FDA.reportPublic FDA data

Crest

Product NDC
69423-897
11-digit product format
694230897
Labeler code
69423
Product ID
69423-897_47e4bcee-5026-eff8-e063-6294a90a9a3c
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
The Procter & Gamble Manufacturing Company
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-10-01
Substance
SODIUM FLUORIDE
Active strength
1.5 mg/g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage69423-89769423-897-29DDiscontinued by firm2026-10-12
excluded packagepackage69423-89769423-897-57DDiscontinued by firm2026-10-12
excluded packagepackage69423-89769423-897-64DDiscontinued by firm2026-10-12

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-0569423-897-57d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0569423-897-64d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0569423-897-29d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2669423-897-57f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2669423-897-64f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2669423-897-29f5e01cc5f278…a2eaf40c39c3…

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
Brand name suffix
Fresh and White
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
f9b31f6b-6b3f-abe0-e053-6294a90acb25Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69423-897-24CrestFresh and White68 g in 1 TUBEPASTE, DENTIFRICE685
69423-897-24CrestFresh and White1 in 1 CARTONPASTE, DENTIFRICE15
69423-897-29CrestFresh and White1 in 1 CARTONPASTE, DENTIFRICE15
69423-897-29CrestFresh and White82 g in 1 TUBEPASTE, DENTIFRICE825
69423-897-57CrestFresh and White1 in 1 CARTONPASTE, DENTIFRICE15
69423-897-57CrestFresh and White161 g in 1 TUBEPASTE, DENTIFRICE1615
69423-897-64CrestFresh and White1 in 1 CARTONPASTE, DENTIFRICE15
69423-897-64CrestFresh and White181 g in 1 TUBEPASTE, DENTIFRICE1815

