FDA.reportPublic FDA data

4871-4873 Morning Fresh Mint Toothpaste, with Fluoride

Manufacturer
Dynarex Corporation
Effective date
2026-05-07
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:56:11

Key Label Information#

Active Ingredients And Purpose

Active Ingredient

Sodium Monofluorophosphate 0.76% (0.13% w/v fluoride ion)

Purpose

Anticavity

Uses

Use(s)

Helps protect against cavities

Warnings

Warning

Do Not Swallow

Directions And Dosage

Directions

• 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 size amount and supervise brushing and rinsing until good habits are established. • Children under 2 years: Use as directed by a dentist or physician.

Other Label Information

Inactive Ingredients

Calcium Carbonate, Carboxymethylcellulose Sodium, Methylparaben, Peppermint Oil, Polyethylene Glycol 400, Propylparaben, Purified Water, Saccharin Sodium, Silicon Dioxide, Sodium Benzoate, Sodium Lauryl Sulfate, Sodium Pyrophosphate, Sodium Silicate, Sorbitol, Titanium Dioxide

Questions?

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

Label

4871 Label

Label

4872 Label

Label Images#

4871 BX MASTER (R251210-5)OL
4871 BX MASTER (R251210-5)OL
4872 BX MASTER (R251210-4)OL
4872 BX MASTER (R251210-4)OL
4873 BX MASTER (R251210-3)OL
4873 BX MASTER (R251210-3)OL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
545626sodium monofluorophosphate 0.76 % ToothpastePSN3
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD3
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY3
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY3
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY3
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY3

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
67777-190-01Morning Fresh Mint Toothpaste, with Fluoride25.14 mL in 1 TUBEPASTE25.143
67777-190-02Morning Fresh Mint Toothpaste, with Fluoride144 in 1 BOXPASTE1443
67777-190-03Morning Fresh Mint Toothpaste, with Fluoride5 in 1 CASEPASTE53
67777-190-04Morning Fresh Mint Toothpaste, with Fluoride44.36 mL in 1 TUBEPASTE44.363
67777-190-05Morning Fresh Mint Toothpaste, with Fluoride1 in 1 BOXPASTE13
67777-190-06Morning Fresh Mint Toothpaste, with Fluoride144 in 1 CASEPASTE1443
67777-190-07Morning Fresh Mint Toothpaste, with Fluoride81.33 mL in 1 TUBEPASTE81.333
67777-190-08Morning Fresh Mint Toothpaste, with Fluoride1 in 1 BOXPASTE13
67777-190-09Morning Fresh Mint Toothpaste, with Fluoride144 in 1 CASEPASTE1443

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67777-19067777-190-01, 67777-190-02, 67777-190-03, 67777-190-04, 67777-190-05, 67777-190-06, 67777-190-07, 67777-190-08, 67777-190-09

Ingredients#

Name, UNII, Kind table
NameUNIIKind
SODIUM SILICATEIJF18F77L3IACT
WATER059QF0KO0RIACT
CALCIUM CARBONATEH0G9379FGKIACT
SODIUM LAURYL SULFATE368GB5141JIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT
SODIUM BENZOATEOJ245FE5EUIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SORBITOL506T60A25RIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
PEPPERMINT OILAV092KU4JHIACT
SODIUM MONOFLUOROPHOSPHATEC810JCZ56QACTIM
POLYETHYLENE GLYCOL 400B697894SGQIACT
SODIUM PYROPHOSPHATEO352864B8ZIACT

Complete SPL Sections#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium Monofluorophosphate 0.76% (0.13% w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity

Use(s)

INDICATIONS & USAGE SECTION

Helps protect against cavities

Warning

WARNINGS SECTION

Do Not Swallow

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 size amount and supervise brushing and rinsing until good habits are established. • Children under 2 years: Use as directed by a dentist or physician.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Calcium Carbonate, Carboxymethylcellulose Sodium, Methylparaben, Peppermint Oil, Polyethylene Glycol 400, Propylparaben, Purified Water, Saccharin Sodium, Silicon Dioxide, Sodium Benzoate, Sodium Lauryl Sulfate, Sodium Pyrophosphate, Sodium Silicate, Sorbitol, Titanium Dioxide

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

4871 Label

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

4872 Label

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

4873 Label

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22025-09-25monthly-update2026-06-03 17:56:02