FDA.reportPublic FDA data

Crest

Product NDC
69423-781
11-digit product format
694230781
Labeler code
69423
Product ID
69423-781_47e36800-0672-cf64-e063-6294a90a85af
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
2022-10-03
Substance
STANNOUS 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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage69423-78169423-781-33DDiscontinued by firm2026-10-16

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage69423-78169423-781-63DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage69423-78169423-781-33DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

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
Pro Health Clean Mint
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
STANNOUS FLUORIDE1.5 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
fb466fb4-0915-a41f-e053-6294a90a2dfbAvailable 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
69423-781-03CrestPro Health Clean Mint1 in 1 CARTONPASTE, DENTIFRICE112
69423-781-03CrestPro Health Clean Mint85 g in 1 TUBEPASTE, DENTIFRICE8512
69423-781-04CrestPro Health Clean Mint1 in 1 CARTONPASTE, DENTIFRICE112
69423-781-04CrestPro Health Clean Mint4 in 1 CELLO PACKPASTE, DENTIFRICE412
69423-781-21CrestPro Health Clean Mint1 in 1 CARTONPASTE, DENTIFRICE112
69423-781-21CrestPro Health Clean Mint59 g in 1 TUBEPASTE, DENTIFRICE5912
69423-781-33CrestPro Health Clean Mint1 in 1 CARTONPASTE, DENTIFRICE112
69423-781-33CrestPro Health Clean Mint94 g in 1 TUBEPASTE, DENTIFRICE9412
69423-781-43CrestPro Health Clean Mint1 in 1 CARTONPASTE, DENTIFRICE112
69423-781-43CrestPro Health Clean Mint121 g in 1 TUBEPASTE, DENTIFRICE12112
69423-781-44CrestPro Health Clean Mint3 in 1 CARTONPASTE, DENTIFRICE312
69423-781-44CrestPro Health Clean Mint121 g in 1 TUBEPASTE, DENTIFRICE12112
69423-781-45CrestPro Health Clean Mint2 in 1 CARTONPASTE, DENTIFRICE212
69423-781-45CrestPro Health Clean Mint121 g in 1 TUBEPASTE, DENTIFRICE12112
69423-781-46CrestPro Health Clean Mint130 g in 1 TUBEPASTE, DENTIFRICE13012
69423-781-46CrestPro Health Clean Mint1 in 1 CARTONPASTE, DENTIFRICE112
69423-781-59CrestPro Health Clean Mint167 g in 1 TUBEPASTE, DENTIFRICE16712
69423-781-59CrestPro Health Clean Mint1 in 1 CARTONPASTE, DENTIFRICE112
69423-781-63CrestPro Health Clean Mint178 g in 1 TUBEPASTE, DENTIFRICE17812
69423-781-63CrestPro Health Clean Mint1 in 1 CARTONPASTE, DENTIFRICE112
69423-781-73CrestPro Health Clean Mint73 g in 1 TUBEPASTE, DENTIFRICE7312
69423-781-73CrestPro Health Clean Mint1 in 1 CARTONPASTE, DENTIFRICE112
69423-781-85CrestPro Health Clean Mint24 g in 1 TUBEPASTE, DENTIFRICE2412
69423-781-85CrestPro Health Clean Mint1 in 1 CARTONPASTE, DENTIFRICE112

