FDA.reportPublic FDA data

Softsoap Antibacterial with Moisturizers White Tea and Berry LHS

Product NDC
35000-249
11-digit product format
350000249
Labeler code
35000
Product ID
35000-249_f2a877b5-60a7-4514-8054-6a9c210f5297
Type
HUMAN OTC DRUG
Nonproprietary name
BENZALKONIUM CHLORIDE
Dosage form
LIQUID
Route
TOPICAL
Labeler
Colgate-Palmolive Company
Application
part333E
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2022-10-04
Marketing end
0000-00-00
Substance
BENZALKONIUM CHLORIDE
Active strength
1 mg/mL
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct35000-249DDiscontinued by firm2026-10-12
excluded packagepackage35000-24935000-249-11DDiscontinued by firm2026-10-12
excluded packagepackage35000-24935000-249-91DDiscontinued by firm2026-10-12

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35000-249-11SOFTSOAP ANTIBACTERIAL WITH MOISTURIZERS WHITE TEA AND BERRY LHS332 mL in 1 BOTTLELIQUID3329
35000-249-91SOFTSOAP ANTIBACTERIAL WITH MOISTURIZERS WHITE TEA AND BERRY LHS1470 mL in 1 BOTTLELIQUID14709

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35000-249SOFTSOAP ANTIBACTERIAL WITH MOISTURIZERS WHITE TEA AND BERRY LHS (BENZALKONIUM CHLORIDE) LIQUID [COLGATE-PALMOLIVE COMPANY]9Legacy NDC, 2 package rows20241215_2e3354f2-42b9-4ecd-be75-24a07875cc1f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapPSN2e3354f2-42b9-4ecd-be75-24a07875cc1f9
1367082Softsoap Antibacterial 0.13 % Medicated Liquid SoapPSN2e3354f2-42b9-4ecd-be75-24a07875cc1f9
1367082benzalkonium chloride 1.3 MG/ML Medicated Liquid Soap [Softsoap Antibacterial]SBD2e3354f2-42b9-4ecd-be75-24a07875cc1f9
1046593benzalkonium chloride 1.3 MG/ML Medicated Liquid SoapSCD2e3354f2-42b9-4ecd-be75-24a07875cc1f9
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapSY2e3354f2-42b9-4ecd-be75-24a07875cc1f9
1046593benzalkonium chloride 1.33 MG/ML Medicated Liquid SoapSY2e3354f2-42b9-4ecd-be75-24a07875cc1f9
1367082Softsoap Antibacterial 0.13 % Medicated Liquid SoapSY2e3354f2-42b9-4ecd-be75-24a07875cc1f9
1367082Softsoap Antibacterial 1.3 MG/ML Medicated Liquid SoapSY2e3354f2-42b9-4ecd-be75-24a07875cc1f9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
35000-249-1135000024911332 mL in 1 BOTTLE (35000-249-11) 332 ml2022-10-040000-00-00NoNoCurrent
35000-249-91350000249911470 mL in 1 BOTTLE (35000-249-91) 1470 ml2022-10-040000-00-00NoNoCurrent