FDA.reportPublic FDA data

Freshmint Sensitive Toothpaste

Product NDC
68747-6031
11-digit product format
687476031
Labeler code
68747
Product ID
68747-6031_7bbd3de6-b26b-49bf-80e8-717d6b33ed17
Type
HUMAN OTC DRUG
Nonproprietary name
Fluoride Toothpaste
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Dabur India Limited
Application
part355
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2009-08-25
Marketing end
0000-00-00
Substance
SODIUM FLUORIDE; POTASSIUM NITRATE
Active strength
2 mg/g; mg/g
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
95250459-30e4-45c1-b08a-993044f49109Product name220250805
d9771140-739b-484b-ae64-b79528ff1211Product name320250801
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68747-6031-12019-10-21C16284748780-1956f9ecf-bed7-621f-e053-dbdaa90a74adSensodyne ®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68747-6031-1Freshmint Sensitive Toothpaste122 g in 1 TUBEPASTE, DENTIFRICE1221

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
POTASSIUM NITRATEACTIVE INGREDIENTRU45X2JN0ZFRESHMINT SENSITIVE TOOTHPASTE (FLUORIDE TOOTHPASTE) PASTE, DENTIFRICE [DABUR INDIA LIMITED]1
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W7FRESHMINT SENSITIVE TOOTHPASTE (FLUORIDE TOOTHPASTE) PASTE, DENTIFRICE [DABUR INDIA LIMITED]1
FLUORIDE IONACTIVE MOIETYQ80VPU408OFRESHMINT SENSITIVE TOOTHPASTE (FLUORIDE TOOTHPASTE) PASTE, DENTIFRICE [DABUR INDIA LIMITED]1
POTASSIUM CATIONACTIVE MOIETY295O53K152FRESHMINT SENSITIVE TOOTHPASTE (FLUORIDE TOOTHPASTE) PASTE, DENTIFRICE [DABUR INDIA LIMITED]1
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311FRESHMINT SENSITIVE TOOTHPASTE (FLUORIDE TOOTHPASTE) PASTE, DENTIFRICE [DABUR INDIA LIMITED]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXFRESHMINT SENSITIVE TOOTHPASTE (FLUORIDE TOOTHPASTE) PASTE, DENTIFRICE [DABUR INDIA LIMITED]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TFRESHMINT SENSITIVE TOOTHPASTE (FLUORIDE TOOTHPASTE) PASTE, DENTIFRICE [DABUR INDIA LIMITED]1
POLYETHYLENE GLYCOL 1500INACTIVE INGREDIENT1212Z7S33AFRESHMINT SENSITIVE TOOTHPASTE (FLUORIDE TOOTHPASTE) PASTE, DENTIFRICE [DABUR INDIA LIMITED]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHFRESHMINT SENSITIVE TOOTHPASTE (FLUORIDE TOOTHPASTE) PASTE, DENTIFRICE [DABUR INDIA LIMITED]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYFRESHMINT SENSITIVE TOOTHPASTE (FLUORIDE TOOTHPASTE) PASTE, DENTIFRICE [DABUR INDIA LIMITED]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FRESHMINT SENSITIVE TOOTHPASTE (FLUORIDE TOOTHPASTE) PASTE, DENTIFRICE [DABUR INDIA LIMITED]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUFRESHMINT SENSITIVE TOOTHPASTE (FLUORIDE TOOTHPASTE) PASTE, DENTIFRICE [DABUR INDIA LIMITED]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JFRESHMINT SENSITIVE TOOTHPASTE (FLUORIDE TOOTHPASTE) PASTE, DENTIFRICE [DABUR INDIA LIMITED]1
SODIUM PHOSPHATE, TRIBASIC, DODECAHYDRATEINACTIVE INGREDIENTB70850QPHRFRESHMINT SENSITIVE TOOTHPASTE (FLUORIDE TOOTHPASTE) PASTE, DENTIFRICE [DABUR INDIA LIMITED]1
SORBITOLINACTIVE INGREDIENT506T60A25RFRESHMINT SENSITIVE TOOTHPASTE (FLUORIDE TOOTHPASTE) PASTE, DENTIFRICE [DABUR INDIA LIMITED]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFRESHMINT SENSITIVE TOOTHPASTE (FLUORIDE TOOTHPASTE) PASTE, DENTIFRICE [DABUR INDIA LIMITED]1
WATERINACTIVE INGREDIENT059QF0KO0RFRESHMINT SENSITIVE TOOTHPASTE (FLUORIDE TOOTHPASTE) PASTE, DENTIFRICE [DABUR INDIA LIMITED]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68747-6031FRESHMINT SENSITIVE TOOTHPASTE (FLUORIDE TOOTHPASTE) PASTE, DENTIFRICE [DABUR INDIA LIMITED]1Legacy NDC, 1 package rows20090908_7bbd3de6-b26b-49bf-80e8-717d6b33ed17.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpastePSN7bbd3de6-b26b-49bf-80e8-717d6b33ed171
1038929potassium nitrate 0.05 MG/MG / sodium fluoride 0.0024 MG/MG ToothpasteSCD7bbd3de6-b26b-49bf-80e8-717d6b33ed171
1038929K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSY7bbd3de6-b26b-49bf-80e8-717d6b33ed171
1038929Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSY7bbd3de6-b26b-49bf-80e8-717d6b33ed171
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY7bbd3de6-b26b-49bf-80e8-717d6b33ed171
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY7bbd3de6-b26b-49bf-80e8-717d6b33ed171
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpasteSY7bbd3de6-b26b-49bf-80e8-717d6b33ed171

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
68747-6031-168747603101122 g in 1 TUBE122 gHistorical