FDA.reportPublic FDA data

Muscular Balm

Product NDC
43405-007
11-digit product format
434050007
Labeler code
43405
Product ID
43405-007_2621e308-8117-7240-e063-6294a90a44ea
Type
HUMAN OTC DRUG
Nonproprietary name
Capsaicin Menthol Methyl Salicylate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Borden Company (Private) Limited
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2010-05-14
Substance
CAPSAICIN; MENTHOL; METHYL SALICYLATE
Active strength
.15; 13.5; 30 g/100g; g/100g; g/100g
NDC exclude flag
No
Listing certified through
2027-12-31
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
Muscular Balm
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAPSAICIN.15 g/100g
MENTHOL13.5 g/100g
METHYL SALICYLATE30 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
S07O44R1ZMInternal UNII lookup
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
1045385Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ed79f14e-6b3d-4bf2-9c34-d019c1ba2582Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43405-007-01Muscular Balm1 in 1 BOXOINTMENT15
43405-007-20Muscular Balm20 g in 1 JAROINTMENT205

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CapsaicinACTIVE INGREDIENTS07O44R1ZMMUSCULAR BALM (CAPSAICIN MENTHOL METHYL SALICYLATE) OINTMENT [BORDEN COMPANY (PRIVATE) LIMITED ]2
MentholACTIVE INGREDIENTL7T10EIP3AMUSCULAR BALM (CAPSAICIN MENTHOL METHYL SALICYLATE) OINTMENT [BORDEN COMPANY (PRIVATE) LIMITED ]2
Methyl SalicylateACTIVE INGREDIENTLAV5U5022YMUSCULAR BALM (CAPSAICIN MENTHOL METHYL SALICYLATE) OINTMENT [BORDEN COMPANY (PRIVATE) LIMITED ]2
CapsaicinACTIVE MOIETYS07O44R1ZMMUSCULAR BALM (CAPSAICIN MENTHOL METHYL SALICYLATE) OINTMENT [BORDEN COMPANY (PRIVATE) LIMITED ]2
MentholACTIVE MOIETYL7T10EIP3AMUSCULAR BALM (CAPSAICIN MENTHOL METHYL SALICYLATE) OINTMENT [BORDEN COMPANY (PRIVATE) LIMITED ]2
Methyl SalicylateACTIVE MOIETYLAV5U5022YMUSCULAR BALM (CAPSAICIN MENTHOL METHYL SALICYLATE) OINTMENT [BORDEN COMPANY (PRIVATE) LIMITED ]2
EucalyptolINACTIVE INGREDIENTRV6J6604TKMUSCULAR BALM (CAPSAICIN MENTHOL METHYL SALICYLATE) OINTMENT [BORDEN COMPANY (PRIVATE) LIMITED ]2
ParaffinINACTIVE INGREDIENTI9O0E3H2ZEMUSCULAR BALM (CAPSAICIN MENTHOL METHYL SALICYLATE) OINTMENT [BORDEN COMPANY (PRIVATE) LIMITED ]2
PetrolatumINACTIVE INGREDIENT4T6H12BN9UMUSCULAR BALM (CAPSAICIN MENTHOL METHYL SALICYLATE) OINTMENT [BORDEN COMPANY (PRIVATE) LIMITED ]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43405-007MUSCULAR BALM (CAPSAICIN MENTHOL METHYL SALICYLATE) OINTMENT [BORDEN COMPANY (PRIVATE) LIMITED]5Current NDC, Legacy NDC, 2 package rows20241106_ed79f14e-6b3d-4bf2-9c34-d019c1ba2582.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 29 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dr.Harry COMFORT ZONE CreamLIDOCAINE 4% PHENYLEPHRINE HCL 0.25% COMFORT ZONE CREAMJiangxi Yudexi Pharmaceutical Co., LTD4d32b89f-72e8-bc93-e063-6394a90a0bc82026-03-17WarningsExact identifier
application number: M017
MiloRod Ultra Muscle Rub Fast-Acting Pain ReliefCAPSAICIN, MENTHOLMilo Rod Import & Export, Inc.c3622dc3-0c05-47c9-b70b-4989467819062026-03-17WarningsExact identifier
application number: M017
