FDA.reportPublic FDA data

Toms Kids Watermelon Wiggle

Product NDC
51009-854
11-digit product format
510090854
Labeler code
51009
Product ID
51009-854_31957ae0-e83f-490a-91da-17893a375b31
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Monofluorophosphate
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Tom's of Maine, Inc.
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-12-01
Substance
SODIUM MONOFLUOROPHOSPHATE
Active strength
1 mg/g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage51009-85451009-854-42DDiscontinued by firm2026-10-21

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
Toms Kids Watermelon Wiggle
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM MONOFLUOROPHOSPHATE1 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
C810JCZ56QInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
545626Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
48eaafb6-99f4-5fd1-10fc-4ea35cbb2c62Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51009-854-42Toms Kids Watermelon Wiggle119 g in 1 TUBEPASTE, DENTIFRICE1193
51009-854-51Toms Kids Watermelon Wiggle144 g in 1 TUBEPASTE, DENTIFRICE1443

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51009-854TOMS KIDS WATERMELON WIGGLE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]2Current NDC, 2 package rows20241027_48eaafb6-99f4-5fd1-10fc-4ea35cbb2c62.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 24 of 49 · 974 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Crest 4in1SODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyce545406-3c4f-1ba7-e053-2a95a90a91ac2026-01-08WarningsExact identifier
application number: M021
Crest 3D White Advanced WhiteningSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyd218ddc0-1d5f-f39b-e053-2995a90a96ed2026-01-08WarningsExact identifier
application number: M021
Crest Pro Health Advanced Antibacterial ProtectionSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyd58bc842-2687-e52d-e053-2995a90a54332026-01-08WarningsExact identifier
application number: M021
Scope Stay StrongSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyd65b3153-2026-a8c0-e053-2a95a90a31d62026-01-08WarningsExact identifier
application number: M021
Crest Pro Health Advanced Whitening CharcoalSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyd6f68485-b92f-41c7-e053-2995a90a4fe52026-01-08WarningsExact identifier
application number: M021
KIDS Crest Advanced Enamel Plus Cavity ProtectionSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyd837ecde-249a-7868-e053-2a95a90a56ae2026-01-08WarningsExact identifier
application number: M021
Crest Pro Health Advanced Whitening Intensive CleaningSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyd6fa4187-a651-647b-e053-2995a90a85672026-01-08WarningsExact identifier
application number: M021
Crest Pro Health Advanced Gum ProtectionSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyd7729dde-c828-34e6-e053-2a95a90a5ee62026-01-08WarningsExact identifier
application number: M021
Crest Densify Daily WhiteningSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyd811306f-4994-7a5a-e053-2995a90adf162026-01-08WarningsExact identifier
application number: M021
Crest Densify Daily ProtectionSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyd810d4e5-ba66-efe1-e053-2995a90abfc02026-01-08WarningsExact identifier
application number: M021
Crest Braces Care Cavity ProtectionSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyd823cba4-c4cf-7d7a-e053-2995a90a01f02026-01-08WarningsExact identifier
application number: M021
Crest Pro Health Advanced Sensitive ReliefSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyd7730674-7513-52cf-e053-2995a90ab32c2026-01-08WarningsExact identifier
application number: M021
Kids Crest Bubblegum FlavorSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company26a7a892-5da4-4749-bbb6-566efab7d7492026-01-08WarningsExact identifier
application number: M021
Crest Complete Multi-Benefit Plus ScopeSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company8c91095d-88c0-4d22-a79a-7d0f0d05302b2026-01-08WarningsExact identifier
application number: M021
Crest Pro Health Advanced Deep Clean MintSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyd774295f-8ebd-9877-e053-2a95a90a9a0e2026-01-08WarningsExact identifier
application number: M021
Crest Pro Health Advanced Enamel RestoreSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyd813f5f0-3135-4a8f-e053-2a95a90a55622026-01-08WarningsExact identifier
application number: M021
Crest 3D White BrillianceSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company8e189fbd-5094-4398-b96c-8f95d89b9cdd2026-01-08WarningsExact identifier
application number: M021
Crest Pro Health Densify RinseSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyd84fb9f9-f2bc-358a-e053-2995a90abf072026-01-08WarningsExact identifier
application number: M021
Kids Crest Strawberry RushSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyeb7a5698-754c-4e46-e053-2a95a90a57b42026-01-08WarningsExact identifier
application number: M021
Crest 3D White Brilliance Daily Cleansing and Whitening SystemSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Company89a6fb36-5109-47f1-95ad-9381471ceeef2026-01-08WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
545626sodium monofluorophosphate 0.76 % ToothpastePSN48eaafb6-99f4-5fd1-10fc-4ea35cbb2c623
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD48eaafb6-99f4-5fd1-10fc-4ea35cbb2c623
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY48eaafb6-99f4-5fd1-10fc-4ea35cbb2c623
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY48eaafb6-99f4-5fd1-10fc-4ea35cbb2c623
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY48eaafb6-99f4-5fd1-10fc-4ea35cbb2c623
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY48eaafb6-99f4-5fd1-10fc-4ea35cbb2c623

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51009-854-4251009085442119 g in 1 TUBE119 gHistorical
51009-854-5151009085451144 g in 1 TUBE (51009-854-51) 144 g2023-12-01NoNoCurrent