FDA.reportPublic FDA data

Gerigentle-Good morning

Manufacturer
Geri-Gentle Corporation
Effective date
2021-08-31
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 23:42:12

Label at a glance#

ProductGerigentle-Good morning
Active ingredientSODIUM MONOFLUOROPHOSPHATE
Label structure9 sections

Dosage and administration

Do not Swallow Supervise children as necessary until capable of using without supervision Instruct children under 12 years of age in good brushing and rinsing habits (to minimize swallowing) Adults and children 6 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician Children under 6 years of age: Do not use unless directed by a ...

Storage and handling

Store at 59°-86°F (15°-30°C) Avoid excessive heat

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium monofluorophosphate 0.76% (0.1% w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity Toothpaste

Use

INDICATIONS & USAGE SECTION

aids in the prevention of dental cavities

Warnings

WARNINGS SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children under 6 years of age!

  • If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center immediately

Directions

DOSAGE & ADMINISTRATION SECTION

  • Do not Swallow
  • Supervise children as necessary until capable of using without supervision
  • Instruct children under 12 years of age in good brushing and rinsing habits (to minimize swallowing)
  • Adults and children 6 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician
  • Children under 6 years of age: Do not use unless directed by a dentist or physician

Other Information

STORAGE AND HANDLING SECTION

  • Store at 59°-86°F (15°-30°C)
  • Avoid excessive heat

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Calcium Carbonate, Water, Sorbitol, Hydrated Silica, Sodium Lauryl Sulfate, Sodium Carboxymethyl Cellulose, Flavor, Sodium Saccharin, Sodium Methyl Paraben, Sodium Propyl Paraben

PRINCIPAL DISPLAY PANEL - 43 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GeriGentle

"Good
Morning!"

Flouride Toothpaste

Reorder No.
91386

Net Wt. 1.5 oz. (43g)

PRINCIPAL DISPLAY PANEL - 43 g Tube Carton
PRINCIPAL DISPLAY PANEL - 43 g Tube Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
545626sodium monofluorophosphate 0.76 % ToothpastePSN5
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD5
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY5
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY5
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY5
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY5

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69771-107-362023-01-30C16284748780-19d75b9d0-3cc1-f424-e053-dadaa90a57ceGerigentle-Good morning
69771-107-362020-12-09C16284748780-19d75b9d0-3cc1-f424-e053-dadaa90a57ceGerigentle-Good morning
69771-107-362020-01-31C16284748780-19d75b9d0-3cc1-f424-e053-dadaa90a57ceGerigentle-Good morning

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69771-107-36Gerigentle-Good morning43 g in 1 TUBEPASTE, DENTIFRICE435
69771-107-36Gerigentle-Good morning1 in 1 CARTONPASTE, DENTIFRICE15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69771-107GERIGENTLE-GOOD MORNING (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [GERI-GENTLE CORPORATION]5Legacy NDC, 2 package rows20210901_7d8efdc9-d1f5-40a1-98a6-22de9ba0e8c3.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
69771-10769771-107-36

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
CALCIUM CARBONATEH0G9379FGKIACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
HYDRATED SILICAY6O7T4G8P9IACT
SODIUM LAURYL SULFATE368GB5141JIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMK679OBS311IACT
SACCHARIN SODIUMSB8ZUX40TYIACT
METHYLPARABEN SODIUMCR6K9C2NHKIACT
PROPYLPARABEN SODIUM625NNB0G9NIACT
SODIUM MONOFLUOROPHOSPHATEC810JCZ56QACTIM

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
cae03130-ecbb-b01c-e053-2995a90aa46b7d8efdc9-d1f5-40a1-98a6-22de9ba0e8c32021-08-31WarningsExact identifier
spl id: cae03130-ecbb-b01c-e053-2995a90aa46b
spl set id: 7d8efdc9-d1f5-40a1-98a6-22de9ba0e8c3

Reported adverse events (FAERS/openFDA)#

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