FDA.reportPublic FDA data

Colgate Phos-Flur Ortho Defense Alcohol Free Anticavity Gushing Grape Fluoride

Product NDC
0126-0034
11-digit product format
001260034
Labeler code
0126
Product ID
0126-0034_0c0515c6-25cb-46b6-ada6-79f8aeb97a28
Type
HUMAN OTC DRUG
Nonproprietary name
SODIUM FLUORIDE
Dosage form
RINSE
Route
DENTAL
Labeler
Colgate Oral Pharmaceuticals, Inc.
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-02-15
Substance
SODIUM FLUORIDE
Active strength
2 mg/10mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Colgate Phos-Flur Ortho Defense Alcohol Free Anticavity Gushing Grape Fluoride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE2 mg/10mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8ZYQ1474W7
Rxcui313029, 1721964

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0126-0034-46Colgate Phos-Flur Ortho Defense Alcohol Free Anticavity Gushing Grape Fluoride500 mL in 1 BOTTLERINSE5008

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0126-0034COLGATE PHOS-FLUR ORTHO DEFENSE ALCOHOL FREE ANTICAVITY GUSHING GRAPE FLUORIDE (SODIUM FLUORIDE) RINSE [COLGATE ORAL PHARMACEUTICALS, INC.]8Current NDC, Legacy NDC, 1 package rows20240113_9a976ac8-d966-4d94-93da-45652f2d2481.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1721964Colgate 0.02 % (0.01 % fluoride ion) Oral RinsePSN9a976ac8-d966-4d94-93da-45652f2d24818
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinsePSN9a976ac8-d966-4d94-93da-45652f2d24818
1721964sodium fluoride 0.2 MG/ML Mouthwash [Colgate]SBD9a976ac8-d966-4d94-93da-45652f2d24818
313029sodium fluoride 0.2 MG/ML MouthwashSCD9a976ac8-d966-4d94-93da-45652f2d24818
1721964Colgate 0.02 % (0.01 % fluoride ion) Oral RinseSY9a976ac8-d966-4d94-93da-45652f2d24818
1721964Colgate 0.2 MG/ML MouthwashSY9a976ac8-d966-4d94-93da-45652f2d24818
313029sodium fluoride 0.02 % (fluoride ion 0.009 % ) Oral RinseSY9a976ac8-d966-4d94-93da-45652f2d24818
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinseSY9a976ac8-d966-4d94-93da-45652f2d24818
1721964Colgate 0.02 % (0.01 % fluoride ion) Oral RinsePSN83aaa7f8-cf61-1faa-e053-2a91aa0a98cd2
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinsePSN83aaa7f8-cf61-1faa-e053-2a91aa0a98cd2
1721964sodium fluoride 0.2 MG/ML Mouthwash [Colgate]SBD83aaa7f8-cf61-1faa-e053-2a91aa0a98cd2
313029sodium fluoride 0.2 MG/ML MouthwashSCD83aaa7f8-cf61-1faa-e053-2a91aa0a98cd2
1721964Colgate 0.02 % (0.01 % fluoride ion) Oral RinseSY83aaa7f8-cf61-1faa-e053-2a91aa0a98cd2
1721964Colgate 0.2 MG/ML MouthwashSY83aaa7f8-cf61-1faa-e053-2a91aa0a98cd2
313029sodium fluoride 0.02 % (fluoride ion 0.009 % ) Oral RinseSY83aaa7f8-cf61-1faa-e053-2a91aa0a98cd2
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinseSY83aaa7f8-cf61-1faa-e053-2a91aa0a98cd2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0126-0034-4600126003446500 mL in 1 BOTTLE (0126-0034-46) 500 ml2011-02-150000-00-00NoNoCurrent