FDA.reportPublic FDA data

pre fense unscented

Product NDC
48404-050
Requested package NDC
48404-050-04
11-digit product format
484040050
Labeler code
48404
Product ID
48404-050_4428ab74-189c-d384-e063-6294a90ad56b
Type
HUMAN OTC DRUG
Nonproprietary name
BENZALKONIUM CHLORIDE
Dosage form
LIQUID
Route
TOPICAL
Labeler
Prefense LLC
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-05-15
Substance
BENZALKONIUM CHLORIDE
Active strength
120 mg/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
pre fense unscented
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE120 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
1052949Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
a59e9bbf-b60e-970a-e053-2a95a90aaa5eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48404-050-01pre fense unscented44.4 mL in 1 BOTTLELIQUID44.47
48404-050-02pre fense unscented236.6 mL in 1 BOTTLELIQUID236.67
48404-050-03pre fense unscented502.8 mL in 1 BOTTLELIQUID502.87
48404-050-04pre fense unscented236.6 mL in 1 BOTTLELIQUID236.67
48404-050-04pre fense unscented3 in 1 PACKAGELIQUID37
48404-050-05pre fense unscented6 in 1 PACKAGELIQUID67
48404-050-05pre fense unscented44.4 mL in 1 BOTTLELIQUID44.47

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
48404-050PRE FENSE UNSCENTED (BENZALKONIUM CHLORIDE) LIQUID [PREFENSE LLC]4Current NDC, Legacy NDC, 7 package rows20250122_a59e9bbf-b60e-970a-e053-2a95a90aaa5e.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
pre fense unscentedBENZALKONIUM CHLORIDEPrefense LLCa59e9bbf-b60e-970a-e053-2a95a90aaa5e2025-11-21WarningsExact identifier
ndc (package): 48404-050-04
ndc (product): 48404-050
ndc11 (package): 48404005004

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1052949benzalkonium chloride 0.12 % Topical SolutionPSNa59e9bbf-b60e-970a-e053-2a95a90aaa5e7
1052949benzalkonium chloride 1.2 MG/ML Topical SolutionSCDa59e9bbf-b60e-970a-e053-2a95a90aaa5e7
1052949benzalkonium chloride 0.12 % Topical SolutionSYa59e9bbf-b60e-970a-e053-2a95a90aaa5e7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
48404-050-04484040050043 BOTTLE in 1 PACKAGE (48404-050-04) / 236.6 mL in 1 BOTTLE3 bottle2020-05-15NoNoCurrent