Home NDC 43405-012 Eagle Brand
Product NDC 43405-012
11-digit product format 434050012
Labeler code 43405
Product ID 43405-012_4e5d63b2-eefe-e63d-e063-6394a90aa14e
Type HUMAN OTC DRUG
Nonproprietary name camphor, menthol
Dosage form OIL
Route TOPICAL
Labeler Borden Company (Private) Limited
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 Ingredient Strength CAMPHOR (SYNTHETIC) 2.2 g/100mL MENTHOL 14 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 5TJD82A1ET Internal UNII lookup L7T10EIP3A Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2672336 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 43405-012-08 Eagle BrandMedicated Roll On Refresh 1 in 1 BOX OIL 1 2 43405-012-08 Eagle BrandMedicated Roll On Refresh 8 mL in 1 BOTTLE, GLASS OIL 8 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43405-012 EAGLE BRAND MEDICATED ROLL ON REFRESH (CAMPHOR, MENTHOL) OIL [BORDEN COMPANY (PRIVATE) LIMITED] 1 Current NDC, 2 package rows 20240102_091451fb-e30a-0012-e063-6394a90a3ba8.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 89 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Lidocaine Patch LIDOCAINE Shenzhen Finona Information Technology Co., Ltd 3875bde5-2e1a-5fdf-e063-6294a90a3c0d 2025-06-26 Warnings Exact identifier application number: M017 SupreH Bee Venom Arthritis Pain Relieving Cream SUPREH BEE VENOM ARTHRITIS PAIN RELIEVING CREAM Shenzhen Xinxin Yunhai Technology Co., Ltd. 3876cc44-7f3a-b084-e063-6294a90a6142 2025-06-26 Warnings Exact identifier application number: M017 MediBalm HYDROCORTISONE BalmRx, LLC 324dd151-84c5-3e2f-e063-6394a90a569d 2025-06-26 Warnings Exact identifier application number: M017 PHIZICO Pain Relief MENTHOL ER3 BRANDS INC. 72715dc5-d1e7-4b4b-8e28-4e367abba322 2025-06-25 Warnings Exact identifier application number: M017 Diva Cramp Care Cream METHYL SALICYLATE, MENTHOL, CAMPHOR Avaria Health & Beauty Corp 37368566-b14e-4d5c-bdde-6eea9073974f 2025-06-25 Warnings Exact identifier application number: M017 H2Ocean NOTHING TATTOO GLIDE AFTERCARE MAX STRENGTH LIDOCAINE HCL H2Ocean, LLC 386bf11b-1d71-44bf-e063-6394a90a2817 2025-06-25 Warnings Exact identifier application number: M017 Burn Relief Extra Strength Kool-Down LIDOCAINE - 3.9% Kool-Down Inc 827fec2f-db3c-adbb-e053-2a91aa0a7c17 2025-06-25 Warnings Exact identifier application number: M017 Hilook Blue Gel Anesthetic LIDOCAINE Guangdong Aimu Biological Technology Co., Ltd 1b9db681-a297-5aa9-e063-6394a90a80ea 2025-06-25 Warnings Exact identifier application number: M017 Hilook Numbing Cream LIDOCAINE Guangdong Aimu Biological Technology Co., Ltd 1b9f1a4c-ca0b-d820-e063-6394a90a3239 2025-06-25 Warnings Exact identifier application number: M017 Lidocaine Knee Pain Relief Gel-Patch LIDOCAINE Guangzhou Zhupuyou E-commerce Co., Ltd 384c1ff8-80bd-86cb-e063-6394a90a2d65 2025-06-24 Warnings Exact identifier application number: M017 Aroamas Cot Nicotine Transdermal Patches Kit NICOTINE TRANSDERMAL PATCHES PCHEERY LLC 38576022-9413-c9af-e063-6294a90afd46 2025-06-24 Warnings Exact identifier application number: M017 NERVE REVERSE PAIN RELIEF MENTHOL Pogue Medical Services da97bcc6-5aa8-48e2-a2c2-c937745bf6d3 2025-06-23 Warnings Exact identifier application number: M017 Medterra Pain Relief Menthol Roll-On MENTHOL Respect Manufacturing Corporation 05a6067a-287a-52d4-e063-6394a90a2c4e 2025-06-23 Warnings Exact identifier application number: M017 Medterra Pain Relief 500mg Hemp Menthol Cream MENTHOL Respect Manufacturing Corporation 06c4640a-ee42-5d1a-e063-6394a90ad254 2025-06-23 Warnings Exact identifier application number: M017 Medterra Pain Relief 1000mg Hemp Menthol Cream MENTHOL Respect Manufacturing Corporation 06e944e8-71f6-9fe9-e063-6294a90a8c37 2025-06-23 Warnings Exact identifier application number: M017 Procure gel MENTHOL TWIN MED, LLC e69c0b68-d408-9fd2-e053-2a95a90ac934 2025-06-20 Warnings Exact identifier application number: M017 A Health Itch Relief Gel ITCH RELIEF GEL Bionpharma, Inc. 38040732-48c9-3533-e063-6394a90af10a 2025-06-20 Warnings Exact identifier application number: M017 SCHOELIF Numbing Cream NUMBING CREAM Guangzhou Qiexiran Cosmetics Co., Ltd. 37eaabb7-884e-0bd5-e063-6294a90ae063 2025-06-19 Warnings Exact identifier application number: M017 Re-Lieved Lidocaine Patch LIDOCAINE PATCH 4% Transfer Technology 37ee539c-df7e-511d-e063-6394a90a4469 2025-06-19 Warnings Exact identifier application number: M017 Re-Lieved Lidocaine Patch LIDOCAINE PATCH 4% Transfer Technology 37eef80a-556f-b090-e063-6294a90a151b 2025-06-19 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 43405-012-08 43405001208 1 BOTTLE, GLASS in 1 BOX (43405-012-08) / 8 mL in 1 BOTTLE, GLASS 2023-11-01 No No Current