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 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
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