FDA.reportPublic FDA data

Crest Pro-Health

Product NDC
69423-765
Requested package NDC
69423-765-41
11-digit product format
694230765
Labeler code
69423
Product ID
69423-765_47e317c2-ea4d-8cce-e063-6394a90a9182
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
2023-01-01
Substance
STANNOUS 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 Pro-Health
Brand name suffix
Sensitive and Gum All Day Protection
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
f4d775a1-a4f6-cd69-e053-2995a90a5f64Available 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
69423-765-03Crest Pro-HealthSensitive and Gum All Day Protection136 g in 1 TUBEPASTE, DENTIFRICE1369
69423-765-03Crest Pro-HealthSensitive and Gum All Day Protection3 in 1 CARTONPASTE, DENTIFRICE39
69423-765-16Crest Pro-HealthSensitive and Gum All Day Protection1 in 1 CARTONPASTE, DENTIFRICE19
69423-765-16Crest Pro-HealthSensitive and Gum All Day Protection1 in 1 CELLO PACKPASTE, DENTIFRICE19
69423-765-28Crest Pro-HealthSensitive and Gum All Day Protection1 in 1 CARTONPASTE, DENTIFRICE19
69423-765-28Crest Pro-HealthSensitive and Gum All Day Protection79 g in 1 TUBEPASTE, DENTIFRICE799
69423-765-33Crest Pro-HealthSensitive and Gum All Day Protection3 in 1 CELLO PACKPASTE, DENTIFRICE39
69423-765-33Crest Pro-HealthSensitive and Gum All Day Protection1 in 1 CARTONPASTE, DENTIFRICE19
69423-765-37Crest Pro-HealthSensitive and Gum All Day Protection1 in 1 CARTONPASTE, DENTIFRICE19
69423-765-37Crest Pro-HealthSensitive and Gum All Day Protection104 g in 1 TUBEPASTE, DENTIFRICE1049
69423-765-41Crest Pro-HealthSensitive and Gum All Day Protection1 in 1 CARTONPASTE, DENTIFRICE19
69423-765-41Crest Pro-HealthSensitive and Gum All Day Protection116 g in 1 TUBEPASTE, DENTIFRICE1169
69423-765-46Crest Pro-HealthSensitive and Gum All Day Protection130 g in 1 TUBEPASTE, DENTIFRICE1309
69423-765-46Crest Pro-HealthSensitive and Gum All Day Protection1 in 1 CARTONPASTE, DENTIFRICE19
69423-765-48Crest Pro-HealthSensitive and Gum All Day Protection136 g in 1 TUBEPASTE, DENTIFRICE1369
69423-765-48Crest Pro-HealthSensitive and Gum All Day Protection1 in 1 CARTONPASTE, DENTIFRICE19
69423-765-52Crest Pro-HealthSensitive and Gum All Day Protection1 in 1 CARTONPASTE, DENTIFRICE19
69423-765-52Crest Pro-HealthSensitive and Gum All Day Protection147 g in 1 TUBEPASTE, DENTIFRICE1479
69423-765-85Crest Pro-HealthSensitive and Gum All Day Protection1 in 1 CARTONPASTE, DENTIFRICE19
69423-765-85Crest Pro-HealthSensitive and Gum All Day Protection24 g in 1 TUBEPASTE, DENTIFRICE249

