FDA.reportPublic FDA data

Softsoap Antibacterial Sparkling Pear

Product NDC
35000-102
11-digit product format
350000102
Labeler code
35000
Product ID
35000-102_9f6f5e3a-dd17-4f65-b4a4-7f10813423a8
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium Chloride
Dosage form
LIQUID
Route
TOPICAL
Labeler
COLGATE PALMOLIVE COMPANY
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-11-16
Substance
BENZALKONIUM CHLORIDE
Active strength
1.33 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct35000-102DDiscontinued by firm2026-08-17
excluded packagepackage35000-10235000-102-11DDiscontinued by firm2026-08-17

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35000-102-11Softsoap Antibacterial Sparkling Pear332 mL in 1 BOTTLELIQUID3326

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35000-102SOFTSOAP ANTIBACTERIAL SPARKLING PEAR (BENZALKONIUM CHLORIDE) LIQUID [COLGATE PALMOLIVE COMPANY]6Current NDC, Legacy NDC, 1 package rows20241030_455e589e-7a13-4847-b194-568ba43a4e86.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapPSN455e589e-7a13-4847-b194-568ba43a4e866
1046593benzalkonium chloride 1.3 MG/ML Medicated Liquid SoapSCD455e589e-7a13-4847-b194-568ba43a4e866
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapSY455e589e-7a13-4847-b194-568ba43a4e866
1046593benzalkonium chloride 1.33 MG/ML Medicated Liquid SoapSY455e589e-7a13-4847-b194-568ba43a4e866

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
35000-102-1135000010211332 mL in 1 BOTTLE (35000-102-11) 332 ml2020-11-160000-00-00NoNoCurrent