FDA.reportPublic FDA data

Sodium Fluoride

Product NDC
67777-180
11-digit product format
677770180
Labeler code
67777
Product ID
67777-180_1be193b6-4c08-4f0a-e063-6394a90a32c7
Type
HUMAN OTC DRUG
Nonproprietary name
Clear Mint, Gel Toothpaste
Dosage form
GEL
Route
DENTAL
Labeler
Dynarex Corporation
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-07-16
Substance
SODIUM FLUORIDE
Active strength
220 mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
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
Sodium Fluoride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE220 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
245598Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1be193b6-4c07-4f0a-e063-6394a90a32c7Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67777-180-01Sodium Fluoride17 g in 1 TUBEGEL171
67777-180-02Sodium Fluoride144 in 1 BOXGEL1441
67777-180-03Sodium Fluoride720 in 1 CASEGEL7201
67777-180-04Sodium Fluoride130 g in 1 TUBEGEL1301
67777-180-05Sodium Fluoride1 in 1 BOXGEL11
67777-180-06Sodium Fluoride60 in 1 CASEGEL601
67777-180-07Sodium Fluoride42.5 g in 1 TUBEGEL42.51
67777-180-08Sodium Fluoride144 in 1 CASEGEL1441
67777-180-09Sodium Fluoride24 g in 1 TUBEGEL241
67777-180-10Sodium Fluoride144 in 1 BOXGEL1441
67777-180-11Sodium Fluoride720 in 1 CASEGEL7201

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67777-180SODIUM FLUORIDE (CLEAR MINT, GEL TOOTHPASTE) GEL [DYNAREX CORPORATION]1Current NDC, 11 package rows20240716_1be193b6-4c07-4f0a-e063-6394a90a32c7.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
245598sodium fluoride 0.22 % ToothpastePSN1be193b6-4c07-4f0a-e063-6394a90a32c71
245598sodium fluoride 0.0022 MG/MG ToothpasteSCD1be193b6-4c07-4f0a-e063-6394a90a32c71
245598sodium fluoride 0.22 % (fluoride 0.1 % ) ToothpasteSY1be193b6-4c07-4f0a-e063-6394a90a32c71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67777-180-016777701800117 g in 1 TUBE17 gHistorical
67777-180-0267777018002144 in 1 BOXHistorical
67777-180-0367777018003720 BOX in 1 CASE (67777-180-03) / 144 TUBE in 1 BOX (67777-180-02) / 17 g in 1 TUBE (67777-180-01) 720 box2024-07-16NoNoCurrent
67777-180-0467777018004130 g in 1 TUBE130 gHistorical
67777-180-05677770180051 in 1 BOXHistorical
67777-180-066777701800660 BOX in 1 CASE (67777-180-06) / 1 TUBE in 1 BOX (67777-180-05) / 130 g in 1 TUBE (67777-180-04) 60 box2024-07-16NoNoCurrent
67777-180-076777701800742.5 g in 1 TUBE42.5 gHistorical
67777-180-0867777018008144 TUBE in 1 CASE (67777-180-08) / 42.5 g in 1 TUBE (67777-180-07) 144 tube2024-07-16NoNoCurrent
67777-180-096777701800924 g in 1 TUBE24 gHistorical
67777-180-1067777018010144 in 1 BOXHistorical
67777-180-1167777018011720 BOX in 1 CASE (67777-180-11) / 144 TUBE in 1 BOX (67777-180-10) / 24 g in 1 TUBE (67777-180-09) 720 box2024-07-16NoNoCurrent