FDA.reportPublic FDA data

Crest

Product NDC
69423-869
11-digit product format
694230869
Labeler code
69423
Product ID
69423-869_47e499e7-cff9-8a21-e063-6294a90a2765
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
2022-02-07
Substance
STANNOUS FLUORIDE
Active strength
1.6 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
Brand name suffix
Pro Health Advanced Deep Clean Mint
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
STANNOUS FLUORIDE1.6 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
d774295f-8ebd-9877-e053-2a95a90a9a0eAvailable 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
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69423-869-03CrestPro Health Advanced Deep Clean Mint3 in 1 CELLO PACKPASTE, DENTIFRICE310
69423-869-03CrestPro Health Advanced Deep Clean Mint1 in 1 CARTONPASTE, DENTIFRICE110
69423-869-08CrestPro Health Advanced Deep Clean Mint5 in 1 CELLO PACKPASTE, DENTIFRICE510
69423-869-08CrestPro Health Advanced Deep Clean Mint1 in 1 CARTONPASTE, DENTIFRICE110
69423-869-32CrestPro Health Advanced Deep Clean Mint2 in 1 CELLO PACKPASTE, DENTIFRICE210
69423-869-32CrestPro Health Advanced Deep Clean Mint1 in 1 CARTONPASTE, DENTIFRICE110
69423-869-33CrestPro Health Advanced Deep Clean Mint3 in 1 CELLO PACKPASTE, DENTIFRICE310
69423-869-33CrestPro Health Advanced Deep Clean Mint1 in 1 CARTONPASTE, DENTIFRICE110
69423-869-35CrestPro Health Advanced Deep Clean Mint1 in 1 CARTONPASTE, DENTIFRICE110
69423-869-35CrestPro Health Advanced Deep Clean Mint99 g in 1 TUBEPASTE, DENTIFRICE9910
69423-869-51CrestPro Health Advanced Deep Clean Mint1 in 1 CARTONPASTE, DENTIFRICE110
69423-869-51CrestPro Health Advanced Deep Clean Mint144 g in 1 TUBEPASTE, DENTIFRICE14410
69423-869-52CrestPro Health Advanced Deep Clean Mint1 in 1 CARTONPASTE, DENTIFRICE110
69423-869-52CrestPro Health Advanced Deep Clean Mint2 in 1 CELLO PACKPASTE, DENTIFRICE210
69423-869-55CrestPro Health Advanced Deep Clean Mint5 in 1 CELLO PACKPASTE, DENTIFRICE510
69423-869-55CrestPro Health Advanced Deep Clean Mint1 in 1 CARTONPASTE, DENTIFRICE110
69423-869-59CrestPro Health Advanced Deep Clean Mint1 in 1 CARTONPASTE, DENTIFRICE110
69423-869-59CrestPro Health Advanced Deep Clean Mint167 g in 1 TUBEPASTE, DENTIFRICE16710

