FDA.reportPublic FDA data

Eagle Brand

Product NDC
60954-013
11-digit product format
609540013
Labeler code
60954
Product ID
60954-013_507281fd-2f32-d36a-e063-6394a90acf3d
Type
HUMAN OTC DRUG
Nonproprietary name
camphor, menthol
Dosage form
OIL
Route
TOPICAL
Labeler
PT. EAGLE INDO PHARMA
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-11-02
Substance
MENTHOL; CAMPHOR (SYNTHETIC)
Active strength
14; 2.2 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 Refresh
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL14 g/100mL
CAMPHOR (SYNTHETIC)2.2 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L7T10EIP3AInternal 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
2672336Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
09260c31-56a3-07aa-e063-6394a90a95fdAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60954-013-24Eagle BrandMedicated Oil Refresh1 in 1 BOXOIL14
60954-013-24Eagle BrandMedicated Oil Refresh24 mL in 1 BOTTLE, GLASSOIL244
60954-013-36Eagle BrandMedicated Oil Refresh36 mL in 1 BOTTLE, GLASSOIL364
60954-013-36Eagle BrandMedicated Oil Refresh1 in 1 BOXOIL14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60954-013EAGLE BRAND MEDICATED OIL REFRESH (CAMPHOR, MENTHOL) OIL [PT. EAGLE INDO PHARMA]3Current NDC, 4 package rows20240120_09260c31-56a3-07aa-e063-6394a90a95fd.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 30 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RICHTOFIT RAPID ACTIVE ARTHRITISMENTHOL AND CAMPHORRICHTOFIT LIMITED LIABILITY COMPANY4b1cdab1-3e50-4ec3-e063-6394a90af75e2026-03-12WarningsExact identifier
application number: M017
5Kind DMSO 4 Lidocaine HCl Pain RelievingLIDOCAINE HYDROCHLORIDE, MENTHOL5KIND TRADING LTD67d8d045-7fa0-46c2-8072-645d8823903b2026-03-11WarningsExact identifier
application number: M017
Rapid ReliefPAIN RELIEF PATCH LIDOCAINE 4%RAPID AID VIET NAM COMPANY LIMITED4ca541b4-7afe-77c5-e063-6294a90ad6922026-03-10WarningsExact identifier
application number: M017
Lidocaine Cream, 4%LIDOCAINEIPG PHARMACEUTICALS, INC.7775bfdd-7eac-4f09-b83f-fc4a16a245582026-03-10WarningsExact identifier
application number: M017
MENTHOL, CAMPHORMENTHOL, CAMPHORCHEMCO CORPORATION4c989283-9a27-e8d2-e063-6294a90a8bfa2026-03-09WarningsExact identifier
application number: M017
Prequel Anti-Itch Solution Medicated CalmingMEDICATED CALMING LOTIONThe Center Brands, LLC419fa45b-992b-676e-e063-6394a90add812026-03-09WarningsExact identifier
application number: M017
Careland Lidocaine 4 Plus Menthol Pain Relieving Gel Patches for back, neck shoulders knees and elbows with borderLIDOCAINE, MENTHOLPlanet (Anhui) Pharmaceutical Co., Ltd.1fda69f7-2bb6-42fc-bcef-677e7b3d7f012026-03-09WarningsExact identifier
application number: M017
Careland Lidocaine 4 plus menthol pain relieving gel-patches with border for kneeMENTHOL, LAUROCAPRAMPlanet (Anhui) Pharmaceutical Co., Ltd.7577625c-87eb-4639-aeab-8a2ab97033fd2026-03-09WarningsExact identifier
application number: M017
Careland Lidocaine Pain RelievingLIDOCAINEPlanet (Anhui) Pharmaceutical Co., Ltd.7de99b81-b3b3-49f1-8aa7-2ff42e1b46a42026-03-09WarningsExact identifier
application number: M017
Rapid ReliefPAIN RELIEF PATCH LIDOCAINE 4%RAPID AID VIET NAM COMPANY LIMITED4ca35030-958c-8f62-e063-6294a90a4d632026-03-09WarningsExact identifier
application number: M017
Welmate Lidocaine Pain Relieving PatchLIDOCAINEYYBA Corpcff71b75-fc4e-29ac-e053-2995a90abd502026-03-06WarningsExact identifier
application number: M017
Heal and Rescue Bunion Pain ReliefLIDOCAINE HCL, MENTHOLRooftop Consumer Health, Inc4c60d4d3-e0a9-6f93-e063-6394a90a16af2026-03-06WarningsExact identifier
application number: M017
JUST CBD - PAIN RELIEFMENTHOL, CAMPHORJust Brands LLC4c493c0b-c58e-cb56-e063-6394a90a93952026-03-05WarningsExact identifier
application number: M017
Hug a BooBoo Medicated booboo WipesBENZOCAINELights Medical Manufacture Co., Ltd.509aaafc-2ef7-4205-818c-7ff5b146e1592026-03-04WarningsExact identifier
application number: M017
CVS Foot PainLIDOCAINE HYDROCHLORIDECVS Pharmacy4c3350c3-2e3e-093c-e063-6394a90a34752026-03-04WarningsExact identifier
application number: M017
Game On SportMENTHOLNatural Essentials, Inc4c3411dc-5378-bd93-e063-6394a90a84062026-03-04WarningsExact identifier
application number: M017
Hydrocortisone 1%HYDROCORTISONETrifecta Pharmaceuticals Usa Llcf4d4a56b-b4b7-9a07-e053-2a95a90ad8532026-03-04WarningsExact identifier
application number: M017
Hydrocortisone 1%HYDROCORTISONETrifecta Pharmaceuticals Usa Llc9987165c-1a0f-dd57-e053-2a95a90ae7352026-03-04WarningsExact identifier
application number: M017
Walgreens Unscented Pain RelievingLIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOLWalgreen Co.41eadb4f-2ca5-42a1-e063-6294a90ab4e22026-03-04WarningsExact identifier
application number: M017
Careland Pain Relief Patch PlusLIDOCAINEPlanet (Anhui) Pharmaceutical Co., Ltd.d55d8a9e-ed2b-4c9b-9ecb-6ec1fd43c9e32026-03-04WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2672336camphor 2.2 % / menthol 14 % Topical OilPSN09260c31-56a3-07aa-e063-6394a90a95fd4
2672336camphor 22 MG/ML / menthol 140 MG/ML Topical OilSCD09260c31-56a3-07aa-e063-6394a90a95fd4
2672336camphor 2.2 % / menthol 14 % Topical OilSY09260c31-56a3-07aa-e063-6394a90a95fd4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
60954-013-24609540013241 BOTTLE, GLASS in 1 BOX (60954-013-24) / 24 mL in 1 BOTTLE, GLASS2023-11-02NoNoCurrent
60954-013-36609540013361 BOTTLE, GLASS in 1 BOX (60954-013-36) / 36 mL in 1 BOTTLE, GLASS2023-11-02NoNoCurrent