FDA.reportPublic FDA data

Eagle

Product NDC
43405-009
Requested package NDC
43405-009-01
11-digit product format
434050009
Labeler code
43405
Product ID
43405-009_238a5d96-2706-118b-e063-6394a90adcf7
Type
HUMAN OTC DRUG
Nonproprietary name
Camphor Menthol Methyl Salicylate
Dosage form
OIL
Route
TOPICAL
Labeler
Borden Company (Private) Limited
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-06-15
Substance
CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE
Active strength
7; 16; 35 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 name suffix
Medicated Aromatic
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAMPHOR (SYNTHETIC)7 g/100mL
MENTHOL16 g/100mL
METHYL SALICYLATE35 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
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
36abfc2c-d424-4df8-968d-866342c96a56Available 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
43405-009-01EagleMedicated Aromatic1 in 1 BOXOIL17
43405-009-03EagleMedicated Aromatic3 mL in 1 BOTTLE, GLASSOIL37
43405-009-08EagleMedicated Aromatic1 in 1 BOXOIL17
43405-009-08EagleMedicated Aromatic8 mL in 1 BOTTLE, GLASSOIL87
43405-009-12EagleMedicated Aromatic12 mL in 1 BOTTLE, GLASSOIL127
43405-009-12EagleMedicated Aromatic1 in 1 BOXOIL17
43405-009-13EagleMedicated Aromatic1 in 1 BOXOIL17
43405-009-24EagleMedicated Aromatic24 mL in 1 BOTTLE, GLASSOIL247

