FDA.reportPublic FDA data

MIPaste One Kids Bubble Gum

Product NDC
61596-101
11-digit product format
615960101
Labeler code
61596
Product ID
61596-101_4651d664-464a-05c1-e063-6394a90a565e
Type
HUMAN OTC DRUG
Nonproprietary name
MIPaste One Kids Bubble Gum
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
GC America Inc.
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-04-21
Substance
SODIUM FLUORIDE
Active strength
.24 g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
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
MIPaste One Kids Bubble Gum
Listing expiration
2026-12-31

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
c07c7853-763b-4383-e053-2995a90ab725Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61596-101-01MIPaste One Kids Bubble Gum46 g in 1 TUBEPASTE, DENTIFRICE463
61596-101-02MIPaste One Kids Bubble Gum1 in 1 BOX, UNIT-DOSEPASTE, DENTIFRICE13
61596-101-10MIPaste One Kids Bubble Gum10 in 1 BOXPASTE, DENTIFRICE103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61596-101MIPASTE ONE KIDS BUBBLE GUM PASTE, DENTIFRICE [GC AMERICA INC.]2Current NDC, Legacy NDC, 3 package rows20240128_c07c7853-763b-4383-e053-2995a90ab725.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 29 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Supersmile Professional Whitening TP Citrus BlastSODIUM MONOFLUOROPHOSPHATERobell Research, Inc25039552-c35d-a69d-e063-6394a90ab1032026-01-08WarningsExact identifier
application number: M021
Supersmile Professional Whitening TP Citrus BlastSODIUM MONOFLUOROPHOSPHATERobell Research, Inc2504686d-b053-51d0-e063-6394a90a789f2026-01-08WarningsExact identifier
application number: M021
Supersmile Professional Whitening TP Peppy Mint 8 ozSODIUM MONOFLUOROPHOSPHATERobell Research, Inc25121ebb-922b-719d-e063-6394a90a23d32026-01-08WarningsExact identifier
application number: M021
Crest Pro-health Gum Detoxify Deep CleanSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyf498b727-c38c-1d67-e053-2995a90a0f112026-01-08WarningsExact identifier
application number: M021
DG health Sensitive Maximum StrengthPOTASSIUM NITRATE, SODIUM FLUORIDEDolgencorp, LLC81cd5d37-3751-625f-e053-2a91aa0a6dfd2026-01-08WarningsExact identifier
application number: M021
Crest 3D White Advanced Glamorous WhiteSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyf5b18988-68c7-40f9-e053-2995a90a22bc2026-01-08WarningsExact identifier
application number: M021
CVS Restore and Defend Sensitive WhiteningSTANNOUS FLUORIDECVS Pharmacy81b72da2-7f41-74ca-e053-2a91aa0a96462026-01-08WarningsExact identifier
application number: M021
Gum and Enamel RepairSTANNOUS FLUORIDECVSccad05d4-7f05-bebd-e053-2a95a90aa52c2026-01-08WarningsExact identifier
application number: M021
CVS Pharmacy Pro DefenseFLUORIDECVS Pharmacy445ec57e-dc3c-49a0-8ca9-4806fcdc03032026-01-08WarningsExact identifier
application number: M021
Gum DetoxifySTANNOUS FLUORIDEWalmartad3f645d-aaf9-2800-e053-2a95a90ab62f2026-01-08WarningsExact identifier
application number: M021
CVS Complete ProtectionSTANNOUS FLOURIDECVSb681b5e4-a0e1-8d0f-e053-2a95a90aa6722026-01-06WarningsExact identifier
application number: M021
Complete ProtectionSTANNOUS FLUORIDETarget03708e08-0189-b83d-e063-6394a90a50e62026-01-06WarningsExact identifier
application number: M021
Brush Buddies Mouthwash 12oz Star Wars Saber Strike StrawberrySODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD.4998c0e6-1de3-11cd-e063-6294a90acb6f2026-01-01WarningsExact identifier
application number: M021
Exceed Total Care Sensitive Spearmint Tooth PolishPOTASSIUM NITRATE AND SODIUM FLUORIDEMelaleuca, Incdc620d3f-880f-df05-e053-2995a90a84092025-12-31WarningsExact identifier
application number: M021
Exceed Total Care Sensitive Peppermint Tooth PolishPOTASSIUM NITRATE AND SODIUM FLUORIDEMelaleuca, Inced2179a4-3d19-6481-e053-2995a90ad6552025-12-31WarningsExact identifier
application number: M021
Koala Pals BerryliciousSODIUM FLUORIDEMelaleuca, Inc.6624be86-c9a8-53b8-e053-2a91aa0a87ef2025-12-31WarningsExact identifier
application number: M021
Whitening Tooth PolishSODIUM FLUORIDEMelaleuca, Inc.6893405a-a2c4-068e-e053-2a91aa0ae5b12025-12-31WarningsExact identifier
application number: M021
Gel 1100 MintSODIUM FLUORIDEDental Alliance Holdings LLCf125fb04-5045-5367-e053-2a95a90aa73b2025-12-29WarningsExact identifier
application number: M021
Gracie Square Hospital AmenitySODIUM MONOFLUOROPHOSPHATEASP Global, LLc89d81053-6950-465e-a5b1-cbf841d7afcb2025-12-29WarningsExact identifier
application number: M021
CloSYS Fluoride RinseSODIUM FLUORIDERowpar Pharmaceuticals, Inc.1a994f24-99ee-4b27-aab0-e816931a22c82025-12-23WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416783sodium fluoride 0.24 % ToothpastePSNc07c7853-763b-4383-e053-2995a90ab7253
416783sodium fluoride 0.0024 MG/MG ToothpasteSCDc07c7853-763b-4383-e053-2995a90ab7253
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSYc07c7853-763b-4383-e053-2995a90ab7253
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSYc07c7853-763b-4383-e053-2995a90ab7253
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSYc07c7853-763b-4383-e053-2995a90ab7253

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61596-101-016159601010146 g in 1 TUBE46 gHistorical
61596-101-02615960101021 in 1 BOX, UNIT-DOSEHistorical
61596-101-106159601011010 BOX, UNIT-DOSE in 1 BOX (61596-101-10) / 1 TUBE in 1 BOX, UNIT-DOSE (61596-101-02) / 46 g in 1 TUBE (61596-101-01) 2021-04-210000-00-00NoNoCurrent