FDA.reportPublic FDA data

Crest 3D White

Product NDC
84126-629
11-digit product format
841260629
Labeler code
84126
Product ID
84126-629_4f09758e-2849-edf1-e063-6394a90a62e8
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium 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
SODIUM 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 3D White
Brand name suffix
Advanced Radiant Mint with Stain Blasting Foam
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE1.5 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8ZYQ1474W7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
891775Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4ee26a82-16fd-f0fb-e063-6394a90a91d1Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84126-629-02Crest 3D WhiteAdvanced Radiant Mint with Stain Blasting Foam2 in 1 CELLO PACKPASTE, DENTIFRICE23
84126-629-02Crest 3D WhiteAdvanced Radiant Mint with Stain Blasting Foam1 in 1 CARTONPASTE, DENTIFRICE13
84126-629-23Crest 3D WhiteAdvanced Radiant Mint with Stain Blasting Foam2 in 1 CARTONPASTE, DENTIFRICE23
84126-629-23Crest 3D WhiteAdvanced Radiant Mint with Stain Blasting Foam68 g in 1 TUBEPASTE, DENTIFRICE683
84126-629-24Crest 3D WhiteAdvanced Radiant Mint with Stain Blasting Foam68 g in 1 TUBEPASTE, DENTIFRICE683
84126-629-24Crest 3D WhiteAdvanced Radiant Mint with Stain Blasting Foam1 in 1 CARTONPASTE, DENTIFRICE13
84126-629-33Crest 3D WhiteAdvanced Radiant Mint with Stain Blasting Foam1 in 1 CARTONPASTE, DENTIFRICE13
84126-629-33Crest 3D WhiteAdvanced Radiant Mint with Stain Blasting Foam93 g in 1 TUBEPASTE, DENTIFRICE933
84126-629-49Crest 3D WhiteAdvanced Radiant Mint with Stain Blasting Foam138 g in 1 TUBEPASTE, DENTIFRICE1383
84126-629-49Crest 3D WhiteAdvanced Radiant Mint with Stain Blasting Foam1 in 1 CARTONPASTE, DENTIFRICE13
84126-629-85Crest 3D WhiteAdvanced Radiant Mint with Stain Blasting Foam1 in 1 CARTONPASTE, DENTIFRICE13
84126-629-85Crest 3D WhiteAdvanced Radiant Mint with Stain Blasting Foam24 g in 1 TUBEPASTE, DENTIFRICE243
84126-629-93Crest 3D WhiteAdvanced Radiant Mint with Stain Blasting Foam93 g in 1 TUBEPASTE, DENTIFRICE933
84126-629-93Crest 3D WhiteAdvanced Radiant Mint with Stain Blasting Foam3 in 1 CARTONPASTE, DENTIFRICE33

