FDA.reportPublic FDA data

Eagle Brand

Product NDC
60954-015
11-digit product format
609540015
Labeler code
60954
Product ID
60954-015_1bc1f58b-341c-384b-e063-6394a90ab995
Type
HUMAN OTC DRUG
Nonproprietary name
menthol, methyl salicylate
Dosage form
OIL
Route
TOPICAL
Labeler
PT. EAGLE INDO PHARMA
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-06-24
Substance
METHYL SALICYLATE; MENTHOL
Active strength
30; 14.5 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
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYL SALICYLATE30 g/100mL
MENTHOL14.5 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1293430Internal RxNorm lookup
1293435Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1bc1bf83-91ee-ec9d-e063-6394a90a3dafAvailable 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
60954-015-24Eagle BrandMedicated Oil24 mL in 1 BOTTLE, GLASSOIL241
60954-015-24Eagle BrandMedicated Oil1 in 1 BOXOIL11
60954-015-36Eagle BrandMedicated Oil1 in 1 BOXOIL11
60954-015-36Eagle BrandMedicated Oil36 mL in 1 BOTTLE, GLASSOIL361

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60954-015EAGLE BRAND MEDICATED OIL (MENTHOL, METHYL SALICYLATE) OIL [PT. EAGLE INDO PHARMA]1Current NDC, 4 package rows20240627_1bc1bf83-91ee-ec9d-e063-6394a90a3daf.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 85 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PROINNATE Numbing CreamMENTHOLGuangzhou Haishi Biological Technology Co., Ltd.39688b2b-c1fe-cd86-e063-6394a90a53452025-07-16WarningsExact identifier
application number: M017
Methyl SalicylateMETHYL SALICYLATEViolaCare, Inc.8f0ba6e7-8aa4-443e-99ae-a255085ddfec2025-07-15WarningsExact identifier
application number: M017
TopCare Hydrocortisone Intensive Healing FormulaHYDROCORTISONETopco Associates LLC7daafc44-e2a4-4f1b-bfca-3309a8e9a9202025-07-15WarningsExact identifier
application number: M017
Hydrocortisone Plus 12 MoisturizersHYDROCORTISONETARGET Corporation72c3889c-b743-4728-a315-6e4063e002002025-07-15WarningsExact identifier
application number: M017
Shopko Hydrocortisone Maximum StrengthHYDROCORTISONEShopko Stores Operating Co., LLC0431a6af-4c9a-4bbd-a535-cba31a5e53cc2025-07-15WarningsExact identifier
application number: M017
Freds Hydrocortisone with AloeHYDROCORTISONEFRED'S, INC.076503bf-8238-4739-bb1c-c385e72f8a962025-07-15WarningsExact identifier
application number: M017
Shopko HydrocortisoneHYDROCORTISONEShopko Stores Operating Co., LLC92bcbde3-401a-4301-854e-c352852317d62025-07-15WarningsExact identifier
application number: M017
TopCare HydrocortisoneHYDROCORTISONETopco Associates LLCbd3585fa-3b48-49b7-8ad1-749bf1e31ed52025-07-15WarningsExact identifier
application number: M017
Methyl Salicylate 25% Pain RelievingMETHYL SALICYLATEPuretek Corporation376797ff-cf13-a3c6-e063-6394a90a9de12025-07-15WarningsExact identifier
application number: M017
TIGER BALM PAIN RELIEVINGCAMPHOR (SYNTHETIC), LEVOMENTHOL, AND CAPSICUMHaw Par Healthcare Ltd.440e97bc-bd97-4733-9955-643b18e7fb182025-07-15WarningsExact identifier
application number: M017
Tiger Balm Pain Relieving Hydrogel LargeCAMPHOR (SYNTHETIC), LEVOMENTHOL, AND CAPSICUMHaw Par Healthcare Ltd.064d04ca-184d-492b-867c-beaa165ab3e02025-07-14WarningsExact identifier
application number: M017
Methyl Salicylate 25% CreamMETHYL SALICYLATEMedcore LLC143f76bf-2de4-466a-8a6b-d6ab6314a2c32025-07-14WarningsExact identifier
application number: M017
BLUESPRING Doctors Pain Formula Pain ReliefMENTHOLACA MANAGEMENT LLC98f3f719-792f-4a93-95b1-90072e0f8bf42025-07-14WarningsExact identifier
application number: M017
Shopko Anti-ItchDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATEShopko Stores Operating Co., LLC130119eb-b87e-4a07-8d2a-317369bfa5412025-07-14WarningsExact identifier
application number: M017
Equate Hydrocortisone Intensive Healing FormulaHYDROCORTISONEWal-Mart Stores Inc.635b49c4-54d2-4b6d-bee8-851fc2c7ca9c2025-07-14WarningsExact identifier
application number: M017
ULTRA STRENGTH ZHENG GU SHUIMENTHOL AND CAMPHORGUANGXI YULIN PHARMACEUTICAL GROUP CO LTD53397663-044d-4e48-989b-2c6257af5f842025-07-14Warnings, Adverse reactionsExact identifier
application number: M017
TIGER BALM PAIN RELIEVING HYDROGELCAMPHOR (SYNTHETIC), LEVOMENTHOL, AND CAPSICUMHaw Par Healthcare Ltd.cb60037f-bceb-4090-a5e4-bdda0cbf9f5c2025-07-14WarningsExact identifier
application number: M017
Avedana Hydrocortisone Cream with AloeHYDROCORTISONEUnipack LLC2a55c426-39b4-4d94-b6b4-6c548c9685e92025-07-13WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONE ACETATERite Aid Corporationcb6e0bed-2ea1-49d2-89e7-2554e7565b742025-07-11WarningsExact identifier
application number: M017
QUALITY CHOICE Maximum Strength Lidocaine Pain Relief Roll OnLIDOCAINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION7b3ff4c1-0b60-4f7a-8aa4-c84b7c7137c42025-07-11WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1293435EAGLE BRAND Medicated 14.5 % / 30 % Topical OilPSN1bc1bf83-91ee-ec9d-e063-6394a90a3daf1
1293430menthol 14.5 % / methyl salicylate 30 % Topical OilPSN1bc1bf83-91ee-ec9d-e063-6394a90a3daf1
1293435menthol 145 MG/ML / methyl salicylate 300 MG/ML Topical Oil [Eagle Brand Medicated Oil]SBD1bc1bf83-91ee-ec9d-e063-6394a90a3daf1
1293430menthol 145 MG/ML / methyl salicylate 300 MG/ML Topical OilSCD1bc1bf83-91ee-ec9d-e063-6394a90a3daf1
1293435Eagle Brand Medicated Oil (menthol 14.5 % / methyl salicylate 30 % ) Topical OilSY1bc1bf83-91ee-ec9d-e063-6394a90a3daf1
1293435Eagle Brand Medicated Oil (menthol 14.5 GM / methyl salicylate 30 GM per 100 ML) Topical OilSY1bc1bf83-91ee-ec9d-e063-6394a90a3daf1
1293430menthol 14.5 % / methyl salicylate 30 % Topical OilSY1bc1bf83-91ee-ec9d-e063-6394a90a3daf1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
60954-015-24609540015241 BOTTLE, GLASS in 1 BOX (60954-015-24) / 24 mL in 1 BOTTLE, GLASS2024-06-24NoNoCurrent
60954-015-36609540015361 BOTTLE, GLASS in 1 BOX (60954-015-36) / 36 mL in 1 BOTTLE, GLASS2024-06-24NoNoCurrent