MIPaste Plus Strawberry

Product NDC
61596-986
11-digit product format
615960986
Labeler code
61596
Product ID
61596-986_51a07861-c024-d263-e063-6294a90ab72e
Type
HUMAN OTC DRUG
Nonproprietary name
sodium fluoride
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
GC America Inc.
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-06-01
Substance
SODIUM FLUORIDE
Active strength
.2 g/100g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 10 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductUExcluded because listing certification expiredfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage61596-986-41UExcluded because listing certification expiredfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductUExcluded because listing certification expired86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage61596-986-41UExcluded because listing certification expired86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductUExcluded because listing certification expiredbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage61596-986-41UExcluded because listing certification expiredbd6a592717d7…303034d00443…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductEExcluded after deficient or non-compliant submission was not correctede2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage61596-986-41EExcluded after deficient or non-compliant submission was not correctede2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductEExcluded after deficient or non-compliant submission was not corrected9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage61596-986-41EExcluded after deficient or non-compliant submission was not corrected9bebd1f3094a…5416666fcb17…

Additional Listing Data#

Finished product
Yes
Brand name base
MIPaste Plus Strawberry
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE.2 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
1235783Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1b68bd67-65d3-4c64-e054-00144ff8d46cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61596-986-40MIPaste Plus Strawberry40 g in 1 TUBEPASTE, DENTIFRICE4010
61596-986-41MIPaste Plus Strawberry1 in 1 BOXPASTE, DENTIFRICE110

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W7MIPASTE PLUS STRAWBERRY (SODIUM FLUORIDE) PASTE, DENTIFRICE MIPASTE PLUS (SODIUM FLUORIDE) PASTE, DENTIFRICE [GC AMERICA INC.]3
FLUORIDE IONACTIVE MOIETYQ80VPU408OMIPASTE PLUS STRAWBERRY (SODIUM FLUORIDE) PASTE, DENTIFRICE MIPASTE PLUS (SODIUM FLUORIDE) PASTE, DENTIFRICE [GC AMERICA INC.]3
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8MIPASTE PLUS STRAWBERRY (SODIUM FLUORIDE) PASTE, DENTIFRICE MIPASTE PLUS (SODIUM FLUORIDE) PASTE, DENTIFRICE [GC AMERICA INC.]3
CALCIUM PHOSPHATEINACTIVE INGREDIENT97Z1WI3NDXMIPASTE PLUS STRAWBERRY (SODIUM FLUORIDE) PASTE, DENTIFRICE MIPASTE PLUS (SODIUM FLUORIDE) PASTE, DENTIFRICE [GC AMERICA INC.]3
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311MIPASTE PLUS STRAWBERRY (SODIUM FLUORIDE) PASTE, DENTIFRICE MIPASTE PLUS (SODIUM FLUORIDE) PASTE, DENTIFRICE [GC AMERICA INC.]3
