FDA.reportPublic FDA data

Handsoap

Product NDC
51316-703
11-digit product format
513160703
Labeler code
51316
Product ID
51316-703_5151d6df-7551-5d8f-e063-6294a90aec43
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium Chloride
Dosage form
SOAP
Route
TOPICAL
Labeler
CVS Pharmacy
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-12-01
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
Handsoap
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
e56e908d-a372-5f3a-e053-2a95a90ac5f6Available 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
51316-703-11Handsoap333 mL in 1 BOTTLE, PLASTICSOAP3338
51316-703-50Handsoap1470 mL in 1 BOTTLE, PLASTICSOAP14708
51316-703-56Handsoap1660 mL in 1 BOTTLE, PLASTICSOAP16608

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-703HANDSOAP (BENZALKONIUM CHLORIDE) SOAP [CVS PHARMACY]5Current NDC, Legacy NDC, 3 package rows20250209_e56e908d-a372-5f3a-e053-2a95a90ac5f6.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
HandsoapBENZALKONIUM CHLORIDECVS Pharmacye56e908d-a372-5f3a-e053-2a95a90ac5f62026-05-08WarningsExact identifier
ndc (product): 51316-703

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapPSNe56e908d-a372-5f3a-e053-2a95a90ac5f68
1046593benzalkonium chloride 1.3 MG/ML Medicated Liquid SoapSCDe56e908d-a372-5f3a-e053-2a95a90ac5f68
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapSYe56e908d-a372-5f3a-e053-2a95a90ac5f68
1046593benzalkonium chloride 1.33 MG/ML Medicated Liquid SoapSYe56e908d-a372-5f3a-e053-2a95a90ac5f68

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51316-703-1151316070311333 mL in 1 BOTTLE, PLASTIC (51316-703-11) 333 ml2024-04-010000-00-00NoNoCurrent
51316-703-50513160703501470 mL in 1 BOTTLE, PLASTIC (51316-703-50) 1470 ml2024-04-01NoNoCurrent
51316-703-56513160703561660 mL in 1 BOTTLE, PLASTIC (51316-703-56) 1660 ml2024-04-010000-00-00NoNoCurrent