FDA.reportPublic FDA data

Beyond Activated Coconut Charcoal and Sea Salt

Product NDC
42199-008
11-digit product format
421990008
Labeler code
42199
Product ID
42199-008_0b3eaa83-c1b4-6390-e063-6394a90ae1cc
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium fluoride
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Beyond International Inc
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-11-10
Marketing end
2026-11-15
Substance
SODIUM FLUORIDE
Active strength
.24 g/100g
NDC exclude flag
No
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Beyond Activated Coconut Charcoal and Sea Salt

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE.24 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8ZYQ1474W7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
416783Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
d075fa15-7309-0c10-e053-2995a90a7c95Available on FDA.report

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

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 50 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
United Airlines Therabody Polaris KitSODIUM MONOFLUOROPHOSPHATEWessco Internationalab667740-55ab-470e-9514-163961502ceb2023-10-26WarningsExact identifier
application number: M021
Cavity Protection Fresh MintSODIUM FLUORIDEOxyfresh Worldwide Inc0ae98f28-7e78-4379-93b0-4f2657415c4d2023-10-25WarningsExact identifier
application number: M021
Tanners Tasty Vanilla BlingSODIUM FLUORIDESheffield Pharmaceuticals LLC521fe01e-7f2e-4d79-9126-e4880cdf4e712023-10-24WarningsExact identifier
application number: M021
Tanners Tasty Ooh La La OrangeSODIUM FLUORIDESheffield Pharmaceuticals LLC6027b961-314e-4f71-8b2f-646ce80214d82023-10-24WarningsExact identifier
application number: M021
Tanners Tasty Cha Cha ChocolateSODIUM FLUORIDESheffield Pharmaceuticals LLC8609dbf3-7620-4a13-b40b-6bd705a78fb02023-10-24WarningsExact identifier
application number: M021
Glister Multi-ActionSODIUM FLUORIDEAccess Business Group LLCe3f2c049-a0f5-4649-a4aa-11bdb252f9512023-10-23WarningsExact identifier
application number: M021
UNITED Asutra TC Kit ColgateSODIUM MONOFLUOROPHOSPHATEMING FAI ENTERPRISE (CAMBODIA) CO., LTD082a581a-c7e5-e614-e063-6394a90a87da2023-10-20WarningsExact identifier
application number: M021
Plak Smacker Anti Cavity FluorideSODIUM FLUORIDEYOUNG PS ACQUISITION, LLCc6dee5fa-9cd4-4a94-9cbe-e977b2bd3dfe2023-10-16WarningsExact identifier
application number: M021
Ionite HSTANNOUS FLUORIDEDharma Research, Inc.152d84ee-d981-4032-bfb1-a559afe71d402023-10-11WarningsExact identifier
application number: M021
Sodium FluorideSODIUM FLUORIDESafco Dental Supply LLC788080b3-fff8-4049-af98-f571824994c22023-10-11WarningsExact identifier
application number: M021
Ionite HSTANNOUS FLUORIDEDharma Research, Inc.5c312b36-07f4-406e-b3d3-c6d1e964635d2023-10-11WarningsExact identifier
application number: M021
Ionite HSTANNOUS FLUORIDEDharma Research, Inc.042636cf-8b61-4022-b0a1-af09c06b145b2023-10-11WarningsExact identifier
application number: M021
Ionite HSTANNOUS FLUORIDEDharma Research, Inc.f4c3569b-7b6a-4566-9e87-492f291c51652023-10-11WarningsExact identifier
application number: M021
UNITED Asutra TC Kit ColgateSODIUM MONOFLUOROPHOSPHATEProcurall Solutions042817f9-675f-056a-e063-6394a90a2d972023-08-30WarningsExact identifier
application number: M021
Colgate Max Fresh Cool MintSODIUM FLUORIDEMission Hills S.A de C.Vd142e43f-415a-41c5-a7db-8b18a039a3232019-04-09WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416783sodium fluoride 0.24 % ToothpastePSNd075fa15-7309-0c10-e053-2995a90a7c952
416783sodium fluoride 0.0024 MG/MG ToothpasteSCDd075fa15-7309-0c10-e053-2995a90a7c952
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSYd075fa15-7309-0c10-e053-2995a90a7c952
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSYd075fa15-7309-0c10-e053-2995a90a7c952
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSYd075fa15-7309-0c10-e053-2995a90a7c952

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42199-008-04421990008041 TUBE in 1 CARTON (42199-008-04) / 130 g in 1 TUBE1 tube2021-11-102026-11-15NoNoCurrent