MIPaste One Perio

Product NDC
61596-300
11-digit product format
615960300
Labeler code
61596
Product ID
61596-300_4651cb98-dcfe-a45b-e063-6294a90ad8b2
Type
HUMAN OTC DRUG
Nonproprietary name
MIPaste One Perio
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
GC America Inc.
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-02-01
Substance
STANNOUS FLUORIDE
Active strength
.454 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 Perio
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
STANNOUS FLUORIDE.454 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3FTR44B32QInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
416784Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d656b72d-48f8-4425-e053-2995a90ab1f2Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61596-300-10MIPaste One Perio10 in 1 BOXPASTE, DENTIFRICE104
61596-300-40MIPaste One Perio42 g in 1 TUBEPASTE, DENTIFRICE424
61596-300-41MIPaste One Perio1 in 1 BOTTLE, UNIT-DOSEPASTE, DENTIFRICE14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61596-300MIPASTE ONE PERIO PASTE, DENTIFRICE [GC AMERICA INC.]3Current NDC, Legacy NDC, 3 package rows20240128_d656b72d-48f8-4425-e053-2995a90ab1f2.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 49 · 974 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
MIPasteOne Kids Blue RaspberryMI PASTE ONE KIDS BLUE RASPBERRYGC America Inc.bf7d668c-752a-2eee-e053-2a95a90add162025-12-19WarningsExact identifier
application number: M021
MIPaste Plus Tutti FruttiMIPASTE PLUS TUTTI FRUTTIGC America Inc.d724bd2a-2a8e-faeb-e053-2995a90aca192025-12-19WarningsExact identifier
application number: M021
MIPaste Plus VanillaMIPASTE PLUS VANILLAGC America Inc.d7244125-1ca5-78ba-e053-2995a90ab7642025-12-19WarningsExact identifier
application number: M021
MIPaste Plus MelonMIPASTE PLUS MELONGC America Inc.d724fe9f-c9ef-d9ad-e053-2995a90a7ecf2025-12-19WarningsExact identifier
application number: M021
MIPaste Plus MintMIPASTE PLUS MINTGC America Inc.d72415b3-c501-141f-e053-2995a90aaaa32025-12-19WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpastePSNd656b72d-48f8-4425-e053-2995a90ab1f24
416784stannous fluoride 0.00454 MG/MG ToothpasteSCDd656b72d-48f8-4425-e053-2995a90ab1f24
416784stannous fluoride 0.454 % (fluoride ion 0.14 % ) ToothpasteSYd656b72d-48f8-4425-e053-2995a90ab1f24
416784stannous fluoride 0.454 % (fluoride ion 0.15 % ) ToothpasteSYd656b72d-48f8-4425-e053-2995a90ab1f24
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpasteSYd656b72d-48f8-4425-e053-2995a90ab1f24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61596-300-106159603001010 BOTTLE, UNIT-DOSE in 1 BOX (61596-300-10) / 1 TUBE in 1 BOTTLE, UNIT-DOSE (61596-300-41) / 42 g in 1 TUBE (61596-300-40) 2022-02-010000-00-00NoNoCurrent
61596-300-406159603004042 g in 1 TUBE42 gHistorical
61596-300-41615960300411 in 1 BOTTLE, UNIT-DOSEHistorical