FDA.reportPublic FDA data

TopCare Antibacterial Hand Fresh and Clean

Product NDC
36800-534
11-digit product format
368000534
Labeler code
36800
Product ID
36800-534_50db7527-3f0e-8b42-e063-6394a90a4f74
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium chloride
Dosage form
LIQUID
Route
TOPICAL
Labeler
Topco Associates LLC
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-06-20
Substance
BENZALKONIUM CHLORIDE
Active strength
1.3 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
TopCare Antibacterial Hand Fresh and Clean
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE1.3 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF5UM2KM3W7
Rxcui1046593

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
36800-534-562022-09-12C16284748780-1ba0f9c33-1d66-a910-e053-dadaa90a0b85NDC 36800-534, Topcare anti bacterial Hand soap
36800-534-562021-01-29C16284748780-1ba0f9c33-1d66-a910-e053-dadaa90a0b85NDC 36800-534, Topcare anti bacterial Hand soap

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-534-50TopCare Antibacterial Hand Fresh and Clean1470 mL in 1 BOTTLE, PLASTICLIQUID14709
36800-534-56TopCare Antibacterial Hand Fresh and Clean1656 mL in 1 BOTTLE, PLASTICLIQUID16569

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-534TOPCARE ANTIBACTERIAL HAND FRESH AND CLEAN (BENZALKONIUM CHLORIDE) LIQUID [TOPCO ASSOCIATES LLC]8Current NDC, Legacy NDC, 2 package rows20240510_182a9b33-1b40-4a8b-8a89-210ce1483205.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapPSN182a9b33-1b40-4a8b-8a89-210ce14832059
1046593benzalkonium chloride 1.3 MG/ML Medicated Liquid SoapSCD182a9b33-1b40-4a8b-8a89-210ce14832059
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapSY182a9b33-1b40-4a8b-8a89-210ce14832059
1046593benzalkonium chloride 1.33 MG/ML Medicated Liquid SoapSY182a9b33-1b40-4a8b-8a89-210ce14832059

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-534-50368000534501470 mL in 1 BOTTLE, PLASTIC (36800-534-50) 1470 ml2023-06-01NoNoCurrent
36800-534-56368000534561656 mL in 1 BOTTLE, PLASTIC (36800-534-56) 1656 ml2019-06-200000-00-00NoNoCurrent