Home NDC 61596-882 MIPaste
Product NDC 61596-882
11-digit product format 615960882
Labeler code 61596
Product ID 61596-882_9c95f1b6-c9f7-7f4c-e053-2a95a90a36db
Type HUMAN OTC DRUG
Nonproprietary name sodium fluoride
Dosage form PASTE, DENTIFRICE
Route DENTAL
Labeler GC America Inc.
Application part355
Marketing category OTC MONOGRAPH FINAL
Marketing start 2015-06-01
Marketing end 0000-00-00
Substance SODIUM FLUORIDE
Active strength 0 g/100g
NDC exclude flag No
Listing certified through 2021-12-31
Current FDA listing Historical FDA.report record 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 date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2022-08-30 03:57 UTC · source 2022-08-29 excluded product product U Excluded because listing certification expired fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 61596-882-41 U Excluded because listing certification expired fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product U Excluded because listing certification expired 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 61596-882-41 U Excluded because listing certification expired 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product U Excluded because listing certification expired bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 61596-882-41 U Excluded because listing certification expired bd6a592717d7…303034d00443…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product E Excluded after deficient or non-compliant submission was not corrected e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 61596-882-41 E Excluded after deficient or non-compliant submission was not corrected e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product E Excluded after deficient or non-compliant submission was not corrected 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 61596-882-41 E Excluded after deficient or non-compliant submission was not corrected 9bebd1f3094a…5416666fcb17…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 61596-882-40 MIPastePlus 40 g in 1 TUBE PASTE, DENTIFRICE 40 10 61596-882-41 MIPastePlus 1 in 1 BOX PASTE, DENTIFRICE 1 10
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded SODIUM FLUORIDE ACTIVE INGREDIENT 8ZYQ1474W7 MIPASTE PLUS STRAWBERRY (SODIUM FLUORIDE) PASTE, DENTIFRICE MIPASTE PLUS (SODIUM FLUORIDE) PASTE, DENTIFRICE [GC AMERICA INC.] 3 FLUORIDE ION ACTIVE MOIETY Q80VPU408O MIPASTE PLUS STRAWBERRY (SODIUM FLUORIDE) PASTE, DENTIFRICE MIPASTE PLUS (SODIUM FLUORIDE) PASTE, DENTIFRICE [GC AMERICA INC.] 3 BUTYLPARABEN INACTIVE INGREDIENT 3QPI1U3FV8 MIPASTE PLUS STRAWBERRY (SODIUM FLUORIDE) PASTE, DENTIFRICE MIPASTE PLUS (SODIUM FLUORIDE) PASTE, DENTIFRICE [GC AMERICA INC.] 3 CALCIUM PHOSPHATE INACTIVE INGREDIENT 97Z1WI3NDX MIPASTE PLUS STRAWBERRY (SODIUM FLUORIDE) PASTE, DENTIFRICE MIPASTE PLUS (SODIUM FLUORIDE) PASTE, DENTIFRICE [GC AMERICA INC.] 3 CARBOXYMETHYLCELLULOSE SODIUM INACTIVE INGREDIENT K679OBS311 MIPASTE PLUS STRAWBERRY (SODIUM FLUORIDE) PASTE, DENTIFRICE MIPASTE PLUS (SODIUM FLUORIDE) PASTE, DENTIFRICE [GC AMERICA INC.] 3 CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM INACTIVE INGREDIENT K679OBS311 MIPASTE PLUS STRAWBERRY (SODIUM FLUORIDE) PASTE, DENTIFRICE MIPASTE PLUS (SODIUM FLUORIDE) PASTE, DENTIFRICE [GC AMERICA INC.] 3 ETHYLPARABEN INACTIVE INGREDIENT 14255EXE39 MIPASTE PLUS STRAWBERRY (SODIUM FLUORIDE) PASTE, DENTIFRICE MIPASTE PLUS (SODIUM FLUORIDE) PASTE, DENTIFRICE [GC AMERICA INC.] 3 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX MIPASTE PLUS STRAWBERRY (SODIUM FLUORIDE) PASTE, DENTIFRICE MIPASTE PLUS (SODIUM FLUORIDE) PASTE, DENTIFRICE [GC AMERICA INC.] 3 PHOSPHORIC ACID INACTIVE INGREDIENT E4GA8884NN MIPASTE PLUS STRAWBERRY (SODIUM FLUORIDE) PASTE, DENTIFRICE MIPASTE PLUS (SODIUM FLUORIDE) PASTE, DENTIFRICE [GC AMERICA INC.] 3 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 MIPASTE PLUS STRAWBERRY (SODIUM FLUORIDE) PASTE, DENTIFRICE MIPASTE PLUS (SODIUM FLUORIDE) PASTE, DENTIFRICE [GC AMERICA INC.] 3 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH MIPASTE PLUS STRAWBERRY (SODIUM FLUORIDE) PASTE, DENTIFRICE MIPASTE PLUS (SODIUM FLUORIDE) PASTE, DENTIFRICE [GC AMERICA INC.] 3 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY MIPASTE PLUS STRAWBERRY (SODIUM FLUORIDE) PASTE, DENTIFRICE MIPASTE PLUS (SODIUM FLUORIDE) PASTE, DENTIFRICE [GC AMERICA INC.] 3 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 MIPASTE PLUS STRAWBERRY (SODIUM FLUORIDE) PASTE, DENTIFRICE MIPASTE PLUS (SODIUM FLUORIDE) PASTE, DENTIFRICE [GC AMERICA INC.] 3 SORBITOL INACTIVE INGREDIENT 506T60A25R MIPASTE PLUS STRAWBERRY (SODIUM FLUORIDE) PASTE, DENTIFRICE MIPASTE PLUS (SODIUM FLUORIDE) PASTE, DENTIFRICE [GC AMERICA INC.] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP MIPASTE PLUS STRAWBERRY (SODIUM FLUORIDE) PASTE, DENTIFRICE MIPASTE PLUS (SODIUM FLUORIDE) PASTE, DENTIFRICE [GC AMERICA INC.] 3 WATER INACTIVE INGREDIENT 059QF0KO0R MIPASTE PLUS STRAWBERRY (SODIUM FLUORIDE) PASTE, DENTIFRICE MIPASTE PLUS (SODIUM FLUORIDE) PASTE, DENTIFRICE [GC AMERICA INC.] 3 XYLITOL INACTIVE INGREDIENT VCQ006KQ1E MIPASTE 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 NDC Dashboard title SPL version Validation Dashboard ZIP 61596-882 MIPASTE PLUS STRAWBERRY (SODIUM FLUORIDE) PASTE, DENTIFRICE MIPASTE PLUS (SODIUM FLUORIDE) PASTE, DENTIFRICE [GC AMERICA INC.] 8 Legacy NDC, 2 package rows 20240131_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 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 61596-882-40 61596088240 40 g in 1 TUBE 40 g Historical 61596-882-41 61596088241 1 TUBE in 1 BOX (61596-882-41) > 40 g in 1 TUBE (61596-882-40) 1 tube 2015-06-01 0000-00-00 No No Current