FDA.reportPublic FDA data

Crest

Product NDC
84126-641
11-digit product format
841260641
Labeler code
84126
Product ID
84126-641_4f1ee453-fd46-dcb2-e063-6394a90a2249
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
2026-01-01
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
Brand name suffix
Clean Breath Peppermint
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
4f1ef07b-ee68-e6ae-e063-6394a90af5e5Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84126-641-25CrestClean Breath Peppermint1 in 1 CARTONPASTE, DENTIFRICE11
84126-641-25CrestClean Breath Peppermint70 g in 1 TUBEPASTE, DENTIFRICE701
84126-641-46CrestClean Breath Peppermint1 in 1 CARTONPASTE, DENTIFRICE11
84126-641-46CrestClean Breath Peppermint130 g in 1 TUBEPASTE, DENTIFRICE1301

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 22 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ACT Restoring Anticavity Fluoride Cool MintSODIUM FLUORIDEChattem, Inc.ef63e193-5804-4b35-bae7-cad29cf4e8bc2026-01-12WarningsExact identifier
application number: M021
Prime Tooth Care BlueberrySODIUM FLUORIDEPrime Tooth Care LLC86642110-4572-4b8b-88f1-8d25fe05701e2026-01-09WarningsExact identifier
application number: M021
Prime Tooth Care Juicy PeachSODIUM FLUORIDEPrime Tooth Care LLC142f1610-3494-459f-a956-760e82169b872026-01-09WarningsExact identifier
application number: M021
Prime Tooth Care Coconut WhipSODIUM FLUORIDEPrime Tooth Care LLC55e95657-9415-4d9c-ac9b-d021aa14e64d2026-01-09WarningsExact identifier
application number: M021
Prime Tooth Care Hami MelonSODIUM FLUORIDEPrime Tooth Care LLC0028f88d-a9fe-4cfa-a6c6-168f9689b5f62026-01-09WarningsExact identifier
application number: M021
Prime Tooth Care Mango SmoothieSODIUM FLUORIDEPrime Tooth Care LLC2f2cf851-2edc-4aaf-9083-c37bc58547de2026-01-09WarningsExact identifier
application number: M021
Prime Tooth Care StrawberriesSODIUM FLUORIDEPrime Tooth Care LLC7b4328bd-5d2d-40ca-8322-5e818e1babf92026-01-09WarningsExact identifier
application number: M021
Prime Tooth Care Summer WatermelonSODIUM FLUORIDEPrime Tooth Care LLCb7c731a1-80e7-4571-a568-db0290a720c12026-01-09WarningsExact identifier
application number: M021
Kids Prime Pediatric Dental Group Anticavity for KidsSODIUM FLUORIDEPrime Tooth Care LLC93259174-447d-4f7a-8e55-990eb8da51512026-01-09WarningsExact identifier
application number: M021
Crest 3D White Brilliance Pro Enamel ProtectSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyf32d5708-8cb1-6499-e053-2995a90ac6322026-01-08WarningsExact identifier
application number: M021
Crest Pro-Health Advanced Complete Care Anticavity FluorideSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyf3a644c0-da04-276d-e053-2a95a90abf272026-01-08WarningsExact identifier
application number: M021
Crest Pro-Health Densify Active RepairSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyf4487d78-1da8-3f33-e053-2a95a90a6d922026-01-08WarningsExact identifier
application number: M021
Crest Pro-Health Densify Sensitive CareSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyf435c1fe-7fbb-1b25-e053-2995a90aca112026-01-08WarningsExact identifier
application number: M021
Crest Pro-Health Densify Pro Intensive RepairSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyf45c9c89-f294-deca-e053-2a95a90ae5572026-01-08WarningsExact identifier
application number: M021
Crest Pro-health Gum Detoxify Deep CleanSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyf49a00de-b16a-66e6-e053-2995a90aedc62026-01-08WarningsExact identifier
application number: M021
Crest Pro-Health Gum Detoxify Gentle WhiteningSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyf49a7dc7-77f3-3911-e053-2a95a90ad55c2026-01-08WarningsExact identifier
application number: M021
Crest Complete Multi-Benefit Whitening plus Cinnamon ExpressionsSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company961295a6-79ae-44b1-e053-2995a90a61302026-01-08WarningsExact identifier
application number: M021
Crest Pro Health Enamel Repair and Gum Intensive CleanSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyf4c2118d-1216-d0d0-e053-2995a90a70882026-01-08WarningsExact identifier
application number: M021
Crest 3D White CharcoalSODIUM FLUORIDEProcter & Gamble Manfuacturing Company96247083-39e9-7ca7-e053-2995a90a75d02026-01-08WarningsExact identifier
application number: M021
Crest 3D White Advanced Express WhiteSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyf4c2d5aa-b0e6-7068-e053-2995a90ae90c2026-01-08WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpastePSN4f1ef07b-ee68-e6ae-e063-6394a90af5e51
416784stannous fluoride 0.00454 MG/MG ToothpasteSCD4f1ef07b-ee68-e6ae-e063-6394a90af5e51
416784stannous fluoride 0.454 % (fluoride ion 0.14 % ) ToothpasteSY4f1ef07b-ee68-e6ae-e063-6394a90af5e51
416784stannous fluoride 0.454 % (fluoride ion 0.15 % ) ToothpasteSY4f1ef07b-ee68-e6ae-e063-6394a90af5e51
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpasteSY4f1ef07b-ee68-e6ae-e063-6394a90af5e51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84126-641-25841260641251 TUBE in 1 CARTON (84126-641-25) / 70 g in 1 TUBE1 tube2026-01-01NoNoCurrent
84126-641-46841260641461 TUBE in 1 CARTON (84126-641-46) / 130 g in 1 TUBE1 tube2026-01-01NoNoCurrent