Osteo Bi-Flex JOINT HEALTH PAIN RELIEVING

Product NDC
59118-837
11-digit product format
591180837
Labeler code
59118
Product ID
59118-837_09d72589-140d-349f-e063-6294a90a4d95
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL, METHYL SALICYLATE
Dosage form
CREAM
Route
TOPICAL
Labeler
Rexall Sundown, LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-08-01
Substance
MENTHOL; METHYL SALICYLATE
Active strength
50; 100 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
Osteo Bi-Flex JOINT HEALTH PAIN RELIEVING
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL50 mg/g
METHYL SALICYLATE100 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
1940367Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
55c55f1c-d2b3-6363-e054-00144ff88e88Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59118-837-01Osteo Bi-Flex JOINT HEALTH PAIN RELIEVING1 in 1 BOXCREAM12
59118-837-01Osteo Bi-Flex JOINT HEALTH PAIN RELIEVING71 g in 1 TUBECREAM712

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59118-837OSTEO BI-FLEX JOINT HEALTH PAIN RELIEVING (MENTHOL, METHYL SALICYLATE) CREAM [REXALL SUNDOWN, LLC]2Current NDC, Legacy NDC, 2 package rows20231111_55c55f1c-d2b3-6363-e054-00144ff88e88.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 151 · 3,010 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
UniShield First Aid BurnLIDOCAINE HCLUnishieldf729c557-da4b-3fb5-e053-6394a90a41962025-09-28WarningsExact identifier
application number: M017
Xpect HydrocortisoneHYDROCORTISONECintas Corporation45ef9be4-54c4-4d85-966b-27708313ded42025-09-26WarningsExact identifier
application number: M017
Zhuifeng Gao Pain RelievingMENTHOLGUILIN CHINA RESOURCES TIANHE PHARMACEUTICAL CO LTD3f12da60-26d1-4407-8e02-c3213ea3ad2a2025-09-26WarningsExact identifier
application number: M017
Gutong Tiegao Pain RelievingMENTHOLGUILIN CHINA RESOURCES TIANHE PHARMACEUTICAL CO LTD5a5c3759-90e0-4a93-99cf-ddbf00aba10d2025-09-26WarningsExact identifier
application number: M017
Zhuanggu Gao Pain RelievingMENTHOLGUILIN CHINA RESOURCES TIANHE PHARMACEUTICAL CO LTDe3e98530-ce4d-47b9-9383-3088814034eb2025-09-26WarningsExact identifier
application number: M017
GUTONG TIEGAO PAIN RELIEVINGCAMPHOR AND MENTHOLGUILIN CHINA RESOURCES TIANHE PHARMACEUTICAL CO LTD3adfac16-ea7b-47df-89f5-91bbd09c4fe12025-09-26WarningsExact identifier
application number: M017
Xpect Sting WipesBENZOCAINE 6%Cintas Corporationfeeae00d-e266-4ae4-90d2-524da38fa8132025-09-26WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONEWalgreens Company0b4053a8-6c1c-621d-e063-6394a90a4f562025-09-25WarningsExact identifier
application number: M017
Unishield 1%HYDROCORTISONEUnishield4871a67f-fbb8-4a6b-ace4-d343490289082025-09-24WarningsExact identifier
application number: M017
Xpect Extra Strength Itch ReliefDIPHENHYDRAMINE HYDROCHLORIDECintas Corporationa373b2c3-5c58-4b64-9358-bdf42dfce08c2025-09-24WarningsExact identifier
application number: M017
Xpect Burn CareBURN CARECintas Corp3665eb99-9602-4949-8af4-3ce7ed24303c2025-09-23WarningsExact identifier
application number: M017
Sheffield Arthritis and Muscle Pain ReliefCAPSICUM OLEORESINSheffield Pharmaceuticals LLC80a1bc65-2986-491f-a062-307d28b08ccb2025-09-22WarningsExact identifier
application number: M017
TheraCare Roll-on Menthol 16% Pain Relief LiquidMENTHOLVeridian Healthcared932050d-2a9a-4a5e-b45d-0a7a864582e02025-09-22WarningsExact identifier
application number: M017
TheraCare Roll-on Menthol 4% Pain ReliefMENTHOLVeridian Healthcarefa121e5f-94b5-4c1d-9c4e-85bb8ede39452025-09-22WarningsExact identifier
application number: M017
Asper FlexLIDOCAINEAkron Pharma Inc.06ddae64-cda7-4eb9-872f-5182c83cb00c2025-09-19WarningsExact identifier
application number: M017
Good Neighbor Pain Relief Patch With Lidocaine 4%LIDOCAINEAmerisource Bergen5f5cc887-d479-4c9a-affc-49d0c331f7422025-09-18WarningsExact identifier
application number: M017
TheraCare Roll-on Lidocaine Pain Relief LiquidLIDOCAINE HCIVeridian Healthcaree942d447-754d-4683-9c99-57c7e83d7ea82025-09-18WarningsExact identifier
application number: M017
TheraCare Roll-on Lidocaine Pain Relief Liquid - LavenderLIDOCAINE HCIVeridian Healthcare6bebce76-30f6-4070-b0fe-58246d0713282025-09-18WarningsExact identifier
application number: M017
HealthWise Roll-On Lidocaine Pain Relief LiquidLIDOCAINE HCIVeridian Healthcare1133f6d4-f4c0-4ce9-e063-6394a90a5f4e2025-09-18WarningsExact identifier
application number: M017
InkKulture NumbingLIDOCAINE HCLProdigy Media Inc85a64315-dfa5-4f23-9f61-1cce694ea6bd2025-09-17WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1940367menthol 5 % / methyl salicylate 10 % Topical CreamPSN55c55f1c-d2b3-6363-e054-00144ff88e882
1940367menthol 50 MG/ML / methyl salicylate 100 MG/ML Topical CreamSCD55c55f1c-d2b3-6363-e054-00144ff88e882
1940367menthol 5 % / methyl salicylate 10 % Topical CreamSY55c55f1c-d2b3-6363-e054-00144ff88e882

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59118-837-01591180837011 TUBE in 1 BOX (59118-837-01) / 71 g in 1 TUBE1 tube2017-08-010000-00-00NoNoCurrent