FDA.reportPublic FDA data

Crest

Product NDC
69423-786
11-digit product format
694230786
Labeler code
69423
Product ID
69423-786_47e3b087-097d-33a9-e063-6394a90a0c62
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
2022-12-30
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
Brand name suffix
Pro Health Whitening Gel
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
fb5b1e94-bed6-8486-e053-6294a90a3a84Available 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
69423-786-03CrestPro Health Whitening Gel1 in 1 CARTONPASTE, DENTIFRICE17
69423-786-03CrestPro Health Whitening Gel85 g in 1 TUBEPASTE, DENTIFRICE857
69423-786-21CrestPro Health Whitening Gel1 in 1 CARTONPASTE, DENTIFRICE17
69423-786-21CrestPro Health Whitening Gel59 g in 1 TUBEPASTE, DENTIFRICE597
69423-786-43CrestPro Health Whitening Gel1 in 1 CARTONPASTE, DENTIFRICE17
69423-786-43CrestPro Health Whitening Gel121 g in 1 TUBEPASTE, DENTIFRICE1217
69423-786-44CrestPro Health Whitening Gel121 g in 1 TUBEPASTE, DENTIFRICE1217
69423-786-44CrestPro Health Whitening Gel2 in 1 CARTONPASTE, DENTIFRICE27
69423-786-45CrestPro Health Whitening Gel3 in 1 CARTONPASTE, DENTIFRICE37
69423-786-45CrestPro Health Whitening Gel121 g in 1 TUBEPASTE, DENTIFRICE1217
69423-786-46CrestPro Health Whitening Gel1 in 1 CARTONPASTE, DENTIFRICE17
69423-786-46CrestPro Health Whitening Gel130 g in 1 TUBEPASTE, DENTIFRICE1307
69423-786-59CrestPro Health Whitening Gel1 in 1 CARTONPASTE, DENTIFRICE17
69423-786-59CrestPro Health Whitening Gel167 g in 1 TUBEPASTE, DENTIFRICE1677

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69423-786CREST PRO HEALTH WHITENING GEL (STANNOUS FLUORIDE) PASTE, DENTIFRICE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]5Current NDC, 14 package rows20250115_fb5b1e94-bed6-8486-e053-6294a90a3a84.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 23 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Crest complete plus Whitening Deep CleanSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company973ce138-c64e-c059-e053-2a95a90a31482026-01-08WarningsExact identifier
application number: M021
Crest Pro Health Gum Detoxify and Restore Pro Deep CleanSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyf4c3ad36-72d8-16e8-e053-2a95a90a87022026-01-08WarningsExact identifier
application number: M021
Crest Pro Health Gum Detoxify and Restore Pro WhiteningSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyf4d65b58-9818-820d-e053-2995a90a9f002026-01-08WarningsExact identifier
application number: M021
Crest Pro-Health Sensitive and Gum All Day ProtectionSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyf4d775a1-a4f6-cd69-e053-2995a90a5f642026-01-08WarningsExact identifier
application number: M021
Crest Pro Health Enamel Repair and Gum Advanced WhiteningSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyf4ead762-17b2-22a0-e053-2a95a90ac8662026-01-08WarningsExact identifier
application number: M021
Crest 3D White Advanced Luminous MintSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyf5c82742-fb27-62a2-e053-2a95a90aa7c42026-01-08WarningsExact identifier
application number: M021
Native WhiteningSODIUM FLUORIDEProcter & Gamble Manufacturing Companya5248d35-f488-3457-e053-2995a90a411e2026-01-08WarningsExact identifier
application number: M021
Crest 3D White Brilliance CharcoalSODIUM FLUORIDEProcter & Gamble Manfuacturing Companyb7882679-339c-554f-e053-2995a90afa7f2026-01-08WarningsExact identifier
application number: M021
Burts Bees Kids Strawberry SplashSODIUM FLUORIDEProcter & Gamble Manufacturing Companyb6c180ae-00da-6fab-e053-2a95a90a089e2026-01-08WarningsExact identifier
application number: M021
Crest Complete Plus Scope OutlastSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyb6f9a813-7ed6-895c-e053-2995a90a9ea62026-01-08WarningsExact identifier
application number: M021
Crest Premium Plus Scope Dual Blast Active FoamSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyb788d16a-8a58-0352-e053-2a95a90a965e2026-01-08WarningsExact identifier
application number: M021
Crest Premium Plus Scope Outlast Active FoamSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyb789587e-7f49-163a-e053-2a95a90a823f2026-01-08WarningsExact identifier
application number: M021
Crest Premium Plus Advanced Whitening Active FoamSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyb81a22dc-b759-24cd-e053-2995a90a91482026-01-08WarningsExact identifier
application number: M021
Crest Premium Plus Deep Clean Active FoamSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyb851fe5c-d904-12da-e053-2a95a90a86f92026-01-08WarningsExact identifier
application number: M021
Crest Baking Soda and Peroxide Whitening with Tartar ProtectionSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyadebbd47-011d-4cd3-a002-1eb67e885e5b2026-01-08WarningsExact identifier
application number: M021
Crest 3D White Advanced Stain ShieldSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyf5c9b5ef-8dd4-a842-e053-2a95a90ad3872026-01-08WarningsExact identifier
application number: M021
Kids Crest Bubblegum RushSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company7baa77f5-fe45-6566-e053-2991aa0a381f2026-01-08WarningsExact identifier
application number: M021
Crest 3D White Vibrant MintSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyf63c3354-a264-8130-e053-2a95a90a20222026-01-08Exact identifier
application number: M021
Crest Pro Health Clean MintSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyfb466fb4-0915-a41f-e053-6294a90a2dfb2026-01-08WarningsExact identifier
application number: M021
Crest Pro Health Clean and FreeSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyfb4771cd-f478-e2bd-e053-6394a90aa83e2026-01-08WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpastePSNfb5b1e94-bed6-8486-e053-6294a90a3a847
416784stannous fluoride 0.00454 MG/MG ToothpasteSCDfb5b1e94-bed6-8486-e053-6294a90a3a847
416784stannous fluoride 0.454 % (fluoride ion 0.14 % ) ToothpasteSYfb5b1e94-bed6-8486-e053-6294a90a3a847
416784stannous fluoride 0.454 % (fluoride ion 0.15 % ) ToothpasteSYfb5b1e94-bed6-8486-e053-6294a90a3a847
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpasteSYfb5b1e94-bed6-8486-e053-6294a90a3a847

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69423-786-03694230786031 TUBE in 1 CARTON (69423-786-03) / 85 g in 1 TUBE1 tube2022-12-30NoNoCurrent
69423-786-21694230786211 TUBE in 1 CARTON (69423-786-21) / 59 g in 1 TUBE1 tube2025-07-01NoNoCurrent
69423-786-43694230786431 TUBE in 1 CARTON (69423-786-43) / 121 g in 1 TUBE1 tube2022-12-30NoNoCurrent
69423-786-44694230786442 TUBE in 1 CARTON (69423-786-44) / 121 g in 1 TUBE2 tube2022-12-30NoNoCurrent
69423-786-45694230786453 TUBE in 1 CARTON (69423-786-45) / 121 g in 1 TUBE3 tube2022-12-30NoNoCurrent
69423-786-46694230786461 TUBE in 1 CARTON (69423-786-46) / 130 g in 1 TUBE1 tube2022-12-30NoNoCurrent
69423-786-59694230786591 TUBE in 1 CARTON (69423-786-59) / 167 g in 1 TUBE1 tube2022-12-30NoNoCurrent