FDA.reportPublic FDA data

COLGATE Great Regular Flavor

Product NDC
35000-913
Requested package NDC
35000-913-01
11-digit product format
350000913
Labeler code
35000
Product ID
35000-913_5c864eeb-a3fa-4e6a-b624-29ed3cd6d2da
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
2005-11-05
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 Great Regular Flavor
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM MONOFLUOROPHOSPHATE1 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
C810JCZ56QInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
545626Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
730f40f6-6ac6-49bd-888b-c0b5818a03c8Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35000-913-01COLGATE Great Regular Flavor1 in 1 CARTONPASTE, DENTIFRICE13
35000-913-01COLGATE Great Regular Flavor28 g in 1 TUBEPASTE, DENTIFRICE283
35000-913-04COLGATE Great Regular Flavor4.25 g in 1 POUCHPASTE, DENTIFRICE4.253
35000-913-20COLGATE Great Regular Flavor24 g in 1 TUBEPASTE, DENTIFRICE243
35000-913-30COLGATE Great Regular Flavor170 g in 1 TUBEPASTE, DENTIFRICE1703
35000-913-30COLGATE Great Regular Flavor3 in 1 CARTONPASTE, DENTIFRICE33
35000-913-33COLGATE Great Regular Flavor36.8 g in 1 TUBEPASTE, DENTIFRICE36.83
35000-913-33COLGATE Great Regular Flavor1 in 1 CARTONPASTE, DENTIFRICE13
35000-913-46COLGATE Great Regular Flavor1 in 1 CARTONPASTE, DENTIFRICE13
35000-913-46COLGATE Great Regular Flavor130 g in 1 TUBEPASTE, DENTIFRICE1303
35000-913-48COLGATE Great Regular Flavor1 in 1 CARTONPASTE, DENTIFRICE13
35000-913-48COLGATE Great Regular Flavor226 g in 1 TUBEPASTE, DENTIFRICE2263
35000-913-58COLGATE Great Regular Flavor70 g in 1 TUBEPASTE, DENTIFRICE703
35000-913-58COLGATE Great Regular Flavor1 in 1 CARTONPASTE, DENTIFRICE13
35000-913-60COLGATE Great Regular Flavor170 g in 1 TUBEPASTE, DENTIFRICE1703
35000-913-64COLGATE Great Regular Flavor181 g in 1 TUBEPASTE, DENTIFRICE1813
35000-913-64COLGATE Great Regular Flavor1 in 1 CARTONPASTE, DENTIFRICE13
35000-913-69COLGATE Great Regular Flavor113 g in 1 TUBEPASTE, DENTIFRICE1133
35000-913-69COLGATE Great Regular Flavor1 in 1 CARTONPASTE, DENTIFRICE13
35000-913-79COLGATE Great Regular Flavor79 g in 1 TUBEPASTE, DENTIFRICE793
35000-913-79COLGATE Great Regular Flavor1 in 1 CARTONPASTE, DENTIFRICE13
35000-913-82COLGATE Great Regular Flavor232 g in 1 TUBEPASTE, DENTIFRICE2323
35000-913-82COLGATE Great Regular Flavor1 in 1 CARTONPASTE, DENTIFRICE13
35000-913-92COLGATE Great Regular Flavor1 in 1 CARTONPASTE, DENTIFRICE13
35000-913-92COLGATE Great Regular Flavor141 g in 1 TUBEPASTE, DENTIFRICE1413
35000-913-93COLGATE Great Regular Flavor99 g in 1 TUBEPASTE, DENTIFRICE993

