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 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 1 of 52 · 1,027 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BIO SPECTRA ATTITUDESODIUM FLUORIDE9055-7588 Qubec Inc. DBA Attitude54bd43c9-489d-4e6b-9031-90ec0e3c45162026-09-01WarningsExact identifier
application number: M021
BIO SPECTRA ATTITUDESODIUM FLUORIDE9055-7588 Qubec Inc. DBA Attitude53c344e9-49f5-48aa-8309-1e15f80b80a02026-09-01WarningsExact identifier
application number: M021
Colgate Optic White Stain Fighter With Baking SodaSODIUM FLUORIDEColgate-Palmolive Company8e6113e2-101b-4bde-90e9-6ab32c6ebf5c2026-08-05WarningsExact identifier
application number: M021
TOTAL TP CLEAN MINT PSTSTANNOUS FLUORIDEColgate-Palmolive Company178d4535-fa57-4b53-b1f8-5c591f2ea9e72026-08-05WarningsExact identifier
application number: M021
COLGATE OPTIC WHITE PRO SERIESSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Companycd954777-697a-4cc7-8f5f-b2caf357ef952026-08-05WarningsExact identifier
application number: M021
COLGATE MAX FRESH WATERMELON BLASTSODIUM FLUORIDEColgate-Palmolive Company6c391ef3-d625-403c-a4dc-6e2212682ed12026-08-04WarningsExact identifier
application number: M021
COLGATE 2 IN 1 KIDS SP STRAWBERRYSODIUM FLUORIDEColgate-Palmolive Companyd037f65c-3d22-4d2a-a0a9-3dcba2357ebd2026-08-04WarningsExact identifier
application number: M021
Colgate ULTRA BRITE Baking Soda and Peroxide WhiteningSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Company2b123d70-4f7d-41b0-b48f-711999e97ee02026-08-04WarningsExact identifier
application number: M021
Rorobell WaWa ToothSODIUM MONOFLUOROPHOSPHATEROROBELL93113481-ad9d-4be0-a7b7-a72c8726127d2026-08-03WarningsExact identifier
application number: M021
COLGATE OPTIC WHITE CHARCOALSODIUM FLUORIDEColgate-Palmolive Company70ed4a93-b68f-4198-b4b7-7cfeb17ba5d22026-07-30WarningsExact identifier
application number: M021
Colgate Optic White CharcoalSODIUM FLUORIDEColgate-Palmolive Company82ac5b9d-19e8-46ac-a195-c7d85f2967d52026-07-30WarningsExact identifier
application number: M021
Supersmile Professional Whitening TP Peppy Mint 1.4 ozSODIUM MONOFLUOROPHOSPHATERobell Research, Inc251264ea-20d2-be19-e063-6394a90aa5f62026-07-29WarningsExact identifier
application number: M021
Natural White Sensitive Enamel Guard Alpine MintSODIUM FLUORIDELornamead Products2e832204-ba2d-6dcb-e063-6394a90a5e6c2026-07-29WarningsExact identifier
application number: M021
Natural White Radiant WhiteFLUORIDELornamead Productsf0b62aaa-4983-4bd3-931e-f1a31b870f622026-07-29WarningsExact identifier
application number: M021
TP OW Pro Series Stain PreventionSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Company76df52a3-b24c-4009-8137-fe644dabebf62026-07-29WarningsExact identifier
application number: M021
Colgate Kids Cavity ProtectionSODIUM FLUORIDEColgate-Palmolive Companyf0e68196-8566-443b-9cc8-b57d5c0015582026-07-29WarningsExact identifier
application number: M021
TP OW Pro Series Vividly FreshSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Companyf0551acf-c4d6-4d49-ae9c-4aeaeb99a7002026-07-29WarningsExact identifier
application number: M021
Colgate MaxFresh with Whitening KnockOut FluorideSODIUM FLUORIDEColgate-Palmolive Company92079d13-3b66-42b7-9990-2727a489b6f62026-07-28WarningsExact identifier
application number: M021
BIO SPECTRA ATTITUDESODIUM FLUORIDE9055-7588 Quebec Inc. DBA Attitude7d04d050-b283-4fce-b1e9-e695b70363f92026-07-27WarningsExact identifier
application number: M021
COLGATE OPTIC WHITE ADVANCED OXYGENATING WHITESODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Companycd805999-86e4-4f6c-9889-fa9a2227d5262026-07-24WarningsExact 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