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

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 Identifiers#

Field, Values table
FieldValues
Unii8ZYQ1474W7
Rxcui245598

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

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