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69423-869CREST PRO HEALTH ADVANCED DEEP CLEAN MINT (STANNOUS FLUORIDE) PASTE, DENTIFRICE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]7Current NDC, Legacy NDC, 18 package rows20250125_d774295f-8ebd-9877-e053-2a95a90a9a0e.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 24 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Crest Pro Health Sensitive and Enamel ShieldSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyfb48b15c-f821-e5cd-e053-6294a90ac64c2026-01-08WarningsExact identifier
application number: M021
Crest 3D White Brilliance Luminous PurpleSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyfbfcd837-4d88-5f82-e053-6394a90afbf62026-01-08WarningsExact identifier
application number: M021
Crest Pro Health with a Touch of ScopeSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyfb572b41-36cd-55d7-e053-6394a90a71c82026-01-08WarningsExact identifier
application number: M021
Crest Pro Health Whitening GelSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyfb5b1e94-bed6-8486-e053-6294a90a3a842026-01-08WarningsExact identifier
application number: M021
Crest 3D White Ultra Vivid MintSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companycba96ef0-0519-059f-e053-2a95a90a43ad2026-01-08WarningsExact identifier
application number: M021
Crest 4in1SODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyce545406-3c4f-1ba7-e053-2a95a90a91ac2026-01-08WarningsExact identifier
application number: M021
Crest 3D White Advanced WhiteningSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyd218ddc0-1d5f-f39b-e053-2995a90a96ed2026-01-08WarningsExact identifier
application number: M021
Crest Pro Health Advanced Antibacterial ProtectionSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyd58bc842-2687-e52d-e053-2995a90a54332026-01-08WarningsExact identifier
application number: M021
Scope Stay StrongSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyd65b3153-2026-a8c0-e053-2a95a90a31d62026-01-08WarningsExact identifier
application number: M021
Crest Pro Health Advanced Whitening CharcoalSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyd6f68485-b92f-41c7-e053-2995a90a4fe52026-01-08WarningsExact identifier
application number: M021
KIDS Crest Advanced Enamel Plus Cavity ProtectionSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyd837ecde-249a-7868-e053-2a95a90a56ae2026-01-08WarningsExact identifier
application number: M021
Crest Pro Health Advanced Whitening Intensive CleaningSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyd6fa4187-a651-647b-e053-2995a90a85672026-01-08WarningsExact identifier
application number: M021
Crest Pro Health Advanced Gum ProtectionSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyd7729dde-c828-34e6-e053-2a95a90a5ee62026-01-08WarningsExact identifier
application number: M021
Crest Densify Daily WhiteningSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyd811306f-4994-7a5a-e053-2995a90adf162026-01-08WarningsExact identifier
application number: M021
Crest Densify Daily ProtectionSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyd810d4e5-ba66-efe1-e053-2995a90abfc02026-01-08WarningsExact identifier
application number: M021
Crest Braces Care Cavity ProtectionSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyd823cba4-c4cf-7d7a-e053-2995a90a01f02026-01-08WarningsExact identifier
application number: M021
Crest Pro Health Advanced Sensitive ReliefSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyd7730674-7513-52cf-e053-2995a90ab32c2026-01-08WarningsExact identifier
application number: M021
Kids Crest Bubblegum FlavorSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company26a7a892-5da4-4749-bbb6-566efab7d7492026-01-08WarningsExact identifier
application number: M021
Crest Complete Multi-Benefit Plus ScopeSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company8c91095d-88c0-4d22-a79a-7d0f0d05302b2026-01-08WarningsExact identifier
application number: M021
Crest Pro Health Advanced Deep Clean MintSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyd774295f-8ebd-9877-e053-2a95a90a9a0e2026-01-08WarningsExact identifier
application number: M021
ndc (product): 69423-869

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpastePSNd774295f-8ebd-9877-e053-2a95a90a9a0e10
416784stannous fluoride 0.00454 MG/MG ToothpasteSCDd774295f-8ebd-9877-e053-2a95a90a9a0e10
416784stannous fluoride 0.454 % (fluoride ion 0.14 % ) ToothpasteSYd774295f-8ebd-9877-e053-2a95a90a9a0e10
416784stannous fluoride 0.454 % (fluoride ion 0.15 % ) ToothpasteSYd774295f-8ebd-9877-e053-2a95a90a9a0e10
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpasteSYd774295f-8ebd-9877-e053-2a95a90a9a0e10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69423-869-03694230869033 CARTON in 1 CELLO PACK (69423-869-03) / 1 TUBE in 1 CARTON / 144 g in 1 TUBE3 carton2022-02-07NoNoCurrent
69423-869-08694230869085 CARTON in 1 CELLO PACK (69423-869-08) / 1 TUBE in 1 CARTON / 164 g in 1 TUBE5 carton2022-02-07NoNoCurrent
69423-869-32694230869322 CARTON in 1 CELLO PACK (69423-869-32) / 1 TUBE in 1 CARTON / 99 g in 1 TUBE2 carton2022-02-07NoNoCurrent
69423-869-33694230869333 CARTON in 1 CELLO PACK (69423-869-33) / 1 TUBE in 1 CARTON / 99 g in 1 TUBE3 carton2022-02-07NoNoCurrent
69423-869-35694230869351 TUBE in 1 CARTON (69423-869-35) / 99 g in 1 TUBE1 tube2022-02-070000-00-00NoNoCurrent
69423-869-51694230869511 TUBE in 1 CARTON (69423-869-51) / 144 g in 1 TUBE1 tube2022-02-070000-00-00NoNoCurrent
69423-869-52694230869522 CARTON in 1 CELLO PACK (69423-869-52) / 1 TUBE in 1 CARTON / 144 g in 1 TUBE2 carton2022-02-07NoNoCurrent
69423-869-55694230869555 CARTON in 1 CELLO PACK (69423-869-55) / 1 TUBE in 1 CARTON / 167 g in 1 TUBE5 carton2022-02-07NoNoCurrent
69423-869-59694230869591 TUBE in 1 CARTON (69423-869-59) / 167 g in 1 TUBE1 tube2022-02-07NoNoCurrent