Eagle Brand

Product NDC
60954-012
11-digit product format
609540012
Labeler code
60954
Product ID
60954-012_507b9495-e9a3-7fba-e063-6394a90a8d84
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
2023-11-01
Substance
CAMPHOR (SYNTHETIC); MENTHOL
Active strength
2.2; 14 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 Roll On Refresh
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5TJD82A1ETInternal UNII lookup
L7T10EIP3AInternal 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
09235f26-2262-6ca2-e063-6394a90ad8f1Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60954-012-08Eagle BrandMedicated Roll On Refresh1 in 1 BOXOIL12
60954-012-08Eagle BrandMedicated Roll On Refresh8 mL in 1 BOTTLE, GLASSOIL82

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60954-012EAGLE BRAND MEDICATED ROLL ON REFRESH (CAMPHOR, MENTHOL) OIL [PT. EAGLE INDO PHARMA]1Current NDC, 2 package rows20240102_09235f26-2262-6ca2-e063-6394a90ad8f1.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 86 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Antibiotic Plus Pain ReliefNEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDETARGET Corporation6fba5890-f48f-4302-a8ac-5087a6e03bd52025-07-11WarningsExact identifier
application number: M017
TopCare Antibiotic Plus Pain ReliefNEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDETopco Associates LLC55dc4025-f07f-41b2-8b18-6a11ee04b5cc2025-07-11WarningsExact identifier
application number: M017
Benadryl Extra Strength Itch ReliefDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATEKenvue Brands LLC309d9be0-e367-429a-a1fa-ab7855477c8a2025-07-10WarningsExact identifier
application number: M017
Bengay Vanishing ScentMENTHOL, UNSPECIFIED FORMKenvue Brands LLC6cc3294b-3b0f-44d0-af71-61db1022d2692025-07-10WarningsExact identifier
application number: M017
Cold Hot Medicated Patch 5% MentholMENTHOLQuality Choicece544a7c-8dc6-4e63-b499-d8a4e0ec48c32025-07-10WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONE ACETATEWalgreen Companybff322f1-59c3-41e0-8685-fcfe52bf4b422025-07-10WarningsExact identifier
application number: M017
CVS CortisoneHYDROCORTISONECVS Pharmacy87631be8-94b8-4718-858d-d2f30e636cce2025-07-10WarningsExact identifier
application number: M017
TopCare Hydrocortisone Plus 12 MoisturizersHYDROCORTISONETopco Associates LLCc40e8e1d-d6d7-4880-99d3-011b97a5e4f32025-07-10WarningsExact identifier
application number: M017
Live Better Hydrocortisone with AloeHYDROCORTISONEThe Great Atlantic & Pacific Tea Company044e6ee2-98a6-4802-b33d-78b8551356c42025-07-10WarningsExact identifier
application number: M017
Rocainol TOPICAL ANALGESICMETHYL SALICYLATE, MENTHOLCompania Internacional de Comercio, S.A.P.I de C.V.827ec7b2-3d87-47e0-a47a-966b25732c322025-07-10WarningsExact identifier
application number: M017
NumbR-XLIDOCAINE HCLProdigy Media Inc16329ab6-4a33-4c38-85e0-5aad9c75d61d2025-07-10WarningsExact identifier
application number: M017
Dr LidoLIDOCAINE HCLProdigy Media Incda0938f0-00e7-4502-8721-d64c71f594fc2025-07-10WarningsExact identifier
application number: M017
Pain Relief PatchCAMPHOR, METHYL SALICYLATE, MENTHOLCDMA, Inc.da1ec2fe-cc37-4126-90a8-6eb4b8f2e57b2025-07-09WarningsExact identifier
application number: M017
ORTHOGEL Menthol 3.5%MENTHOLLiquidCapsule Manufacturing LLC4fd4b7ac-1971-4abe-8fbb-74ab69e120612025-07-09WarningsExact identifier
application number: M017
Good Neighbor Pharmacy Hydrocortisone Plus 12 MoisturizersHYDROCORTISONEAmerisourceBergenf36acdb8-a526-4bb7-a557-e1dcbbc1cf452025-07-08WarningsExact identifier
application number: M017
Good Neighbor Pharmacy Hydrocortisone with AloeHYDROCORTISONEAmerisourceBergen0c544792-63d9-400c-9888-207c44fdc75e2025-07-08WarningsExact identifier
application number: M017
Good Neighbor Pharmacy HydrocortisoneHYDROCORTISONEAmerisourceBergen58b0b7ba-e547-4e0f-b04d-8e1e6a5d4fcf2025-07-08WarningsExact identifier
application number: M017
Publix HydroHYDROCORTISONEPublix Super Markets Inc29296b0f-0eed-4bb9-8727-c25c2bcf9fd62025-07-08WarningsExact identifier
application number: M017
Publix hydro plusHYDROCORTISONEPublix Super Markets Inca00d82c1-6b09-424a-be78-2603eee3fb9d2025-07-08WarningsExact identifier
application number: M017
TattooTATTOO CREAMPerfso (HK) Co., Limited39773cab-12df-4520-e063-6294a90abc5b2025-07-08WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2672336camphor 2.2 % / menthol 14 % Topical OilPSN09235f26-2262-6ca2-e063-6394a90ad8f12
2672336camphor 22 MG/ML / menthol 140 MG/ML Topical OilSCD09235f26-2262-6ca2-e063-6394a90ad8f12
2672336camphor 2.2 % / menthol 14 % Topical OilSY09235f26-2262-6ca2-e063-6394a90ad8f12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
60954-012-08609540012081 BOTTLE, GLASS in 1 BOX (60954-012-08) / 8 mL in 1 BOTTLE, GLASS2023-11-01NoNoCurrent