FDA.reportPublic FDA data

Dial Professional Antibacterial and Sensitive Fragrance Free

Product NDC
54340-309
11-digit product format
543400309
Labeler code
54340
Product ID
54340-309_458696c6-881f-d85c-e063-6294a90ac119
Type
HUMAN OTC DRUG
Nonproprietary name
BENZALKONIUM CHLORIDE
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Henkel Corporation
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-01-01
Substance
BENZALKONIUM CHLORIDE
Active strength
.13 g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Dial Professional Antibacterial and Sensitive Fragrance Free
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE.13 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF5UM2KM3W7
Rxcui1046593

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54340-309-01Dial Professional Antibacterial and Sensitive Fragrance Free1000 mL in 1 BOTTLE, DISPENSINGSOLUTION10002
54340-309-02Dial Professional Antibacterial and Sensitive Fragrance Free8 in 1 CARTONSOLUTION82
54340-309-03Dial Professional Antibacterial and Sensitive Fragrance Free3785 mL in 1 BOTTLE, DISPENSINGSOLUTION37852
54340-309-04Dial Professional Antibacterial and Sensitive Fragrance Free4 in 1 CARTONSOLUTION42
54340-309-05Dial Professional Antibacterial and Sensitive Fragrance Free325 mL in 1 BOTTLE, PUMPSOLUTION3252
54340-309-06Dial Professional Antibacterial and Sensitive Fragrance Free12 in 1 CARTONSOLUTION122

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54340-309DIAL PROFESSIONAL ANTIBACTERIAL DEFENSE SPRING WATER (BENZALKONIUM CHLORIDE) SOLUTION DIAL PROFESSIONAL ANTIBACTERIAL AND SENSITIVE FRAGRANCE FREE (BENZALKONIUM CHLORIDE) SOLUTION DIAL PROFESSIONAL ANTIBACTERIAL DEFENSE GOLD (BENZALKONIUM CHLORIDE) SOLUTION [HENKEL CORPORATION]1Current NDC, 6 package rows20241222_29644a9d-3954-a6e5-e063-6394a90a82c7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapPSN29644a9d-3954-a6e5-e063-6394a90a82c72
1046593benzalkonium chloride 1.3 MG/ML Medicated Liquid SoapSCD29644a9d-3954-a6e5-e063-6394a90a82c72
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapSY29644a9d-3954-a6e5-e063-6394a90a82c72
1046593benzalkonium chloride 1.33 MG/ML Medicated Liquid SoapSY29644a9d-3954-a6e5-e063-6394a90a82c72

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
54340-309-01543400309011000 mL in 1 BOTTLE, DISPENSING1000 mlHistorical
54340-309-02543400309028 BOTTLE, DISPENSING in 1 CARTON (54340-309-02) / 1000 mL in 1 BOTTLE, DISPENSING (54340-309-01) 2024-01-01NoNoHistorical
54340-309-03543400309033785 mL in 1 BOTTLE, DISPENSING3785 mlHistorical
54340-309-04543400309044 BOTTLE, DISPENSING in 1 CARTON (54340-309-04) / 3785 mL in 1 BOTTLE, DISPENSING (54340-309-03) 2024-01-01NoNoHistorical
54340-309-0554340030905325 mL in 1 BOTTLE, PUMP325 mlHistorical
54340-309-065434003090612 BOTTLE, PUMP in 1 CARTON (54340-309-06) / 325 mL in 1 BOTTLE, PUMP (54340-309-05) 2024-01-01NoNoHistorical