FDA.reportPublic FDA data

Sodium Monofluorophosphate

Manufacturer
Dynarex Corporation
Effective date
2024-07-03
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:15:15

Label at a glance#

ProductSodium Monofluorophosphate
Active ingredientSODIUM MONOFLUOROPHOSPHATE
Label structure13 sections

Dosage and administration

• Adults and children 2 years and older: Brush teeth thoroughly 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 Monofluorophosphate 0.76%

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) immediatley.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of childen under 6 years of age

Directions

DOSAGE & ADMINISTRATION SECTION

• Adults and children 2 years and older: Brush teeth thoroughly 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

Calcium Carbonate, Carboxymethylcellulose Sodium, Hydrated Silica, Peppermint Oil, Purified Water, Saccharin Sodium, Sodium Benzoate, Sodium Lauryl Sulfate, Sodium Silicate, Sorbitol, Titanium Dioxide

Other Information

OTHER SAFETY INFORMATION

Store between 15°-35ºC (59º-95ºF)

Questions?

OTC - QUESTIONS SECTION

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

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

5910_IN_MASTER5910_IN_MASTER5910 White Toothpaste

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

5911_IN_MASTER5911_IN_MASTER5911 White Toothpaste

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

5912_BX_MASTER5912_BX_MASTER5912 White Toothpaste

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

5913_BX_MASTER5913_BX_MASTER5913 White Toothpaste

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

4914_BX_MASTER4914_BX_MASTER5914 White Toothpaste

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
545626sodium monofluorophosphate 0.76 % ToothpastePSN2
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD2
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY2
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY2
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY2
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY2

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
67777-181-01Sodium Monofluorophosphate42.5 g in 1 TUBEPASTE42.52
67777-181-02Sodium Monofluorophosphate144 in 1 CASEPASTE1442
67777-181-03Sodium Monofluorophosphate78 g in 1 TUBEPASTE782
67777-181-04Sodium Monofluorophosphate144 in 1 CASEPASTE1442
67777-181-05Sodium Monofluorophosphate130 g in 1 TUBEPASTE1302
67777-181-06Sodium Monofluorophosphate1 in 1 BOXPASTE12
67777-181-07Sodium Monofluorophosphate60 in 1 CASEPASTE602
67777-181-08Sodium Monofluorophosphate24 g in 1 TUBEPASTE242
67777-181-09Sodium Monofluorophosphate144 in 1 BOXPASTE1442
67777-181-10Sodium Monofluorophosphate720 in 1 CASEPASTE7202
67777-181-11Sodium Monofluorophosphate17 g in 1 TUBEPASTE172
67777-181-12Sodium Monofluorophosphate144 in 1 BOXPASTE1442
67777-181-13Sodium Monofluorophosphate720 in 1 CASEPASTE7202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67777-181SODIUM MONOFLUOROPHOSPHATE (WHITE TOOTHPASTE) PASTE [DYNAREX CORPORATION]2Current NDC, 13 package rows20240716_1be422b9-6320-ed5c-e063-6294a90a7e42.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67777-18167777-181-01, 67777-181-02, 67777-181-03, 67777-181-04, 67777-181-05, 67777-181-06, 67777-181-07, 67777-181-08, 67777-181-09, 67777-181-10, 67777-181-11, 67777-181-12, 67777-181-13

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM MONOFLUOROPHOSPHATEC810JCZ56QACTIM
CALCIUM CARBONATEH0G9379FGKIACT
SODIUM SILICATEIJF18F77L3IACT
SORBITOL506T60A25RIACT
HYDRATED SILICAY6O7T4G8P9IACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM BENZOATEOJ245FE5EUIACT
WATER059QF0KO0RIACT
PEPPERMINT OILAV092KU4JHIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
SODIUM LAURYL SULFATE368GB5141JIACT
TITANIUM DIOXIDE15FIX9V2JPIACT

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 MonofluorophosphateWHITE TOOTHPASTEDynarex Corporation1be422b9-6320-ed5c-e063-6294a90a7e422024-07-03WarningsExact identifier
ndc (package): 67777-181-03
ndc (package): 67777-181-04
ndc (package): 67777-181-05
ndc (package): 67777-181-07
ndc (package): 67777-181-09
ndc (package): 67777-181-02
ndc (package): 67777-181-01
ndc (package): 67777-181-06
ndc (package): 67777-181-08
ndc (package): 67777-181-13
ndc (package): 67777-181-11
ndc (package): 67777-181-12
ndc (package): 67777-181-10
ndc (product): 67777-181
ndc11 (package): 67777018102
ndc11 (package): 67777018104
ndc11 (package): 67777018106
ndc11 (package): 67777018110
ndc11 (package): 67777018101
ndc11 (package): 67777018108
ndc11 (package): 67777018105
ndc11 (package): 67777018103
ndc11 (package): 67777018111
ndc11 (package): 67777018109
ndc11 (package): 67777018107
ndc11 (package): 67777018112
ndc11 (package): 67777018113
spl id: 1c58c582-92e0-4533-e063-6394a90a9fe5
spl set id: 1be422b9-6320-ed5c-e063-6294a90a7e42

Reported adverse events (FAERS/openFDA)#

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