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69423-781CREST PRO HEALTH CLEAN MINT (STANNOUS FLUORIDE) PASTE, DENTIFRICE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]7Current NDC, 24 package rows20250115_fb466fb4-0915-a41f-e053-6294a90a2dfb.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 25 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Crest Pro Health Advanced Enamel RestoreSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyd813f5f0-3135-4a8f-e053-2a95a90a55622026-01-08WarningsExact identifier
application number: M021
Crest 3D White BrillianceSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company8e189fbd-5094-4398-b96c-8f95d89b9cdd2026-01-08WarningsExact identifier
application number: M021
Crest Pro Health Densify RinseSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyd84fb9f9-f2bc-358a-e053-2995a90abf072026-01-08WarningsExact identifier
application number: M021
Kids Crest Strawberry RushSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyeb7a5698-754c-4e46-e053-2a95a90a57b42026-01-08WarningsExact identifier
application number: M021
Crest 3D White Brilliance Daily Cleansing and Whitening SystemSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Company89a6fb36-5109-47f1-95ad-9381471ceeef2026-01-08WarningsExact identifier
application number: M021
Crest Pro-Health Advanced w/Extra WhiteningSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company2c1c5563-0b7e-4c7c-b49f-3d72e078cd282026-01-08WarningsExact identifier
application number: M021
Crest 3D White Stain Eraser Fresh MintSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyc81ba39d-c7ea-b2a5-e053-2995a90a0fe72026-01-08Exact identifier
application number: M021
Crest Premium Plus Breath Bacteria BlastSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyc3f1d477-6dd8-0ac4-e053-2a95a90a37422026-01-08WarningsExact identifier
application number: M021
Crest Premium Plus Active Foam Whitening scopeSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyc72b15e0-e69c-65fc-e053-2a95a90a54c82026-01-08WarningsExact identifier
application number: M021
Crest Complete Plus Scope Outlast UltraSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyc3f63455-b09e-9877-e053-2a95a90a18442026-01-08WarningsExact identifier
application number: M021
Crest Tartar Protection Fresh Mint GelSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company3d81d605-4f9b-3bb5-e054-00144ff88e882026-01-08WarningsExact identifier
application number: M021
Crest Complete plus WhiteningSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companye3b1f139-4fe8-f005-e053-2995a90a53b42026-01-08WarningsExact identifier
application number: M021
Crest 3D White Radiant MintSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyf3dd7a34-a0d8-4ac6-bbd1-7c3b86187a572026-01-08WarningsExact identifier
application number: M021
Crest Complete Plus Active Fresh plus Whitening ScopeSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyc599d33f-788f-7fdd-e053-2a95a90a5f572026-01-08WarningsExact identifier
application number: M021
Crest Complete Multi Benefit Whitening plus Scope OutlastSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company66c41b24-d394-6609-e053-2a91aa0a0a2c2026-01-08WarningsExact identifier
application number: M021
Crest Complete Plus 3 in 1SODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyb6fab2eb-da5c-749f-e053-2995a90a13572026-01-08WarningsExact identifier
application number: M021
Crest Tartar ProtectionSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company85477763-1db5-482f-90e5-e71f5c1b47652026-01-08WarningsExact identifier
application number: M021
Crest Fresh and WhiteSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyf9b31f6b-6b3f-abe0-e053-6294a90acb252026-01-08WarningsExact identifier
application number: M021
Crest Complete plus Whitening Deep CleanSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyc367c2cc-5e0f-bc4e-e053-2995a90a2e2c2026-01-08WarningsExact identifier
application number: M021
Crest 3D White Glamorous WhiteSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyc3f29f95-81b9-3989-e053-2a95a90af3a62026-01-08WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpastePSNfb466fb4-0915-a41f-e053-6294a90a2dfb12
416784stannous fluoride 0.00454 MG/MG ToothpasteSCDfb466fb4-0915-a41f-e053-6294a90a2dfb12
416784stannous fluoride 0.454 % (fluoride ion 0.14 % ) ToothpasteSYfb466fb4-0915-a41f-e053-6294a90a2dfb12
416784stannous fluoride 0.454 % (fluoride ion 0.15 % ) ToothpasteSYfb466fb4-0915-a41f-e053-6294a90a2dfb12
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpasteSYfb466fb4-0915-a41f-e053-6294a90a2dfb12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69423-781-03694230781031 TUBE in 1 CARTON (69423-781-03) / 85 g in 1 TUBE1 tube2022-10-03NoNoCurrent
69423-781-04694230781044 CARTON in 1 CELLO PACK (69423-781-04) / 1 TUBE in 1 CARTON / 121 g in 1 TUBE4 carton2025-10-06NoNoCurrent
69423-781-21694230781211 TUBE in 1 CARTON (69423-781-21) / 59 g in 1 TUBE1 tube2025-07-01NoNoCurrent
69423-781-33694230781331 in 1 CARTONHistorical
69423-781-43694230781431 TUBE in 1 CARTON (69423-781-43) / 121 g in 1 TUBE1 tube2022-10-03NoNoCurrent
69423-781-44694230781443 TUBE in 1 CARTON (69423-781-44) / 121 g in 1 TUBE3 tube2022-10-03NoNoCurrent
69423-781-45694230781452 TUBE in 1 CARTON (69423-781-45) / 121 g in 1 TUBE2 tube2022-10-03NoNoCurrent
69423-781-46694230781461 TUBE in 1 CARTON (69423-781-46) / 130 g in 1 TUBE1 tube2022-10-03NoNoCurrent
69423-781-59694230781591 TUBE in 1 CARTON (69423-781-59) / 167 g in 1 TUBE1 tube2022-10-03NoNoCurrent
69423-781-63694230781631 TUBE in 1 CARTON (69423-781-63) / 178 g in 1 TUBE1 tube2022-10-03NoNoCurrent
69423-781-73694230781731 TUBE in 1 CARTON (69423-781-73) / 73 g in 1 TUBE1 tube2022-10-03NoNoCurrent
69423-781-85694230781851 TUBE in 1 CARTON (69423-781-85) / 24 g in 1 TUBE1 tube2022-10-03NoNoCurrent