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 35 of 49 · 974 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Target Kids Watermelon MintSODIUM FLUORIDETarget35bc2e4d-f1c7-438e-e063-6394a90aead02025-10-17WarningsExact identifier
application number: M021
MediChoice FluorideSODIUM MONOFLUOROPHOSPHATEO&M HALYARD, INC.a87956fa-8975-4a44-9e9a-4b2191e401fe2025-10-09WarningsExact identifier
application number: M021
BRUSH BUDDIES BARBIE ANTICAVITY FLUORIDE BUBBLEGUMSODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD.1b6f893d-74ac-421e-a78b-f495ac425af02025-10-09WarningsExact identifier
application number: M021
BRUSH BUDDIES HOTWHEEL ANTICAVITY FLUORIDE STRAWBERRYSODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD.a3e989f8-e6a2-4e13-8faa-77e95895166d2025-10-09WarningsExact identifier
application number: M021
TARGET UP AND UP ANTICAVITYSODIUM FLUORIDE 0.05%TARGET CORPORATION2992efce-1c66-df40-e063-6294a90ab3c02025-10-08WarningsExact identifier
application number: M021
MediChoice Premium Anticavity FluorideSODIUM FLUORIDEO&M HALYARD, INC.c6ba9b51-b958-4836-adc8-871529a43fc62025-10-08WarningsExact identifier
application number: M021
TidaloveSPICY CINNAMON TOOTHPASTE TABLETSParanmare LLC4092fcbf-27f7-b067-e063-6394a90a41c62025-10-07WarningsExact identifier
application number: M021
TidaloveCOOL MINT TOOTHPASTE TABLETSParanmare LLC4093060c-23a5-c77a-e063-6394a90a93042025-10-07WarningsExact identifier
application number: M021
TidaloveYUZU MINT TOOTHPASTE TABLETSParanmare LLC40946943-21cf-b114-e063-6394a90aed3f2025-10-07WarningsExact identifier
application number: M021
Optimax Purple Anticavity FluorideSODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INCfdb16e59-5be1-4bd0-a940-d542d67fb2df2025-10-02WarningsExact identifier
application number: M021
Intensive Enamel Repair Whitening TPINTENSIVE ENAMEL REPAIR WHITENING TPTopco Associates LLC3012a8da-7595-2f7c-e063-6294a90ae1202025-09-30WarningsExact identifier
application number: M021
Made by Dentists For Kids Eyeball Juice (Watermelon)SODIUM FLUORIDEMADE BY DENTISTS INCb2ad2b19-6fdf-454d-9b1d-49b1c81016fd2025-09-30WarningsExact identifier
application number: M021
ACT Restoring Anticavity Fluoride Mint BurstSODIUM FLUORIDEChattem, Inc.a38363e6-7105-4663-95a0-09ecb2948f832025-09-30WarningsExact identifier
application number: M021
UNPA CHA CHA TOOTHPASTESODIUM MONOFLUOROPHOSPHATEDONG IL PHARMS CO.,LTD3fae966e-0246-b9f2-e063-6394a90a494c2025-09-26WarningsExact identifier
application number: M021
Cloveden ToothSODIUM MONOFLUOROPHOSPHATEDONG IL PHARMS CO.,LTD3fb01bea-7205-49ba-e063-6294a90a38412025-09-26WarningsExact identifier
application number: M021
Cloveden Sensitive Care ToothSODIUM FLUORIDEDONG IL PHARMS CO.,LTD3fb153f1-ba6e-7251-e063-6294a90abe622025-09-26WarningsExact identifier
application number: M021
Cloveden 100 times higher concentratedCETYLPYRIDINIUM CHLORIDEDONG IL PHARMS CO.,LTD3fb1a2ee-381e-a9e8-e063-6394a90a864b2025-09-26WarningsExact identifier
application number: M021
unpa Cha Cha ToothpasteSODIUM MONOFLUOROPHOSPHATELycl Inc.230b3cf2-053a-4e8b-8d50-05bbc877faa82025-09-25WarningsExact identifier
application number: M021
TheraBreath AnticavitySODIUM FLUORIDEChurch & Dwight Co., Inc.3c5d58f1-ea8c-4708-bbc6-21e1cd1446da2025-09-19WarningsExact identifier
application number: M021
Optimax Professional Whitening Anticavity FluorideSODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INC8c4b9db9-8f23-4dd5-ab6e-1c2f9a3da5b12025-09-18WarningsExact 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