FDA.reportPublic FDA data

pre fense

Product NDC
48404-051
Requested package NDC
48404-051-05
11-digit product format
484040051
Labeler code
48404
Product ID
48404-051_44278015-2997-7473-e063-6294a90ac3bf
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
2020-05-11
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
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
fad70060-8bb6-4b06-a353-666132f64c26Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48404-051-01pre fense44.4 mL in 1 BOTTLELIQUID44.49
48404-051-02pre fense237 mL in 1 BOTTLELIQUID2379
48404-051-03pre fense1000 mL in 1 POUCHLIQUID10009
48404-051-04pre fense1893 mL in 1 JUGLIQUID18939
48404-051-05pre fense6 in 1 PACKAGELIQUID69
48404-051-05pre fense44.4 mL in 1 BOTTLELIQUID44.49
48404-051-06pre fense3 in 1 PACKAGELIQUID39
48404-051-06pre fense236.6 mL in 1 BOTTLELIQUID236.69

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZALKONIUM CHLORIDEACTIVE INGREDIENTF5UM2KM3W7PRE FENSE (BENZALKONIUM CHLORIDE) LIQUID [PREFENSE LLC]2
BENZALKONIUMACTIVE MOIETY7N6JUD5X6YPRE FENSE (BENZALKONIUM CHLORIDE) LIQUID [PREFENSE LLC]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPPRE FENSE (BENZALKONIUM CHLORIDE) LIQUID [PREFENSE LLC]2
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KXPRE FENSE (BENZALKONIUM CHLORIDE) LIQUID [PREFENSE LLC]2
EAST INDIAN LEMONGRASS OILINACTIVE INGREDIENTUP0M8M3VZWPRE FENSE (BENZALKONIUM CHLORIDE) LIQUID [PREFENSE LLC]2
ORANGE PEELINACTIVE INGREDIENTTI9T76XD44PRE FENSE (BENZALKONIUM CHLORIDE) LIQUID [PREFENSE LLC]2
WATERINACTIVE INGREDIENT059QF0KO0RPRE FENSE (BENZALKONIUM CHLORIDE) LIQUID [PREFENSE LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
48404-051PRE FENSE (BENZALKONIUM CHLORIDE) LIQUID [PREFENSE LLC]8Current NDC, Legacy NDC, 8 package rows20250122_fad70060-8bb6-4b06-a353-666132f64c26.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 fenseBENZALKONIUM CHLORIDEPrefense LLCfad70060-8bb6-4b06-a353-666132f64c262025-11-21WarningsExact identifier
ndc (package): 48404-051-05
ndc (product): 48404-051
ndc11 (package): 48404005105

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1052949benzalkonium chloride 0.12 % Topical SolutionPSNfad70060-8bb6-4b06-a353-666132f64c269
1052949benzalkonium chloride 1.2 MG/ML Topical SolutionSCDfad70060-8bb6-4b06-a353-666132f64c269
1052949benzalkonium chloride 0.12 % Topical SolutionSYfad70060-8bb6-4b06-a353-666132f64c269

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
48404-051-05484040051056 BOTTLE in 1 PACKAGE (48404-051-05) / 44.4 mL in 1 BOTTLE6 bottle2020-05-11NoNoCurrent