FDA.reportPublic FDA data

Goby Peppermint

Manufacturer
BGLG, Inc.
Effective date
2021-04-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:40:07

Label at a glance#

ProductGoby Peppermint
Active ingredientSODIUM FLUORIDE
Label structure6 sections

Dosage and administration

Apply a pea-sized amount. Brush teeth thoroughly. Consult with a dentist or physician if needed.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

sodium fluoride, .24%
(0.15% w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity

Use

INDICATIONS & USAGE SECTION

Helps prevent cavities

Warning

WARNINGS SECTION

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Apply a pea-sized amount. Brush teeth thoroughly. Consult with a dentist or physician if needed.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

water, sorbitol, hydrated silica, glycerin, cocamidopropyl betaine, PEG-12, flavor, titanium dioxide, cellulose gum, sodium benzoate, sodium saccharin

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
416783sodium fluoride 0.24 % ToothpastePSN1
416783sodium fluoride 0.0024 MG/MG ToothpasteSCD1
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSY1
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY1
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81788-001-002023-01-30C16284748780-1f386c64a-3be7-0266-e053-dadaa90a7c1aGoby peppermint Toothpaste

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81788-001-00Goby Peppermint99 g in 1 TUBEPASTE991

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81788-001GOBY PEPPERMINT (SODIUM FLUORIDE) PASTE [BGLG, INC.]1Legacy NDC, 1 package rows20210501_c0541f32-f039-3630-e053-2a95a90a12d6.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
81788-00181788-001-00

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
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
HYDRATED SILICAY6O7T4G8P9IACT
GLYCERINPDC6A3C0OXIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
POLYETHYLENE GLYCOL 600NL4J9F21N9IACT
METHYL SALICYLATELAV5U5022YIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
SODIUM BENZOATEOJ245FE5EUIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM

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
c0539abe-fa93-d4a6-e053-2a95a90a1975c0541f32-f039-3630-e053-2a95a90a12d62021-04-19WarningsExact identifier
spl id: c0539abe-fa93-d4a6-e053-2a95a90a1975
spl set id: c0541f32-f039-3630-e053-2a95a90a12d6

Reported adverse events (FAERS/openFDA)#

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