FDA.reportPublic FDA data

Beyond Activated Coconut Charcoal and Sea Salt

Manufacturer
Beyond International Inc
Effective date
2023-11-28
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:02:51

Label at a glance#

ProductBeyond Activated Coconut Charcoal and Sea Salt
Active ingredientSODIUM FLUORIDE
Label structure11 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Sodium fluoride 0.24% (0.15% w/v fluoride ion)

OTC - PURPOSE SECTION

Purpose

Anticavity

INDICATIONS & USAGE SECTION

Uses

  • Aids in prevention of dental cavities.

WARNINGS SECTION

Warnings

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of 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 right away.

DOSAGE & ADMINISTRATION SECTION

Directions

  • adults and children 2 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 doctor.
  • instruct children under 6 years of age in good brushing or rinsing habits (to minimize swallowing)
  • supervise children as necessary until good habits are established
  • children under 2 years: ask a dentist or doctor

INACTIVE INGREDIENT SECTION

Inactive ingredients Sorbitol, Silica, Water (Aqua), Propylene Glycol, Activated Charcoal, PEG-1450, Sodium Lauryl Sulfate, PEG-400, Cellulose Gum, Sodium Hydroxide, Hydroxyethylellulose, Sea Salt, Sodium Saccharin, Sodium Benzoate, Disodium EDTA, Calcium Peroxide, Polyvinyl Alcohol, Ethylcellulose, Glycerin, Grape (Vitis Vinifera) Seed Oil, Eugenol, Flavor, Titanium Dioxide

OTC - QUESTIONS SECTION

Questions or comments? 866-695-6452

SPL UNCLASSIFIED SECTION

Manufactured by:

BEYOND® INTERNATIONAL INC.

711 Julie Rivers Dr.

Sugar Land, TX 77478 USA

©2020 BEYOND® INTERNATIONAL INC.

www.beyonddent.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Vegan

beyond®

Activated Coconut CHARCOAL & SEA SALT

FLUORIDE ANTICAVITY TOOTHPASTE

  • Deeply Whitens
  • Fights Cavities
  • Reduces Plaque
  • Soothes Gums

NET WT. 4.6 OZ (130g)


Charcoal Sea Salt TP-FDACharcoal Sea Salt TP-FDA

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
416783sodium fluoride 0.24 % ToothpastePSN2
416783sodium fluoride 0.0024 MG/MG ToothpasteSCD2
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSY2
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY2
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42199-008-04Beyond Activated Coconut Charcoal and Sea Salt130 g in 1 TUBEPASTE, DENTIFRICE1302
42199-008-04Beyond Activated Coconut Charcoal and Sea Salt1 in 1 CARTONPASTE, DENTIFRICE12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42199-008BEYOND ACTIVATED COCONUT CHARCOAL AND SEA SALT (SODIUM FLUORIDE) PASTE, DENTIFRICE [BEYOND INTERNATIONAL INC]2Current NDC, Legacy NDC, 2 package rows20231129_d075fa15-7309-0c10-e053-2995a90a7c95.zip

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42199-00842199-008-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
CALCIUM PEROXIDE7FRO2ENO91IACT
GRAPE SEED OIL930MLC8XGGIACT
EUGENOL3T8H1794QWIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
ETHYLCELLULOSES7Z8S9VYZ4BIACT
GLYCERINPDC6A3C0OXIACT
HYDRATED SILICAY6O7T4G8P9IACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
ACTIVATED CHARCOAL2P3VWU3H10IACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
HYDROXYETHYL CELLULOSE (5000 MPA.S AT 1%)X70SE62ZARIACT
POLYETHYLENE GLYCOL 1450OJ4Z5Z32L4IACT
SODIUM BENZOATEOJ245FE5EUIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM LAURYL SULFATE368GB5141JIACT
SEA SALT87GE52P74GIACT
SODIUM HYDROXIDE55X04QC32IIACT
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990IACT
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
Beyond Activated Coconut Charcoal and Sea SaltSODIUM FLUORIDEBeyond International Incd075fa15-7309-0c10-e053-2995a90a7c952023-11-28WarningsExact identifier
ndc (package): 42199-008-04
ndc (product): 42199-008
ndc11 (package): 42199000804
spl id: 0b3eaa83-c1b4-6390-e063-6394a90ae1cc
spl set id: d075fa15-7309-0c10-e053-2995a90a7c95

Reported adverse events (FAERS/openFDA)#

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