Walgreens Burn PadBURN PADWalgreens3f8d7624-cf1e-1992-e063-6294a90a38062026-03-17Boxed warning, WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONEMericon Industries8f351b04-8f6d-4353-9100-13a8a80d656a2026-03-17WarningsExact identifier
application number: M017
Shoe Pain ReliefLIDOCAINE HCI 4%Sole Amie0f2ccd5f-b9f4-40fc-b82f-173b0f19bf402026-03-16WarningsExact identifier
application number: M017
CVS Muscle BalmMENTHOL, CAMPHORCVS Health42796fc4-03be-3b02-e063-6394a90af2ab2026-03-16WarningsExact identifier
application number: M017
Crane Safety HydrocortisoneHYDROCORTISONECrane Safety LLC96d9527d-9bf7-ce82-e053-2995a90aff0c2026-03-16WarningsExact identifier
application number: M017
CVS Health Pain Relief FootMENTHOL, UNSPECIFIED FORMNATURAL ESSENTIALS, INC.0f646876-69d0-49db-ade2-2b3eb26dd3992026-03-16WarningsExact identifier
application number: M017
Walgreens Cold Therapy Pain Relief Foot CreamMENTHOLWalgreen Co.3bc8ece3-d555-3efb-e063-6394a90a19812026-03-16WarningsExact identifier
application number: M017
RICHTOFIT RAPID ACTIVE LEG AND FOOTMENTHOLRICHTOFIT LIMITED LIABILITY COMPANY4c357696-ca96-e6ad-e063-6294a90aaadb2026-03-16WarningsExact identifier
application number: M017
Xpect Stopain ClinicalMENTHOLCintas Corporation348e6062-b31e-435e-a153-6aa868b50efa2026-03-13WarningsExact identifier
application number: M017
DGH GREASELESS MUSCLE RUB ANALGESICMENTHOL, UNSPECIFIED FORM AND METHYL SALICYLATEDOLLAR GENERAL225abfe0-ec72-4667-96b2-7657e989672b2026-03-13WarningsExact identifier
application number: M017
CVS Professional Pain ReliefMENTHOLCVS Pharmacy48836a5b-0baa-b7ee-e063-6294a90ac12b2026-03-13WarningsExact identifier
application number: M017
Keeps Climax DelayLIDOCAINE HYDROCHLORIDECosco International, Inc.3bfd3173-2dac-40a9-aec3-982b1d47d8fa2026-03-12WarningsExact identifier
application number: M017
NanoX Pain RelievingMENTHOL, METHYL SALICYLATEMG Science Technologies LLC4cc38927-8a8c-2df3-e063-6294a90aa0c12026-03-12WarningsExact identifier
application number: M017
Hand SanitizerALCOHOLProStat First Aid4cd4c51c-88bb-3797-e063-6294a90a8f702026-03-12WarningsExact identifier
application number: M017
CVS Lidocaine Pain ReliefLIDOCAINE HYDROCHLORIDE, MENTHOLCVS Pharmacy48c045ae-56b5-62c2-e063-6394a90aaf442026-03-12WarningsExact identifier
application number: M017
Hydrocortisone 1%HYDROCORTISONEProStat First Aid4cd62cba-075a-7448-e063-6394a90ab48d2026-03-12WarningsExact identifier
application number: M017
Medicated Pain Relief PatchCAMPHOR, MENTHOL, METHYL SALICYLATEKroger Company47cc4b05-a937-4624-bf41-85b8bd7c049e2026-03-12WarningsExact identifier
application number: M017
Lidocaine HCLLIDOCAINE HCLMatthias Therapeutics, LLC4cdb27b5-9178-0328-e063-6394a90a50b52026-03-12WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1045385capsaicin 0.15 % / menthol 13.5 % / methyl salicylate 30 % Topical OintmentPSNed79f14e-6b3d-4bf2-9c34-d019c1ba25825
1045385capsaicin 0.0015 MG/MG / menthol 0.135 MG/MG / methyl salicylate 0.3 MG/MG Topical OintmentSCDed79f14e-6b3d-4bf2-9c34-d019c1ba25825
1045385capsaicin 0.15 % / menthol 13.5 % / methyl salicylate 30 % Topical OintmentSYed79f14e-6b3d-4bf2-9c34-d019c1ba25825

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43405-007-01434050007011 JAR in 1 BOX (43405-007-01) / 20 g in 1 JAR (43405-007-20) 1 jar2010-05-140000-00-00NoNoCurrent
43405-007-204340500072020 g in 1 JAR20 gHistorical