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CAMPHOR (SYNTHETIC)ACTIVE INGREDIENT5TJD82A1ETEAGLE MEDICATED AROMATIC (CAMPHOR MENTHOL METHYL SALICYLATE) OIL [BORDEN COMPANY (PRIVATE) LIMITED ]1
MENTHOLACTIVE INGREDIENTL7T10EIP3AEAGLE MEDICATED AROMATIC (CAMPHOR MENTHOL METHYL SALICYLATE) OIL [BORDEN COMPANY (PRIVATE) LIMITED ]1
METHYL SALICYLATEACTIVE INGREDIENTLAV5U5022YEAGLE MEDICATED AROMATIC (CAMPHOR MENTHOL METHYL SALICYLATE) OIL [BORDEN COMPANY (PRIVATE) LIMITED ]1
CAMPHOR (SYNTHETIC)ACTIVE MOIETY5TJD82A1ETEAGLE MEDICATED AROMATIC (CAMPHOR MENTHOL METHYL SALICYLATE) OIL [BORDEN COMPANY (PRIVATE) LIMITED ]1
MENTHOLACTIVE MOIETYL7T10EIP3AEAGLE MEDICATED AROMATIC (CAMPHOR MENTHOL METHYL SALICYLATE) OIL [BORDEN COMPANY (PRIVATE) LIMITED ]1
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZEAGLE MEDICATED AROMATIC (CAMPHOR MENTHOL METHYL SALICYLATE) OIL [BORDEN COMPANY (PRIVATE) LIMITED ]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MEAGLE MEDICATED AROMATIC (CAMPHOR MENTHOL METHYL SALICYLATE) OIL [BORDEN COMPANY (PRIVATE) LIMITED ]1
EUCALYPTUS OILINACTIVE INGREDIENT2R04ONI662EAGLE MEDICATED AROMATIC (CAMPHOR MENTHOL METHYL SALICYLATE) OIL [BORDEN COMPANY (PRIVATE) LIMITED ]1
LIGHT MINERAL OILINACTIVE INGREDIENTN6K5787QVPEAGLE MEDICATED AROMATIC (CAMPHOR MENTHOL METHYL SALICYLATE) OIL [BORDEN COMPANY (PRIVATE) LIMITED ]1
SPIKE LAVENDER OILINACTIVE INGREDIENT7S2HYV1VJQEAGLE MEDICATED AROMATIC (CAMPHOR MENTHOL METHYL SALICYLATE) OIL [BORDEN COMPANY (PRIVATE) LIMITED ]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43405-009EAGLE MEDICATED AROMATIC (CAMPHOR MENTHOL METHYL SALICYLATE) OIL [BORDEN COMPANY (PRIVATE) LIMITED]7Current NDC, Legacy NDC, 8 package rows20241004_36abfc2c-d424-4df8-968d-866342c96a56.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 78 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lidocaine-Pain-Relief-PatchLIDOCAINE-PAIN-RELIEF-PATCHHenan Enokon Medical Instrument Co., Ltd.3ecfa867-50f6-d98a-e063-6394a90aefa02025-09-14WarningsExact identifier
application number: M017
Meijer Hydrocortsione CreamHYDROCORTSIONE CREAM 1%Meijer Distribution Inc.1cbddb7e-f2e3-0951-e063-6394a90a3d372025-09-12WarningsExact identifier
application number: M017
JO Prolonger with BenzocaineBENZOCAINECC Wellness LLCd955f612-1267-f1be-e053-2995a90a53452025-09-12WarningsExact identifier
application number: M017
JO for Him Prolonger with LidocaineLIDOCAINECC Wellness LLCb12dc6a3-142d-3219-e053-2995a90aead02025-09-12WarningsExact identifier
application number: M017
Walgreens Medicated Foot PowderMENTHOLDavion, Inc58e1e7f7-6284-411f-9765-0e63eabca0f32025-09-12WarningsExact identifier
application number: M017
PAIN RELIEF PATCHESLIDOCAINEAmerisource Bergen614f1e56-891f-4620-be10-0c075a1dbc3f2025-09-11WarningsExact identifier
application number: M017
Industrial Itch and Pain ReliefDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATER & R Lotion, Inc236415fc-f923-4a82-b54a-ecaf666dd2e02025-09-11WarningsExact identifier
application number: M017
Eco Lips Menthol Medicated Lip BalmMENTHOLEco Lips, Inc.fc4c25d6-6109-dfd8-e053-6394a90a4e912025-09-10WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONE 1%Encube Ethicals, Inc.d6f5c0df-6262-4704-bb24-430f66bb2ca82025-09-09WarningsExact identifier
application number: M017
Blue-Emu Lidocaine Pain Relief CreamLIDOCAINE CREAM 4%Kingsway Pharmaceuticals dba NFI, LLC592811f2-e21c-6a58-e053-2991aa0a69a92025-09-09WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONEUnifirst First Aid Corporation282ed5ef-8c2a-4092-9d99-1a7eee7a39e32025-09-09WarningsExact identifier
application number: M017
LubeLife Climax Control DelayBENZOCAINECC Wellness LLCe1a98e6d-0c24-75b8-e053-2a95a90ad1362025-09-09WarningsExact identifier
application number: M017
Blue-Emu Maximum Pain ReliefTROLAMINE SALICYLATEKingsway Pharmaceuticals dba NFI, LLCc863351a-951b-4f7c-a9c0-4289d702054a2025-09-09WarningsExact identifier
application number: M017
Tiger Balm Neck and Shoulder RubCAMPHOR (SYNTHETIC) AND MENTHOLHaw Par Healthcare Ltd.02a65b25-78b2-4e29-9484-40e2228fb3842025-09-09WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONEUnifirst First Aid Corporatione90df2e5-2ef4-47dd-bd74-be9cea6d9d852025-09-08WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONEUnifirst First Aid Corporation69d6645e-db3c-4dc0-a9a5-e2bc963e2f282025-09-08WarningsExact identifier
application number: M017
SupreH Arnica Bruise CreamSUPREH ARNICA REMEDY PLUS BRUISE CREAMShenzhen Xinxin Yunhai Technology Co., Ltd.3e41fc0e-54c3-2622-e063-6294a90a13c92025-09-07WarningsExact identifier
application number: M017
MentholMENTHOLFlexiGo Inc3607c326-6db0-a2cd-e063-6394a90a9eb62025-09-06WarningsExact identifier
application number: M017
TIDL PAIN RELIEF CRYOTHERAPY MENTHOL CreamPAIN RELIEF CRYOTHERAPY MENTHOL CREAMShenzhen Sam Technology Co., Ltd.3e08cc87-2385-0838-e063-6394a90abf9b2025-09-05WarningsExact identifier
application number: M017
TIDL CLINICAL CRYOTHERAPY MENTHOL CreamCLINICAL CRYOTHERAPY MENTHOL CREAMShenzhen Sam Technology Co., Ltd.3e090b98-1db7-4174-e063-6394a90aa5392025-09-05WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1654728camphor 7 % / menthol 16 % / methyl salicylate 35 % Topical OilPSN36abfc2c-d424-4df8-968d-866342c96a567
1654728camphor 70 MG/ML / menthol 160 MG/ML / methyl salicylate 350 MG/ML Topical OilSCD36abfc2c-d424-4df8-968d-866342c96a567
1654728camphor 7 % / menthol 16 % / methyl salicylate 35 % Topical OilSY36abfc2c-d424-4df8-968d-866342c96a567

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43405-009-01434050009011 BOTTLE, GLASS in 1 BOX (43405-009-01) / 24 mL in 1 BOTTLE, GLASS (43405-009-24) 2015-06-150000-00-00NoNoCurrent