FDA.reportPublic FDA data

ANTIBACTERIAL HANDWASH

Product NDC
52000-043
11-digit product format
520000043
Labeler code
52000
Product ID
52000-043_4e4c1ae2-218f-4a7a-9f4a-9ba501ad547e
Type
HUMAN OTC DRUG
Nonproprietary name
benzalkonium chloride
Dosage form
LIQUID
Route
TOPICAL
Labeler
Universal Distribution Center LLC
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-08-01
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
ANTIBACTERIAL HANDWASH
Brand name suffix
TROPICAL BEACH
Listing expiration
2026-12-31

Active Ingredients#

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

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
1046593Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
747affab-118b-882d-e053-2a91aa0a2564Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52000-043-01ANTIBACTERIAL HANDWASHTROPICAL BEACH400 mL in 1 BOTTLELIQUID4003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52000-043ANTIBACTERIAL HANDWASH TROPICAL BEACH (BENZALKONIUM CHLORIDE) LIQUID [UNIVERSAL DISTRIBUTION CENTER LLC]3Current NDC, Legacy NDC, 1 package rows20241212_747affab-118b-882d-e053-2a91aa0a2564.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
ANTIBACTERIAL HANDWASH TROPICAL BEACHBENZALKONIUM CHLORIDEUniversal Distribution Center LLC747affab-118b-882d-e053-2a91aa0a25642024-10-15WarningsExact identifier
ndc (product): 52000-043

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapPSN747affab-118b-882d-e053-2a91aa0a25643
1046593benzalkonium chloride 1.3 MG/ML Medicated Liquid SoapSCD747affab-118b-882d-e053-2a91aa0a25643
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapSY747affab-118b-882d-e053-2a91aa0a25643
1046593benzalkonium chloride 1.33 MG/ML Medicated Liquid SoapSY747affab-118b-882d-e053-2a91aa0a25643

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52000-043-0152000004301400 mL in 1 BOTTLE (52000-043-01) 400 ml2018-08-010000-00-00NoNoCurrent