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Tolnaftate 10 mg/g Cream, 1 tube — NDC 11527-0051-40 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Tolnaftate 10 mg/g Cream, 1 tube — NDC 11527-051-40 (Billing 11527-0051-40)

by Sheffield Pharmaceuticals LLC · 1 TUBE in 1 CARTON / 35.4 g in 1 TUBE

This is a package of 1 tube of Tolnaftate 10 mg/g Cream from Sheffield Pharmaceuticals LLC, marketed since Oct 2009 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 11527-0051-40
🏷️ FDA NDC (as labeled) 11527-051-40 billing pads the product segment with a zero
This package
Contains1 tube Pack sizes2 compare ↓
Main listing for product 11527-051 · Also comes in: 14 g 11527-051-51
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 11527-051-40 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
11527 labeler · 051 product · 40 package
Package marketed since
Oct 7, 2009
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 1152705140 7
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 11527-051-40
Product NDC 11527-051
11-digit billing NDC 11527005140
NCPDP billing unit GM — per gram (weight)
RxCUI 103951
UNII 06KB629TKV
Application # M005
SPL Set ID ca52af37-c3a2-414c-a24a-a37a92925133
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2009-10-07
Route TOPICAL
Dosage form CREAM
Substance TOLNAFTATE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 007339
GCN 30300
HICL code 003186
Ingredient (HICL) Tolnaftate
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q5
Therapeutic class — intermediate (HIC2) Agents Acting Principally On The Skin
HIC3 code Q5F
Therapeutic class — specific (HIC3) Topical Antifungals
AHFS code 84:04.08.40
AHFS class Thiocarbamates(Skin And Mucous Membrane)
FDB label name ANTIFUNGAL 1% CREAM
FDB brand name Antifungal Cream
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 007339
  • GCN: 30300
  • HICL (First Databank): 003186
  • AHFS class code: 84:04.08.40
  • RxCUI (RxNorm): 103951
Why two NDCs? The FDA registers this code as 11527-051-40 — 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 → 11527-0051-40. 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.

RxNorm drug class

This medicine belongs to the Other antifungals for topical use class.

Drug family (ATC) Other antifungals for topical use
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name ANTIFUNGAL 1% CREAM Ingredient Tolnaftate
📗 Our plain-language guide HelloPharmacist
  • It treats fungal skin infections like athlete's foot, ringworm and, in some products, jock itch. Many products also help prevent athlete's foot. Some are made for skin around the n...
  • Wash and dry the area well, then apply a thin layer. Most products are used twice a day, morning and night. The length of use varies, often 4 weeks for athlete's foot and ringworm,...
  • The main one is skin irritation. If that happens, stop using it and talk to a doctor.
  • Call if you see no improvement within 4 weeks for athlete's foot or ringworm, or 2 weeks for jock itch. Call if irritation develops. Call right away if anyone swallows it.
📖 Read our full Tolnaftate guide →
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.
Try another pack size: 14 g
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
11527-0051-40 You're viewing this Main listing 1 TUBE in 1 CARTON / 35.4 g in 1 TUBE 2009-10-07 — Active
11527-0051-51 11527-051-51 1 TUBE in 1 CARTON / 14 g in 1 TUBE 2009-10-07 — Active

