FDA.reportPublic FDA data

Dalan Therapy Antibacterial Hand Wash, Cool Protection

Product NDC
51209-015
11-digit product format
512090015
Labeler code
51209
Product ID
51209-015_48fd8d25-558e-323e-e063-6394a90a2bae
Type
HUMAN OTC DRUG
Nonproprietary name
BENZALKONIUM CHLORIDE
Dosage form
LIQUID
Route
TOPICAL
Labeler
DALAN KIMYA ENDUSTRI ANONIM SIRKETI
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-04-03
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
Dalan Therapy Antibacterial Hand Wash, Cool Protection
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
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51209-015-002026-01-23C16284748780-1f386c649-e866-0266-e053-dadaa90a7c1aDalan Therapy Antibacterial Hand Wash, Cool Protection
51209-015-002023-01-30C16284748780-1f386c649-e866-0266-e053-dadaa90a7c1aDalan Therapy Antibacterial Hand Wash, Cool Protection

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51209-015-00Dalan Therapy Antibacterial Hand Wash, Cool Protection300 mL in 1 BOTTLELIQUID3002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51209-015DALAN THERAPY ANTIBACTERIAL HAND WASH, COOL PROTECTION (BENZALKONIUM CHLORIDE) LIQUID [DALAN KIMYA ENDUSTRI ANONIM SIRKETI]1Current NDC, Legacy NDC, 1 package rows20200407_a2a1e927-3b65-372e-e053-2a95a90accdc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapPSNa2a1e927-3b65-372e-e053-2a95a90accdc2
1046593benzalkonium chloride 1.3 MG/ML Medicated Liquid SoapSCDa2a1e927-3b65-372e-e053-2a95a90accdc2
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapSYa2a1e927-3b65-372e-e053-2a95a90accdc2
1046593benzalkonium chloride 1.33 MG/ML Medicated Liquid SoapSYa2a1e927-3b65-372e-e053-2a95a90accdc2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51209-015-0051209001500300 mL in 1 BOTTLE (51209-015-00) 300 ml2020-04-030000-00-00NoNoCurrent