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMINACTIVE INGREDIENTK679OBS311MIPASTE PLUS STRAWBERRY (SODIUM FLUORIDE) PASTE, DENTIFRICE MIPASTE PLUS (SODIUM FLUORIDE) PASTE, DENTIFRICE [GC AMERICA INC.]3
ETHYLPARABENINACTIVE INGREDIENT14255EXE39MIPASTE PLUS STRAWBERRY (SODIUM FLUORIDE) PASTE, DENTIFRICE MIPASTE PLUS (SODIUM FLUORIDE) PASTE, DENTIFRICE [GC AMERICA INC.]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXMIPASTE PLUS STRAWBERRY (SODIUM FLUORIDE) PASTE, DENTIFRICE MIPASTE PLUS (SODIUM FLUORIDE) PASTE, DENTIFRICE [GC AMERICA INC.]3
PHOSPHORIC ACIDINACTIVE INGREDIENTE4GA8884NNMIPASTE PLUS STRAWBERRY (SODIUM FLUORIDE) PASTE, DENTIFRICE MIPASTE PLUS (SODIUM FLUORIDE) PASTE, DENTIFRICE [GC AMERICA INC.]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3MIPASTE PLUS STRAWBERRY (SODIUM FLUORIDE) PASTE, DENTIFRICE MIPASTE PLUS (SODIUM FLUORIDE) PASTE, DENTIFRICE [GC AMERICA INC.]3
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHMIPASTE PLUS STRAWBERRY (SODIUM FLUORIDE) PASTE, DENTIFRICE MIPASTE PLUS (SODIUM FLUORIDE) PASTE, DENTIFRICE [GC AMERICA INC.]3
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYMIPASTE PLUS STRAWBERRY (SODIUM FLUORIDE) PASTE, DENTIFRICE MIPASTE PLUS (SODIUM FLUORIDE) PASTE, DENTIFRICE [GC AMERICA INC.]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MIPASTE PLUS STRAWBERRY (SODIUM FLUORIDE) PASTE, DENTIFRICE MIPASTE PLUS (SODIUM FLUORIDE) PASTE, DENTIFRICE [GC AMERICA INC.]3
SORBITOLINACTIVE INGREDIENT506T60A25RMIPASTE PLUS STRAWBERRY (SODIUM FLUORIDE) PASTE, DENTIFRICE MIPASTE PLUS (SODIUM FLUORIDE) PASTE, DENTIFRICE [GC AMERICA INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMIPASTE PLUS STRAWBERRY (SODIUM FLUORIDE) PASTE, DENTIFRICE MIPASTE PLUS (SODIUM FLUORIDE) PASTE, DENTIFRICE [GC AMERICA INC.]3
WATERINACTIVE INGREDIENT059QF0KO0RMIPASTE PLUS STRAWBERRY (SODIUM FLUORIDE) PASTE, DENTIFRICE MIPASTE PLUS (SODIUM FLUORIDE) PASTE, DENTIFRICE [GC AMERICA INC.]3
XYLITOLINACTIVE INGREDIENTVCQ006KQ1EMIPASTE PLUS STRAWBERRY (SODIUM FLUORIDE) PASTE, DENTIFRICE MIPASTE PLUS (SODIUM FLUORIDE) PASTE, DENTIFRICE [GC AMERICA INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61596-986MIPASTE PLUS STRAWBERRY (SODIUM FLUORIDE) PASTE, DENTIFRICE MIPASTE PLUS (SODIUM FLUORIDE) PASTE, DENTIFRICE [GC AMERICA INC.]8Current NDC, Legacy NDC, 2 package rows20240131_1b68bd67-65d3-4c64-e054-00144ff8d46c.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 1 of 52 · 1,037 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BIO SPECTRA ATTITUDESODIUM FLUORIDE9055-7588 Qubec Inc. DBA Attitude54bd43c9-489d-4e6b-9031-90ec0e3c45162026-09-01WarningsExact identifier
application number: M021
BIO SPECTRA ATTITUDESODIUM FLUORIDE9055-7588 Qubec Inc. DBA Attitude53c344e9-49f5-48aa-8309-1e15f80b80a02026-09-01WarningsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDENice-Pak Products, LLCc71d4064-f938-477b-9346-eb38be65390d2026-08-25Warnings, Adverse reactionsExact identifier
application number: M021
AIM Whitening with Baking SodaSODIUM FLUORIDEChurch & Dwight Co., Inc.1d0fd0b4-33ba-5764-e054-00144ff88e882026-08-25WarningsExact identifier
application number: M021
OPTIC WHITE PRO SERIES VIBRANT CLEANSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Companyb1ada157-a9a0-4eec-83a2-6e448d7f12dc2026-08-21WarningsExact identifier
