Home NDC 11527-420 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 Ingredient Strength POTASSIUM NITRATE 50 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination RU45X2JN0Z Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 312544 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 11527-420-45 Dr. Sheffield Sensitive Care 1 in 1 CARTON PASTE, DENTIFRICE 1 3 11527-420-45 Dr. Sheffield Sensitive Care 141 g in 1 TUBE PASTE, DENTIFRICE 141 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 11527-420 DR. SHEFFIELD SENSITIVE CARE (SENSITIVE TOOTH PASTE) PASTE, DENTIFRICE [SHEFFIELD PHARMACEUTICALS LLC] 3 Current NDC, Legacy NDC, 2 package rows 20231201_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 24 of 40 · 786 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 11527-420-45 11527042045 1 TUBE in 1 CARTON (11527-420-45) / 141 g in 1 TUBE 1 tube 2017-05-15 0000-00-00 No No Current