Ben E. Keith FIHS

Product NDC
50980-207
11-digit product format
509800207
Labeler code
50980
Product ID
50980-207_09c78743-cb8d-483c-a5f5-781cc220c0e2
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium Chloride
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Ben E. Keith Foods
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-05-31
Marketing end
2026-11-18
Substance
BENZALKONIUM CHLORIDE
Active strength
1.3 mg/mL
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ben E. Keith FIHS

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE1.3 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF5UM2KM3W7
Rxcui1020365

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50980-207-312022-06-03C16284748780-1d6a99b39-48db-a426-e053-dadaa90af4c2Drug Facts
50980-207-312022-01-28C16284748780-1d6a99b39-48db-a426-e053-dadaa90af4c2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50980-207-12Ben E. Keith FIHS1000 mL in 1 BAGSOLUTION10005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50980-207BEN E. KEITH FIHS (BENZALKONIUM CHLORIDE) SOLUTION [BEN E. KEITH FOODS]5Current NDC, Legacy NDC, 1 package rows20250305_4ca21370-1ecf-42c6-9c32-79cf994c336b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1020365benzalkonium chloride 0.13 % Topical FoamPSN4ca21370-1ecf-42c6-9c32-79cf994c336b5
1020365benzalkonium chloride 1.3 MG/ML Topical FoamSCD4ca21370-1ecf-42c6-9c32-79cf994c336b5
1020365benzalkonium chloride 0.13 % Topical FoamSY4ca21370-1ecf-42c6-9c32-79cf994c336b5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50980-207-12509800207121000 mL in 1 BAG (50980-207-12) 1000 ml2016-05-312026-11-18NoNoCurrent
50980-207-31509800207311000 mL in 1 BAG (50980-207-31) 1000 ml2016-05-310000-00-00NoNoCurrent