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 76 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Methyl SalicylateMETHYL SALICYLATEPHARMACURE LLC66b13044-69d2-4559-9e65-8a4c601c077a2025-10-06WarningsExact identifier
application number: M017
Methyl SalicylateMETHYL SALICYLATEPHARMACURE LLCf119a1bd-095f-41f5-86d5-c0ee4f19fd2c2025-10-06WarningsExact identifier
application number: M017
LIDOCAINELIDOCAINEPHARMACURE LLC31d5e5c9-6ec4-4496-8a4c-cca39a2cbe322025-10-06WarningsExact identifier
application number: M017
Tempo coolMENTHOLThe Egyptian Saudi Co. For Medical Manufacturing (Masco-Mid) S.A.Ebd642389-6d03-4e09-a71c-312fb90eae892025-10-06WarningsExact identifier
application number: M017
Menthopatch HotMENTHOL , CAPSICUM EXTRACTTHE EGYPTIAN SAUDI CO FOR MEDICAL MANUFACTURING MASCOMID3d289be3-c237-4065-a8ac-e8c2e51b76a52025-10-06WarningsExact identifier
application number: M017
Mentho patch coolMENTHOLTHE EGYPTIAN SAUDI CO FOR MEDICAL MANUFACTURING MASCOMID02251a4a-fc6f-42c9-a244-6f4835de5edd2025-10-06WarningsExact identifier
application number: M017
Feminine Anti-Itch CremeBENZOCAINE, RESORCINOLQuality Choice (CHAIN DRUG MARKETING ASSOCIATION)aa6cc963-dc60-5222-e053-2995a90acaf62025-10-06WarningsExact identifier
application number: M017
TheraCare 2% Diphenhydramine Anti-Itch CreamDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATEVeridian Healthcare5999b677-63dd-49c6-b5b8-7b3c117ecc5c2025-10-06WarningsExact identifier
application number: M017
HealthWise Pain ReliefMENTHOLVeridian Healthcare06be5331-7a1e-4ab3-9f17-2d350bd4b8902025-10-02WarningsExact identifier
application number: M017
equate Burn ReliefLIDOCAINE HYDROCHLORIDEWalmart Inca90cbd92-80a5-4463-8152-b83165121a6f2025-10-02WarningsExact identifier
application number: M017
AsperFlex HOTCAMPHOR, MENTHOL, METHYL SALICYLATEAkron Pharma Inc.a6cb0656-8866-44ff-b40c-73655ff687212025-10-02WarningsExact identifier
application number: M017
AsperFlex Original Maximum StrengthMENTHOLAkron Pharma Inc.d766c61e-c48b-4aff-97b0-678159479e032025-10-02WarningsExact identifier
application number: M017
HealthWise Feminine Anti-Itch CreamBENZOCAINE, RESORCINOLVeridian Healthcare1f9110da-f448-8e20-e063-6294a90a42752025-10-02WarningsExact identifier
application number: M017
PROSTAT FIRST AID Burn Ease, 0.9gLIDOCAINEProStat First Aid LLCdc704403-e2aa-47f7-a7f4-f6afe1547ca82025-10-01WarningsExact identifier
application number: M017
PROSTAT FIRST AID Burn Ease, 0.9gLIDOCAINEProStat First Aid LLCe02558a9-fe2b-4f28-9fd3-7308f859d7592025-10-01WarningsExact identifier
application number: M017
FL Burn Ease, 0.9gLIDOCAINEProStat First Aid LLC4dc0d579-ab42-4ea5-9788-5e54d7d318a32025-10-01WarningsExact identifier
application number: M017
Carmex Classic Lip Balm MedicatedCAMPHOR (SYNTHETIC), WHITE PETROLATUMCarma Laboratories, Inc.c7a7626c-cf82-4301-af79-c5e85367e7772025-10-01WarningsExact identifier
application number: M017
Viaderma Calm Anti-ItchHYDROCORTISONEViaDerma Distribution, Inc.7afa2ccd-bfc6-48fc-9a14-a0c6d645844e2025-10-01WarningsExact identifier
application number: M017
AsperFlex AdvanceCAMPHOR, MENTHOL, METHYL SALICYLATEAkron Pharma Inc.d23d7f2b-4dcd-4c31-9d12-340f233018b42025-10-01WarningsExact identifier
application number: M017
HEATING PAIN RELIEFMETHYL SALICYLATE, MENTHOLSUNSET NOVELTIES, INC4024d604-c8c7-2d73-e063-6294a90a2e802025-10-01WarningsExact 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