SoapSY41ed32ea-5a3b-fa50-e063-6394a90a20c41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
63900-101-02639000101024 BOTTLE, PLASTIC in 1 BOX (63900-101-02) / 3785 mL in 1 BOTTLE, PLASTIC (63900-101-01) 2025-10-13NoNoCurrent