FDA.reportPublic FDA data

Sodium Fluoride

Manufacturer
Dynarex Corporation
Effective date
2024-06-27
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:15:15

Label at a glance#

ProductSodium Fluoride
Active ingredientSODIUM FLUORIDE
Label structure12 sections

Dosage and administration

• Adults and children 2 years of age and older: Brush teeth thoroughtly after meals or at least twice a day or use as directed by a dentist or physician. • Children under 6 years: To minimize swallowing, use a pea sized amount and supervise child's brushing and rinsing until good habits are established. • Children under 2 years: Ask a dentist or physician.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium Fluoride 0.22% (0.1% w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity

Use(s)

INDICATIONS & USAGE SECTION

Helps protect against cavities

Warnings

WARNINGS SECTION

If you accidentally swallow more than used for brushing, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

Keep Out of Reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children under 6 years of age

Directions

DOSAGE & ADMINISTRATION SECTION

• Adults and children 2 years of age and older: Brush teeth thoroughtly after meals or at least twice a day or use as directed by a dentist or physician.

• Children under 6 years: To minimize swallowing, use a pea sized amount and supervise child's brushing and rinsing until good habits are established.

• Children under 2 years: Ask a dentist or physician.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Carboxymethylcellulose Sodium, Hydrated Silica, Peppermint Oil, Polyethylene Glycol 1450, Purified Water, Saccharin Sodium, Sodium Benzoate, Sodium Lauryl Sulfate, Sorbitol

Other Information

OTHER SAFETY INFORMATION

Store between 15º-35ºC (59º-95ºF)

Questions?

OTC - QUESTIONS SECTION

1-888-396-2739 Monday - Friday 9AM - 5PM EST

Label 5900

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

5900_BX_MASTER5900_BX_MASTER5900 Clear Mint, Gel Toothpaste

Label 5901

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

5901_BX_MASTER5901_BX_MASTER5901 Clear Mint, Gel Toothpaste

Label 5902

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

5902_IN_MASTER5902_IN_MASTER5902 Clear Mint, Gel Toothpaste

Label 5903

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

5903_BX_MASTER5903_BX_MASTER5903 Clear Mint, Gel Toothpaste

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
245598sodium fluoride 0.22 % ToothpastePSN1
245598sodium fluoride 0.0022 MG/MG ToothpasteSCD1
245598sodium fluoride 0.22 % (fluoride 0.1 % ) ToothpasteSY1

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

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67777-18067777-180-01, 67777-180-02, 67777-180-03, 67777-180-04, 67777-180-05, 67777-180-06, 67777-180-07, 67777-180-08, 67777-180-09, 67777-180-10, 67777-180-11

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
PEPPERMINT OILAV092KU4JHIACT
SODIUM BENZOATEOJ245FE5EUIACT
POLYETHYLENE GLYCOL 1450OJ4Z5Z32L4IACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM
HYDRATED SILICAY6O7T4G8P9IACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
WATER059QF0KO0RIACT
SODIUM LAURYL SULFATE368GB5141JIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SORBITOL506T60A25RIACT

Source Document#

Source XML

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sodium FluorideCLEAR MINT, GEL TOOTHPASTEDynarex Corporation1be193b6-4c07-4f0a-e063-6394a90a32c72024-06-27WarningsExact identifier
ndc (package): 67777-180-05
ndc (package): 67777-180-06
ndc (package): 67777-180-09
ndc (package): 67777-180-04
ndc (package): 67777-180-03
ndc (package): 67777-180-10
ndc (package): 67777-180-08
ndc (package): 67777-180-07
ndc (package): 67777-180-01
ndc (package): 67777-180-02
ndc (package): 67777-180-11
ndc (product): 67777-180
ndc11 (package): 67777018004
ndc11 (package): 67777018005
ndc11 (package): 67777018011
ndc11 (package): 67777018010
ndc11 (package): 67777018003
ndc11 (package): 67777018002
ndc11 (package): 67777018007
ndc11 (package): 67777018006
ndc11 (package): 67777018001
ndc11 (package): 67777018008
ndc11 (package): 67777018009
spl id: 1be193b6-4c08-4f0a-e063-6394a90a32c7
spl set id: 1be193b6-4c07-4f0a-e063-6394a90a32c7

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.