FDA.reportPublic FDA data

Rugby Pain Relieving

Product NDC
0536-1101
11-digit product format
005361101
Labeler code
0536
Product ID
0536-1101_762c29bd-6162-470b-acca-53cfbddcfa2d
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol, Unspecified Form and Methyl Salicylate
Dosage form
CREAM
Route
TOPICAL
Labeler
Rugby Laboratories
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-05-11
Substance
MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE
Active strength
10; 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
Rugby Pain Relieving
Brand name suffix
Analgesic
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL, UNSPECIFIED FORM10 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
259203Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4c11876c-57ec-4429-a8c4-fb95baa4074aAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0536-1101-45Rugby Pain RelievingAnalgesic85 g in 1 TUBECREAM855
0536-1101-45Rugby Pain RelievingAnalgesic1 in 1 CARTONCREAM15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1101-45GM - Gram0536-1101f6b2ad5e-2228-458f-85c1-49e5fbc9529312016-11-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0536-1101RUGBY PAIN RELIEVING ANALGESIC (MENTHOL, UNSPECIFIED FORM AND METHYL SALICYLATE) CREAM [RUGBY LABORATORIES]4Current NDC, Legacy NDC, 2 package rows20240217_4c11876c-57ec-4429-a8c4-fb95baa4074a.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 105 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OKeeffes Working Hands Pain Relief Skin ProtectantALLANTOIN, LIDOCAINE HYDROCHLORIDEThe Gorilla Glue Company/O'Keeffe's Company0685da25-c9fa-e1cd-e063-6394a90ae1b32025-01-01WarningsExact identifier
application number: M017
Icy Hot with Lidocaine Pain RelievingLIDOCAINE HCL AND MENTHOLChattem, Inc.75b28b06-77ea-4fea-b516-2e8a0dac70372025-01-01WarningsExact identifier
application number: M017
Advanced Seal Barrier plus Pain ReliefLIDOCAINEKericure Inc.7ac95325-e6e9-4c56-9315-876c00af7c982025-01-01WarningsExact identifier
application number: M017
FixMySkin Healing Balm Fragrance-FreeHYDROCORTISONELovely Skin, Inc.c12af4c6-2f05-46ec-b901-1a4fcd7501802024-12-31WarningsExact identifier
application number: M017
Pain Relieving Cream LidocaineBENZYL ALCOHOL, LIDOCAINE HCITrifecta Pharmaceuticals USA LLC039a2036-54b2-cf28-e063-6294a90a8ce62024-12-31WarningsExact identifier
application number: M017
Cold Therapy Pain Relief WalgreensMENTHOL 10.5%WALGREEN COMPANYf1daa68d-1b12-c28a-e053-2995a90a09492024-12-31WarningsExact identifier
application number: M017
Calypxo Pain ReliefMETHYL SALICYLATE, MENTHOLAdvanced Rx of Tennessee, LLC0b7736df-c7e0-7d00-e063-6294a90aa57e2024-12-31WarningsExact identifier
application number: M017
New TerocinMETHYL SALICYLATE, CAPSAICIN, AND MENTHOLAdvanced Rx Pharmacy of Tennessee, LLCf4bfc4a6-06ef-1f76-e053-2995a90a2b8f2024-12-31WarningsExact identifier
application number: M017
LidocaineLIDOCAINEAdvanced Rx Pharmacy of Tennessee, LLC01cb19a4-ce22-144d-e063-6294a90a8aa32024-12-31WarningsExact identifier
application number: M017
Satohap Lidocaine 4% Menthol 1% Pain Relieving CreamLIDOCAINE, MENTHOLSato Pharmaceutical Co., Ltd.2251e96b-d050-4ec2-a6b9-6659610885bf2024-12-30WarningsExact identifier
application number: M017
hydrocortisoneHYDROCORTISONESafewayaf2e2ef3-0f3f-4592-8081-b6553ade2f5a2024-12-26WarningsExact identifier
application number: M017
Comforte Menstrual Cramp Relief CreamMENTHOLPMS4PMS LLCc121537e-3333-4f35-8c77-20086158dff42024-12-26WarningsExact identifier
application number: M017
N-Labs Arcticzen Pain Relief KneeCAMPHOR (SYNTHETIC), MENTHOLNUTRIOMO LABS PTE. LTD05ee574a-854c-4a77-be77-082055075c4d2024-12-26WarningsExact identifier
application number: M017
BiteMD External Analgesic First Aid AntisepticBENZOCAINE, CAMPHOR (SYNTHETIC), AND PHENOLUnited Industries Corporation4c60db03-6d2b-4ae0-a200-718b3a50eb0f2024-12-23WarningsExact identifier
application number: M017
GNP Anti ItchCAMPHOR, MENTHOLAMERISOURCEBERGEN DRUG CORPORATIONb4f2d6f7-2287-47d8-e053-2995a90ae3352024-12-23WarningsExact identifier
application number: M017
cool and heat pain relieving liquidMENTHOLBionpharma Inc.ec6f59d8-45c5-46a0-e053-2995a90a239f2024-12-23WarningsExact identifier
application number: M017
FOOT WORKS MAXIMUM CRACKED HEELBENZALKONIUM CHLORIDE, LIDOCAINECOSMAX USA, CORPORATION29f92230-d1d4-5e94-e063-6294a90af8122024-12-23WarningsExact identifier
application number: M017
pain relief roll-onLIDOCAINE 4%Bionpharma Inc.f607b6dc-8d13-604a-e053-2995a90a59ab2024-12-23WarningsExact identifier
application number: M017
Veneno de Abeja Aceite De Vibora BrandMETHYL SALICYLATEMiramar Cosmetics, Inc DBA Miramar Laba6c4889c-e7a9-44b9-bd9a-70fd6e8c48252024-12-23WarningsExact identifier
application number: M017
Itch ReliefHYDROCORTISONE 1%Trifecta Pharmaceuticals USA LLCaf5daf6c-bcad-8ebf-e053-2a95a90af1b02024-12-20WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
259203menthol 1 % / methyl salicylate 15 % Topical CreamPSNfcf48536-224e-4a3d-9124-770031823972101
259203menthol 10 MG/ML / methyl salicylate 150 MG/ML Topical CreamSCDfcf48536-224e-4a3d-9124-770031823972101
259203menthol 1 % / methyl salicylate 15 % Topical CreamSYfcf48536-224e-4a3d-9124-770031823972101
259203menthol 1 % / methyl salicylate 15 % Topical CreamPSN4c11876c-57ec-4429-a8c4-fb95baa4074a5
259203menthol 10 MG/ML / methyl salicylate 150 MG/ML Topical CreamSCD4c11876c-57ec-4429-a8c4-fb95baa4074a5
259203menthol 1 % / methyl salicylate 15 % Topical CreamSY4c11876c-57ec-4429-a8c4-fb95baa4074a5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0536-1101-45005361101451 TUBE in 1 CARTON (0536-1101-45) / 85 g in 1 TUBE1 tube2016-05-110000-00-00NoNoCurrent