Home NDC 60954-016 Eagle Brand
Product NDC 60954-016
11-digit product format 609540016
Labeler code 60954
Product ID 60954-016_1bd59e66-e366-a201-e063-6394a90a25fe
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 Roll On
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength METHYL SALICYLATE 30 g/100mL MENTHOL 14.5 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination LAV5U5022Y Internal UNII lookup L7T10EIP3A Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1293430 Internal RxNorm lookup 1293435 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 60954-016-08 Eagle BrandMedicated Roll On 8 mL in 1 BOTTLE, GLASS OIL 8 1 60954-016-08 Eagle BrandMedicated Roll On 1 in 1 BOX OIL 1 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60954-016 EAGLE BRAND MEDICATED ROLL ON (MENTHOL, METHYL SALICYLATE) OIL [PT. EAGLE INDO PHARMA] 1 Current NDC, 2 package rows 20240628_1bd5cf69-9a08-5e2e-e063-6394a90a03cd.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 98 of 151 · 3,010 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Thera Plus Hydrocortisone Maximum Strength HYDROCORTISONE FOURSTAR GROUP USA, INC. c2bc8f0c-38ea-4124-bc51-bf22e6751a92 2025-03-04 Warnings Exact identifier application number: M017 Thera Plus Eczema Hydrocortisone Anti Itch HYDROCORTISONE Fourstar Group USA, Inc. 7c72217b-db9a-4573-9f14-4c11528fa452 2025-03-04 Warnings Exact identifier application number: M017 Thera Plus Maximum Strength Hydrocortisone HYDROCORTISONE Fourstar Group USA, Inc. fb89dca6-c0c0-4092-b3f5-e59c956c3d6c 2025-03-04 Warnings Exact identifier application number: M017 Peppermint soothing cream CAMPHORIC ACID, MENTHOL, UNSPECIFIED FORM, BORNEOL Henan Lijitang Medical Technology Co., Ltd. 2f6bc332-3006-710d-e063-6394a90acea5 2025-03-03 Warnings Exact identifier application number: M017 Thera Plus Pain Relief Arthritis and Muscle CAPSAICIN FOURSTAR GROUP USA, INC. dcff0a2d-7190-4b0c-abde-ba009b8ef005 2025-02-28 Warnings Exact identifier application number: M017 GoodSense Anti-Itch DIPHENHYDRAMINE HCL, ZINC ACETATE Geiss, Destin & Dunn, Inc 2f38bdfc-6135-1b8a-e063-6294a90a6703 2025-02-28 Warnings Exact identifier application number: M017 Capsaicin 0.05% Cream CAPSAICIN 0.05% Puretek Corporation 2cf17a28-711f-77bd-e063-6394a90a7061 2025-02-28 Warnings Exact identifier application number: M017 Lidocaine Pain-Relief Patches LIDOCAINE PATCH Meijer, Inc 2f247929-6bff-1e59-e063-6394a90acdba 2025-02-27 Warnings Exact identifier application number: M017 Lightning Products BURN RELIEF LIDOCAINE HYDROCHLORIDE Nantong Health & Beyond Hygienic Products Inc. 555ac696-e761-4a5a-bed8-945dc64d5be5 2025-02-27 Warnings Exact identifier application number: M017 Hydrocortisone with aloe HYDROCORTISONE Encube Ethicals, Inc. 12a1774d-a97e-4787-b6b1-8e8cd40b7b70 2025-02-26 Warnings Exact identifier application number: M017 Thera Plus Maximum Strength Feminine Anti-Itch BENZOCAINE, RESORCINOL FOURSTAR GROUP USA, INC. 0007e3ea-882b-4000-8e70-2bcec2c08613 2025-02-26 Warnings Exact identifier application number: M017 Tattoo numbing cream LIDOCAINE BLOOMWELL GARDENS LLC 2ea9d34e-408d-f8d6-e063-6394a90a72a4 2025-02-26 Warnings Exact identifier application number: M017 Icy Hot Pro No-Mess CAMPHOR, MENTHOL Chattem, Inc. 9e8fedf5-fb59-4531-b288-715f851ee05b 2025-02-26 Warnings Exact identifier application number: M017 Family Wellness Max Strength 1 Hydrocortisone Cream HYDROCORTISONE Family Dollar Stores, Inc bca5ac2c-45cd-44e3-98f1-317a04e44d7d 2025-02-25 Warnings Exact identifier application number: M017 Tylenol Precise Nighttime Pain Relieving CAMPHOR, MENTHOL Kenvue Brands LLC 2ef4fe16-0820-6aad-e063-6294a90a8449 2025-02-25 Warnings Exact identifier application number: M017 LidoPro Pain Relief CAPSAICIN AND LIDOCAINE Preferred Pharmaceuticals Inc. c259ef92-5d07-4590-adf1-3a106333eee0 2025-02-21 Warnings Exact identifier application number: M017 Cortizone 10 Ultra Soothing Itch Relief HYDROCORTISONE Chattem, Inc. 8a9e2d32-a65f-4253-8041-4146f4e3b738 2025-02-21 Warnings Exact identifier application number: M017 AVCOO Pain Relief Roll On MENTHOL ADP Health Limited 420d8cdc-f47f-4d33-bf25-9033ff266c49 2025-02-19 Warnings Exact identifier application number: M017 AVCOO Pain Relief MENTHOL ADP Health Limited 700ce2cf-749e-40be-91c3-850d9b2168ca 2025-02-19 Warnings Exact identifier application number: M017 Sunburn Relief Gel LIDOCAINE HCL Jell Pharmaceuticals Pvt. Ltd 2e7c49de-5438-4858-e063-6294a90ad98c 2025-02-19 Warnings Exact identifier application number: M017
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 60954-016-08 60954001608 1 BOTTLE, GLASS in 1 BOX (60954-016-08) / 8 mL in 1 BOTTLE, GLASS 2024-06-24 No No Current