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 5 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sensitive Teeth and GumsPOTASSIUM NITRATE, SODIUM FLUORIDEChurch & Dwight Co., Inc.935172db-d78f-0c69-e053-2a95a90a0b692026-07-23WarningsExact identifier
application number: M021
Essentials Whiten and StrengthenSODIUM FLUORIDE 0.24%Church & Dwight Co., Inc.96548550-2cd1-b757-e053-2995a90a15ea2026-07-23WarningsExact identifier
application number: M021
TP COL OW PurpleSODIUM FLUORIDEColgate-Palmolive Companyea0db59f-f9c0-49a8-9717-69cdf071f6e12026-07-23WarningsExact identifier
application number: M021
Colgate Max Fresh Cool MintSODIUM FLUORIDEColgate-Palmolive Company00652bb2-090c-4eaa-8fc2-e0be6913a7242026-07-22WarningsExact identifier
application number: M021
Colgate Ultra White CharcoalSODIUM FLUORIDEColgate-Palmolive Company95d06fcc-f56d-43f1-924a-3f91fda59bdf2026-07-22WarningsExact identifier
application number: M021
COLGATE Great Regular FlavorSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Company730f40f6-6ac6-49bd-888b-c0b5818a03c82026-07-20WarningsExact identifier
application number: M021
COLGATE KPOP DEMON HUNTERS BUBBLE POPSODIUM FLUORIDEColgate-Palmolive Companybf465181-01e9-44ca-91f8-03110a6067742026-07-16WarningsExact identifier
application number: M021
Colgate Minions Mild Bubble Fruit FluorideSODIUM FLUORIDEColgate-Palmolive Company16634b99-f305-48bf-ac54-a9f53797a9e52026-07-16WarningsExact identifier
application number: M021
Freshen Up Holiday mintSODIUM FLUORIDEDabur India Limited56aaa9f5-7eac-11d9-e063-6294a90af3a82026-07-15WarningsExact identifier
application number: M021
Freshen Up pepper mintSODIUM FLUORIDEDabur India Limited56aaba60-523e-6ac7-e063-6394a90a27562026-07-15WarningsExact identifier
application number: M021
Freshen-up Matcha MintSODIUM FLUORIDEDabur India Limited56aac050-73e7-298c-e063-6294a90a26eb2026-07-15WarningsExact identifier
application number: M021
Freshen Up twisted peppermintSODIUM FLUORIDEDabur India Limited56aac7a7-c086-2fa5-e063-6294a90aa9592026-07-15WarningsExact identifier
application number: M021
Freshen Up Vanilla MintSODIUM FLUORIDEDabur India Limited56aad223-db88-7cf6-e063-6394a90a6b722026-07-15WarningsExact identifier
application number: M021
Freshen UpSODIUM FLUORIDEMKJ BRANDS LLC2dcd4816-caa5-c006-e063-6394a90ac4872026-07-15WarningsExact identifier
application number: M021
Freshen UpSODIUM FLUORIDEDABUR INDIA LIMITED56acecd2-6966-2ee4-e063-6394a90a356f2026-07-15WarningsExact identifier
application number: M021
Colgate Max Fresh Advanced WhiteningSODIUM FLUORIDEColgate-Palmolive Company01c07c25-2748-4d90-9505-094e2c977c9c2026-07-15WarningsExact identifier
application number: M021
Crest StrawberrySODIUM FLUORIDEThe Procter & Gamble Manufacturing Company7d51c67b-7409-e5a7-e053-2a91aa0a81fa2026-07-14WarningsExact identifier
application number: M021
Freshen UpSODIUM FLUORIDE, POTASSIUM NITRATEMKJ BRANDS LLC476f453b-9215-0a11-e063-6294a90a5cd42026-07-14WarningsExact identifier
application number: M021
Freshen Up Vanilla MintSODIUM FLUORIDEMKJ BRANDS LLC525662da-42be-eaa6-e063-6294a90af1102026-07-14WarningsExact identifier
application number: M021
Freshen Up twisted peppermintSODIUM FLUORIDEMKJ BRANDS LLC526acbdd-6531-692d-e063-6394a90ab9f12026-07-14WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
891775sodium fluoride 0.243 % ToothpastePSN4ee26a82-16fd-f0fb-e063-6394a90a91d13
891775sodium fluoride 0.00243 MG/MG ToothpasteSCD4ee26a82-16fd-f0fb-e063-6394a90a91d13
891775sodium fluoride 0.243 % (fluoride ion 0.13 % ) ToothpasteSY4ee26a82-16fd-f0fb-e063-6394a90a91d13
891775sodium fluoride 0.243 % (fluoride ion 0.14 % ) ToothpasteSY4ee26a82-16fd-f0fb-e063-6394a90a91d13
891775sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSY4ee26a82-16fd-f0fb-e063-6394a90a91d13
891775sodium fluoride 0.243 % (fluoride ion 0.16 % ) ToothpasteSY4ee26a82-16fd-f0fb-e063-6394a90a91d13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84126-629-02841260629022 CARTON in 1 CELLO PACK (84126-629-02) / 1 TUBE in 1 CARTON / 68 g in 1 TUBE2 carton2026-01-01NoNoCurrent
84126-629-23841260629232 TUBE in 1 CARTON (84126-629-23) / 68 g in 1 TUBE2 tube2026-01-01NoNoCurrent
84126-629-24841260629241 TUBE in 1 CARTON (84126-629-24) / 68 g in 1 TUBE1 tube2026-01-01NoNoCurrent
84126-629-33841260629331 TUBE in 1 CARTON (84126-629-33) / 93 g in 1 TUBE1 tube2026-01-01NoNoCurrent
84126-629-49841260629491 TUBE in 1 CARTON (84126-629-49) / 138 g in 1 TUBE1 tube2026-01-01NoNoCurrent
84126-629-85841260629851 TUBE in 1 CARTON (84126-629-85) / 24 g in 1 TUBE1 tube2026-01-01NoNoCurrent
84126-629-93841260629933 TUBE in 1 CARTON (84126-629-93) / 93 g in 1 TUBE3 tube2026-01-01NoNoCurrent