FDA.reportPublic FDA data

Dial Antibacterial Calm and Soothe

Product NDC
54340-266
Requested package NDC
54340-266-12
11-digit product format
543400266
Labeler code
54340
Product ID
54340-266_5f51e2cd-a33d-4d70-e063-6394a90a4c9d
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium Chloride
Dosage form
SOAP
Route
TOPICAL
Labeler
Henkel Corporation
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-09-07
Substance
BENZALKONIUM CHLORIDE
Active strength
.1 g/100g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Dial Antibacterial Calm and Soothe
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE.1 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
F5UM2KM3W7Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
e81a2af6-fb4c-702d-e053-2995a90a6eafAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54340-266-09Dial Antibacterial Calm and Soothe904 g in 1 CELLO PACKSOAP90411
54340-266-10Dial Antibacterial Calm and Soothe339 g in 1 CELLO PACKSOAP33911
54340-266-11Dial Antibacterial Calm and Soothe4 in 1 CARTONSOAP411
54340-266-12Dial Antibacterial Calm and Soothe12 in 1 CARTONSOAP1211

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54340-266DIAL ANTIBACTERIAL CALM AND SOOTHE (BENZALKONIUM CHLORIDE) SOAP [HENKEL CORPORATION]10Current NDC, Legacy NDC, 4 package rows20241222_e81a2af6-fb4c-702d-e053-2995a90a6eaf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1926450benzalkonium chloride 0.1 % Medicated Bar SoapPSNe81a2af6-fb4c-702d-e053-2995a90a6eaf11
1926450benzalkonium chloride 0.001 MG/MG Medicated Bar SoapSCDe81a2af6-fb4c-702d-e053-2995a90a6eaf11
1926450benzalkonium chloride 0.1 % Medicated Bar SoapSYe81a2af6-fb4c-702d-e053-2995a90a6eaf11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
54340-266-125434002661212 CELLO PACK in 1 CARTON (54340-266-12) / 339 g in 1 CELLO PACK (54340-266-10) 12 cello pack2023-01-02NoNoCurrent