FDA.reportPublic FDA data

Dial Antibacterial Calm and Soothe

Product NDC
54340-266
Requested package NDC
54340-266-11
11-digit product format
543400266
Labeler code
54340
Product ID
54340-266_4390101d-46d6-3d87-e063-6294a90ad605
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Dial Antibacterial Calm and Soothe
Listing expiration
2026-12-31

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 RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1926450Internal RxNorm 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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dial Antibacterial Calm and SootheBENZALKONIUM CHLORIDEHenkel Corporatione81a2af6-fb4c-702d-e053-2995a90a6eaf2025-11-14WarningsExact identifier
ndc (package): 54340-266-11
ndc (product): 54340-266
ndc11 (package): 54340026611

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
54340-266-11543400266114 CELLO PACK in 1 CARTON (54340-266-11) / 904 g in 1 CELLO PACK (54340-266-09) 4 cello pack2023-02-01NoNoCurrent