application number: M021
Colgate Max Fresh Clean MintSODIUM FLUORIDEColgate-Palmolive Company7cb85fc4-573b-45d7-a430-f2fd17320c432026-08-21WarningsExact identifier
application number: M021
Therabreath WhiteningSODIUM FLUORIDEChurch & Dwight Co., Inc.3ba04b55-38f9-76f3-e063-6394a90a3c032026-08-21WarningsExact identifier
application number: M021
Therabreath Deep CleanSTANNOUS FLUORIDEChurch & Dwight Co., Inc.3c372f26-e0c4-0659-e063-6294a90ae9f92026-08-21WarningsExact identifier
application number: M021
TheraBreathPOTASSIUM NITRATE, SODIUM FLUORIDEChurch & Dwight Co., Inc.4b812a38-f7cb-51c8-e063-6394a90ab82c2026-08-21WarningsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEYour Military Exchangeseb95e0ca-a94c-41cb-9f54-6c64ed9a97332026-08-21Warnings, Adverse reactionsExact identifier
application number: M021
Pop On Toothpaste.POP ON TOOTHPASTE.POPONSMILES,LLC4a0edab5-ae36-91b5-e063-6294a90aa6852026-08-21WarningsExact identifier
application number: M021
COLGATE OPTIC WHITE PRO SERIES EXPRESS WHITESODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Company188dc3ac-64c9-438e-858b-846f725c6ea02026-08-21WarningsExact identifier
application number: M021
freshSTART Anticavity fluoride toothpaste.ANTICAVITY FLUORIDE TOOTHPASTEGuangzhou Xinuo Technology Co., Ltd.596432d5-3541-6dff-e063-6294a90a9d422026-08-19WarningsExact identifier
application number: M021
COLGATE 2IN1 WHITENING STAIN LIFTERSSODIUM FLUORIDEColgate-Palmolive Company26f1f873-06b2-45ef-a4b9-32f997642bc72026-08-17WarningsExact identifier
application number: M021
COLGATE OPTIC WHITE PRO SERIES HI WHITESODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Company8b210b6c-b712-4f14-906c-306922573a262026-08-17WarningsExact identifier
application number: M021
SprinJene NaturalSODIUM MONOFLUOROPHOSPHATEHealth and Natural Beauty USA Corpe64cecc3-0845-4bdf-a449-d78248791ccf2026-08-17WarningsExact identifier
application number: M021
ATOMY ANTICAVITY TOOTHSODIUM MONOFLUOROPHOSPHATEATOMY CO., LTD.592caccc-e3a9-9c66-e063-6394a90a26e32026-08-16WarningsExact identifier
application number: M021
SprinJene Health BoostSODIUM MONOFLUOROPHOSPHATEHealth and Natural Beauty USA Corp9be87bcd-403a-4d7e-8ded-9833249565d12026-08-14WarningsExact identifier
application number: M021
SprinJene Fresh BoostSODIUM FLUORIDEHealth and Natural Beauty USA Corp919f6f51-6c43-4f1c-9bc7-029bf76c0e682026-08-14WarningsExact identifier
application number: M021
SprinJene Natural Sensitivity ReliefSODIUM MONOFLUOROPHOSPHATE AND POTASSIUM NITRATEHealth and Natural Beauty USA Corp32cc5bc2-60c9-4cb4-acde-485ae494aba22026-08-14WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1235783sodium fluoride 0.2 % ToothpastePSN1b68bd67-65d3-4c64-e054-00144ff8d46c10
1235783sodium fluoride 0.002 MG/MG ToothpasteSCD1b68bd67-65d3-4c64-e054-00144ff8d46c10
1235783sodium fluoride 0.2 % ToothpasteSY1b68bd67-65d3-4c64-e054-00144ff8d46c10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61596-986-406159609864040 g in 1 TUBE40 gHistorical
61596-986-41615960986411 TUBE in 1 BOX (61596-986-41) / 40 g in 1 TUBE (61596-986-40) 1 tube2015-06-010000-00-00NoNoCurrent