Pack size FAQ

What quantity is in this package?
This package contains 1 tube — 1 tube in 1 carton / 35.4 g in 1 tube.
What NDC number is used to bill for this package of Tolnaftate 10 mg/g Cream?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
CR-371059 Tolnaftate 1% Cream 1 g/100g 00536-1315-43 Rugby 1 g $0.090 — Availability likely —
Tolnaftate Antifungal 10 mg/g 24385-0032-03 Amerisource 1 tube $0.119 — Availability likely —
Tolnaftate Cream 1% ANTIFUNGAL 1 g/100g 70000-0084-01 CARDINAL 1 tube $0.119 — Availability likely —
sunmark antifungal 10 mg/g 49348-0155-29 Strategic 1 tube $0.150 — Availability likely —
Tolnaftate Antifungal 1 g/100g 51672-2020-01 Sun 1 tube $0.150 — Availability likely —
Tolnaftate Antifungal 1 g/100g 70677-1001-01 STRATEGIC 1 tube $0.150 — Availability likely —
Odor-Eaters Athletes Foot 1 g/100g 10157-3100-01 Blistex 1 tube — — FDA listed —
Mentholatum Heel Revival Cream 10 mg/g 10742-0020-01 The 1 tube — — FDA listed —
Tinactin 10 mg/g 11523-0934-02 Bayer 1 tube — — FDA listed —
Tinactin 10 mg/g 11523-1190-01 Bayer 1 tube — — FDA listed —
Tolnaftate 10 mg/gthis 11527-0051-40 Sheffield 1 tube — — FDA listed —
Signature Care Antifungal Cream Tolnaftate 1% 10 mg/g 21130-0887-14 BETTER 1 tube — — FDA listed —
meijer antifungal 10 mg/g 41250-0499-01 Meijer 1 tube — — FDA listed —
AVON HeXashield Athletes Foot Cream 10 mg/g 43136-0104-01 Tai 1 tube — — FDA listed —
CLARUS Antifungal 1 g/100g 44577-0001-01 Clinical 45 g — — FDA listed —
CLARUS Antifungal 10 mg/g 44577-0470-00 Clinical 1 tube — — FDA listed —
equate Athletes Foot 10 mg/g 49035-0499-03 Wal-Mart 1 tube — — FDA listed —
sunmark antifungal 10 mg/g 50090-3358-00 A-S 1 tube — — FDA listed —
CR-371059 Tolnaftate 1% 1 g/100g 50090-6147-00 A-S 14.8 g — — FDA listed —
CAREALL Tolnaftate 10 mg/g 51824-0001-01 New 28 g — — FDA listed —
Family Wellness Athletes Foot Tolnaftate 1 Cream 10 mg/g 55319-0991-00 Family 1 tube — — FDA listed —
Athletes Foot Antifungal .01 mg/10g 55910-0341-24 Dollar 1 tube — — FDA listed —
Pedikleer 1 g/100g 57237-0354-15 Rising 1 tube — — FDA listed —
Hongo Killer 10 mg/g 58593-0286-01 Efficient 1 tube — — FDA listed —
Family Care Antifungal 10 mg/g 65923-0021-28 United 1 tube — — FDA listed —
Winco Antifungal 10 mg/g 67091-0051-28 WinCo 1 tube — — FDA listed —
Winco Foods Tolnaftate 10 mg/g 67091-0276-28 Winco 1 tube — — FDA listed —
Natureplex Tolnaftate Antifungal 10 mg/g 67234-0032-01 Natureplex, 1 tube — — FDA listed —
Tolnaftate Cream 1% 10 mg/g 68016-0152-01 Pharmacy 1 tube — — FDA listed —
Tolnaftate 10 mg/g 68071-4245-05 NuCare 14.18 g — — FDA listed —
Skinheal Antifungal 1 g/100g 69070-0305-01 Zhejiang 1 tube — — FDA listed —
Tolnaftate Cream 1% ANTIFUNGAL 1 g/100g 69396-0016-05 Trifecta 1 tube — — FDA listed —
Tolnaftate Cream 1% ANTIFUNGAL 1 g/100g 69396-0042-05 Trifecta 1 tube — — FDA listed —
Tolnaftate 1 g/100g 69396-0130-01 Trifecta 1 tube — — FDA listed —
Canespies 1 g/100g 69729-0610-05 OPMX 1 tube — — FDA listed —
CVS Health Athletes Foot 10 mg/g 69842-0336-14 CVS 1 tube — — FDA listed —
Athletes Foot 10 mg/g 70084-0510-01 Quantum, 1 tube — — FDA listed —
Aftate Athlete Foot Cream 1 g/100g 70356-0001-01 Sabel 28 g — — FDA listed —
TheraCare Antifungal Cream 10 mg/g 71101-0017-01 Veridian 1 tube — — FDA listed —
Funginix Af 1 g/100g 71229-0103-11 The 28 g — — FDA listed —
Funginix Jock Itch Treatment 1 g/100g 71229-0104-11 The 28 g — — FDA listed —
TriTolnacide C 1 g/100mL 73352-0561-10 Trifluent 1 bottle — — FDA listed —
Dr.Scholl s Odor X Athlete s Foot 10 mg/g 73469-0618-01 Scholl's 1 bottle — — FDA listed —
Thera plus Antifungal Tolnaftate 10 mg/g 80684-0040-01 FOURSTAR 1 tube — — FDA listed —
Derman antifungal cream 10 mg/g 81929-0004-01 Taisho 1 tube — — FDA listed —
Up and Up Antifungal 10 mg/g 82442-0020-28 Target 1 tube — — FDA listed —
Antifungal 1 g/100g 83324-0049-01 Chain 1 tube — — FDA listed —
Sylvirene Fungal Nail Renewal 1 g/100mL 85248-0068-01 Jiangxi 30 ml — — FDA listed —
Tagrid Athletes Foot Treament 10 mg/g 85384-0008-01 TAGRID 100 g — — FDA listed —
Initial Drug Listing - Hermon Athletes Foot 1% Tolnaftate Cream .6 g/60g 85398-0017-01 Beautivity 60 g — — FDA listed —
Antifungal Medicated Bar 10 mg/g 85424-0001-01 RoyceDerm 232 g — — FDA listed —
Tagrid Antifungal 10 mg/g 85384-0013-01 TAGRID 113.4 g — — FDA listed —
Tagrid Antifungal 10 mg/g 85384-0010-01 TAGRID 142 g — — FDA listed —
DG Health Athletes Foot 10 mg/g 55910-0027-28 Dolgencorp, 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

🏛️
2009
On the market since
Oct 2009
📍
2026
Currently FDA-listed
17 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.

