FDA.reportPublic FDA data

pre fense

Product NDC
48404-051
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 Identifiers#

Field, Values table
FieldValues
UniiF5UM2KM3W7
Rxcui1052949

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

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 startMarketing endSampleExclude flagStatus
48404-051-014840400510144.4 mL in 1 BOTTLE (48404-051-01) 44.4 ml2020-05-110000-00-00NoNoCurrent
48404-051-0248404005102237 mL in 1 BOTTLE (48404-051-02) 237 ml2020-05-110000-00-00NoNoCurrent
48404-051-03484040051031000 mL in 1 POUCH (48404-051-03) 1000 ml2020-05-110000-00-00NoNoCurrent
48404-051-04484040051041893 mL in 1 JUG (48404-051-04) 1893 ml2020-05-110000-00-00NoNoCurrent
48404-051-05484040051056 BOTTLE in 1 PACKAGE (48404-051-05) / 44.4 mL in 1 BOTTLE6 bottle2020-05-11NoNoCurrent
48404-051-06484040051063 BOTTLE in 1 PACKAGE (48404-051-06) / 236.6 mL in 1 BOTTLE3 bottle2020-05-11NoNoCurrent