FDA.reportPublic FDA data

Crest Pro-Health

Product NDC
69423-925
11-digit product format
694230925
Labeler code
69423
Product ID
69423-925_47e4c65f-d03c-daab-e063-6294a90a4a99
Type
HUMAN OTC DRUG
Nonproprietary name
Stannous fluoride
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
The Procter & Gamble Manufacturing Company
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-01-04
Substance
STANNOUS FLUORIDE
Active strength
1.4 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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage69423-92569423-925-52DDiscontinued by firm2026-10-15
excluded packagepackage69423-92569423-925-85DDiscontinued by firm2026-10-15

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 · 24 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 2025-12-0569423-925-85d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0569423-925-52d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2669423-925-85f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2669423-925-52f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3169423-925-522ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3169423-925-852ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2869423-925-52a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2869423-925-85a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2169423-925-52cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2169423-925-85cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1069423-925-52cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1069423-925-85cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3169423-925-85302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3169423-925-52302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2069423-925-85ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2069423-925-52ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1069423-925-850efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1069423-925-520efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-0869423-925-85ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0869423-925-52ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-0369423-925-85367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-0369423-925-52367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-0969423-925-85557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-0969423-925-52557ba5c1ecfa…9c80585c8c6e…

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 Pro-Health
Brand name suffix
Advanced Gum Restore Deep Clean
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
STANNOUS FLUORIDE1.4 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3FTR44B32QInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
416784Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c5745cc4-213d-1dde-e053-2995a90af562Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69423-925-03Crest Pro-HealthAdvanced Gum Restore Deep Clean1 in 1 CARTONPASTE, DENTIFRICE110
69423-925-03Crest Pro-HealthAdvanced Gum Restore Deep Clean3 in 1 CELLO PACKPASTE, DENTIFRICE310
69423-925-27Crest Pro-HealthAdvanced Gum Restore Deep Clean76 g in 1 TUBEPASTE, DENTIFRICE7610
69423-925-27Crest Pro-HealthAdvanced Gum Restore Deep Clean1 in 1 CARTONPASTE, DENTIFRICE110
69423-925-37Crest Pro-HealthAdvanced Gum Restore Deep Clean1 in 1 CARTONPASTE, DENTIFRICE110
69423-925-37Crest Pro-HealthAdvanced Gum Restore Deep Clean104 g in 1 TUBEPASTE, DENTIFRICE10410
69423-925-48Crest Pro-HealthAdvanced Gum Restore Deep Clean136 g in 1 TUBEPASTE, DENTIFRICE13610
69423-925-48Crest Pro-HealthAdvanced Gum Restore Deep Clean1 in 1 CARTONPASTE, DENTIFRICE110
69423-925-52Crest Pro-HealthAdvanced Gum Restore Deep Clean147 g in 1 TUBEPASTE, DENTIFRICE14710
69423-925-52Crest Pro-HealthAdvanced Gum Restore Deep Clean1 in 1 CARTONPASTE, DENTIFRICE110
69423-925-63Crest Pro-HealthAdvanced Gum Restore Deep Clean3 in 1 CELLO PACKPASTE, DENTIFRICE310
69423-925-63Crest Pro-HealthAdvanced Gum Restore Deep Clean1 in 1 CARTONPASTE, DENTIFRICE110
69423-925-85Crest Pro-HealthAdvanced Gum Restore Deep Clean1 in 1 CARTONPASTE, DENTIFRICE110
69423-925-85Crest Pro-HealthAdvanced Gum Restore Deep Clean24 g in 1 TUBEPASTE, DENTIFRICE2410

