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
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Colgate Phos-Flur Ortho Defense Alcohol Free Anticavity Gushing Grape Fluoride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE2 mg/10mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8ZYQ1474W7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
313029Internal RxNorm lookup
1721964Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9a976ac8-d966-4d94-93da-45652f2d2481Available on FDA.report

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 49 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Murchison Hume Dental KitSODIUM MONOFLUOROPHOSPHATEBuzz Products Inc.b1a442e1-86cf-cba6-e053-2995a90a593a2023-12-20WarningsExact identifier
application number: M021
United Airlines Polaris Kit with ColgateSODIUM MONOFLUOROPHOSPHATEBuzz Export Services Pty Ltd (Buzz Products)de4564a4-1012-baad-e053-2a95a90a11b72023-12-20WarningsExact identifier
application number: M021
Orajel Complete ProtectionSODIUM FLUORIDEChurch & Dwight Co., Inc.daebd16f-d278-446d-8b7a-33add5a74fdd2023-12-19WarningsExact identifier
application number: M021
Orajel Sensitivity ReliefSODIUM FLUORIDE AND POTASSIUM NITRATEChurch & Dwight Co., Inc.7b9d9e7d-3844-4d18-ab03-bd0e9dcfccdb2023-12-19WarningsExact identifier
application number: M021
ORTHO GUARDSODIUM FLUORIDEMassco Dental A Division of Dunagin Pharmaceuticals8d3e0dd0-b584-413b-adf3-5c2d05ab72dd2023-12-17WarningsExact identifier
application number: M021
Beyond Activated Coconut Charcoal and Sea SaltSODIUM FLUORIDEBeyond International Incd075fa15-7309-0c10-e053-2995a90a7c952023-11-28WarningsExact identifier
application number: M021
Pro-Den RxSTANNOUS FLUORIDEDen-mat Holdings, Llc9036aa8a-59b1-41b0-b3cb-529d3303a1c02023-11-20WarningsExact identifier
application number: M021
FluoridexSTANNOUS FLUORIDE RINSEDEN-MAT HOLDINGS, LLC5e81f073-c0ca-aa38-e053-2a91aa0ab37b2023-11-20WarningsExact identifier
application number: M021
Hello Vitamin C WhiteningSODIUM FLUORIDEColgate-Palmolive Company38a0276e-910c-527d-1736-65928b9d4ca42023-11-20WarningsExact identifier
application number: M021
POP Feeling PeachySODIUM FLUORIDELG H&H CO., LTD.0abaf99b-9547-46ae-e063-6394a90a6c152023-11-17WarningsExact identifier
application number: M021
UNIVERSAL ANTI-CAVITY FLUORIDESODIUM MONOFLUOROPHOSPHATEUniversal Distribution Center LLCe3356374-befa-41b0-ab0f-edfd5a0626012023-11-16WarningsExact identifier
application number: M021
ANTI CAVITY FLUORIDESODIUM MONOFLUOROPHOSPHATEUniversal Distribution Center LLC421fc2f0-b118-4e7a-a399-ba4780028c542023-11-16WarningsExact identifier
application number: M021
UNIVERSAL CHARCOAL WITH ALOE VERA ANTI-CAVITY FLUORIDESODIUM FLUORIDEUniversal Distribution Center LLC3411924d-1002-460c-83e8-c0c7fbff9ad12023-11-16WarningsExact identifier
application number: M021
ADVANCED WHITENING ANTI CAVITY FLUORIDESODIUM MONOFLUOROPHOSPHATEUniversal Distribution Center LLC8ea8a8d9-b7e4-468f-9a09-4ec634cbd80e2023-11-16WarningsExact identifier
application number: M021
UNIVERSAL ADVANCED WHITENING ANTI-CAVITY FLUORIDESODIUM MONOFLUOROPHOSPHATEUniversal Distribution Center LLC879dfaf0-27c8-41a3-8d01-a1c3eec9edfc2023-11-15WarningsExact identifier
application number: M021
EUTHYMOL Extraordinary Pink WhiteningSODIUM FLUORIDELG H&H CO., LTD.0989936c-237d-dc63-e063-6294a90a885f2023-11-07WarningsExact identifier
application number: M021
Eurofresh WhiteningSODIUM FLUORIDEFarmasi US LLCb56b2b55-e3a4-785a-e053-2a95a90a7abf2023-11-05WarningsExact identifier
application number: M021
Farmasi WhiteningSODIUM FLUORIDEFarmasi US LLC25b3608e-abed-41ca-9971-21981b8a46102023-11-05WarningsExact identifier
application number: M021
United Airlines Therabody UPP KitSODIUM MONOFLUOROPHOSPHATEWessco Internationalfb6c355b-a67d-c4b4-e053-6394a90a0e662023-10-26WarningsExact identifier
application number: M021
United Dental KitSODIUM MONOFLUOROPHOSPHATEWessco International7f348fe7-9918-4934-bed0-f0a77c09d0462023-10-26WarningsExact identifier
application number: M021

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