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69423-897CREST FRESH AND WHITE (SODIUM FLUORIDE) PASTE, DENTIFRICE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]3Current NDC, 8 package rows20250110_f9b31f6b-6b3f-abe0-e053-6294a90acb25.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 8 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Crest Plus Scope plus Whitening Minty Fresh with MouthwashSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company54ed8e02-3c2f-750c-e063-6394a90a4d332026-06-23WarningsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDEH E Bc68b0644-685d-4c62-bf5d-3a5bbea3b0522026-06-22Warnings, Adverse reactionsExact identifier
application number: M021
Tom Whole Care Peppermint fights cavities whitening fresh breath helps fight tartarSODIUM MONOFLUOROPHOSPHATETom's of Maine, Inc.fdbadaae-eab7-4d9a-acf7-815ca93f877c2026-06-16WarningsExact identifier
application number: M021
Natural Fluoride Fresh Mint cavity protection whitening fresh breathSODIUM FLUORIDETom's of Maine, Inc.fce5e8b5-34f8-4a45-a662-82c9034198092026-06-16WarningsExact identifier
application number: M021
Toms Whole Care Spearmint fights cavities whitening fresh breath helps fight tartarSODIUM MONOFLUOROPHOSPHATETom's of Maine, Inc.ebb62015-0027-459a-a9cf-56b640f9f4562026-06-16WarningsExact identifier
application number: M021
Toms Wicked Fresh Spearmint Ice fresh breath / cavity protectionSODIUM MONOFLUOROPHOSPHATETom's of Maine, Inc.b9962eac-186e-4da2-929d-393f18ed02342026-06-16WarningsExact identifier
application number: M021
Toms Wicked Fresh Cool Peppermint fresh breath / cavity protectionSODIUM MONOFLUOROPHOSPHATETom's of Maine, Inc.1c029b10-29b0-4131-9134-cebfca4328a32026-06-16WarningsExact identifier
application number: M021
Toms Whole Care Cinnamon Clove FIGHTS CAVITIES WHITENING FRESH BREATH HELPS FIGHT TARTARSODIUM MONOFLUOROPHOSPHATETom's of Maine, Inc.3e7ab39a-989c-4924-af3e-689404912bee2026-06-16WarningsExact identifier
application number: M021
Crest Plus Cinnamon plus WhiteningSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company53fb780d-3e8b-6747-e063-6294a90a82112026-06-11WarningsExact identifier
application number: M021
Colgate Total SF WhiteningSTANNOUS FLUORIDECOLGATE PALMOLIVE COMPANY7f6b6aa8-50da-151b-c448-9e427d37398f2026-06-11WarningsExact identifier
application number: M021
Colgate MaxClean with Whitening SmartfoamSODIUM FLUORIDEColgate-Palmolive Companyc712ae6b-eff3-4c54-b1fc-37304758d0592026-06-11WarningsExact identifier
application number: M021
Colgate Total Sensitivity Mineral ShieldSTANNOUS FLUORIDEColgate-Palmolive Companyf065318c-1e2a-c04d-f254-f8127b05a88f2026-06-10WarningsExact identifier
application number: M021
Toms Whole Care Mouthwash Fresh MintSODIUM FLUORIDETom's of Maine, Inc.6875f5c1-853c-43da-8226-c09a5518f9bb2026-06-10WarningsExact identifier
application number: M021
Colgate Total SF Fresh Mint StripeSTANNOUS FLUORIDECOLGATE PALMOLIVE COMPANY657020c7-e85c-4c61-9f62-b50351e4b4e52026-06-10WarningsExact identifier
application number: M021
Optimax Anticavity Fluoride BubblegumSODIUM MONOFLUOROPHOSPHATEWhite Glo USA Inc1adc752b-2ba8-4d8f-b4f1-5741f864255b2026-06-09WarningsExact identifier
application number: M021
Kids Crest Cavity Protection Sparkle FunSODIUM FLUORIDEProcter & Gamble Manufactura, S. de R.L. de C.V.df182c22-bbf1-448d-81e8-35cb431d2afc2026-06-08WarningsExact identifier
application number: M021
PEROXICARESODIUM FLUORIDEChurch & Dwight Co., Inc.55262538-15ce-455c-93b1-bb02b5f81d6b2026-06-07WarningsExact identifier
application number: M021
Optimax Anticavity Fluoride RaspberrySODIUM MONOFLUOROPHOSPHATEWhite Glo USA Inc57e1d1cb-da58-4cd2-b960-4056e0b0d2142026-06-05WarningsExact identifier
application number: M021
3ECARE Dual FormulaWhiteningToothpasteSODIUM FLUORIDEHangzhou Namei Zhikang Technology Co., Ltd.533fb7dd-7f84-59c5-e063-6394a90accad2026-06-02WarningsExact identifier
application number: M021
3ECARE Dual FormulaToothpastefor sensitiveteethPOTASSIUM NITRATE SODIUM MONOFLUOROPHOSPHATEHangzhou Namei Zhikang Technology Co., Ltd.533fc83e-a8cf-15c1-e063-6294a90a7b742026-06-02WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
891775sodium fluoride 0.243 % ToothpastePSNf9b31f6b-6b3f-abe0-e053-6294a90acb255
891775sodium fluoride 0.00243 MG/MG ToothpasteSCDf9b31f6b-6b3f-abe0-e053-6294a90acb255
891775sodium fluoride 0.243 % (fluoride ion 0.13 % ) ToothpasteSYf9b31f6b-6b3f-abe0-e053-6294a90acb255
891775sodium fluoride 0.243 % (fluoride ion 0.14 % ) ToothpasteSYf9b31f6b-6b3f-abe0-e053-6294a90acb255
891775sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSYf9b31f6b-6b3f-abe0-e053-6294a90acb255
891775sodium fluoride 0.243 % (fluoride ion 0.16 % ) ToothpasteSYf9b31f6b-6b3f-abe0-e053-6294a90acb255

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69423-897-24694230897241 TUBE in 1 CARTON (69423-897-24) / 68 g in 1 TUBE1 tube2021-10-01NoNoCurrent
69423-897-29694230897291 in 1 CARTONHistorical
69423-897-57694230897571 in 1 CARTONHistorical
69423-897-64694230897641 in 1 CARTONHistorical