FDA.reportPublic FDA data

COLGATE OPTIC WHITE ADVANCED STAIN PREVENTION

Product NDC
35000-075
11-digit product format
350000075
Labeler code
35000
Product ID
35000-075_e350af75-446a-4f14-b4dc-7c7a269c3318
Type
HUMAN OTC DRUG
Nonproprietary name
SODIUM MONOFLUOROPHOSPHATE
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Colgate-Palmolive Company
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-08-24
Substance
SODIUM MONOFLUOROPHOSPHATE
Active strength
1 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
COLGATE OPTIC WHITE ADVANCED STAIN PREVENTION
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM MONOFLUOROPHOSPHATE1 mg/g

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
35000-075-32350000075321 TUBE in 1 CARTON (35000-075-32) / 90 g in 1 TUBE1 tube2026-08-24NoNoCurrent