FDA.reportPublic FDA data

JOSEPHS LION PAIN RELIEVING

Product NDC
55614-680
11-digit product format
556140680
Labeler code
55614
Product ID
55614-680_434702e8-8633-67e3-e063-6394a90a156d
Type
HUMAN OTC DRUG
Nonproprietary name
Camphor, Menthol, Methyl Salicylate
Dosage form
OIL
Route
TOPICAL
Labeler
MADISON ONE ACME INC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-06-04
Substance
CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE
Active strength
5; 8; 10 g/100mL; g/100mL; g/100mL
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
JOSEPHS LION PAIN RELIEVING
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAMPHOR (SYNTHETIC)5 g/100mL
MENTHOL8 g/100mL
METHYL SALICYLATE10 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5TJD82A1ETInternal 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
2372438Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
69b88e21-2001-4fb2-b6eb-17f2d6e0ef2eAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55614-680-01JOSEPHS LION PAIN RELIEVING1 in 1 BOXOIL13
55614-680-01JOSEPHS LION PAIN RELIEVING50 mL in 1 BOTTLE, GLASSOIL503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55614-680JOSEPHS LION PAIN RELIEVING (CAMPHOR, MENTHOL, METHYL SALICYLATE) OIL [MADISON ONE ACME INC]2Current NDC, Legacy NDC, 2 package rows20241127_69b88e21-2001-4fb2-b6eb-17f2d6e0ef2e.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 49 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Trauma LessMENTHOLNatures Formulae Health Products Ltd.781e94d5-1d34-7202-e053-2991aa0ae7682025-12-29WarningsExact identifier
application number: M017
Quality Choice Cold Therapy GelMENTHOLChain Drug Marketing Association, Inc.f9c659cd-e7fa-ac2d-e053-6294a90a25732025-12-29WarningsExact identifier
application number: M017
PAIN RELIEF PATCHESLIDOCAINEHarris Teeter5a0501e8-bc06-4e33-8db8-93b21a7151412025-12-29WarningsExact identifier
application number: M017
Hot and Cold Medicated PatchMENTHOLHarris Teeter9debd4ef-c21b-41ae-afd1-58f47c51c99c2025-12-29WarningsExact identifier
application number: M017
Maximum OTC Strength Feminine Anti-Itch CremeBENZOCAINE, RESORCINOLQuality Choice (CHAIN DRUG MARKETING ASSOCIATION)0e9a711c-ddf4-af63-e063-6294a90a0ebe2025-12-29WarningsExact identifier
application number: M017
Pain Relief PatchesCAMPHOR, MENTHOL, METHYL SALICYLATEHarris Teeter3f5b4eee-49c4-408c-9af2-e7924c26ac632025-12-29WarningsExact identifier
application number: M017
talc-free medicated bodyMENTHOLDavion, Inc27b9b4dc-4d4f-4e9d-b388-a7c6807a0e9b2025-12-29WarningsExact identifier
application number: M017
H-E-B Medicated Corn Starch Foot PowderMENTHOLDavion, Inca6675e00-bc6b-4466-a283-4cece5f919702025-12-29WarningsExact identifier
application number: M017
Maximum Strength Medicated Foot PowderMENTHOLDavion, Inc7b442d99-ac19-4f65-828d-954c5350ef5a2025-12-29WarningsExact identifier
application number: M017
HEB Medicated Cornstarch Body PowderMENTHOLDavion, Incdf1331fb-48df-4f21-8564-0468078fd12d2025-12-29WarningsExact identifier
application number: M017
Honest Med Capsaicin PatchCAPSAICINProper Buys LLC30169d44-b1b2-5c0f-e063-6294a90ae1592025-12-28WarningsExact identifier
application number: M017
Honest Med Lidocaine Lavender Roll-onLIDOCAINE HCLProper Buys LLC2dcd40a9-3fdd-a71e-e063-6294a90a704f2025-12-28WarningsExact identifier
application number: M017
Honest Med Lidocaine Pain Relief PatchLIDOCAINEProper Buys LLC13a5243f-7116-e4da-e063-6394a90aa5432025-12-28WarningsExact identifier
application number: M017
CVS Health Pain-Relieving PatchMENTHOL, METHYL SALICYLATE, CAMPHORCVS Pharmacy, Inc.1f90899c-eeca-2362-e063-6294a90aa0da2025-12-28WarningsExact identifier
application number: M017
CVS Health Cooling PatchMENTHOLCVS Pharmacy, Inc1f90cefe-bcce-5e17-e063-6294a90a57362025-12-28WarningsExact identifier
application number: M017
Point Relief LidoSpot with MentholLIDOCAINE, MENTHOLFabrication Enterprisesf0c69693-bfea-4006-9620-63b222d25d382025-12-28WarningsExact identifier
application number: M017
DISCOUNT DRUG MART PAIN RELIEF PATCHESLIDOCAINEDiscount Drug Mart, Ince36e7d0a-d554-4601-b535-b41ee84a6b242025-12-28WarningsExact identifier
application number: M017
Medicated Pain Relief PatchesCAMPHOR, MENTHOL, METHYL SALICYLATEDiscount Drug Mart, Incc01e1a14-bfbc-4c52-8a67-b77acf2d88532025-12-28WarningsExact identifier
application number: M017
TopCare Pain Relief PatchLIDOCAINE, MENTHOLTopco Associates LLCd4c89c4f-d69a-7786-e053-2995a90a71e72025-12-28WarningsExact identifier
application number: M017
Kroger Lidocaine Pain RelievingLIDOCAINE HCLKroger Company12d94ba6-56ac-3816-e063-6394a90a44c62025-12-28WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2372438camphor 5 % / menthol 8 % / methyl salicylate 10 % Topical OilPSN69b88e21-2001-4fb2-b6eb-17f2d6e0ef2e3
2372438camphor 50 MG/ML / menthol 80 MG/ML / methyl salicylate 100 MG/ML Topical OilSCD69b88e21-2001-4fb2-b6eb-17f2d6e0ef2e3
2372438camphor 5 % / menthol 8 % / methyl salicylate 10 % Topical OilSY69b88e21-2001-4fb2-b6eb-17f2d6e0ef2e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55614-680-01556140680011 BOTTLE, GLASS in 1 BOX (55614-680-01) / 50 mL in 1 BOTTLE, GLASS2020-06-040000-00-00NoNoCurrent