FDA.reportPublic FDA data

PERIOSCIENCES SENSITIVE AO Pro

Product NDC
53238-002
11-digit product format
532380002
Labeler code
53238
Product ID
53238-002_4a6b7785-aecc-90ae-e063-6294a90ad279
Type
HUMAN OTC DRUG
Nonproprietary name
POTASSIUM NITRATE, SODIUM MONOFLUOROPHOSPHATE
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
PERIOSCIENCES LLC
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-05-27
Substance
POTASSIUM NITRATE; SODIUM MONOFLUOROPHOSPHATE
Active strength
50; 1.3 mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
PERIOSCIENCES SENSITIVE AO Pro
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POTASSIUM NITRATE50 mg/mL
SODIUM MONOFLUOROPHOSPHATE1.3 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiRU45X2JN0Z, C810JCZ56Q
Rxcui1426152

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
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
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53238-002-90PERIOSCIENCES SENSITIVE AO Pro90 mL in 1 TUBEPASTE, DENTIFRICE9012
53238-002-90PERIOSCIENCES SENSITIVE AO Pro1 in 1 CARTONPASTE, DENTIFRICE112

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
POTASSIUM NITRATEACTIVE INGREDIENTRU45X2JN0ZPERIOSCIENCES SENSITIVE AO PRO (POTASSIUM NITRATE, SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [PERIOSCIENCES LLC]5
SODIUM MONOFLUOROPHOSPHATEACTIVE INGREDIENTC810JCZ56QPERIOSCIENCES SENSITIVE AO PRO (POTASSIUM NITRATE, SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [PERIOSCIENCES LLC]5
FLUORIDE IONACTIVE MOIETYQ80VPU408OPERIOSCIENCES SENSITIVE AO PRO (POTASSIUM NITRATE, SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [PERIOSCIENCES LLC]5
NITRATE IONACTIVE MOIETYT93E9Y2844PERIOSCIENCES SENSITIVE AO PRO (POTASSIUM NITRATE, SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [PERIOSCIENCES LLC]5
ALLANTOININACTIVE INGREDIENT344S277G0ZPERIOSCIENCES SENSITIVE AO PRO (POTASSIUM NITRATE, SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [PERIOSCIENCES LLC]5
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311PERIOSCIENCES SENSITIVE AO PRO (POTASSIUM NITRATE, SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [PERIOSCIENCES LLC]5
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KXPERIOSCIENCES SENSITIVE AO PRO (POTASSIUM NITRATE, SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [PERIOSCIENCES LLC]5
FERULIC ACIDINACTIVE INGREDIENTAVM951ZWSTPERIOSCIENCES SENSITIVE AO PRO (POTASSIUM NITRATE, SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [PERIOSCIENCES LLC]5
GLYCERININACTIVE INGREDIENTPDC6A3C0OXPERIOSCIENCES SENSITIVE AO PRO (POTASSIUM NITRATE, SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [PERIOSCIENCES LLC]5
HYDRATED SILICAINACTIVE INGREDIENTY6O7T4G8P9PERIOSCIENCES SENSITIVE AO PRO (POTASSIUM NITRATE, SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [PERIOSCIENCES LLC]5
MENTHOLINACTIVE INGREDIENTL7T10EIP3APERIOSCIENCES SENSITIVE AO PRO (POTASSIUM NITRATE, SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [PERIOSCIENCES LLC]5
PHLORETININACTIVE INGREDIENTS5J5OE47MKPERIOSCIENCES SENSITIVE AO PRO (POTASSIUM NITRATE, SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [PERIOSCIENCES LLC]5
POTASSIUM CHLORIDEINACTIVE INGREDIENT660YQ98I10PERIOSCIENCES SENSITIVE AO PRO (POTASSIUM NITRATE, SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [PERIOSCIENCES LLC]5
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4PERIOSCIENCES SENSITIVE AO PRO (POTASSIUM NITRATE, SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [PERIOSCIENCES LLC]5
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PERIOSCIENCES SENSITIVE AO PRO (POTASSIUM NITRATE, SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [PERIOSCIENCES LLC]5
SODIUM ASCORBYL PHOSPHATEINACTIVE INGREDIENT836SJG51DRPERIOSCIENCES SENSITIVE AO PRO (POTASSIUM NITRATE, SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [PERIOSCIENCES LLC]5
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOPERIOSCIENCES SENSITIVE AO PRO (POTASSIUM NITRATE, SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [PERIOSCIENCES LLC]5
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRPERIOSCIENCES SENSITIVE AO PRO (POTASSIUM NITRATE, SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [PERIOSCIENCES LLC]5
SODIUM METHYL COCOYL TAURATEINACTIVE INGREDIENTJVL98CG53GPERIOSCIENCES SENSITIVE AO PRO (POTASSIUM NITRATE, SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [PERIOSCIENCES LLC]5
SODIUM POLYMETAPHOSPHATEINACTIVE INGREDIENTP1BM4ZH95LPERIOSCIENCES SENSITIVE AO PRO (POTASSIUM NITRATE, SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [PERIOSCIENCES LLC]5
SORBITOLINACTIVE INGREDIENT506T60A25RPERIOSCIENCES SENSITIVE AO PRO (POTASSIUM NITRATE, SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [PERIOSCIENCES LLC]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPERIOSCIENCES SENSITIVE AO PRO (POTASSIUM NITRATE, SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [PERIOSCIENCES LLC]5
TRIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENT91D9GV0Z28PERIOSCIENCES SENSITIVE AO PRO (POTASSIUM NITRATE, SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [PERIOSCIENCES LLC]5
WATERINACTIVE INGREDIENT059QF0KO0RPERIOSCIENCES SENSITIVE AO PRO (POTASSIUM NITRATE, SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [PERIOSCIENCES LLC]5
XYLITOLINACTIVE INGREDIENTVCQ006KQ1EPERIOSCIENCES SENSITIVE AO PRO (POTASSIUM NITRATE, SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [PERIOSCIENCES LLC]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53238-002PERIOSCIENCES SENSITIVE AO PRO (POTASSIUM NITRATE, SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [PERIOSCIENCES LLC]11Current NDC, Legacy NDC, 2 package rows20250130_acca8964-b575-468c-8b40-514dfbf50778.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1426152potassium nitrate 5 % / sodium monofluorophosphate 0.76 % ToothpastePSNacca8964-b575-468c-8b40-514dfbf5077812
1426152potassium nitrate 0.05 MG/MG / sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCDacca8964-b575-468c-8b40-514dfbf5077812
1426152K+ nitrate 0.05 MG/MG / Sodium monofluorophosphate 0.0076 MG/MG ToothpasteSYacca8964-b575-468c-8b40-514dfbf5077812
1426152Pot nitrate 0.05 MG/MG / Sodium monofluorophosphate 0.0076 MG/MG ToothpasteSYacca8964-b575-468c-8b40-514dfbf5077812
1426152potassium nitrate 5 % / sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % ) ToothpasteSYacca8964-b575-468c-8b40-514dfbf5077812

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53238-002-90532380002901 TUBE in 1 CARTON (53238-002-90) / 90 mL in 1 TUBE1 tube2013-05-270000-00-00NoNoCurrent