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Dr Sheffield Muscle Rub Cream 100 mg/g; 150 mg/g Cream — NDC 11527-0057-40 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Dr Sheffield Muscle Rub Cream 100 mg/g; 150 mg/g Cream — NDC 11527-057-40 (Billing 11527-0057-40)

by Sheffield Pharmaceuticals LLC · 1 TUBE in 1 CARTON / 35 g in 1 TUBE

This is a package of Dr Sheffield Muscle Rub Cream 100 mg/g; 150 mg/g Cream from Sheffield Pharmaceuticals LLC, marketed since Apr 2002 and currently FDA-listed. It is this product's only package size.

NDC 11527-0057-40
🏷️ FDA NDC (as labeled) 11527-057-40 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 →

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 11527-057-40
Product NDC 11527-057
11-digit billing NDC 11527005740
NCPDP billing unit GM — per gram (weight)
RxCUI 311498
UNII L7T10EIP3A, LAV5U5022Y
Application # M017
SPL Set ID 60d1d826-a53e-42e5-bc30-1b2c2690445b
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2002-04-24
Route TOPICAL
Dosage form CREAM
Substance MENTHOL; METHYL SALICYLATE

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

GPI-14 90809902603700
GPI class Muscle Rub
GCN Seq No 061801
GCN 97586
HICL code 002583
Ingredient (HICL) Methyl Salicylate/Menthol
HIC1 code L
Therapeutic class — broad (HIC1) Skin/Subcutaneous Tissue
HIC2 code L6
Therapeutic class — intermediate (HIC2) Irritants
HIC3 code L6A
Therapeutic class — specific (HIC3) Irritants/Counter-Irritants
AHFS code 28:08.04.24
AHFS class Salicylates
FDB label name MUSCLE RUB 15%-10% CREAM
FDB brand name Muscle Rub
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 061801
  • GCN: 97586
  • GPI-14 (Medi-Span): 90809902603700
  • HICL (First Databank): 002583
  • AHFS class code: 28:08.04.24
  • RxCUI (RxNorm): 311498
Why two NDCs? The FDA registers this code as 11527-057-40 — 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 → 11527-0057-40. 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.

Clinical

Label name MUSCLE RUB 15%-10% CREAM Ingredient Methyl Salicylate/Menthol
📗 Our plain-language guide HelloPharmacist
  • It is used on the skin for short-term relief of minor muscle and joint aches. That includes arthritis, backache, strains, sprains and bruises. Some products, like Diclofenac Sodium...
  • Apply it only to clean, intact skin, and follow your product's directions on how often. Wash your hands after using creams or handling patches, and keep it away from your eyes. Don...
  • A short burning feeling, redness or mild irritation where you apply it is the most common. It usually fades in several days. Stop and call your doctor if you get severe burning, bl...
  • Be careful. Methyl salicylate is a salicylate, related to aspirin, and labels say to talk to a doctor first if you are prone to allergic reactions to aspirin or salicylates. Some l...
📖 Read our full Menthol / Methyl Salicylate 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.
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
11527-0057-40 You're viewing this Main listing 1 TUBE in 1 CARTON / 35 g in 1 TUBE 2002-04-24 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Muscle Rub 100 mg/g; 150 mg/g 00536-1349-57 Rugby 1 tube $0.037 — Availability likely —
Dr Sheffield Muscle Rub Cream 100 mg/g; 150 mg/gthis 11527-0057-40 Sheffield 1 tube — — FDA listed —
Arthritis Hot 10 g/100g; 15 g/100g 41167-0600-03 Chattem, 1 tube — — FDA listed —
CVS Muscle Rub 150 mg/g; 100 mg/g 51316-0994-03 CVS 85 g — — FDA listed —
CAREALL Muscle Rub Ultra Strength 100 mg/g; 150 mg/g 51824-0007-03 New 85 g — — FDA listed —
CAREALL Muscle Rub Ultra Strength 100 mg/g; 150 mg/g 51824-0105-03 New 85 g — — FDA listed —
Analgesic Balm 10 g/100g; 15 g/100g 57896-0116-01 Geri-Care 1 tube — — FDA listed —
DynaRub 10 g/100g; 15 g/100g 67777-0113-50 Dynarex 72 tubes — — FDA listed —
Dr Sheffield Muscle Rub Cream 100 mg/g; 150 mg/g 68071-1624-05 NuCare 35 g — — FDA listed —
Rugby Muscle Rub Cream 100 mg/g; 150 mg/g 68071-3789-03 NuCare 1 tube — — FDA listed —
Muscle Rub Cream 10 g/100g; 15 g/100g 68788-8544-08 Preferred 1 tube — — FDA listed —
Rugby Muscle Rub Cream 100 mg/g; 150 mg/g 68788-8729-08 Preferred 1 tube — — FDA listed —
Muscle Rub Cream .1 g/100g; .15 g/100g 69396-0024-05 Trifecta 1 tube — — FDA listed —
Muscle Rub Cream 10 g/100g; 15 g/100g 69396-0110-30 Trifecta 1 tube — — FDA listed —
Pain Reliever Cream 10 g/100g; 15 g/100g 69396-0151-01 Trifecta 1 tube — — FDA listed —
TheraCare Muscle and Join Pain Relieving Cream 100 mg/g; 150 mg/g 71101-0012-01 Veridian 1 tube — — FDA listed —
AsperFlex 100 mg/g; 150 mg/g 71399-6854-03 Akron 85 g — — FDA listed —
Calypxo HP Pain Relief 15 g/100g; 10 g/100g 76420-0999-01 Asclemed 113 g — — FDA listed —
Muscle Rub 10 g/100g; 15 g/100g 87236-0005-01 Aldermed 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

