FDA.reportPublic FDA data

berkley jensen

Product NDC
63148-350
11-digit product format
631480350
Labeler code
63148
Product ID
63148-350_515341c9-5d49-2351-e063-6394a90ae780
Type
HUMAN OTC DRUG
Nonproprietary name
BENZALKONIUM CHLORIDE
Dosage form
SOAP
Route
TOPICAL
Labeler
Apollo Health and Beauty Care
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-08-15
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
berkley jensen
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
da94f82d-42aa-41e8-e053-2995a90a8381Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63148-350-11berkley jensen333 mL in 1 BOTTLE, PLASTICSOAP3336

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63148-350BERKLEY JENSEN (BENZALKONIUM CHLORIDE) SOAP [APOLLO HEALTH AND BEAUTY CARE]4Current NDC, Legacy NDC, 1 package rows20241022_da94f82d-42aa-41e8-e053-2995a90a8381.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
berkley jensenBENZALKONIUM CHLORIDEApollo Health and Beauty Careda94f82d-42aa-41e8-e053-2995a90a83812026-05-08WarningsExact identifier
ndc (product): 63148-350

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapPSNda94f82d-42aa-41e8-e053-2995a90a83816
1046593benzalkonium chloride 1.3 MG/ML Medicated Liquid SoapSCDda94f82d-42aa-41e8-e053-2995a90a83816
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapSYda94f82d-42aa-41e8-e053-2995a90a83816
1046593benzalkonium chloride 1.33 MG/ML Medicated Liquid SoapSYda94f82d-42aa-41e8-e053-2995a90a83816

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63148-350-1163148035011333 mL in 1 BOTTLE, PLASTIC (63148-350-11) 333 ml2022-08-150000-00-00NoNoCurrent