Handsoap

Product NDC
36800-535
11-digit product format
368000535
Labeler code
36800
Product ID
36800-535_511532ba-27ac-4788-e063-6394a90a0120
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium chloride
Dosage form
SOAP
Route
TOPICAL
Labeler
Topco Associates LLC
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-08-12
Substance
BENZALKONIUM CHLORIDE
Active strength
130 mg/100mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Handsoap
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE130 mg/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF5UM2KM3W7
Rxcui1046593

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
36800-535-562024-10-19C16284748780-11030e365-2f79-111a-e063-dadaa90a10e2Topcare Antibacterial Hand Soap.
36800-535-562024-01-30C16284748780-11030e365-2f79-111a-e063-dadaa90a10e2Topcare Antibacterial Hand Soap.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-535-56Handsoap1650 mL in 1 BOTTLE, PLASTICSOAP16503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-535HANDSOAP (BENZALKONIUM CHLORIDE) SOAP [TOPCO ASSOCIATES LLC]2Current NDC, Legacy NDC, 1 package rows20241021_e60ff14a-f78d-c9fa-e053-2995a90a7f10.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapPSNe60ff14a-f78d-c9fa-e053-2995a90a7f103
1046593benzalkonium chloride 1.3 MG/ML Medicated Liquid SoapSCDe60ff14a-f78d-c9fa-e053-2995a90a7f103
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapSYe60ff14a-f78d-c9fa-e053-2995a90a7f103
1046593benzalkonium chloride 1.33 MG/ML Medicated Liquid SoapSYe60ff14a-f78d-c9fa-e053-2995a90a7f103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-535-56368000535561650 mL in 1 BOTTLE, PLASTIC (36800-535-56) 1650 ml2022-08-120000-00-00NoNoCurrent