FDA.reportPublic FDA data

Dr Sheffield Muscle Rub Cream

Product NDC
11527-057
11-digit product format
115270057
Labeler code
11527
Product ID
11527-057_d737e806-5edc-48c3-bd75-812f2d63a5de
Type
HUMAN OTC DRUG
Nonproprietary name
Muscle Rub Cream
Dosage form
CREAM
Route
TOPICAL
Labeler
Sheffield Pharmaceuticals LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2002-04-24
Substance
MENTHOL; METHYL SALICYLATE
Active strength
100; 150 mg/g; 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 Muscle Rub Cream
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL100 mg/g
METHYL SALICYLATE150 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L7T10EIP3AInternal UNII lookup
LAV5U5022YInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
311498Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
60d1d826-a53e-42e5-bc30-1b2c2690445bAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11527-057-40Dr Sheffield Muscle Rub Cream35 g in 1 TUBECREAM353
11527-057-40Dr Sheffield Muscle Rub Cream1 in 1 CARTONCREAM13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11527-057-40GM - Gram11527-05726d8e8b2-348c-4d8f-8004-760fc160fd0b12016-10-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3ADR SHEFFIELD MUSCLE RUB CREAM (MUSCLE RUB CREAM) CREAM [FARIA LLC DBA SHEFFIELD PHARMACEUTICALS]1
METHYL SALICYLATEACTIVE INGREDIENTLAV5U5022YDR SHEFFIELD MUSCLE RUB CREAM (MUSCLE RUB CREAM) CREAM [FARIA LLC DBA SHEFFIELD PHARMACEUTICALS]1
MENTHOLACTIVE MOIETYL7T10EIP3ADR SHEFFIELD MUSCLE RUB CREAM (MUSCLE RUB CREAM) CREAM [FARIA LLC DBA SHEFFIELD PHARMACEUTICALS]1
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZDR SHEFFIELD MUSCLE RUB CREAM (MUSCLE RUB CREAM) CREAM [FARIA LLC DBA SHEFFIELD PHARMACEUTICALS]1
CARBOMER 940INACTIVE INGREDIENT4Q93RCW27EDR SHEFFIELD MUSCLE RUB CREAM (MUSCLE RUB CREAM) CREAM [FARIA LLC DBA SHEFFIELD PHARMACEUTICALS]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNDR SHEFFIELD MUSCLE RUB CREAM (MUSCLE RUB CREAM) CREAM [FARIA LLC DBA SHEFFIELD PHARMACEUTICALS]1
OLETH-3 PHOSPHATEINACTIVE INGREDIENT8Q0Z18J1VLDR SHEFFIELD MUSCLE RUB CREAM (MUSCLE RUB CREAM) CREAM [FARIA LLC DBA SHEFFIELD PHARMACEUTICALS]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APDR SHEFFIELD MUSCLE RUB CREAM (MUSCLE RUB CREAM) CREAM [FARIA LLC DBA SHEFFIELD PHARMACEUTICALS]1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKDR SHEFFIELD MUSCLE RUB CREAM (MUSCLE RUB CREAM) CREAM [FARIA LLC DBA SHEFFIELD PHARMACEUTICALS]1
WATERINACTIVE INGREDIENT059QF0KO0RDR SHEFFIELD MUSCLE RUB CREAM (MUSCLE RUB CREAM) CREAM [FARIA LLC DBA SHEFFIELD PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11527-057DR SHEFFIELD MUSCLE RUB CREAM (MUSCLE RUB CREAM) CREAM [SHEFFIELD PHARMACEUTICALS LLC]3Current NDC, Legacy NDC, 2 package rows20231129_60d1d826-a53e-42e5-bc30-1b2c2690445b.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 45 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DZUL - LIDO CREMELIDOCAINE HCL, MENTHOLCaball Sales, Inc.063387e4-a1b1-a467-e063-6294a90a6cbd2026-01-08WarningsExact identifier
application number: M017
TOPICAINELIDOCAINE 4%ESBA LABORATORIES INC.7f96e980-891e-743d-e053-2a91aa0aea5f2026-01-08WarningsExact identifier
application number: M017
LUBRICAINELIDOCAINE 4%ESBA LABORATORIES INC.9d7416b1-607d-34e0-e053-2a95a90aa3c32026-01-08WarningsExact identifier
application number: M017
0.5% LIDOCAINE BURN RELIEFLIDOCAINE HYDROCHLORIDEUniversal Distribution Center LLC0a1aeff0-bade-457b-a0ac-099d646c0b2e2026-01-08WarningsExact identifier
application number: M017
4% MENTHOL COLD THERAPYMENTHOLUniversal Distribution Center LLC66892993-a755-4584-b2a8-2e8d7ac705932026-01-08WarningsExact identifier
