FDA.reportPublic FDA data

Irish Spring Antibacterial Bar

Product NDC
35000-068
Requested package NDC
35000-068-06
11-digit product format
350000068
Labeler code
35000
Product ID
35000-068_760b36bf-6395-4a42-8b3e-2b74d193d79a
Type
HUMAN OTC DRUG
Nonproprietary name
Chloroxylenol
Dosage form
SOAP
Route
TOPICAL
Labeler
Colgate-Palmolive Company
Application
part333E
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2021-01-01
Marketing end
0000-00-00
Substance
CHLOROXYLENOL
Active strength
3 mg/g
NDC exclude flag
No
Listing certified through
2024-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage35000-06835000-068-06IInactivated by FDA2026-10-05

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
07cba15c-4adc-1039-9ab9-45f5b7e84f4fProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35000-068-01Irish Spring Antibacterial Bar104.8 g in 1 APPLICATORSOAP104.89
35000-068-01Irish Spring Antibacterial Bar1 in 1 CARTONSOAP19
35000-068-03Irish Spring Antibacterial Bar1 in 1 CARTONSOAP19
35000-068-03Irish Spring Antibacterial Bar3 in 1 CELLO PACKSOAP39
35000-068-06Irish Spring Antibacterial Bar6 in 1 CELLO PACKSOAP69
35000-068-06Irish Spring Antibacterial Bar1 in 1 CARTONSOAP19
35000-068-08Irish Spring Antibacterial Bar8 in 1 CELLO PACKSOAP89
35000-068-08Irish Spring Antibacterial Bar1 in 1 CARTONSOAP19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35000-068IRISH SPRING ANTIBACTERIAL BAR (CHLOROXYLENOL) SOAP [COLGATE-PALMOLIVE COMPANY]9Legacy NDC, 8 package rows20241211_ed85cb7e-57e9-48ac-bf38-c1608a66f33a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1860597chloroxylenol 0.3 % Medicated Bar SoapPSNed85cb7e-57e9-48ac-bf38-c1608a66f33a9
1860597chloroxylenol 0.003 MG/MG Medicated Bar SoapSCDed85cb7e-57e9-48ac-bf38-c1608a66f33a9
1860597chloroxylenol 0.3 % Medicated Bar SoapSYed85cb7e-57e9-48ac-bf38-c1608a66f33a9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
35000-068-06350000068066 CARTON in 1 CELLO PACK (35000-068-06) > 1 APPLICATOR in 1 CARTON > 104.8 g in 1 APPLICATOR6 carton2021-01-010000-00-00NoNoCurrent