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Dr. Sheffield Sensitive Care Sensitive Tooth Paste 50 mg/g Paste, Dentifrice — NDC 11527-0420-45 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Dr. Sheffield Sensitive Care Sensitive Tooth Paste 50 mg/g Paste, Dentifrice — NDC 11527-420-45 (Billing 11527-0420-45)

by Sheffield Pharmaceuticals LLC · 1 TUBE in 1 CARTON / 141 g in 1 TUBE

This is a package of Dr. Sheffield Sensitive Care Sensitive Tooth Paste 50 mg/g Paste, Dentifrice from Sheffield Pharmaceuticals LLC, marketed since May 2017 and currently FDA-listed. It is this product's only package size.

NDC 11527-0420-45
🏷️ FDA NDC (as labeled) 11527-420-45 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 11527-420-45 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
11527 labeler · 420 product · 45 package
Package marketed since
May 15, 2017
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 1152742045 6
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 11527-420-45
Product NDC 11527-420
11-digit billing NDC 11527042045
RxCUI 312544
UNII RU45X2JN0Z
Application # M022
SPL Set ID 702a0dec-64cf-4834-8d80-f3d4f0c08a3a
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2017-05-15
Route ORAL
Dosage form PASTE, DENTIFRICE
Substance POTASSIUM NITRATE
Quick answers
  • RxCUI (RxNorm): 312544
Why two NDCs? The FDA registers this code as 11527-420-45 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 11527-0420-45. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

Clinical

🧪 What is this product?

Dr. Sheffield Sensitive Care Sensitive Tooth Paste is an over-the-counter toothpaste that contains potassium nitrate as its active ingredient. Potassium nitrate is commonly used in toothpaste products to help reduce tooth sensitivity by blocking sensation pathways in the tooth. This product is an OTC monograph drug, meaning it is marketed under FDA's established rule-book for over-the-counter oral care products rather than through an individually reviewed application.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer gPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
11527-0420-45 You're viewing this Main listing 1 TUBE in 1 CARTON / 141 g in 1 TUBE 2017-05-15 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Dr. Sheffield Sensitive Care 50 mg/gthis 11527-0420-45 Sheffield 1 tube — — FDA listed —
Attitude Adult Fluoride-free - Sensitive - Spearmint 5 g/100g 61649-0743-01 9055-7588 120 g — — FDA listed —
SprinJene Natural Sensitivity and Gum 50 mg/g 63404-1984-01 Health 1 tube — — FDA listed —
Sensitivity Relief Fluoride Free 50 mg/g 63404-2105-01 Health 1 tube — — FDA listed —
Boka Sensitive 5 g/100g 87161-0444-02 Karaka 1 tube — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2017
On the market since
May 2017
📍
2026
Currently FDA-listed
9 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

Color white
FlavorMint
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII ZY81Z83H0X
    Aloe vera leaf is a plant extract derived from the aloe plant. It is used in medicines as a natural moisturizer and skin-soothing agent in topical formulations.
  • UNII H0G9379FGK
    Calcium carbonate is a white mineral powder used as a filler and buffering agent in medicines. It helps give tablets their bulk and size while neutralizing stomach acid in some formulations.
  • UNII O7TSZ97GEP
    A mineral compound that serves as a filler and binding agent in tablets and capsules. It adds bulk to the medicine and helps hold ingredients together during manufacturing.
  • UNII 5C69YCD2YJ
    Carrageenan is a natural thickener and stabilizer extracted from red seaweed. It's used in medicines to create gel-like textures, improve consistency, and help keep ingredients from separating during storage.
  • UNII Q9L0O73W7L
    Coconut oil is a natural fat extracted from coconut fruit. It's used in medicines as a lubricant, emollient, or carrier to help dissolve or deliver active ingredients smoothly through the formulation.
  • UNII N534J96ODY
    A natural resin extracted from the myrrh tree, used in medicines as a binder and flavoring agent. It helps hold tablet ingredients together and may provide mild aromatic or taste properties to the formulation.
  • UNII IWY3IWX2G8
    A plant extract derived from wild yam root. It's used in medicines as a natural binding and thickening agent to help hold ingredients together and improve the product's texture and consistency.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII M30XO5X4XD
    A dried plant root extract from Florentine iris used as a natural fragrance, flavoring, and binding agent in medications. It helps hold tablet ingredients together and adds mild pleasant taste or aroma.
  • UNII G43C57162K
    A natural plant extract from tea tree leaves used in topical formulations. It acts as a fragrance, preservative, and antimicrobial agent to help maintain product freshness and sensory appeal.
  • UNII 6Y8XYV2NOF
    A waxy substance made by honeybees from plant resins and pollen. In medicines, it acts as a binder and coating agent to hold ingredients together and protect the product.
  • UNII 1L8K0593B6
    A natural extract from South American quillaja tree wood. Used as an emulsifier and foaming agent to help mix oil and water-based ingredients and create stable suspensions in liquid medicines and formulations.
  • UNII NR100Y25G0
    A plant-derived ingredient from the sarsaparilla root. It may be used as a natural flavor or thickening agent in liquid formulations.
  • UNII 6TC6NN0876
    A natural sweetener extracted from stevia plant leaves. It sweetens the medicine to improve taste without adding calories, helping make medications easier to take.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
  • UNII TTV12P4NEE
    Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.
  • UNII VCQ006KQ1E
    Xylitol is a naturally occurring sugar alcohol derived from plants. It's used in medicines as a sweetener, bulking agent, and to improve taste, especially in liquid formulations and chewable tablets.
  • UNII E2H9ET15AT
    Yucca schidigera root is a plant extract used as a natural flavor masker and foaming agent. It helps reduce bitter tastes and improve how the medicine mixes or disperses in liquids.

18 inactive ingredients listed in the exact product block matched to this NDC.

The official label also statesDicalcium 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

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerSheffield Pharmaceuticals LLC
FDA applicationM022 (OTC MONOGRAPH DRUG)
Labeler code11527
First marketedMay 2017
Product typeHuman Otc Drug
Portfolio29 products on file

More NDCs from Sheffield Pharmaceuticals LLC labeler code 11527

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 When Using This Product 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 2 words ▾

Drug Fact

⏱️ Dosage and Administration 68 words ▾

Directions 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.

⚠️ Warnings 66 words ▾

Warnings 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.

🧪 Active Ingredient 5 words ▾

Active Ingredient Potassium Nitrate 5%

🧪 Inactive Ingredients 77 words ▾

Inactive ingredients 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

🎯 Purpose 3 words ▾

Purpose Tooth desensitizer

📄 When Using This Product 17 words ▾

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

📄 Keep Out of Reach of Children 28 words ▾

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.

📄 Questions or Comments 3 words ▾

Questions? Call 1-800-222-1087

📄 Package Label / Principal Display Panel 57 words ▾

Principal Primary Panel Tube 5.0 oz Dr. Sheffield Certifed Natural Toothpaste Sensitive Care Natural Mint NET WT. 5 OZ (141g) Dr Sheffield Certified Natural Toothpaste Sensitive Tube.jpg

Principal Primary Panel Carton 5.0 oz Dr. Sheffield Certifed Natural Tooth Paste Sensitive Care Natural Mint Flavor NET WT. 5 oz ( 141g) Dr Sheffield Certified Natural Toothpaste Sensitive carton.jpg

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

About this NDC listing & data coverage

Over-the-counter (OTC) product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Sheffield Pharmaceuticals LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Sheffield Pharmaceuticals LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 11527-0325-33 · Sheffield 11527-0478-64 · Sheffield →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.