FDA.reportPublic FDA data

CVS Pharmacy

Product NDC
51316-704
11-digit product format
513160704
Labeler code
51316
Product ID
51316-704_50dba80d-5a00-2849-e063-6294a90a8130
Type
HUMAN OTC DRUG
Nonproprietary name
BENZALKONIUM CHLORIDE
Dosage form
SOAP
Route
TOPICAL
Labeler
CVS Pharmacy Inc
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
CVS Pharmacy
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
e78ad7c1-23ab-6fec-e053-2995a90a16c0Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51316-704-07CVS Pharmacy222 mL in 1 BOTTLE, PLASTICSOAP2224
51316-704-32CVS Pharmacy946 mL in 1 BOTTLE, PLASTICSOAP9464

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-704CVS PHARMACY (BENZALKONIUM CHLORIDE) SOAP [CVS PHARMACY INC]3Current NDC, Legacy NDC, 2 package rows20250209_e78ad7c1-23ab-6fec-e053-2995a90a16c0.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
CVS PharmacyBENZALKONIUM CHLORIDECVS Pharmacy Ince78ad7c1-23ab-6fec-e053-2995a90a16c02022-08-15WarningsExact identifier
ndc (product): 51316-704

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapPSNe78ad7c1-23ab-6fec-e053-2995a90a16c04
1046593benzalkonium chloride 1.3 MG/ML Medicated Liquid SoapSCDe78ad7c1-23ab-6fec-e053-2995a90a16c04
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapSYe78ad7c1-23ab-6fec-e053-2995a90a16c04
1046593benzalkonium chloride 1.33 MG/ML Medicated Liquid SoapSYe78ad7c1-23ab-6fec-e053-2995a90a16c04

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51316-704-0751316070407222 mL in 1 BOTTLE, PLASTIC (51316-704-07) 222 ml2022-08-150000-00-00NoNoCurrent
51316-704-3251316070432946 mL in 1 BOTTLE, PLASTIC (51316-704-32) 946 ml2022-08-150000-00-00NoNoCurrent