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 132 of 152 · 3,029 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Eagle Brand Medicated Oil Aromatic CAMPHOR, MENTHOL, METHYL SALICYLATE Borden Company (Private) Limited 0e808f89-62dc-3790-e063-6394a90a2351 2024-05-13 Warnings Exact identifier application number: M017 Walgreens Lidocaine Plus Cream BENZYL ALCOHOL AND LIDOCAINE HYDROCHLORIDE Walgreens Company e33e0097-31d6-8083-e053-2a95a90af5d2 2024-05-09 Warnings Exact identifier application number: M017 Professional Therapy MuscleCare Pro Pain Relieving Cold Gel CAMPHOR, MENTHOL ACTIVE AND INNOVATIVE, LLC 1794c512-5f42-4ec3-e063-6394a90a87cd 2024-05-03 Warnings Exact identifier application number: M017 Professional Therapy MuscleCare Pro MENTHOL AND CAMPHOR ACTIVE AND INNOVATIVE, LLC 17961a84-6bee-c75f-e063-6394a90af576 2024-05-03 Warnings Exact identifier application number: M017 Aspercreme with Lidocaine Pain Relieving Creme LIDOCAINE HYDROCHLORIDE Chattem, Inc. d5da67c3-c2ec-4e3e-abe9-cc862dcfc8bd 2024-05-01 Warnings Exact identifier application number: M017 Lidocaine HCl 4 Percent LIDOCAINE HYDROCHLORIDE ARI BRANDS, LLC 81aff5c5-91c0-4173-a432-d20115613580 2024-04-30 Warnings Exact identifier application number: M017 HealthWise 3x Medicated Pain Relief Patch 120 Bulk CAMPHOR,MENTHOL, METHYL SALICYLATE Veridian Healthcare 17545078-05e1-9338-e063-6394a90a678c 2024-04-30 Warnings Exact identifier application number: M017 Professional Therapy MuscleCare Pro Roll-on CAMPHOR, MENTHOL ACTIVE AND INNOVATIVE, LLC 1755ec89-c404-1c17-e063-6394a90ab9fb 2024-04-30 Warnings Exact identifier application number: M017 PAIN RELIEF Gel-Roll On MENTHOL Shanghai Chuangshi Medical Technology (Group) Co., Ltd. f0bc2a14-6bda-428c-e053-2995a90a4ced 2024-04-29 Warnings Exact identifier application number: M017 PAIN RELIEF Gel-Tube MENTHOL Shanghai Chuangshi Medical Technology (Group) Co., Ltd. f0bec1d4-2e18-4519-e053-2a95a90a1bbb 2024-04-29 Warnings Exact identifier application number: M017 THERAPLEX AIM Anti-Itch Moisturizing HYDROCORTISONE THERAPLEX, LLC d1b231b6-cc9f-488a-9121-501831473772 2024-04-27 Warnings Exact identifier application number: M017 HYDROCORTISONE HYDROCORTISONE ACETATE JHK Inc dba American Safety & First Aid 64adc8d0-7ca4-4c1a-813f-f1df47e916f2 2024-04-25 Warnings Exact identifier application number: M017 HealthWise Lidocaine Plus Cream BENZYL ALCOHOL, LIDOCAINE HYDROCHLORIDE Veridian Healthcare 16f26249-b508-2c6e-e063-6394a90a265b 2024-04-25 Warnings Exact identifier application number: M017 Hydrocortisone Cream with Aloe HYDROCORTISONE Cardinal Health 110 dba LEADER 16f2f3cb-4611-5867-e063-6394a90af107 2024-04-25 Warnings Exact identifier application number: M017 Burn LIDOCAINE HYDROCHLORIDE JHK Inc 5a4ac4cc-015a-48e7-81f8-93a895049afd 2024-04-25 Warnings Exact identifier application number: M017 Cold Therapy Pain Relief MENTHOL, UNSPECIFIED FORM Walgreen Co. ede15818-5d17-477d-a8be-7b36bb0770a6 2024-04-22 Warnings Exact identifier application number: M017 Anti Itch HYDROCORTISONE Neilmed Pharmaceuticals Inc. 14b4f066-fde4-ac97-e063-6394a90ae64c 2024-04-20 Warnings Exact identifier application number: M017 Walgreens Cold Therapy Pain Relief Patch MENTHOL 5% Walgreens Company e33c90d1-2729-970f-e053-2995a90ad97a 2024-04-18 Warnings Exact identifier application number: M017 HealthWise Cold Therapy Pain Relief Patch MENTHOL Veridian Healthcare 0ce356e0-90a3-ad52-e063-6294a90a404a 2024-04-18 Warnings Exact identifier application number: M017 Walgreens Scalp Relief External analgesic HYDROCORTISONE Walgreen Company da0a24c7-9295-4f22-b2c7-40000dad4b81 2024-04-18 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