FDA.reportPublic FDA data

Dr. Sheffield Sensitive Care

Product NDC
11527-420
11-digit product format
115270420
Labeler code
11527
Product ID
11527-420_1dbaf50f-34ac-4468-80c8-49e58ee2f07d
Type
HUMAN OTC DRUG
Nonproprietary name
Sensitive Tooth Paste
Dosage form
PASTE, DENTIFRICE
Route
ORAL
Labeler
Sheffield Pharmaceuticals LLC
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-05-15
Substance
POTASSIUM NITRATE
Active strength
50 mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Dr. Sheffield Sensitive Care
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POTASSIUM NITRATE50 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
RU45X2JN0ZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
312544Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
702a0dec-64cf-4834-8d80-f3d4f0c08a3aAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11527-420-452020-04-21C16284748780-19d75b9d0-ed04-f424-e053-dadaa90a57ceDr. Sheffield Sensitive Care
11527-420-452020-01-31C16284748780-19d75b9d0-ed04-f424-e053-dadaa90a57ceDr. Sheffield Sensitive Care

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11527-420-45Dr. Sheffield Sensitive Care1 in 1 CARTONPASTE, DENTIFRICE13
11527-420-45Dr. Sheffield Sensitive Care141 g in 1 TUBEPASTE, DENTIFRICE1413

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11527-420DR. SHEFFIELD SENSITIVE CARE (SENSITIVE TOOTH PASTE) PASTE, DENTIFRICE [SHEFFIELD PHARMACEUTICALS LLC]3Current NDC, Legacy NDC, 2 package rows20231201_702a0dec-64cf-4834-8d80-f3d4f0c08a3a.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 38 of 40 · 782 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Gelato Topical AnestheticBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc80182c43-100f-4b15-a07e-819599ab95622023-12-07WarningsExact identifier
application number: M022
Gelato Topical AnestheticBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Incc19e6426-8f1e-47b3-a3a6-551a5bec6cd92023-12-07WarningsExact identifier
application number: M022
Gelato Topical AnestheticBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc1f8431bb-f33c-4fd8-9472-9b59ffb5f18e2023-12-07WarningsExact identifier
application number: M022
Gelato Topical AnestheticBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc1163d248-d648-443e-bed0-ccb7fd26ba632023-12-07WarningsExact identifier
application number: M022
Gelato Topical AnestheticBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc88caabe2-a096-44d0-98d3-afad1935c0122023-12-07WarningsExact identifier
application number: M022
Gelato Topical AnestheticBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Incc1b02a2f-db1f-44f0-a74a-d02c085c5bd72023-12-07WarningsExact identifier
application number: M022
Gelato Topical AnestheticBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc39081585-fe6a-4ba1-93f8-d92d26fe75bc2023-12-07WarningsExact identifier
application number: M022
Quala Topical Anesthetic GelBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.d7c69357-795c-03d8-e053-2a95a90a03a62023-12-06WarningsExact identifier
application number: M022
Dr. Sheffield Sensitive CareSENSITIVE TOOTH PASTESheffield Pharmaceuticals LLC702a0dec-64cf-4834-8d80-f3d4f0c08a3a2023-11-30WarningsExact identifier
application number: M022
ndc (product): 11527-420
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLCf3bf106c-5320-ced2-e053-2a95a90a71ac2023-11-29WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLC0b517321-25ed-2676-e063-6294a90ab4c92023-11-29WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLC0b51b67c-03ac-5730-e063-6394a90a50602023-11-29WarningsExact identifier
application number: M022
Pearl WhitePOTASSIUM NITRATE, SODIUM FLUORIDEBeyond International Inc.51c79544-9536-5863-e054-00144ff8d46c2023-11-28WarningsExact identifier
application number: M022
UNIVERSAL SENSITIVE ANTI-CAVITY FLUORIDEPOTASSIUM NITRATE AND SODIUM FLUORIDEUniversal Distribution Center LLCfcf59439-7e06-4129-a89f-cdeecdf8d4882023-11-17WarningsExact identifier
application number: M022
PerioRestoreHYDROGEN PEROXIDEDEN-MAT HOLDINGS, LLC.97a07c36-1af8-a636-e053-2a95a90ad6db2023-11-13WarningsExact identifier
application number: M022
Wild Horse 777 OralPHENOLWild Horse 777, Inc.b0b517bb-969f-0c65-e053-2995a90a48b12023-11-10WarningsExact identifier
application number: M022
ORCA Pain Reliever Putty with MentholMENTHOLORCA Products, LLC188cb01a-3d0f-43d9-983e-6475c0c5b06e2023-11-10WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLC33fbdbc7-e10d-4181-926f-9b591b5b07e32023-11-08WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLC0d2c8c0c-4c72-4400-b3b5-ed578fa351672023-11-08WarningsExact identifier
application number: M022
Hydrogen PeroxideHYDROGEN PEROXIDEDegasa, S.A. de C.V.45ac0275-4c68-3897-e054-00144ff8d46c2023-11-05WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312544potassium nitrate 5 % ToothpastePSN702a0dec-64cf-4834-8d80-f3d4f0c08a3a3
312544potassium nitrate 0.05 MG/MG ToothpasteSCD702a0dec-64cf-4834-8d80-f3d4f0c08a3a3
312544K+ nitrate 0.05 MG/MG ToothpasteSY702a0dec-64cf-4834-8d80-f3d4f0c08a3a3
312544Pot nitrate 0.05 MG/MG ToothpasteSY702a0dec-64cf-4834-8d80-f3d4f0c08a3a3
312544potassium nitrate 5 % ToothpasteSY702a0dec-64cf-4834-8d80-f3d4f0c08a3a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11527-420-45115270420451 TUBE in 1 CARTON (11527-420-45) / 141 g in 1 TUBE1 tube2017-05-150000-00-00NoNoCurrent