FDA.reportPublic FDA data

Muscular Balm

Product NDC
43405-007
Requested package NDC
43405-007-01
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 72 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Family Care Anti-ItchHYDROCORTISONEUnited Exchange Corp.8e4d46d8-7084-0666-e053-2995a90ad5202025-10-21WarningsExact identifier
application number: M017
Coralite Pain ReliefCAMPHOR, MENTHOL, METHYL SALICYLATEUnited Exchange Corp.69aec845-3d4c-d226-e053-2991aa0afd122025-10-21WarningsExact identifier
application number: M017
WHITE FLOWER ANALGESIC BALMCAMPHOR, MENTHOL AND METHYL SALICYLATEHOE HIN PAK FAH YEOW MANUFACTORY LTDf3e3b8b5-b12b-49ac-9318-b0c358b136e92025-10-21WarningsExact identifier
application number: M017
Mountain Ice Sports RecoveryMENTHOLMountainside Medical Equipment, Inc.98638529-3c17-436e-901f-c8aea52bdab62025-10-20WarningsExact identifier
application number: M017
Lip Clear Lysine PlusMENTHOL, UNSPECIFIED FORMQuantum, Inc.21a5b4fb-baed-4766-9820-5c6051c147202025-10-20WarningsExact identifier
application number: M017
Buzz Away Sting SootheMENTHOLQuantum, Inc.419e34ea-17b2-ec32-e063-6394a90a603d2025-10-20WarningsExact identifier
application number: M017
Family Care Anti-ItchHYDROCORTISONEUnited Exchange Corp.deb09e89-9794-89a7-e053-2a95a90abdf82025-10-20WarningsExact identifier
application number: M017
Numbing CreamMENTHOLFlexiGo Inc41571c8f-332b-f423-e063-6394a90a88972025-10-20WarningsExact identifier
application number: M017
Soothing Nerve TherapyMENTHOLWise Consumer Products40829d6b-5005-7ec9-e063-6294a90a970e2025-10-20WarningsExact identifier
application number: M017
Numbing CreamMENTHOLFlexiGo Inc4146fd51-b18c-393d-e063-6294a90a4d9a2025-10-20WarningsExact identifier
application number: M017
Lidocaine 4% Maximum OTC StrengthLIDOCAINECardinal Health 107, LLC975031df-d46d-4098-b1c0-1c0c92b419952025-10-20WarningsExact identifier
application number: M017
Cortizone 10 Intensive HealingHYDROCORTISONEChattem, Inc.bb3d1a3e-4c0c-4694-9c05-80152dd9bd1c2025-10-20WarningsExact identifier
application number: M017
Sting relief padBENZOCAINE, ALCOHOLGuangdong Comfort Medical Products Co., Ltd.6e905065-10a9-1ded-e053-2a91aa0a46a12025-10-19WarningsExact identifier
application number: M017
CVS Cold and HotMENTHOLCVS Pharmacya44cec95-822a-40b6-e053-2995a90ae31c2025-10-17WarningsExact identifier
application number: M017
Sombra MaxSOMBRA MAXSombra Cosmetics Inc.41623a46-e6e7-907e-e063-6394a90afc4c2025-10-17WarningsExact identifier
application number: M017
POMADA DRAGON PAIN RELIEVINGCAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATETELEVISA CONSUMER PRODUCTS USAc283291d-feaa-4f89-8fde-9e3957ea8b9f2025-10-17WarningsExact identifier
application number: M017
Ear Pain MDLIDOCAINE HYDROCHLORIDEEosera Inc78c4418f-7f0f-447f-a94f-d4c89a081af12025-10-17WarningsExact identifier
application number: M017
WOFANLI Quit Smoking Nicotine PatchesNICOTINE TRANSDERMAL PATCHESShenzhen Paxi Trading Co., Ltd.414217c1-ff3a-b556-e063-6394a90aa5db2025-10-16WarningsExact identifier
application number: M017
WOFANLI Quit Smoking Nicotine PatchesNICOTINE TRANSDERMAL PATCHESShenzhen Paxi Trading Co., Ltd.41422d04-160b-51b2-e063-6294a90ab2b22025-10-16WarningsExact identifier
application number: M017
WOFANLI Quit Smoking Nicotine PatchesNICOTINE TRANSDERMAL PATCHESShenzhen Paxi Trading Co., Ltd.41427275-4c35-bbdf-e063-6294a90a14cf2025-10-16WarningsExact 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