FDA.reportPublic FDA data

Dr. Sheffield Sensitive Care

Manufacturer
Sheffield Pharmaceuticals LLC
Effective date
2023-11-30
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:03:00

Label at a glance#

ProductDr. Sheffield Sensitive Care
Active ingredientPOTASSIUM NITRATE
Label structure9 sections

Indications and uses

Builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact.

Dosage and administration

Adults and children 12 years of age and older: Apply at least a 1 inch strip of the product onto a soft bristle toothbrush. Brush teeth thoroughly for at least 1 minute twice a day (morning and evening) or as recommended by a dentist or doctor.  Make sure to brush all sensitive areas of the teeth. Children under 12 years of age: consult a dentist or doctor.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Potassium Nitrate 5%

Purpose

OTC - PURPOSE SECTION

Tooth desensitizer

Uses

OTC - WHEN USING SECTION

Builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact.

Warnings 

WARNINGS SECTION

When using this product, if pain/sensivity still persists after 4 weeks of use, please ask your dentist.

Stop Use and ask a Dentist, if the problem persists or worsens, Sensitive teeth may indicate a serious problem that may neeed prompt care of a dentist. 

When using this product, if pain/sensivity still persists after 4 weeks of use, stop use and contact your dentist.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of Children, If more than used for brushing is accidently swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years of age and older: Apply at least a 1 inch strip of the product onto a soft bristle toothbrush. Brush teeth thoroughly for at least 1 minute twice a day (morning and evening) or as recommended by a dentist or doctor. 
Make sure to brush all sensitive areas of the teeth.
Children under 12 years of age: consult a dentist or doctor.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Dicalcium Phosphate Dihydrate, Water (purified), Glycerin, Calcium Carbonate, Organic Cocos Nucifera (Coconut) oil, Quillaja Saponaria Wood Extract, Organic Aloe Barbadensis Leaf, Xylitol, Carrageenan, Xanthum Gum, Stevia Rebaudiana Leaf/Stem Extract, Yucca Schidigera Root extract, Quillaja Saponaria Bark Extract, Smilax Aristolochiaefolia Root extract, Dioscorea Villosa (Wild Yam) Root extract, Natural Peppermint flavor, Natural Menthol, Natural Spearmint Flavor, Natural Fennel Flavor, Iris Florentina (Orris) Root Powder, Propolis Extract, Organic Melaleuca Alternifolia(teatree) oil, Commiphora Myrrha (Myrrha) ResinExtract, Sodium Benzoate

Principal Primary Panel Tube 5.0 oz

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dr Sheffield Certified Natural Toothpaste Sensitive Tube.jpgDr Sheffield Certified Natural Toothpaste Sensitive Tube.jpg

Dr. Sheffield Certifed Natural Toothpaste

Sensitive Care Natural Mint

NET WT. 5 OZ (141g)

Dr Sheffield Certified Natural Toothpaste Sensitive Tube.jpgDr Sheffield Certified Natural Toothpaste Sensitive Tube.jpg

Dr Sheffield Certified Natural Toothpaste Sensitive Tube.jpg
Dr Sheffield Certified Natural Toothpaste Sensitive Tube.jpg

Principal Primary Panel Carton 5.0 oz

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dr Sheffield Certified Natural Toothpaste Sensitive carton.jpgDr Sheffield Certified Natural Toothpaste Sensitive carton.jpg

Dr. Sheffield Certifed Natural Tooth Paste 

Sensitive Care Natural Mint Flavor

NET WT. 5 oz ( 141g)

Dr Sheffield Certified Natural Toothpaste Sensitive carton.jpgDr Sheffield Certified Natural Toothpaste Sensitive carton.jpg

Dr Sheffield Certified Natural Toothpaste Sensitive carton.jpgDr Sheffield Certified Natural Toothpaste Sensitive carton.jpg

Dr Sheffield Certified Natural Toothpaste Sensitive carton.jpg
Dr Sheffield Certified Natural Toothpaste Sensitive carton.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
312544potassium nitrate 5 % ToothpastePSN3
312544potassium nitrate 0.05 MG/MG ToothpasteSCD3
312544K+ nitrate 0.05 MG/MG ToothpasteSY3
312544Pot nitrate 0.05 MG/MG ToothpasteSY3
312544potassium nitrate 5 % ToothpasteSY3

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

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11527-42011527-420-45

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
POTASSIUM NITRATERU45X2JN0ZACTIB
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEO7TSZ97GEPIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
CALCIUM CARBONATEH0G9379FGKIACT
COCONUT OILQ9L0O73W7LIACT
QUILLAJA SAPONARIA WOOD1L8K0593B6IACT
ALOE VERA LEAFZY81Z83H0XIACT
XYLITOLVCQ006KQ1EIACT
CARRAGEENAN5C69YCD2YJIACT
XANTHAN GUMTTV12P4NEEIACT
STEVIA REBAUDIUNA LEAF6TC6NN0876IACT
YUCCA SCHIDIGERA ROOTE2H9ET15ATIACT
SMILAX ARISTOLOCHIIFOLIA ROOTNR100Y25G0IACT
DIOSCOREA VILLOSA ROOTIWY3IWX2G8IACT
IRIS GERMANICA VAR. FLORENTINA ROOTM30XO5X4XDIACT
PROPOLIS WAX6Y8XYV2NOFIACT
MELALEUCA ALTERNIFOLIA LEAFG43C57162KIACT
COMMIPHORA MYRRHA TOPN534J96ODYIACT

Source Document#

Source XML · Source PDF

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dr. Sheffield Sensitive CareSENSITIVE TOOTH PASTESheffield Pharmaceuticals LLC702a0dec-64cf-4834-8d80-f3d4f0c08a3a2023-11-30WarningsExact identifier
ndc (package): 11527-420-45
ndc (product): 11527-420
ndc11 (package): 11527042045
spl id: 1dbaf50f-34ac-4468-80c8-49e58ee2f07d
spl set id: 702a0dec-64cf-4834-8d80-f3d4f0c08a3a

Reported adverse events (FAERS/openFDA)#

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