🏛️
2002
On the market since
Apr 2002
📍
2026
Currently FDA-listed
24 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 4Q93RCW27E
    A synthetic polymer made from acrylic acid that's crosslinked for stability. It acts as a thickener and gelling agent in creams and gels, helping the medicine spread evenly and maintain its texture.
  • UNII 936JST6JCN
    Cetyl alcohol is a waxy, fatty substance derived from plant or animal sources. It acts as an emulsifier and thickener in medicines, helping blend oil and water components and giving products a smooth, creamy texture.
  • UNII 8Q0Z18J1VL
    A surfactant derived from oleic acid, a naturally occurring fatty acid. It helps mix oil and water-based ingredients together in formulations, improving product stability and texture.
  • UNII 4ELV7Z65AP
    Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
  • UNII 9O3K93S3TK
    Trolamine is an alkaline compound used as a pH buffer and emulsifier in medicines. It helps neutralize acids, stabilize formulations, and enable mixing of oil and water-based ingredients.
  • 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.

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

The official label also statesCarbomer, Cetyl Alcohol, Oleth-3 Phosphate, Stearic acid, Triethanolamine, Purified 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 applicationM017 (OTC MONOGRAPH DRUG)
Labeler code11527
First marketedApr 2002
Product typeHuman Otc Drug
Portfolio29 products on file
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 22 words ▾

Uses For temporary relief of minor aches and pains of muscle and joints associated with simple backaches, arthritis, strains, bruises and sprains

⏱️ Dosage and Administration 43 words ▾

Directions Adults and children 2 years of age and older; Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age; consult a doctor. Unless treating hands, wash hands throughly wit hsoap and waterimmediately after use.

⚠️ Warnings 106 words ▾

Warnings For external use only Avoid contact with eyes and mucous membranes If conditions worsens, or if symtoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor. Do not apply to wounds or damaged skin. Do not apply bandage tightly.

Do not use with a heating pad or on wounds, damaged, broken (open) or irritated skin. Discontinue use if excessive irritation of skin develops. If pregnant or breast feeding, ask a health professional before use.

A temporary burning sensation may occur upon application, but generally disappears in a few days.

🧪 Active Ingredient 9 words ▾

Active Ingredients Menthol - 10% Methyl salicylate - 15%

🧪 Inactive Ingredients 12 words ▾

Inactive ingredients Carbomer, Cetyl Alcohol, Oleth-3 Phosphate, Stearic acid, Triethanolamine, Purified Water

🎯 Purpose 5 words ▾

Purpose Topical Analgesic Topical Analgesic

📄 Keep Out of Reach of Children 24 words ▾

Keep this and all drugs out of the reach of children. I f swallowed, get medical help or contact a Poison Control Center immediately.

📄 Package Label / Principal Display Panel 70 words ▾

Principal Display Panel - 1.25 oz Carton Sheffield Pharmaceuticals NDC 11527- 057-40 MUSCLE RUB Cream Menthol 10%, Methyl Salicylate 15% Topical Analgesic Net WT. 1.25 oz ( 35g) Principal Display Panel - 1.25 oz Carton

Principal Display Panel - 1.25 oz Tube Sheffield Pharmaceuticals NDC 11527- 057-40 MUSCLE RUB Cream Menthol 10%, Methyl Salicylate 15% Topical Analgesic Net WT. 1.25 oz ( 35g) Principal Display Panel - 1.25 oz Tube

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 Dr Sheffield Muscle Rub Cream (this brand).

Top reported reactions

Thermal Burn4
Accidental Exposure To Product By Child2
Blister2
Ocular Hyperaemia2
Application Site Hypoaesthesia1
Application Site Pain1
Application Site Vesicles1

Reporter sex

13 reports
Male · 31%
Female · 69%

Serious outcomes

Hospitalization2
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 2 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.
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.
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.