Colgate Enamel Health Mouthwash

Product NDC
35000-728
Requested package NDC
35000-728-33
11-digit product format
350000728
Labeler code
35000
Product ID
35000-728_07c961b1-21e6-4fea-9880-b8093bac7829
Type
HUMAN OTC DRUG
Nonproprietary name
SODIUM FLUORIDE
Dosage form
RINSE
Route
DENTAL
Labeler
Colgate-Palmolive Company
Application
part355
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2015-08-01
Marketing end
0000-00-00
Substance
SODIUM FLUORIDE
Active strength
0 mg/mL
NDC exclude flag
No
Listing certified through
2021-12-31
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 packagepackage35000-72835000-728-33DDiscontinued by firm2026-10-05

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
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W7COLGATE ENAMEL HEALTH MOUTHWASH (SODIUM FLUORIDE) RINSE [COLGATE-PALMOLIVE COMPANY]1
FLUORIDE IONACTIVE MOIETYQ80VPU408OCOLGATE ENAMEL HEALTH MOUTHWASH (SODIUM FLUORIDE) RINSE [COLGATE-PALMOLIVE COMPANY]1
CETYLPYRIDINIUM CHLORIDEINACTIVE INGREDIENTD9OM4SK49PCOLGATE ENAMEL HEALTH MOUTHWASH (SODIUM FLUORIDE) RINSE [COLGATE-PALMOLIVE COMPANY]1
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SCOLGATE ENAMEL HEALTH MOUTHWASH (SODIUM FLUORIDE) RINSE [COLGATE-PALMOLIVE COMPANY]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCOLGATE ENAMEL HEALTH MOUTHWASH (SODIUM FLUORIDE) RINSE [COLGATE-PALMOLIVE COMPANY]1
PEG-40 CASTOR OILINACTIVE INGREDIENT4ERD2076EFCOLGATE ENAMEL HEALTH MOUTHWASH (SODIUM FLUORIDE) RINSE [COLGATE-PALMOLIVE COMPANY]1
PHOSPHORIC ACIDINACTIVE INGREDIENTE4GA8884NNCOLGATE ENAMEL HEALTH MOUTHWASH (SODIUM FLUORIDE) RINSE [COLGATE-PALMOLIVE COMPANY]1
POLOXAMER 338INACTIVE INGREDIENTF75JV2T505COLGATE ENAMEL HEALTH MOUTHWASH (SODIUM FLUORIDE) RINSE [COLGATE-PALMOLIVE COMPANY]1
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2COLGATE ENAMEL HEALTH MOUTHWASH (SODIUM FLUORIDE) RINSE [COLGATE-PALMOLIVE COMPANY]1
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4COLGATE ENAMEL HEALTH MOUTHWASH (SODIUM FLUORIDE) RINSE [COLGATE-PALMOLIVE COMPANY]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3COLGATE ENAMEL HEALTH MOUTHWASH (SODIUM FLUORIDE) RINSE [COLGATE-PALMOLIVE COMPANY]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYCOLGATE ENAMEL HEALTH MOUTHWASH (SODIUM FLUORIDE) RINSE [COLGATE-PALMOLIVE COMPANY]1
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENT22ADO53M6FCOLGATE ENAMEL HEALTH MOUTHWASH (SODIUM FLUORIDE) RINSE [COLGATE-PALMOLIVE COMPANY]1
SORBITOLINACTIVE INGREDIENT506T60A25RCOLGATE ENAMEL HEALTH MOUTHWASH (SODIUM FLUORIDE) RINSE [COLGATE-PALMOLIVE COMPANY]1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4COLGATE ENAMEL HEALTH MOUTHWASH (SODIUM FLUORIDE) RINSE [COLGATE-PALMOLIVE COMPANY]1
WATERINACTIVE INGREDIENT059QF0KO0RCOLGATE ENAMEL HEALTH MOUTHWASH (SODIUM FLUORIDE) RINSE [COLGATE-PALMOLIVE COMPANY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35000-728COLGATE ENAMEL HEALTH MOUTHWASH (SODIUM FLUORIDE) RINSE [COLGATE-PALMOLIVE COMPANY]9Legacy NDC20231207_7e264195-b024-440b-bafc-1d200694fdb0.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
35000-728-33350000728331000 mL in 1 BOTTLE (35000-728-33) 1000 ml2015-08-010000-00-00NoNoCurrent