Antibacterial LHS

Product NDC
63148-113
11-digit product format
631480113
Labeler code
63148
Product ID
63148-113_50dbc8ff-3d39-4641-e063-6394a90abf91
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium Chloride
Dosage form
LIQUID
Route
TOPICAL
Labeler
Apollo Health and Beauty Care
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-01-05
Substance
BENZALKONIUM CHLORIDE
Active strength
130 mg/100mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Antibacterial LHS
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE130 mg/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
0970a4e2-c7b5-bcb7-e063-6394a90a4353Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63148-113-11Antibacterial LHS333 mL in 1 BOTTLE, PLASTICLIQUID3335

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63148-113ANTIBACTERIAL LHS (BENZALKONIUM CHLORIDE) LIQUID [APOLLO HEALTH AND BEAUTY CARE]3Current NDC, 1 package rows20240223_0970a4e2-c7b5-bcb7-e063-6394a90a4353.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
Antibacterial LHSBENZALKONIUM CHLORIDEApollo Health and Beauty Care0970a4e2-c7b5-bcb7-e063-6394a90a43532026-05-02WarningsExact identifier
ndc (product): 63148-113

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapPSN0970a4e2-c7b5-bcb7-e063-6394a90a43535
1046593benzalkonium chloride 1.3 MG/ML Medicated Liquid SoapSCD0970a4e2-c7b5-bcb7-e063-6394a90a43535
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapSY0970a4e2-c7b5-bcb7-e063-6394a90a43535
1046593benzalkonium chloride 1.33 MG/ML Medicated Liquid SoapSY0970a4e2-c7b5-bcb7-e063-6394a90a43535

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
63148-113-1163148011311333 mL in 1 BOTTLE, PLASTIC (63148-113-11) 333 ml2024-01-05NoNoCurrent