FDA.reportPublic FDA data

Crest Cavity Protection

Product NDC
37000-025
Requested package NDC
37000-025-08
11-digit product format
370000025
Labeler code
37000
Product ID
37000-025_47e4cda7-53e4-6dcf-e063-6394a90ae844
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
GEL, DENTIFRICE
Route
DENTAL
Labeler
The Procter & Gamble Manufacturing Company
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1995-06-16
Substance
SODIUM FLUORIDE
Active strength
1.5 mg/g
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
Crest Cavity Protection
Brand name suffix
Cool Mint Gel
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE1.5 mg/g

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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
891775Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3d7fffb9-47e0-73cd-e054-00144ff88e88Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
37000-025-062023-03-29Crest Cavity Protection Cool Mint Gel
37000-025-062023-03-29Crest Cavity Protection Cool Mint Gel
37000-025-062023-03-29Crest Cavity Protection Cool Mint Gel
37000-025-082023-03-29Crest Cavity Protection Cool Mint Gel
37000-025-082023-03-29Crest Cavity Protection Cool Mint Gel
37000-025-082023-03-29Crest Cavity Protection Cool Mint Gel
37000-025-572023-03-29Crest Cavity Protection Cool Mint Gel
37000-025-572023-03-29Crest Cavity Protection Cool Mint Gel
37000-025-572023-03-29Crest Cavity Protection Cool Mint Gel
37000-025-062023-01-30Crest Cavity Protection Cool Mint Gel
37000-025-062023-01-30Crest Cavity Protection Cool Mint Gel
37000-025-062023-01-30Crest Cavity Protection Cool Mint Gel
37000-025-082023-01-30Crest Cavity Protection Cool Mint Gel
37000-025-082023-01-30Crest Cavity Protection Cool Mint Gel
37000-025-082023-01-30Crest Cavity Protection Cool Mint Gel
37000-025-572023-01-30Crest Cavity Protection Cool Mint Gel
37000-025-572023-01-30Crest Cavity Protection Cool Mint Gel
37000-025-572023-01-30Crest Cavity Protection Cool Mint Gel
37000-025-062021-02-12Crest Cavity Protection Cool Mint Gel
37000-025-062021-02-12Crest Cavity Protection Cool Mint Gel
37000-025-062021-02-12Crest Cavity Protection Cool Mint Gel
37000-025-082021-02-12Crest Cavity Protection Cool Mint Gel
37000-025-082021-02-12Crest Cavity Protection Cool Mint Gel
37000-025-082021-02-12Crest Cavity Protection Cool Mint Gel
37000-025-572021-02-12Crest Cavity Protection Cool Mint Gel
37000-025-572021-02-12Crest Cavity Protection Cool Mint Gel
37000-025-572021-02-12Crest Cavity Protection Cool Mint Gel
37000-025-062021-01-29Crest Cavity Protection Cool Mint Gel
37000-025-062021-01-29Crest Cavity Protection Cool Mint Gel
37000-025-062021-01-29Crest Cavity Protection Cool Mint Gel
37000-025-082021-01-29Crest Cavity Protection Cool Mint Gel
37000-025-082021-01-29Crest Cavity Protection Cool Mint Gel
37000-025-082021-01-29Crest Cavity Protection Cool Mint Gel
37000-025-572021-01-29Crest Cavity Protection Cool Mint Gel
37000-025-572021-01-29Crest Cavity Protection Cool Mint Gel
37000-025-572021-01-29Crest Cavity Protection Cool Mint Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37000-025-06Crest Cavity ProtectionCool Mint Gel1 in 1 CARTONGEL, DENTIFRICE110
37000-025-06Crest Cavity ProtectionCool Mint Gel181 g in 1 TUBEGEL, DENTIFRICE18110
37000-025-08Crest Cavity ProtectionCool Mint Gel1 in 1 CARTONGEL, DENTIFRICE110
37000-025-08Crest Cavity ProtectionCool Mint Gel232 g in 1 TUBEGEL, DENTIFRICE23210
37000-025-57Crest Cavity ProtectionCool Mint Gel161 g in 1 TUBEGEL, DENTIFRICE16110
37000-025-57Crest Cavity ProtectionCool Mint Gel1 in 1 CARTONGEL, DENTIFRICE110

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37000-025CREST CAVITY PROTECTION COOL MINT GEL (SODIUM FLUORIDE) GEL, DENTIFRICE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]9Current NDC, Legacy NDC, 6 package rows20250110_3d7fffb9-47e0-73cd-e054-00144ff88e88.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 2 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Colgate MaxFresh Clean MintSODIUM FLUORIDEColgate-Palmolive Company7cb85fc4-573b-45d7-a430-f2fd17320c432026-08-26WarningsExact identifier
application number: M021
COLGATE OPTIC WHITE PRO SERIES HIGH IMPACT WHITESODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Company8b210b6c-b712-4f14-906c-306922573a262026-08-26WarningsExact identifier
application number: M021
Crest Pro-Health Sensitivity ReliefSODIUM FLUORIDE AND POTASSIUM NITRATEThe Procter & Gamble Manufacturing Company59dff762-7f66-8bdc-e063-6294a90a9f182026-08-25WarningsExact 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
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
COLGATE TOTAL ACTIVE PREVENTION CLEAN MINTSTANNOUS FLUORIDEColgate-Palmolive Company178d4535-fa57-4b53-b1f8-5c591f2ea9e72026-08-21WarningsExact 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 Sensitive ProRelief WhiteningSTANNOUS FLUORIDEColgate-Palmolive Company8d9d485e-6efb-4bca-a779-9e8b0aeed14c2026-08-18WarningsExact 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
891775sodium fluoride 0.243 % ToothpastePSN3d7fffb9-47e0-73cd-e054-00144ff88e8810
891775sodium fluoride 0.00243 MG/MG ToothpasteSCD3d7fffb9-47e0-73cd-e054-00144ff88e8810
891775sodium fluoride 0.243 % (fluoride ion 0.13 % ) ToothpasteSY3d7fffb9-47e0-73cd-e054-00144ff88e8810
891775sodium fluoride 0.243 % (fluoride ion 0.14 % ) ToothpasteSY3d7fffb9-47e0-73cd-e054-00144ff88e8810
891775sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSY3d7fffb9-47e0-73cd-e054-00144ff88e8810
891775sodium fluoride 0.243 % (fluoride ion 0.16 % ) ToothpasteSY3d7fffb9-47e0-73cd-e054-00144ff88e8810
891775sodium fluoride 0.243 % ToothpastePSNdba7a572-a2f0-4c95-b2a7-cf7301e8ca9d4
891775sodium fluoride 0.00243 MG/MG ToothpasteSCDdba7a572-a2f0-4c95-b2a7-cf7301e8ca9d4
891775sodium fluoride 0.243 % (fluoride ion 0.13 % ) ToothpasteSYdba7a572-a2f0-4c95-b2a7-cf7301e8ca9d4
891775sodium fluoride 0.243 % (fluoride ion 0.14 % ) ToothpasteSYdba7a572-a2f0-4c95-b2a7-cf7301e8ca9d4
891775sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSYdba7a572-a2f0-4c95-b2a7-cf7301e8ca9d4
891775sodium fluoride 0.243 % (fluoride ion 0.16 % ) ToothpasteSYdba7a572-a2f0-4c95-b2a7-cf7301e8ca9d4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37000-025-08370000025081 TUBE in 1 CARTON (37000-025-08) / 232 g in 1 TUBE1 tube1995-06-160000-00-00NoNoCurrent