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35000-913COLGATE GREAT REGULAR FLAVOR (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [COLGATE-PALMOLIVE COMPANY]3Current NDC, Legacy NDC, 26 package rows20241127_730f40f6-6ac6-49bd-888b-c0b5818a03c8.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 9 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Walgreens Restore and DefendSTANNOUS FLUORIDEWalgreense808ea4b-9081-085b-e053-2a95a90a4f9b2026-06-02WarningsExact identifier
application number: M021
Hello Unicorn Splash unicorn splash anticavity fluoride rinseSODIUM FLUORIDEColgate-Palmolive Companya1014431-7d23-aaff-6dc7-ab58683d03382026-06-02WarningsExact identifier
application number: M021
Therabreath AnticavitySODIUM FLUORIDEChurch & Dwight Co., Inc.feab3d45-ff95-4b32-8258-7d932a7380c92026-06-01WarningsExact identifier
application number: M021
Orajel Toy Story 5 AnticavitySODIUM FLUORIDEChurch & Dwight Co., Inc.4b80947d-f389-2f80-e063-6294a90abd552026-06-01WarningsExact identifier
application number: M021
Arm and HammerSODIUM FLUORIDEChurch & Dwight Co., Inc.54113245-0c1e-739e-e063-6294a90aea422026-06-01WarningsExact identifier
application number: M021
Arm and HammerSODIUM FLUORIDEChurch & Dwight Co., Inc.545258fd-8179-fffc-e063-6394a90a467f2026-06-01WarningsExact identifier
application number: M021
Orajel Paw PatrolSODIUM FLUORIDEChurch & Dwight Co., Inc.99d87bea-3e99-5d04-e053-2a95a90aaf542026-06-01WarningsExact identifier
application number: M021
Orajel SuperMarioANTICAVITY TOOTHPASTEChurch & Dwight Co., Inc.27d2f6cb-8661-da9c-e063-6394a90a5bde2026-06-01WarningsExact identifier
application number: M021
Orajel KidsToothpasteSODIUM FLUORIDEChurch & Dwight Co., Inc.99d62125-c2c5-5926-e053-2995a90aaa292026-06-01WarningsExact identifier
application number: M021
AIM CAVITY PROTECTION Multi BenefitSODIUM FLUORIDEChurch & Dwight Co., Inc.1d0f8a33-0b01-40e2-e054-00144ff88e882026-06-01WarningsExact identifier
application number: M021
Crest plus Tartar Protection WhiteningSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company560980ea-749f-593d-e063-6394a90a1b9e2026-06-01WarningsExact identifier
application number: M021
Colgate Revitalizing WhiteSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Companyc67223ae-b068-41c5-a15b-7ae9840b93ef2026-05-27WarningsExact identifier
application number: M021
Colgate Kids Harry PotterSODIUM FLUORIDEColgate-Palmolive Company61c06da4-9f02-4fbc-b80f-1c443e2984962026-05-26WarningsExact identifier
application number: M021
sodium fluoride rinseSODIUM FLUORIDE RINSERockland Cosmetics, Inc.52430b12-4d5f-d1e1-e063-6394a90abd642026-05-20Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEH E Bd0a52519-3339-40ea-93e5-78f76d348a4d2026-05-14Warnings, Adverse reactionsExact identifier
application number: M021
Burts Bees Extra WhiteSODIUM FLUORIDEProcter & Gamble Manufacturing Companyc92524fd-8b93-592d-e053-2a95a90a88c62026-05-13WarningsExact identifier
application number: M021
MIPaste Plus StrawberrySODIUM FLUORIDEGC America Inc.1b68bd67-65d3-4c64-e054-00144ff8d46c2026-05-12WarningsExact identifier
application number: M021
White Glo Purple Color Corrector Fluoride AnticavitySODIUM MONOFLUOROPHOSPHATEWhite Glo USA Inc6f8b77c3-9833-4c75-b41c-a2bc126161572026-05-12WarningsExact identifier
application number: M021
botalab HERBAL COMPLETE TOOTHSODIUM FLUORIDEKMPHARMACEUTICAL CO., LTD.51365ef7-ed94-2650-e063-6394a90ab89e2026-05-07WarningsExact identifier
application number: M021
Morning Fresh Mint Toothpaste, with FluorideMORNING FRESH MINT TOOTHPASTE, WITH FLUORIDEDynarex Corporation2a42d8ce-e7f2-caa5-e063-6294a90ac01f2026-05-07WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
545626sodium monofluorophosphate 0.76 % ToothpastePSN730f40f6-6ac6-49bd-888b-c0b5818a03c83
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD730f40f6-6ac6-49bd-888b-c0b5818a03c83
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY730f40f6-6ac6-49bd-888b-c0b5818a03c83
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY730f40f6-6ac6-49bd-888b-c0b5818a03c83
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY730f40f6-6ac6-49bd-888b-c0b5818a03c83
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY730f40f6-6ac6-49bd-888b-c0b5818a03c83
545626sodium monofluorophosphate 0.76 % ToothpastePSNf89bf259-b738-8229-e053-6394a90a0c592
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCDf89bf259-b738-8229-e053-6394a90a0c592
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSYf89bf259-b738-8229-e053-6394a90a0c592
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSYf89bf259-b738-8229-e053-6394a90a0c592
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSYf89bf259-b738-8229-e053-6394a90a0c592
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSYf89bf259-b738-8229-e053-6394a90a0c592

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
35000-913-01350000913011 TUBE in 1 CARTON (35000-913-01) / 28 g in 1 TUBE1 tube2005-11-050000-00-00NoNoCurrent