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 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 · 1,037 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
Anticavity Fluoride RinseSODIUM FLUORIDENice-Pak Products, LLCc71d4064-f938-477b-9346-eb38be65390d2026-08-25Warnings, Adverse reactionsExact identifier
application number: M021
AIM Whitening with Baking SodaSODIUM FLUORIDEChurch & Dwight Co., Inc.1d0fd0b4-33ba-5764-e054-00144ff88e882026-08-25WarningsExact identifier
application number: M021
OPTIC WHITE PRO SERIES VIBRANT CLEANSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Companyb1ada157-a9a0-4eec-83a2-6e448d7f12dc2026-08-21WarningsExact identifier
application number: M021
Colgate Max Fresh Clean MintSODIUM FLUORIDEColgate-Palmolive Company7cb85fc4-573b-45d7-a430-f2fd17320c432026-08-21WarningsExact identifier
application number: M021
Therabreath WhiteningSODIUM FLUORIDEChurch & Dwight Co., Inc.3ba04b55-38f9-76f3-e063-6394a90a3c032026-08-21WarningsExact identifier
application number: M021
Therabreath Deep CleanSTANNOUS FLUORIDEChurch & Dwight Co., Inc.3c372f26-e0c4-0659-e063-6294a90ae9f92026-08-21WarningsExact identifier
application number: M021
TheraBreathPOTASSIUM NITRATE, SODIUM FLUORIDEChurch & Dwight Co., Inc.4b812a38-f7cb-51c8-e063-6394a90ab82c2026-08-21WarningsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEYour Military Exchangeseb95e0ca-a94c-41cb-9f54-6c64ed9a97332026-08-21Warnings, Adverse reactionsExact identifier
application number: M021
Pop On Toothpaste.POP ON TOOTHPASTE.POPONSMILES,LLC4a0edab5-ae36-91b5-e063-6294a90aa6852026-08-21WarningsExact identifier
application number: M021
COLGATE OPTIC WHITE PRO SERIES EXPRESS WHITESODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Company188dc3ac-64c9-438e-858b-846f725c6ea02026-08-21WarningsExact identifier
application number: M021
freshSTART Anticavity fluoride toothpaste.ANTICAVITY FLUORIDE TOOTHPASTEGuangzhou Xinuo Technology Co., Ltd.596432d5-3541-6dff-e063-6294a90a9d422026-08-19WarningsExact identifier
application number: M021
COLGATE 2IN1 WHITENING STAIN LIFTERSSODIUM FLUORIDEColgate-Palmolive Company26f1f873-06b2-45ef-a4b9-32f997642bc72026-08-17WarningsExact identifier
application number: M021
COLGATE OPTIC WHITE PRO SERIES HI WHITESODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Company8b210b6c-b712-4f14-906c-306922573a262026-08-17WarningsExact identifier
application number: M021
SprinJene NaturalSODIUM MONOFLUOROPHOSPHATEHealth and Natural Beauty USA Corpe64cecc3-0845-4bdf-a449-d78248791ccf2026-08-17WarningsExact identifier
application number: M021
ATOMY ANTICAVITY TOOTHSODIUM MONOFLUOROPHOSPHATEATOMY CO., LTD.592caccc-e3a9-9c66-e063-6394a90a26e32026-08-16WarningsExact identifier
application number: M021
SprinJene Health BoostSODIUM MONOFLUOROPHOSPHATEHealth and Natural Beauty USA Corp9be87bcd-403a-4d7e-8ded-9833249565d12026-08-14WarningsExact identifier
application number: M021
SprinJene Fresh BoostSODIUM FLUORIDEHealth and Natural Beauty USA Corp919f6f51-6c43-4f1c-9bc7-029bf76c0e682026-08-14WarningsExact identifier
application number: M021
SprinJene Natural Sensitivity ReliefSODIUM MONOFLUOROPHOSPHATE AND POTASSIUM NITRATEHealth and Natural Beauty USA Corp32cc5bc2-60c9-4cb4-acde-485ae494aba22026-08-14WarningsExact 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