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69423-925CREST PRO-HEALTH ADVANCED GUM RESTORE DEEP CLEAN (STANNOUS FLUORIDE) PASTE, DENTIFRICE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]8Current NDC, Legacy NDC, 14 package rows20250227_c5745cc4-213d-1dde-e053-2995a90af562.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 29 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Supersmile Professional Whitening TP Citrus BlastSODIUM MONOFLUOROPHOSPHATERobell Research, Inc25039552-c35d-a69d-e063-6394a90ab1032026-01-08WarningsExact identifier
application number: M021
Supersmile Professional Whitening TP Citrus BlastSODIUM MONOFLUOROPHOSPHATERobell Research, Inc2504686d-b053-51d0-e063-6394a90a789f2026-01-08WarningsExact identifier
application number: M021
Supersmile Professional Whitening TP Peppy Mint 8 ozSODIUM MONOFLUOROPHOSPHATERobell Research, Inc25121ebb-922b-719d-e063-6394a90a23d32026-01-08WarningsExact identifier
application number: M021
Crest Pro-health Gum Detoxify Deep CleanSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyf498b727-c38c-1d67-e053-2995a90a0f112026-01-08WarningsExact identifier
application number: M021
DG health Sensitive Maximum StrengthPOTASSIUM NITRATE, SODIUM FLUORIDEDolgencorp, LLC81cd5d37-3751-625f-e053-2a91aa0a6dfd2026-01-08WarningsExact identifier
application number: M021
Crest 3D White Advanced Glamorous WhiteSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyf5b18988-68c7-40f9-e053-2995a90a22bc2026-01-08WarningsExact identifier
application number: M021
CVS Restore and Defend Sensitive WhiteningSTANNOUS FLUORIDECVS Pharmacy81b72da2-7f41-74ca-e053-2a91aa0a96462026-01-08WarningsExact identifier
application number: M021
Gum and Enamel RepairSTANNOUS FLUORIDECVSccad05d4-7f05-bebd-e053-2a95a90aa52c2026-01-08WarningsExact identifier
application number: M021
CVS Pharmacy Pro DefenseFLUORIDECVS Pharmacy445ec57e-dc3c-49a0-8ca9-4806fcdc03032026-01-08WarningsExact identifier
application number: M021
Gum DetoxifySTANNOUS FLUORIDEWalmartad3f645d-aaf9-2800-e053-2a95a90ab62f2026-01-08WarningsExact identifier
application number: M021
CVS Complete ProtectionSTANNOUS FLOURIDECVSb681b5e4-a0e1-8d0f-e053-2a95a90aa6722026-01-06WarningsExact identifier
application number: M021
Complete ProtectionSTANNOUS FLUORIDETarget03708e08-0189-b83d-e063-6394a90a50e62026-01-06WarningsExact identifier
application number: M021
Brush Buddies Mouthwash 12oz Star Wars Saber Strike StrawberrySODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD.4998c0e6-1de3-11cd-e063-6294a90acb6f2026-01-01WarningsExact identifier
application number: M021
Exceed Total Care Sensitive Spearmint Tooth PolishPOTASSIUM NITRATE AND SODIUM FLUORIDEMelaleuca, Incdc620d3f-880f-df05-e053-2995a90a84092025-12-31WarningsExact identifier
application number: M021
Exceed Total Care Sensitive Peppermint Tooth PolishPOTASSIUM NITRATE AND SODIUM FLUORIDEMelaleuca, Inced2179a4-3d19-6481-e053-2995a90ad6552025-12-31WarningsExact identifier
application number: M021
Koala Pals BerryliciousSODIUM FLUORIDEMelaleuca, Inc.6624be86-c9a8-53b8-e053-2a91aa0a87ef2025-12-31WarningsExact identifier
application number: M021
Whitening Tooth PolishSODIUM FLUORIDEMelaleuca, Inc.6893405a-a2c4-068e-e053-2a91aa0ae5b12025-12-31WarningsExact identifier
application number: M021
Gel 1100 MintSODIUM FLUORIDEDental Alliance Holdings LLCf125fb04-5045-5367-e053-2a95a90aa73b2025-12-29WarningsExact identifier
application number: M021
Gracie Square Hospital AmenitySODIUM MONOFLUOROPHOSPHATEASP Global, LLc89d81053-6950-465e-a5b1-cbf841d7afcb2025-12-29WarningsExact identifier
application number: M021
CloSYS Fluoride RinseSODIUM FLUORIDERowpar Pharmaceuticals, Inc.1a994f24-99ee-4b27-aab0-e816931a22c82025-12-23WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpastePSNc5745cc4-213d-1dde-e053-2995a90af56210
416784stannous fluoride 0.00454 MG/MG ToothpasteSCDc5745cc4-213d-1dde-e053-2995a90af56210
416784stannous fluoride 0.454 % (fluoride ion 0.14 % ) ToothpasteSYc5745cc4-213d-1dde-e053-2995a90af56210
416784stannous fluoride 0.454 % (fluoride ion 0.15 % ) ToothpasteSYc5745cc4-213d-1dde-e053-2995a90af56210
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpasteSYc5745cc4-213d-1dde-e053-2995a90af56210

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69423-925-03694230925033 CARTON in 1 CELLO PACK (69423-925-03) / 1 TUBE in 1 CARTON / 136 g in 1 TUBE3 carton2021-01-04NoNoCurrent
69423-925-27694230925271 TUBE in 1 CARTON (69423-925-27) / 76 g in 1 TUBE1 tube2022-01-010000-00-00NoNoCurrent
69423-925-37694230925371 TUBE in 1 CARTON (69423-925-37) / 104 g in 1 TUBE1 tube2021-01-040000-00-00NoNoCurrent
69423-925-48694230925481 TUBE in 1 CARTON (69423-925-48) / 136 g in 1 TUBE1 tube2021-01-04NoNoCurrent
69423-925-52694230925521 TUBE in 1 CARTON (69423-925-52) > 147 g in 1 TUBE1 tube2021-12-010000-00-00NoNoCurrent
69423-925-63694230925633 CARTON in 1 CELLO PACK (69423-925-63) / 1 TUBE in 1 CARTON / 104 g in 1 TUBE3 carton2021-01-04NoNoCurrent
69423-925-85694230925851 TUBE in 1 CARTON (69423-925-85) > 24 g in 1 TUBE1 tube2021-01-040000-00-00NoNoCurrent