MIPaste Plus Strawberry

Product NDC
61596-986
Requested package NDC
61596-986-41
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 · 5 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2022-08-30 03:57 UTC · source 2022-08-29UExcluded because listing certification expiredfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08UExcluded because listing certification expired86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01UExcluded because listing certification expiredbd6a592717d7…303034d00443…
2020-12-18 03:04 UTC · source 2020-12-17EExcluded after deficient or non-compliant submission was not correctede2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10EExcluded 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 · 1,027 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
Colgate Optic White Stain Fighter With Baking SodaSODIUM FLUORIDEColgate-Palmolive Company8e6113e2-101b-4bde-90e9-6ab32c6ebf5c2026-08-05WarningsExact identifier
application number: M021
TOTAL TP CLEAN MINT PSTSTANNOUS FLUORIDEColgate-Palmolive Company178d4535-fa57-4b53-b1f8-5c591f2ea9e72026-08-05WarningsExact identifier
application number: M021
COLGATE OPTIC WHITE PRO SERIESSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Companycd954777-697a-4cc7-8f5f-b2caf357ef952026-08-05WarningsExact identifier
application number: M021
COLGATE MAX FRESH WATERMELON BLASTSODIUM FLUORIDEColgate-Palmolive Company6c391ef3-d625-403c-a4dc-6e2212682ed12026-08-04WarningsExact identifier
application number: M021
COLGATE 2 IN 1 KIDS SP STRAWBERRYSODIUM FLUORIDEColgate-Palmolive Companyd037f65c-3d22-4d2a-a0a9-3dcba2357ebd2026-08-04WarningsExact identifier
application number: M021
Colgate ULTRA BRITE Baking Soda and Peroxide WhiteningSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Company2b123d70-4f7d-41b0-b48f-711999e97ee02026-08-04WarningsExact identifier
application number: M021
Rorobell WaWa ToothSODIUM MONOFLUOROPHOSPHATEROROBELL93113481-ad9d-4be0-a7b7-a72c8726127d2026-08-03WarningsExact identifier
application number: M021
COLGATE OPTIC WHITE CHARCOALSODIUM FLUORIDEColgate-Palmolive Company70ed4a93-b68f-4198-b4b7-7cfeb17ba5d22026-07-30WarningsExact identifier
application number: M021
Colgate Optic White CharcoalSODIUM FLUORIDEColgate-Palmolive Company82ac5b9d-19e8-46ac-a195-c7d85f2967d52026-07-30WarningsExact identifier
application number: M021
Supersmile Professional Whitening TP Peppy Mint 1.4 ozSODIUM MONOFLUOROPHOSPHATERobell Research, Inc251264ea-20d2-be19-e063-6394a90aa5f62026-07-29WarningsExact identifier
application number: M021
Natural White Sensitive Enamel Guard Alpine MintSODIUM FLUORIDELornamead Products2e832204-ba2d-6dcb-e063-6394a90a5e6c2026-07-29WarningsExact identifier
application number: M021
Natural White Radiant WhiteFLUORIDELornamead Productsf0b62aaa-4983-4bd3-931e-f1a31b870f622026-07-29WarningsExact identifier
application number: M021
TP OW Pro Series Stain PreventionSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Company76df52a3-b24c-4009-8137-fe644dabebf62026-07-29WarningsExact identifier
application number: M021
Colgate Kids Cavity ProtectionSODIUM FLUORIDEColgate-Palmolive Companyf0e68196-8566-443b-9cc8-b57d5c0015582026-07-29WarningsExact identifier
application number: M021
TP OW Pro Series Vividly FreshSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Companyf0551acf-c4d6-4d49-ae9c-4aeaeb99a7002026-07-29WarningsExact identifier
application number: M021
Colgate MaxFresh with Whitening KnockOut FluorideSODIUM FLUORIDEColgate-Palmolive Company92079d13-3b66-42b7-9990-2727a489b6f62026-07-28WarningsExact identifier
application number: M021
BIO SPECTRA ATTITUDESODIUM FLUORIDE9055-7588 Quebec Inc. DBA Attitude7d04d050-b283-4fce-b1e9-e695b70363f92026-07-27WarningsExact identifier
application number: M021
COLGATE OPTIC WHITE ADVANCED OXYGENATING WHITESODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Companycd805999-86e4-4f6c-9889-fa9a2227d5262026-07-24WarningsExact 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
61596-986-41615960986411 TUBE in 1 BOX (61596-986-41) / 40 g in 1 TUBE (61596-986-40) 1 tube2015-06-010000-00-00NoNoCurrent