FDA.reportPublic FDA data

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

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 Identifiers#

Field, Values table
FieldValues
Unii8ZYQ1474W7
Rxcui1235783

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

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