FDA.reportPublic FDA data

Crest Premium Plus

Product NDC
37000-994
11-digit product format
370000994
Labeler code
37000
Product ID
37000-994_47e347f8-eb74-9c1c-e063-6294a90ab479
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
2021-01-07
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 Premium Plus
Brand name suffix
Deep Clean Active 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
b851fe5c-d904-12da-e053-2a95a90a86f9Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
37000-994-522024-02-06Crest Premium Plus Deep Clean Active Foam
37000-994-522024-02-06Crest Premium Plus Deep Clean Active Foam
37000-994-722024-02-06Crest Premium Plus Deep Clean Active Foam
37000-994-722024-02-06Crest Premium Plus Deep Clean Active Foam
37000-994-522024-01-30Crest Premium Plus Deep Clean Active Foam
37000-994-522024-01-30Crest Premium Plus Deep Clean Active Foam
37000-994-722024-01-30Crest Premium Plus Deep Clean Active Foam
37000-994-722024-01-30Crest Premium Plus Deep Clean Active Foam

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37000-994-15Crest Premium PlusDeep Clean Active Foam1 in 1 CARTONPASTE, DENTIFRICE18
37000-994-15Crest Premium PlusDeep Clean Active Foam3 in 1 CELLO PACKPASTE, DENTIFRICE38
37000-994-52Crest Premium PlusDeep Clean Active Foam147 g in 1 TUBEPASTE, DENTIFRICE1478
37000-994-52Crest Premium PlusDeep Clean Active Foam1 in 1 CARTONPASTE, DENTIFRICE18
37000-994-72Crest Premium PlusDeep Clean Active Foam1 in 1 CARTONPASTE, DENTIFRICE18
37000-994-72Crest Premium PlusDeep Clean Active Foam204 g in 1 TUBEPASTE, DENTIFRICE2048

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37000-994CREST PREMIUM PLUS DEEP CLEAN ACTIVE FOAM (SODIUM FLUORIDE) PASTE, DENTIFRICE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]6Current NDC, Legacy NDC, 6 package rows20250115_b851fe5c-d904-12da-e053-2a95a90a86f9.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 27 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Crest plus Tartar Protection WhiteningSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company08776dfc-b07a-3729-e063-6394a90aeeed2026-01-08WarningsExact identifier
application number: M021
Crest Plus Active Fresh plus Whitening ScopeSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company17f3b749-01ea-2561-e063-6294a90a5d3b2026-01-08WarningsExact identifier
application number: M021
Crest 3D White Advanced Deep CleanSODIUM FLUORIDEProcter & Gamble Manfuacturing Company128613c4-c06b-bdf5-e063-6294a90acd342026-01-08WarningsExact identifier
application number: M021
Crest 3D White Brilliance Pro RinseSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company13a01190-a6f3-17b3-e063-6294a90a36c22026-01-08WarningsExact identifier
application number: M021
HEB HEBuddyFLUORIDEHEB2c972c65-34aa-4348-b997-c5e65a8845752026-01-08WarningsExact identifier
application number: M021
ARC 2 in 1 Whitening and AnticavitySODIUM MONOFLUOROPHOSPHATEThe Procter & Gamble Manufacturing Company12634efa-35e3-76d7-e063-6294a90a3de42026-01-08Exact identifier
application number: M021
Crest Plus Whitening Deep CleanSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company15482445-39f3-7e02-e063-6294a90ad1dc2026-01-08WarningsExact identifier
application number: M021
H E B Restore and DefendFLUORIDEHEB56080493-9ab8-4b4f-be5f-7df22dee133f2026-01-08WarningsExact identifier
application number: M021
Crest Plus Cinnamon Expressions plus WhiteningSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company151d2a0a-448f-7744-e063-6294a90acd3b2026-01-08WarningsExact identifier
application number: M021
Oral B Mouth Sore Special Care RinseHYDROGEN PEROXIDEThe Procter & Gamble Manufacturing Company22e2dc15-5794-28ed-e063-6394a90a36d32026-01-08WarningsExact identifier
application number: M021
Crest Pro-Health Advanced Anti-Cavity Max CavitySODIUM FLUORIDEThe Procter & Gamble Manufacturing Company15d70b80-3b25-bc32-e063-6394a90a163e2026-01-08WarningsExact identifier
application number: M021
Crest 3D White Brilliance Bright MintSODIUM FLUORIDEProcter & Gamble Manfuacturing Company1dee0584-0fed-61c6-e063-6394a90adbcd2026-01-08WarningsExact identifier
application number: M021
HEB Gleaming White Arctic MintSODIUM FLUORIDEHEB8248eddb-20a5-7084-e053-2991aa0a16b52026-01-08WarningsExact identifier
application number: M021
Crest Pro-Health Gum Rescue Pro Soothing CleanSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Company2f10c7ac-eb60-011e-e063-6394a90aca132026-01-08WarningsExact identifier
application number: M021
Crest Deep Cleanse Cavity DefenseSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company2e09cb3b-cf59-15b1-e063-6394a90a5c6a2026-01-08WarningsExact identifier
application number: M021
Crest Pro-Health Maximum Cavity ProtectionSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Company2eaeddc5-1559-9378-e063-6394a90a4ed72026-01-08WarningsExact identifier
application number: M021
Crest 3D White Deep Stain Remover Dazzling MintSODIUM MONOFLUOROPHOSPHATEThe Procter & Gamble Manufacturing Company2f11e935-1711-5f1a-e063-6294a90af7d82026-01-08Exact identifier
application number: M021
HEB Gleaming White Fresh MintSODIUM FLUORIDEHEB82491c8f-d2c2-2e4a-e053-2a91aa0a572f2026-01-08WarningsExact identifier
application number: M021
Crest 3D White Brilliance Pro Ultra WhiteSODIUM MONOFLUOROPHOSPHATEThe Procter & Gamble Manufacturing Company338acdf2-548c-0614-e063-6294a90af6352026-01-08Exact identifier
application number: M021
KIDS Crest Advanced Sugar and Bacteria ShieldSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Company2f371af0-a2d4-25a6-e063-6394a90a923d2026-01-08WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
891775sodium fluoride 0.243 % ToothpastePSNb851fe5c-d904-12da-e053-2a95a90a86f98
891775sodium fluoride 0.00243 MG/MG ToothpasteSCDb851fe5c-d904-12da-e053-2a95a90a86f98
891775sodium fluoride 0.243 % (fluoride ion 0.13 % ) ToothpasteSYb851fe5c-d904-12da-e053-2a95a90a86f98
891775sodium fluoride 0.243 % (fluoride ion 0.14 % ) ToothpasteSYb851fe5c-d904-12da-e053-2a95a90a86f98
891775sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSYb851fe5c-d904-12da-e053-2a95a90a86f98
891775sodium fluoride 0.243 % (fluoride ion 0.16 % ) ToothpasteSYb851fe5c-d904-12da-e053-2a95a90a86f98

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37000-994-15370000994153 CARTON in 1 CELLO PACK (37000-994-15) / 1 TUBE in 1 CARTON / 147 g in 1 TUBE3 carton2023-01-01NoNoCurrent
37000-994-52370000994521 TUBE in 1 CARTON (37000-994-52) / 147 g in 1 TUBE1 tube2021-01-070000-00-00NoNoCurrent
37000-994-72370000994721 TUBE in 1 CARTON (37000-994-72) / 204 g in 1 TUBE1 tube2021-01-070000-00-00NoNoCurrent