FDA.reportPublic FDA data

Eagle Brand

Product NDC
60954-014
11-digit product format
609540014
Labeler code
60954
Product ID
60954-014_5071daf7-c363-4c64-e063-6294a90a80b4
Type
HUMAN OTC DRUG
Nonproprietary name
camphor, menthol, methyl salicylate
Dosage form
OIL
Route
TOPICAL
Labeler
PT. EAGLE INDO PHARMA
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-11-01
Substance
MENTHOL; METHYL SALICYLATE; CAMPHOR (SYNTHETIC)
Active strength
16; 35; 7 g/100mL; g/100mL; g/100mL
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
Eagle Brand
Brand name suffix
Medicated Oil Aromatic
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL16 g/100mL
METHYL SALICYLATE35 g/100mL
CAMPHOR (SYNTHETIC)7 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L7T10EIP3AInternal UNII lookup
LAV5U5022YInternal UNII lookup
5TJD82A1ETInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1654728Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0ef7c3aa-94a3-9fe9-e063-6394a90ab13dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60954-014-24Eagle BrandMedicated Oil Aromatic1 in 1 BOXOIL13
60954-014-24Eagle BrandMedicated Oil Aromatic24 mL in 1 BOTTLE, GLASSOIL243
60954-014-36Eagle BrandMedicated Oil Aromatic36 mL in 1 BOTTLE, GLASSOIL363
60954-014-36Eagle BrandMedicated Oil Aromatic1 in 1 BOXOIL13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60954-014EAGLE BRAND MEDICATED OIL AROMATIC (CAMPHOR, MENTHOL, METHYL SALICYLATE) OIL [PT. EAGLE INDO PHARMA]2Current NDC, 4 package rows20240515_0ef7c3aa-94a3-9fe9-e063-6394a90ab13d.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 95 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MUSCLEMENTHOLWATER-JEL TECHNOLOGIES1af399af-07b0-4899-9bcc-1e244b63b1cf2025-04-08WarningsExact identifier
application number: M017
Lidocaine with MentholLIDOCAINE HCL AND MENTHOLKareway Product, Inc.9ee46a5b-d00c-4254-e053-2995a90aeb3a2025-04-08WarningsExact identifier
application number: M017
Foster and Thrive Lidocaine Pain Relief PatchLIDOCAINE 4%Strategic Sourcing Services LLC324802c9-e2c2-bf74-e063-6394a90a86972025-04-08WarningsExact identifier
application number: M017
OARS AND ALPS MUSCLE RECOVERY BALMMENTHOL, METHYL SALICYLATECosco International, Inc8745802f-018d-4cf8-bbf3-3b04c8f545382025-04-08WarningsExact identifier
application number: M017
NOVUM APRMENTHOLNOVUM SOLUTIONS INC1b869a1f-5787-4d03-a546-43a8217b2b2c2025-04-07WarningsExact identifier
application number: M017
MAG 5 PT ROLL-ON PAIN RELIEF COOLINGMENTHOLRENU LABORATORIES, LLC31e4fa2c-3a98-d618-e063-6394a90aec1c2025-04-07WarningsExact identifier
application number: M017
RockSauce FIERY HOT PAIN RELIEFMETHYL SALICYLATE, MENTHOL, CAPSAICINImplus Footcare, LLCcc7cbf4a-8274-e463-e053-2995a90a51e02025-04-07WarningsExact identifier
application number: M017
RockSauce FIERY HOT PAIN RELIEFMETHYL SALICYLATE, MENTHOL, CAPSAICINImplus Footcare, LLCbdee018a-2c3c-3116-e053-2a95a90ac8d82025-04-07WarningsExact identifier
application number: M017
RockSauce FIERY HOT PAIN RELIEFMETHYL SALICYLATE, MENTHOL, CAPSAICINImplus Footcare, LLCbdee2b65-2759-0e62-e053-2a95a90a03782025-04-07WarningsExact identifier
application number: M017
RockSauce ICY COLD PAIN RELIEFMENTHOLImplus Footcare, LLCbdc7c7f3-ac98-8fe9-e053-2a95a90a26632025-04-07WarningsExact identifier
application number: M017
RockSauce ICY COLD PAIN RELIEFMENTHOLImplus Footcare, LLCbd4fdff1-9174-31c2-e053-2a95a90a749f2025-04-07WarningsExact identifier
application number: M017
GREEN GUARD Topical Pain ReliefLIDOCAINE HCIUltra Distributors Incb6f0041c-47fc-0bcd-e053-2a95a90ab1f92025-04-07WarningsExact identifier
application number: M017
CBD Clinic Pain Relief - Level 5MENTHOL, CAMPHORABACUS HEALTH PRODUCTS, INC.f0ebc1c6-93fb-efd6-e053-2995a90a25bb2025-04-07WarningsExact identifier
application number: M017
CBD Clinic Pain Relief - Level 4MENTHOL, CAMPHORABACUS HEALTH PRODUCTS, INC.f0e9ac7c-a840-2e05-e053-2a95a90a33f12025-04-07WarningsExact identifier
application number: M017
CBDMEDIC Active Sport Pain ReliefCAMPHOR AND MENTHOLABACUS HEALTH PRODUCTS, INC.f0ec5f47-2f8e-0558-e053-2a95a90aa7ca2025-04-07WarningsExact identifier
application number: M017
Hot Cold Medicated PatchesHOT COLD MEDICATED PATCHESHenan Enokon Medical Instrument Co., Ltd.159266a8-94fa-e2ff-e063-6394a90a9a772025-04-02WarningsExact identifier
application number: M017
Pain Relief PatchPAIN RELIEF PATCHHenan Enokon Medical Instrument Co., Ltd.1592d29d-e275-a44d-e063-6294a90ab17d2025-04-02WarningsExact identifier
application number: M017
JointflexCAMPHORStrides Consumer LLC766b73f2-67bd-4d5c-805c-1057b3981ebf2025-04-02WarningsExact identifier
application number: M017
Olu Pain ManagementLIDOCAINE AND CAMPHORAsclemed USA, Inc.d4d556c1-b64b-4b8e-8e4b-4f40eda242502025-04-01WarningsExact identifier
application number: M017
Hempvana Maximum Strength Pain Relief Cream 10% Trolamine SalicylateTROLAMINE SALICYLATETELEBRANDS CORP31ce185e-07b7-d837-e063-6394a90a1fb02025-04-01WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1654728camphor 7 % / menthol 16 % / methyl salicylate 35 % Topical OilPSN0ef7c3aa-94a3-9fe9-e063-6394a90ab13d3
1654728camphor 70 MG/ML / menthol 160 MG/ML / methyl salicylate 350 MG/ML Topical OilSCD0ef7c3aa-94a3-9fe9-e063-6394a90ab13d3
1654728camphor 7 % / menthol 16 % / methyl salicylate 35 % Topical OilSY0ef7c3aa-94a3-9fe9-e063-6394a90ab13d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
60954-014-24609540014241 BOTTLE, GLASS in 1 BOX (60954-014-24) / 24 mL in 1 BOTTLE, GLASS2023-11-01NoNoCurrent
60954-014-36609540014361 BOTTLE, GLASS in 1 BOX (60954-014-36) / 36 mL in 1 BOTTLE, GLASS2023-11-01NoNoCurrent