Home NDC 83591-416 EMU THERAPY Cool Menthol Therapy Pain Relief Cream
Product NDC 83591-416
11-digit product format 835910416
Labeler code 83591
Product ID 83591-416_097667a6-8c92-70ba-e063-6294a90a7af0
Type HUMAN OTC DRUG
Nonproprietary name MENTHOL
Dosage form CREAM
Route TOPICAL
Labeler ACA MANAGEMENT LLC
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-08-08
Substance MENTHOL
Active strength 27.5 mg/mL
NDC exclude flag No
Listing certified through 2026-12-31
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 EMU THERAPY Cool Menthol Therapy Pain Relief Cream
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL 27.5 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 2643471 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 83591-416-00 EMU THERAPY Cool Menthol Therapy Pain Relief Cream 237 mL in 1 JAR CREAM 237 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83591-416 EMU THERAPY COOL MENTHOL THERAPY PAIN RELIEF CREAM (MENTHOL) CREAM [ACA MANAGEMENT LLC] 4 Current NDC, 1 package rows 20231106_16894346-3513-41b1-b09f-72d84edcc4ac.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 27 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join SPARTAN LIDOCAINE TIV PRIME SRL 4e04146a-ed19-2271-e063-6394a90a50f0 2026-03-27 Warnings Exact identifier application number: M017 Walgreens Pain Relieving Lidocaine LIDOCAINE Walgreen Co. 41d5bdc4-66c8-31ab-e063-6394a90a1195 2026-03-27 Warnings Exact identifier application number: M017 Walgreens Cool N Heat Patch LIDOCAINE, MENTHOL Walgreen Co. 41d64a88-90fc-27ca-e063-6294a90a602b 2026-03-27 Warnings Exact identifier application number: M017 Softlips Naturals Medicated CAMPHOR, MENTHOL The Mentholatum Company 4e05d134-6c7f-1501-e063-6294a90ad27d 2026-03-27 Warnings Exact identifier application number: M017 Walgreens Cool N Heat Patch XL MENTHOL Walgreen Co. 41e92435-7f77-a593-e063-6394a90a4b38 2026-03-27 Warnings Exact identifier application number: M017 Walgreens Cool N Heat Back Patch MENTHOL Walgreen Co. 41e81110-4b79-1fa6-e063-6394a90ae90c 2026-03-27 Warnings Exact identifier application number: M017 Softlips Naturals Medicated Elderberry Acai CAMPHOR, MENTHOL The Mentholatum Company 4e0743a6-d450-043b-e063-6394a90ad1c2 2026-03-27 Warnings Exact identifier application number: M017 QFSN Pain Relief Cream PAIN RELIEF CREAM Qiaofusheng Pharmaceuticals Co., Ltd. 4d215da1-87f5-d35d-e063-6394a90ac348 2026-03-27 Warnings Exact identifier application number: M017 FlexSport Roll On METHYL SALICYLATE Pharmadel LLC bf8de3da-7628-6112-e053-2995a90a8e16 2026-03-26 Warnings Exact identifier application number: M017 Kofal Original METHYL SALICYLATE Pharmadel LLC 984780fd-496b-150b-e053-2995a90aed77 2026-03-26 Warnings Exact identifier application number: M017 Kofal Fuerte METHYL SALICYLATE Pharmadel LLC 98488a07-eba0-2b4e-e053-2995a90ad6ab 2026-03-26 Warnings Exact identifier application number: M017 Kofal Max Power MENTHOL Pharmadel LLC fe1f1408-b0cb-67a4-e053-6394a90ad609 2026-03-26 Warnings Exact identifier application number: M017 Kofal METHYL SALICYLATE Pharmadel LLC 9cac377d-97bc-f0b7-e053-2a95a90a2e12 2026-03-26 Warnings Exact identifier application number: M017 Milagroso CAMPHOR Pharmadel LLC 12b0401c-84d5-07cd-e063-6394a90a052c 2026-03-26 Warnings Exact identifier application number: M017 Ubredol METHYL SALICYLATE Pharmadel LLC fe96eead-1722-c05d-e053-6394a90a850f 2026-03-26 Warnings Exact identifier application number: M017 DZUL PAIN FREEZE INSTANT PAIN RELIEF MENTHOL Caball Sales, Inc. 4df3abcc-17f3-17f2-e063-6294a90afcca 2026-03-26 Warnings Exact identifier application number: M017 Equate Cool and Heat Extra Strength MENTHOL Wal-Mart Stores Inc ca3088a7-e1ec-4e69-80d9-fd0051bde938 2026-03-25 Warnings Exact identifier application number: M017 Ultra Strength Muscle Rub - CVS Health Ultra Strength Muscle Rub CAMPHOR, MENTHOL, METHYL SALICYLATE CVS Pharmacy 2ea95529-ec4b-c2ce-e063-6394a90a0739 2026-03-25 Warnings Exact identifier application number: M017 NUMBING CREAMS MENTHOL LIDOCAINE Yongchun Lihui Trading Co., Ltd. 4dd38cdf-d644-6da0-e063-6294a90afb3d 2026-03-25 Warnings Exact identifier application number: M017 ANTIPHLAMINE L-MENTHOL, L-CAMPHOR, METHYL SALICYLATE Masaem Company 4dd3ab12-6cd3-1060-e063-6394a90a2dec 2026-03-25 Warnings Exact identifier application number: M017
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 83591-416-00 83591041600 237 mL in 1 JAR (83591-416-00) 237 ml 2023-08-08 No No Current