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 10 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Crest Pro-Health Breath Purify and Gum CareCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Companyd71ed31f-cc33-2fc3-e053-2995a90ad39b2026-01-08WarningsExact identifier
application number: M022
Crest Pro-Health ClinicalCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Company0a295ee0-55c2-4f21-8f0a-70efc0e516942026-01-08WarningsExact identifier
application number: M022
Crest Pro-Health Gum CareCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Companyd721e2cb-8f67-3d07-e053-2995a90ae65a2026-01-08WarningsExact identifier
application number: M022
Crest Pro-Health AdvantageCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Companyddcd56fe-25d6-8195-e053-2a95a90a575a2026-01-08WarningsExact identifier
application number: M022
Crest Pro-Health Bacteria GuardCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Companyc2dc1f31-625d-a032-e053-2995a90a730d2026-01-08WarningsExact identifier
application number: M022
Crest Pro Health Gum plus Bacteria GuardCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Companyc598a4ab-5981-0068-e053-2a95a90af4fa2026-01-08WarningsExact identifier
application number: M022
Oral B Gum Detoxify Special Care RinseCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Companyc2dcdde4-5542-1f87-e053-2995a90a261c2026-01-08WarningsExact identifier
application number: M022
Crest Pro-Health Intense Fresh MintCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Company62991165-ec81-48a8-e053-2991aa0a54f32026-01-08WarningsExact identifier
application number: M022
Crest Gum CareCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Company72f1a02f-1d02-7e83-e053-2a91aa0a79472026-01-08WarningsExact identifier
application number: M022
Crest Pro-Health Intense Clean MintCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Company6287bc3e-8b05-45d3-e053-2991aa0aaa102026-01-08WarningsExact identifier
application number: M022
Crest Pro-Health Multi-Protection Refreshing Clean MintCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Company8867d791-7e93-4f39-aaaf-bfbee8296fd92026-01-08WarningsExact identifier
application number: M022
4x Medicated Toothache and Gum CreamBENZOCAINEHEBa71c5259-cbcf-7566-e053-2995a90a2cb62026-01-08WarningsExact identifier
application number: M022
Topco Associates LLC Maximum StrengthFLUORIDETopco Associates LLC387d264c-90cc-5e67-e063-6394a90a713d2026-01-08WarningsExact identifier
application number: M022
TopCare Sensitive Extra WhiteningPOTASSIUM NITRATE, SODIUM FLUORIDETOPCO Assoc. LLC835f41cf-e920-7df7-e053-2a91aa0a44792026-01-08WarningsExact identifier
application number: M022
Scope Icy BlastCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Company164ed151-01d3-021a-e063-6294a90a0e512026-01-08WarningsExact identifier
application number: M022
Crest Pro-Health Advanced Enamel CareSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company1660e7d7-5b8d-8aba-e063-6294a90a50d82026-01-08WarningsExact identifier
application number: M022
Crest Deep Cleanse Germ TreatmentCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Company2d6b15d4-7827-ec2f-e063-6294a90a82c82026-01-08WarningsExact identifier
application number: M022
Crest Scope OriginalCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Company21eed451-9368-146c-e063-6294a90af62b2026-01-08WarningsExact identifier
application number: M022
3x Medicated Mouth Sore GelBENZOCAINEHEBa71c5259-cbd1-7566-e053-2995a90a2cb62026-01-08WarningsExact identifier
application number: M022
HEB Extra WhiteningFLUORIDEHEBb76c3591-6383-4661-b3db-7a56b11202f72026-01-08WarningsExact 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