FDA.reportPublic FDA data

Dial refresh and renew Antibacterial

Product NDC
54340-017
Requested package NDC
54340-017-03
11-digit product format
543400017
Labeler code
54340
Product ID
54340-017_28f4a243-ce2d-80e8-e063-6394a90a1ce0
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
2022-11-22
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 refresh and renew Antibacterial
Brand name suffix
Mountain Fresh
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
f9a347aa-808c-2095-e053-6394a90a58b1Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54340-017-03Dial refresh and renew AntibacterialMountain Fresh113 g in 1 PACKETSOAP1132
54340-017-03Dial refresh and renew AntibacterialMountain Fresh3 in 1 PACKAGESOAP32
54340-017-08Dial refresh and renew AntibacterialMountain Fresh113 g in 1 PACKETSOAP1132
54340-017-08Dial refresh and renew AntibacterialMountain Fresh8 in 1 PACKAGESOAP82

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54340-017DIAL REFRESH AND RENEW ANTIBACTERIAL MOUNTAIN FRESH (BENZALKONIUM CHLORIDE) SOAP [HENKEL CORPORATION]2Current NDC, 4 package rows20241222_f9a347aa-808c-2095-e053-6394a90a58b1.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 refresh and renew Antibacterial Mountain FreshBENZALKONIUM CHLORIDEHenkel Corporationf9a347aa-808c-2095-e053-6394a90a58b12024-12-10WarningsExact identifier
ndc (package): 54340-017-03
ndc (product): 54340-017
ndc11 (package): 54340001703

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1926450benzalkonium chloride 0.1 % Medicated Bar SoapPSNf9a347aa-808c-2095-e053-6394a90a58b12
1926450benzalkonium chloride 0.001 MG/MG Medicated Bar SoapSCDf9a347aa-808c-2095-e053-6394a90a58b12
1926450benzalkonium chloride 0.1 % Medicated Bar SoapSYf9a347aa-808c-2095-e053-6394a90a58b12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
54340-017-03543400017033 PACKET in 1 PACKAGE (54340-017-03) / 113 g in 1 PACKET3 packet2022-11-22NoNoCurrent