FDA.reportPublic FDA data

Dial refresh and renew

Product NDC
54340-260
11-digit product format
543400260
Labeler code
54340
Product ID
54340-260_28f4db68-f795-4270-e063-6294a90ad4a0
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
2023-01-02
Substance
BENZALKONIUM CHLORIDE
Active strength
.1 g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
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 refresh and renew
Brand name suffix
Antibacterial white
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
f7f5ed83-1b9b-230a-e053-6394a90ad2aeAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54340-260-01Dial refresh and renewAntibacterial white113 g in 1 PACKETSOAP1132
54340-260-03Dial refresh and renewAntibacterial white113 g in 1 PACKETSOAP1132
54340-260-03Dial refresh and renewAntibacterial white3 in 1 PACKAGESOAP32
54340-260-04Dial refresh and renewAntibacterial white4 in 1 PACKAGESOAP42
54340-260-04Dial refresh and renewAntibacterial white113 g in 1 PACKETSOAP1132
54340-260-08Dial refresh and renewAntibacterial white8 in 1 PACKAGESOAP82
54340-260-08Dial refresh and renewAntibacterial white113 g in 1 PACKETSOAP1132
54340-260-12Dial refresh and renewAntibacterial white12 in 1 PACKAGESOAP122
54340-260-12Dial refresh and renewAntibacterial white113 g in 1 PACKETSOAP1132

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54340-260DIAL REFRESH AND RENEW ANTIBACTERIAL WHITE (BENZALKONIUM CHLORIDE) SOAP [HENKEL CORPORATION]2Current NDC, 9 package rows20250108_f7f5ed83-1b9b-230a-e053-6394a90ad2ae.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 whiteBENZALKONIUM CHLORIDEHenkel Corporationf7f5ed83-1b9b-230a-e053-6394a90ad2ae2025-01-01WarningsExact identifier
ndc (product): 54340-260

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1926450benzalkonium chloride 0.1 % Medicated Bar SoapPSNf7f5ed83-1b9b-230a-e053-6394a90ad2ae2
1926450benzalkonium chloride 0.001 MG/MG Medicated Bar SoapSCDf7f5ed83-1b9b-230a-e053-6394a90ad2ae2
1926450benzalkonium chloride 0.1 % Medicated Bar SoapSYf7f5ed83-1b9b-230a-e053-6394a90ad2ae2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
54340-260-0154340026001113 g in 1 PACKET (54340-260-01) 113 g2023-01-02NoNoCurrent
54340-260-03543400260033 PACKET in 1 PACKAGE (54340-260-03) / 113 g in 1 PACKET3 packet2023-01-02NoNoCurrent
54340-260-04543400260044 PACKET in 1 PACKAGE (54340-260-04) / 113 g in 1 PACKET4 packet2023-01-02NoNoCurrent
54340-260-08543400260088 PACKET in 1 PACKAGE (54340-260-08) / 113 g in 1 PACKET8 packet2023-01-02NoNoCurrent
54340-260-125434002601212 PACKET in 1 PACKAGE (54340-260-12) / 113 g in 1 PACKET12 packet2023-01-02NoNoCurrent