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69423-765CREST PRO-HEALTH SENSITIVE AND GUM ALL DAY PROTECTION (STANNOUS FLUORIDE) PASTE, DENTIFRICE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]7Current NDC, 20 package rows20250125_f4d775a1-a4f6-cd69-e053-2995a90a5f64.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 20 of 49 · 974 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GuruNanda Anti-CavitySODIUM FLUORIDEGURUNANDA, LLC3b07b72f-4efc-eb0f-e063-6294a90a70a82026-01-19WarningsExact identifier
application number: M021
GuruNanda AnticavitySODIUM FLUORIDEGURUNANDA, LLC3e90d516-3172-3c8d-e063-6294a90a394f2026-01-19WarningsExact identifier
application number: M021
HismilePEACH ICED TEA FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTEHismile Pty Ltd0eba92d1-cbdc-9c96-e063-6294a90a9afc2026-01-15WarningsExact identifier
application number: M021
HismileCOCONUT WHIP FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTEHismile Pty Ltd0ef3cfb6-6bae-1682-e063-6394a90aca882026-01-15WarningsExact identifier
application number: M021
HismileMANGO SORBET FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTEHismile Pty Ltd0ef3f4f8-fdc4-2056-e063-6394a90a6fd72026-01-15WarningsExact identifier
application number: M021
HismileSMOOTH MINT FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTEHismile Pty Ltd0ef41051-dfa0-b105-e063-6294a90a551f2026-01-15WarningsExact identifier
application number: M021
HismileWATERMELON FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTEHismile Pty Ltd0ef43107-58ec-d4ee-e063-6294a90ad8d72026-01-15WarningsExact identifier
application number: M021
HismileRED VELVET FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTEHismile Pty Ltd0ef56539-dc21-c6ea-e063-6394a90a57902026-01-15WarningsExact identifier
application number: M021
HismileGRAPE BUBBLEGUM FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTEHismile Pty Ltd0ef6f8b5-8565-b364-e063-6294a90aabbc2026-01-15WarningsExact identifier
application number: M021
HismileSTRAWBERRY FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTEHismile Pty Ltd0ef766ae-754a-f185-e063-6294a90a32992026-01-15WarningsExact identifier
application number: M021
HismileBANANA FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTEHismile Pty Ltd0ef7be5b-df8f-9f32-e063-6394a90a47242026-01-15WarningsExact identifier
application number: M021
HismileVANILLA FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTEHismile Pty Ltd0ef8d0ef-a051-f610-e063-6394a90a85372026-01-15WarningsExact identifier
application number: M021
HISMILESODIUM FLUORIDEHISMILE PTY LTD1d40b98b-2e9a-d84a-e063-6294a90a20962026-01-15WarningsExact identifier
application number: M021
HISMILESODIUM FLUORIDEHISMILE PTY LTD1d44863e-93be-2b80-e063-6294a90a4a9d2026-01-15WarningsExact identifier
application number: M021
HISMILESODIUM FLUORIDEHISMILE PTY LTD1d458ccc-8f1e-f9c8-e063-6294a90a8da42026-01-15WarningsExact identifier
application number: M021
HISMILESODIUM FLUORIDEHISMILE PTY LTD1d447939-fbf6-42f6-e063-6294a90af6d92026-01-15WarningsExact identifier
application number: M021
HISMILESODIUM FLUORIDEHISMILE PTY LTD1de591d9-9cab-e63d-e063-6394a90ac8eb2026-01-15WarningsExact identifier
application number: M021
Ice Pop Flavor Sodium Fluoride Anticavity ToothpastSODIUM FLUORIDEHISMILE PTY LTD20e1603e-bcd1-6a5e-e063-6294a90ad1db2026-01-15WarningsExact identifier
application number: M021
HismileCANDY CANE FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTEHISMILE PTY LTD1e725b7e-accc-f51c-e063-6394a90a455c2026-01-15WarningsExact identifier
application number: M021
Enamelon Preventive TreatmentSTANNOUS FLUORIDEPremier Dental Products Company04c3f178-7905-404d-9ac2-67c453287ddf2026-01-13WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpastePSNf4d775a1-a4f6-cd69-e053-2995a90a5f649
416784stannous fluoride 0.00454 MG/MG ToothpasteSCDf4d775a1-a4f6-cd69-e053-2995a90a5f649
416784stannous fluoride 0.454 % (fluoride ion 0.14 % ) ToothpasteSYf4d775a1-a4f6-cd69-e053-2995a90a5f649
416784stannous fluoride 0.454 % (fluoride ion 0.15 % ) ToothpasteSYf4d775a1-a4f6-cd69-e053-2995a90a5f649
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpasteSYf4d775a1-a4f6-cd69-e053-2995a90a5f649

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69423-765-41694230765411 TUBE in 1 CARTON (69423-765-41) / 116 g in 1 TUBE1 tube2023-02-16NoNoCurrent