application number: M017
Private Label Antifungal Barrier Cream2% MICONAZOLE NITRATE CREAMSwiss-American CDMO, LLCe74bddea-c1ac-4e4e-84bd-5a9defb85b2d2026-01-08WarningsExact identifier
application number: M017
2.0% LIDOCAINE BURNLIDOCAINE HYDROCHLORIDEUniversal Distribution Center LLCe1911279-85f7-4053-b6da-8f4e991347a22026-01-08WarningsExact identifier
application number: M017
POMG PAIN RELIEF ROLLERLIDOCAINE HYDROCHLORIDE, MENTHOLPOMG LLC1fa980fb-fc0e-fdd0-e063-6394a90adc132026-01-07WarningsExact identifier
application number: M017
Artridon GlucosamineMENTHOL, METHYL SALICYLATEPharmadel LLC73572156-4cce-0669-e053-2991aa0aaecc2026-01-07WarningsExact identifier
application number: M017
HealthWise Cooling Pain ReliefMENTHOLVeridian Healthcare6e2ad0ab-e3a8-4e3a-8f1d-2cd6351185bd2026-01-07WarningsExact identifier
application number: M017
Hydrocortisone 1% Anti-Itch CreamHYDROCORTISONEDLC Laboratories, Inc.16eeec2c-065d-4da0-e063-6294a90a38732026-01-07WarningsExact identifier
application number: M017
Maximum Strength HydrocortisoneHYDROCORTISONEDLC Laboratories, Inccaf50f12-f35c-4e9e-8ef7-3b0c84e225ee2026-01-07WarningsExact identifier
application number: M017
EARTHS CARE MUSCLE AND JOINT RUBCAMPHORDLC Laboratories, Inc.71e33e06-4dc3-4ead-a122-ff89d93a64de2026-01-07WarningsExact identifier
application number: M017
Amour CBDPAIN RELIEF CREAMSVD Premium Products95b45e79-b1e7-17b2-e053-2995a90a88362026-01-07WarningsExact identifier
application number: M017
Tiger Balm Active MuscleMETHYL SALICYLATE AND MENTHOL, UNSPECIFIED FORMHaw Par Healthcare Ltd.845a4ead-f9c0-4009-bcae-b17cd388439b2026-01-07WarningsExact identifier
application number: M017
3X Medicated Toothache and Gum GelBENZOCAINERite Aid996f7989-17ce-5b28-e053-2995a90af8b82026-01-06WarningsExact identifier
application number: M017
QNTAMAX Muscle and Joint Pain RelievingCAMPHOR (SYNTHETIC), MENTHOLQntamax LLC6622b94c-824e-4e84-a8d8-b60bb0b866e22026-01-06WarningsExact identifier
application number: M017
Winco Muscle and Joint Pain Relief Gel 2ozWINCO BENGAY VANISHING SCENT MUSCLE AND JOINT PAIN RELIEFWINCO FOODS, LLC47bedf4e-4036-cf43-e063-6394a90a91d62026-01-06WarningsExact identifier
application number: M017
Pain Relief Hot PatchMENTHOL AND CAPSAICINUniversal Distribution Center LLC110bcb16-ef0b-4bc8-8877-173a0494e1ad2026-01-06WarningsExact identifier
application number: M017
WOFANLI Quit Smoking Nicotine PatchesNICOTINE PATCHESShenzhen Paxi Trading Co., Ltd.4582b4e9-0c24-069d-e063-6394a90a6f4b2026-01-05WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311498menthol 10 % / methyl salicylate 15 % Topical CreamPSN5786a559-a387-120d-e053-2991aa0ab6477
311498menthol 100 MG/ML / methyl salicylate 150 MG/ML Topical CreamSCD5786a559-a387-120d-e053-2991aa0ab6477
311498menthol 10 % / methyl salicylate 15 % Topical CreamSY5786a559-a387-120d-e053-2991aa0ab6477
311498menthol 10 GM / methyl salicylate 15 GM per 100 GM Topical CreamSY5786a559-a387-120d-e053-2991aa0ab6477
311498menthol 10 % / methyl salicylate 15 % Topical CreamPSN60d1d826-a53e-42e5-bc30-1b2c2690445b3
311498menthol 100 MG/ML / methyl salicylate 150 MG/ML Topical CreamSCD60d1d826-a53e-42e5-bc30-1b2c2690445b3
311498menthol 10 % / methyl salicylate 15 % Topical CreamSY60d1d826-a53e-42e5-bc30-1b2c2690445b3
311498menthol 10 GM / methyl salicylate 15 GM per 100 GM Topical CreamSY60d1d826-a53e-42e5-bc30-1b2c2690445b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11527-057-40115270057401 TUBE in 1 CARTON (11527-057-40) / 35 g in 1 TUBE1 tube2002-04-240000-00-00NoNoCurrent