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 4 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GingiCaine Gel, Mint JulepGINGICAINE GEL, MINT JULEP FLABVORGingi-Pak a Division of the Belport6285fe10-08ba-8044-e053-2991aa0a8e8b2026-06-29WarningsExact identifier
application number: M022
GingiCaine Gel, Pina ColadaGINGICAINE GEL, PINA COLADA FLAVORGingi-Pak a Division of the Belport6284e1fe-be33-69bf-e053-2991aa0a90ab2026-06-29WarningsExact identifier
application number: M022
GingiCaine Gel, Chocolate MintGINGICAINE GEL, CHOCOLATE MINT FLAVORGingi-Pak a Division of the Belport6285c4f2-c139-49a9-e053-2991aa0a2b032026-06-29WarningsExact identifier
application number: M022
UltraCare Anesthetic GelBENZOCAINEThe Bellport Company, Inc. dba Gingi-Pakf5dd8fa8-0b6a-5a30-e053-2995a90ad1942026-06-26WarningsExact identifier
application number: M022
GingiCaine GelGINGICAINE GEL BANANA FLAVORGingi-Pak a Division of the Belport62857d06-a829-4efa-e053-2991aa0a6d152026-06-25WarningsExact identifier
application number: M022
GingiCaine Gel, Cotton Candy FlavorGINGICAINE GEL, COTTON CANDY FLAVORGingi-Pak a Division of the Belport628515a5-175f-ac2c-e053-2991aa0a19ce2026-06-25WarningsExact identifier
application number: M022
Perox-A-Mint SolutionHYDROGEN PEROXIDESage Products, LLC50823ff5-ad08-4449-bc4a-9a8ae25ec0d52026-06-24WarningsExact identifier
application number: M022
Antiseptic Oral RinseCETYLPYRIDINIUM CHLORIDESage Products LLCefff8bae-154d-46bc-8dd4-7168004256632026-06-24Exact identifier
application number: M022
Anbesol Maximum StrengthBENZOCAINEFoundation Consumer Brands8c6ac499-9bd2-4ea5-9f26-df7947bff4a62026-06-22WarningsExact identifier
application number: M022
Anbesol Maximum StrengthBENZOCAINEFoundation Consumer Brandsdcc37403-0192-4658-bb7a-059273ce00472026-06-22WarningsExact identifier
application number: M022
ToothachePOLYHEXAMETHYLENE BIGUANIDE HYDROCHLORIDEGuchutang Biotechnology (Longyan) Co., Ltd54ad2ceb-272f-e5ba-e063-6394a90aec5f2026-06-20WarningsExact identifier
application number: M022
Hydrogen PeroxideHYDROGEN PEROXIDEDelon Laboratories (1990) Ltdd4aa09bf-8207-47dd-bc42-01e660da94382026-06-16WarningsExact identifier
application number: M022
TideFresh MOUTH SORE AND TOOTHACHEBENZOCAINE 20% MOUTH SORE AND TOOTHACHEWenzhou Yuyuan Pharmaceutical Co., Ltd.541e1814-c00e-efdf-e063-6394a90a41a12026-06-13WarningsExact identifier
application number: M022
Chloraseptic Sore Throat MaxPHENOL AND GLYCERINPrestige Brands Holdings, Inc.882c940c-b3c3-4aa4-8d64-e4260f066ff42026-06-08WarningsExact identifier
application number: M022
OrazenSODIUM MONOFLUOROPHOSPHATEOrazen Incfa5b6bd8-443f-79e7-e053-6394a90a55132026-06-03WarningsExact identifier
application number: M022
Fishermans Friend Mixed BerryMENTHOLLofthouse of Fleetwood53391c4d-ee2d-ade3-e063-6394a90ac77d2026-06-01WarningsExact identifier
application number: M022
Orajel Medicated for Toothache and Gum, LiquidBENZOCAINE AND MENTHOLChurch & Dwight Co., Inc.ac3d605d-241d-1a6f-e053-2a95a90ae3912026-06-01WarningsExact identifier
application number: M022
MUCINEX INSTASOOTHE SORE THROAT PLUS PAIN RELIEFBENZOCAINE AND MENTHOL, UNSPECIFIED FORMReckitt Benckiser LLC6140d487-d87c-4954-9247-83492bcc57382026-05-27WarningsExact identifier
application number: M022
Dolodent Maximum StrengthBENZOCAINEPharmadel LLC351ecc2b-cc1a-2bbf-e063-6394a90a5c142026-05-26WarningsExact identifier
application number: M022
MOUTH ULCERPANTHENOLGuangzhou Shengli Shidai Cosmetics Co., Ltd.5264f81c-bffe-4f6d-e063-6394a90ae3bf2026-05-22WarningsExact 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