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 129 of 151 · 3,010 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tidl Pain Relief Evening Therapy Spray.PAIN RELIEF EVENING THERAPY SPRAYShenzhen Sam Technology Co., Ltd.1d1a2f4a-7b25-e595-e063-6394a90a00d52024-07-13WarningsExact identifier
application number: M017
TIDL PAIN RELIEF HEAT THERAPY ROLL-ONPAIN RELIEF HEAT THERAPY ROLL-ONShenzhen Sam Technology Co., Ltd.1d0b7b8f-9e5d-00f7-e063-6394a90af87c2024-07-12WarningsExact identifier
application number: M017
TIDL PAIN RELIEF CRYO THERAPY original formula Spray.PAIN RELIEF CRYO THERAPY ORIGINAL FORMULA SPRAYShenzhen Sam Technology Co., Ltd.1d0b94ec-f956-dff2-e063-6294a90aca4a2024-07-12WarningsExact identifier
application number: M017
TIDL PAIN RELIEF CRYO THERAPY MAX Strength Spray.PAIN RELIEF CRYO THERAPY MAX STRENGTH SPRAYShenzhen Sam Technology Co., Ltd.1d0bf4f9-6b02-6cec-e063-6294a90a36c72024-07-12WarningsExact identifier
application number: M017
Burn ReliefLIDOCAINE HCI 2.0%Trifecta Pharmaceuticals USA, LLC.e5e524cd-bb22-715f-e053-2995a90ab5d32024-07-12WarningsExact identifier
application number: M017
Ralli Rapid Pain ReliefMENTHOLTroy Manufacturing, Inc.1d10e3ca-dc93-8e1a-e063-6394a90a47c02024-07-12WarningsExact identifier
application number: M017
TIDL PAIN RELIEF HEAT THERAPY Spray.PAIN RELIEF HEAT THERAPY SPRAYShenzhen Sam Technology Co., Ltd.1d199826-1b27-b6e7-e063-6394a90a69ad2024-07-12WarningsExact identifier
application number: M017
Tidl Pain Relief Morning Therapy Spray.PAIN RELIEF MORNING THERAPY SPRAYShenzhen Sam Technology Co., Ltd.1d19d070-3818-73de-e063-6394a90a89582024-07-12WarningsExact identifier
application number: M017
Hydrocortisone with aloeHYDROCORTISONE WITH ALOE ANTI ITCHNeilMed Pharmaceuticals Inc.032b9f58-5f64-04dd-e063-6294a90a6bb92024-07-10WarningsExact identifier
application number: M017
Octagon Pain ReliefMENTHOL, UNSPECIFIED FORMNATURAL ESSENTIALS, INC.9926f733-1506-4224-9d70-b1813cd81ec32024-07-08WarningsExact identifier
application number: M017
LidoReal PatchLIDOCAINE AND MENTHOLFORREAL PHARMACEUTICALS LLC19f1c037-b4b8-47b0-b0f9-036691c1d3072024-07-05WarningsExact identifier
application number: M017
Lip Medex Lip BalmPETROLATUM, CAMPHOR (SYNTHETIC), MENTHOL, UNSPECIFIED FORM, AND PHENOLBlistex Inc.988f97e8-a59f-4bc0-9d71-60607364a6862024-07-01WarningsExact identifier
application number: M017
Maybelline New York BABY LIPS DR RESCURE MENTHOL EXTERNAL ANALGESIC MEDICATED BALMMENTHOLL'Oreal USA Products Incd580982f-dda6-4b03-bf84-342b9f2c6d932024-06-29WarningsExact identifier
application number: M017
Lip Medex CherryPETROLATUM, CAMPHOR (SYNTHETIC), AND MENTHOL, UNSPECIFIED FORMBlistex Inc.fa8b3fb1-08e5-4876-9c4a-6aa8c9f23af82024-06-28WarningsExact identifier
application number: M017
10% Methyl Salicylate Pain Relief Patch10% METHYL SALICYLATEAkron Coating & Adhesives1be1f1ce-3238-a8ed-e063-6294a90a5aed2024-06-27Exact identifier
application number: M017
Genuine First Aid Alcohol Cleansing PadBENZOCAINE, ALCOHOLGFA Production (Xiamen) Co., Ltd.c39c4d80-9718-459f-8ae4-ada043bba5b72024-06-26WarningsExact identifier
application number: M017
Eagle Brand Medicated Roll OnMENTHOL, METHYL SALICYLATEPT. EAGLE INDO PHARMA1bd5cf69-9a08-5e2e-e063-6394a90a03cd2024-06-26WarningsExact identifier
application number: M017
Solarcaine Burn Pain Relief 4ozSOLARCAINE BURN PAIN RELIEF 4OZWellSpring Pharmaceutical Corporation2c0389db-ceb2-422b-9575-bdb8fe649a1e2024-06-26WarningsExact identifier
application number: M017
astoneaHYDROCORTISONEASTONEA LABS PRIVATE LIMITEDde09e859-c5fd-0cc5-e053-2a95a90a147e2024-06-25WarningsExact identifier
application number: M017
HealthWise Pain Relief Lidocaine PatchLIDOCAINE 4%Veridian Healthcare0190196d-5f78-042b-e063-6294a90a37142024-06-25WarningsExact 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