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 Identifiers#

Field, Values table
FieldValues
UniiF5UM2KM3W7
Rxcui1046593

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

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