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 I835H2IHHX
    A waxy substance derived from plant oils, used as an emulsifier and solubilizer to help mix oil and water ingredients together and keep them blended throughout the product's shelf life.
  • UNII 2DMT128M1S
    A waxy solid derived from plant or animal sources. It acts as an emulsifier to blend oil and water components, and also thickens the medicine to give it the right texture and consistency.
  • UNII 36W53O7109
    Chlorocresol is a phenolic antimicrobial chemical used as a preservative in liquid medicines and injectable solutions. It prevents bacterial and fungal growth to maintain product safety and shelf-life.
  • UNII T5L8T28FGP
    Mineral oil is a clear, odorless liquid derived from crude oil. It acts as a lubricant and emollient in medications, helping pills slide smoothly during manufacturing and aiding moisture retention in topical products.
  • UNII 4T6H12BN9U
    Petrolatum is a purified mineral oil-based jelly derived from petroleum. In medicines, it acts as an emollient, lubricant, and moisture barrier to soften skin, reduce friction, and help prevent water loss from formulations.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII KH7I04HPUU
    A salt compound made from sodium and phosphoric acid, used as a buffer to help maintain a stable pH level in the medicine, and sometimes as a binder or filler in tablets and capsules.
  • 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.

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

The official label also statesCeteth-20, Cetostearyl Alcohol, Chlorocresol, Mineral Oil, White Petrolatum, Propylene Glycol, Sodium Phosphate Monobasic, Water

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 applicationM005 (OTC MONOGRAPH DRUG)
Labeler code11527
First marketedOct 2009
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 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 28 words ▾

Uses Cures most athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis). Relieves the itching, irratation, redness, scaling and discomfort which can accompany these conditions.

⏱️ Dosage and Administration 98 words ▾

Directions Clean the affected area and dry thoroughly. Apply a thin layer of the product over the affected area twice daily (morning and night) or as directed by a doctor. Supervise children in the use of this product.

For athlete's foot Pay special attention to the spaces between the toes. Wear well fitting ventilated shoes. Change shoes and socks at least once daily.

For athlete's foot and ringworm, use daily for 4 weeks. For jock itch, use daily for 2 weeks. If condition persists longer, consult a doctor.

This product is not effective on the scalp or nails.

⚠️ Warnings 53 words ▾

Warnings Do not use on children under 2 years of age unless directed by a doctor. For external use only avoid contact with eyes. Irritation occurs or if there is no improvement within 4 weeks (for athlete's foot and ringworm)irritation occurs or if there is no improvement within 2 weeks (for jock itch).

🧪 Active Ingredient 5 words ▾

Active ingredient Tolnaftate USP 1%

🧪 Inactive Ingredients 16 words ▾

Inactive ingredients Ceteth-20, Cetostearyl Alcohol, Chlorocresol, Mineral Oil, White Petrolatum, Propylene Glycol, Sodium Phosphate Monobasic, Water

🎯 Purpose 3 words ▾

Purpose Antifungal Cream

📄 Keep Out of Reach of Children 26 words ▾

Keep this and all drugs out of the reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

📄 Questions or Comments 2 words ▾

Questions? 1-800-222-1087

📄 Package Label / Principal Display Panel 64 words ▾

Principal Display Panel – 1.25 oz Tube Dr. Sheffield's NDC 11527-051-40 1% Tolnafate Antifungal Cream CURES Most: ATHLETE'S FOOT JOCK ITCH RINGWORM Net Wt.

1.25OZ (35.4 g) Sheffield Antifungal 1.25oz Tube

Principal Display Panel – 1.25 oz Carton Dr. Sheffield's NDC 11527-051-40 1% Tolnafate Antifungal Cream CURES Most: ATHLETE'S FOOT JOCK ITCH RINGWORM Net Wt.

1.25OZ (35.4 g) Sheffield Antifungal

1.25 Carton

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

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Tolnaftate — the ingredient across all brands.

Top reported reactions

Pain94
Fatigue88
Nausea86
Dyspnoea81
Diarrhoea73
Anxiety69
Headache57

Age at onset

Infant3
Child12
Adolescent3
Adult103
Elderly83

Reporter sex

1,403 reports
Male · 45%
Female · 55%
Unknown · 0%

Serious outcomes

Hospitalization390
Life-threatening60
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 108 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

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.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 1 tube (11527-0051-51). Each has its own NDC and its own page — see the package list near the top of this page.
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.
← 11527-0045-42 · Sheffield 11527-0052-51 · 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.