Benzalkonium chloride

Product NDC
75712-416
11-digit product format
757120416
Labeler code
75712
Product ID
75712-416_4c0f997d-d3ca-c39e-e063-6294a90ae38d
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium chloride
Dosage form
LIQUID
Route
TOPICAL
Labeler
Old East Main Co.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-01-02
Substance
BENZALKONIUM CHLORIDE
Active strength
1.3 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Benzalkonium chloride
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF5UM2KM3W7
Rxcui1046593

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75712-416-96Benzalkonium chloride221 mL in 1 BOTTLE, PUMPLIQUID2212

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapPSN4769b25a-1cc5-5d37-e063-6294a90a6fbb2
1046593benzalkonium chloride 1.3 MG/ML Medicated Liquid SoapSCD4769b25a-1cc5-5d37-e063-6294a90a6fbb2
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapSY4769b25a-1cc5-5d37-e063-6294a90a6fbb2
1046593benzalkonium chloride 1.33 MG/ML Medicated Liquid SoapSY4769b25a-1cc5-5d37-e063-6294a90a6fbb2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
75712-416-9675712041696221 mL in 1 BOTTLE, PUMP (75712-416-96) 221 ml2026-01-02NoNoHistorical