FDA.reportPublic FDA data

Colgate MaxFresh Charcoal

Product NDC
35000-990
11-digit product format
350000990
Labeler code
35000
Product ID
35000-990_447f0849-ffaf-47c0-94ff-d29f78a90509
Type
HUMAN OTC DRUG
Nonproprietary name
SODIUM FLUORIDE
Dosage form
GEL, DENTIFRICE
Route
DENTAL
Labeler
Colgate-Palmolive Company
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-10-01
Substance
SODIUM FLUORIDE
Active strength
1.1 mg/g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage35000-99035000-990-34DDiscontinued by firm2026-10-20
excluded packagepackage35000-99035000-990-60DDiscontinued by firm2026-10-20
excluded packagepackage35000-99035000-990-95DDiscontinued by firm2026-10-20
excluded packagepackage35000-99035000-990-99DDiscontinued by firm2026-10-20

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 MaxFresh Charcoal
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE1.1 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
416783Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
890c4c29-bba8-4775-a053-10c6292df930Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35000-990-34Colgate MaxFresh Charcoal170 g in 1 TUBEGEL, DENTIFRICE17019
35000-990-34Colgate MaxFresh Charcoal2 in 1 CARTONGEL, DENTIFRICE219
35000-990-58Colgate MaxFresh Charcoal1 in 1 CARTONGEL, DENTIFRICE119
35000-990-58Colgate MaxFresh Charcoal70.8 g in 1 TUBEGEL, DENTIFRICE70.819
35000-990-60Colgate MaxFresh Charcoal1 in 1 CARTONGEL, DENTIFRICE119
35000-990-60Colgate MaxFresh Charcoal170 g in 1 TUBEGEL, DENTIFRICE17019
35000-990-69Colgate MaxFresh Charcoal113 g in 1 TUBEGEL, DENTIFRICE11319
35000-990-69Colgate MaxFresh Charcoal1 in 1 CARTONGEL, DENTIFRICE119
35000-990-95Colgate MaxFresh Charcoal1 in 1 CARTONGEL, DENTIFRICE119
35000-990-95Colgate MaxFresh Charcoal178 g in 1 TUBEGEL, DENTIFRICE17819
35000-990-99Colgate MaxFresh Charcoal1 in 1 CARTONGEL, DENTIFRICE119
35000-990-99Colgate MaxFresh Charcoal53.8 g in 1 TUBEGEL, DENTIFRICE53.819

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35000-990COLGATE MAXFRESH CHARCOAL (SODIUM FLUORIDE) GEL, DENTIFRICE [COLGATE-PALMOLIVE COMPANY]15Current NDC, Legacy NDC, 12 package rows20241101_890c4c29-bba8-4775-a053-10c6292df930.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 25 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Crest Pro Health Advanced Enamel RestoreSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyd813f5f0-3135-4a8f-e053-2a95a90a55622026-01-08WarningsExact identifier
application number: M021
Crest 3D White BrillianceSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company8e189fbd-5094-4398-b96c-8f95d89b9cdd2026-01-08WarningsExact identifier
application number: M021
Crest Pro Health Densify RinseSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyd84fb9f9-f2bc-358a-e053-2995a90abf072026-01-08WarningsExact identifier
application number: M021
Kids Crest Strawberry RushSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyeb7a5698-754c-4e46-e053-2a95a90a57b42026-01-08WarningsExact identifier
application number: M021
Crest 3D White Brilliance Daily Cleansing and Whitening SystemSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Company89a6fb36-5109-47f1-95ad-9381471ceeef2026-01-08WarningsExact identifier
application number: M021
Crest Pro-Health Advanced w/Extra WhiteningSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company2c1c5563-0b7e-4c7c-b49f-3d72e078cd282026-01-08WarningsExact identifier
application number: M021
Crest 3D White Stain Eraser Fresh MintSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyc81ba39d-c7ea-b2a5-e053-2995a90a0fe72026-01-08Exact identifier
application number: M021
Crest Premium Plus Breath Bacteria BlastSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyc3f1d477-6dd8-0ac4-e053-2a95a90a37422026-01-08WarningsExact identifier
application number: M021
Crest Premium Plus Active Foam Whitening scopeSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyc72b15e0-e69c-65fc-e053-2a95a90a54c82026-01-08WarningsExact identifier
application number: M021
Crest Complete Plus Scope Outlast UltraSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyc3f63455-b09e-9877-e053-2a95a90a18442026-01-08WarningsExact identifier
application number: M021
Crest Tartar Protection Fresh Mint GelSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company3d81d605-4f9b-3bb5-e054-00144ff88e882026-01-08WarningsExact identifier
application number: M021
Crest Complete plus WhiteningSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companye3b1f139-4fe8-f005-e053-2995a90a53b42026-01-08WarningsExact identifier
application number: M021
Crest 3D White Radiant MintSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyf3dd7a34-a0d8-4ac6-bbd1-7c3b86187a572026-01-08WarningsExact identifier
application number: M021
Crest Complete Plus Active Fresh plus Whitening ScopeSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyc599d33f-788f-7fdd-e053-2a95a90a5f572026-01-08WarningsExact identifier
application number: M021
Crest Complete Multi Benefit Whitening plus Scope OutlastSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company66c41b24-d394-6609-e053-2a91aa0a0a2c2026-01-08WarningsExact identifier
application number: M021
Crest Complete Plus 3 in 1SODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyb6fab2eb-da5c-749f-e053-2995a90a13572026-01-08WarningsExact identifier
application number: M021
Crest Tartar ProtectionSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company85477763-1db5-482f-90e5-e71f5c1b47652026-01-08WarningsExact identifier
application number: M021
Crest Fresh and WhiteSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyf9b31f6b-6b3f-abe0-e053-6294a90acb252026-01-08WarningsExact identifier
application number: M021
Crest Complete plus Whitening Deep CleanSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyc367c2cc-5e0f-bc4e-e053-2995a90a2e2c2026-01-08WarningsExact identifier
application number: M021
Crest 3D White Glamorous WhiteSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyc3f29f95-81b9-3989-e053-2a95a90af3a62026-01-08WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416783sodium fluoride 0.24 % ToothpastePSN890c4c29-bba8-4775-a053-10c6292df93019
416783sodium fluoride 0.0024 MG/MG ToothpasteSCD890c4c29-bba8-4775-a053-10c6292df93019
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSY890c4c29-bba8-4775-a053-10c6292df93019
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY890c4c29-bba8-4775-a053-10c6292df93019
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY890c4c29-bba8-4775-a053-10c6292df93019

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
35000-990-34350000990342 TUBE in 1 CARTON (35000-990-34) > 170 g in 1 TUBE2 tube2020-11-160000-00-00NoNoCurrent
35000-990-58350000990581 TUBE in 1 CARTON (35000-990-58) / 70.8 g in 1 TUBE1 tube2020-10-010000-00-00NoNoCurrent
35000-990-60350000990601 TUBE in 1 CARTON (35000-990-60) > 170 g in 1 TUBE1 tube2020-10-240000-00-00NoNoCurrent
35000-990-69350000990691 TUBE in 1 CARTON (35000-990-69) / 113 g in 1 TUBE1 tube2024-06-17NoNoCurrent
35000-990-95350000990951 TUBE in 1 CARTON (35000-990-95) > 178 g in 1 TUBE1 tube2021-01-290000-00-00NoNoCurrent
35000-990-99350000990991 TUBE in 1 CARTON (35000-990-99) > 53.8 g in 1 TUBE1 tube2020-10-010000-00-00NoNoCurrent