FDA.reportPublic FDA data

HIMark

Product NDC
63148-401
11-digit product format
631480401
Labeler code
63148
Product ID
63148-401_515196b3-8057-0623-e063-6294a90a4e44
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
2023-06-01
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
HIMark
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
f96022c6-268b-9085-e053-6294a90a0e3fAvailable 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
63148-401-07HIMark221 mL in 1 BOTTLE, PLASTICLIQUID2217
63148-401-50HIMark1478 mL in 1 BOTTLE, PLASTICLIQUID14787

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63148-401HIMARK (BENZALKONIUM CHLORIDE) LIQUID [APOLLO HEALTH AND BEAUTY CARE]4Current NDC, 2 package rows20250209_f96022c6-268b-9085-e053-6294a90a0e3f.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
HIMarkBENZALKONIUM CHLORIDEApollo Health and Beauty Caref96022c6-268b-9085-e053-6294a90a0e3f2026-05-08WarningsExact identifier
ndc (product): 63148-401

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapPSNf96022c6-268b-9085-e053-6294a90a0e3f7
1046593benzalkonium chloride 1.3 MG/ML Medicated Liquid SoapSCDf96022c6-268b-9085-e053-6294a90a0e3f7
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapSYf96022c6-268b-9085-e053-6294a90a0e3f7
1046593benzalkonium chloride 1.33 MG/ML Medicated Liquid SoapSYf96022c6-268b-9085-e053-6294a90a0e3f7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
63148-401-0763148040107221 mL in 1 BOTTLE, PLASTIC (63148-401-07) 221 ml2023-06-01NoNoCurrent
63148-401-50631480401501478 mL in 1 BOTTLE, PLASTIC (63148-401-50) 1478 ml2023-06-01NoNoCurrent