Home NDC 54155-052-01 PO SUM ON MEDICATED
Product NDC 54155-052
Requested package NDC 54155-052-01
11-digit product format 541550052
Labeler code 54155
Product ID 54155-052_5d2fb4f7-1b53-3343-e063-6394a90a2cfb
Type HUMAN OTC DRUG
Nonproprietary name MENTHOL
Dosage form OIL
Route TOPICAL
Labeler PO SUM ON MEDICINE FACTORY LIMITED
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-08-27
Marketing end 2030-09-02
Substance MENTHOL
Active strength 15 g/100mL
NDC exclude flag No
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 PO SUM ON MEDICATED Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL 15 g/100mL
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 54155-052-01 PO SUM ON MEDICATED 30 mL in 1 BOTTLE, GLASS OIL 30 6 54155-052-01 PO SUM ON MEDICATED 1 in 1 CAN OIL 1 6 54155-052-02 PO SUM ON MEDICATED 5.6 mL in 1 BOTTLE, GLASS OIL 5.6 6 54155-052-02 PO SUM ON MEDICATED 1 in 1 BOX OIL 1 6
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54155-052 PO SUM ON MEDICATED (MENTHOL) OIL [PO SUM ON MEDICINE FACTORY LIMITED] 5 Current NDC, Legacy NDC, 4 package rows 20241127_7239a241-afbf-4877-8608-59dff8d16187.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 53 of 151 · 3,010 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Frankincense and Myrrh Arthritis Pain Therapy MENTHOL Wise Consumer Products 2410a199-f4a3-da6c-e063-6394a90aaace 2025-12-17 Warnings Exact identifier application number: M017 Lidocaine LIDOCAINE, MENTHOL Vive Health LLC 462d3b24-643e-91da-e063-6394a90a0e1d 2025-12-17 Warnings Exact identifier application number: M017 Teevodar Pain Relieving MENTHOL Sod-e Biotech Ltd 205b0fef-4f00-db2e-e063-6294a90a93b8 2025-12-17 Warnings Exact identifier application number: M017 Frankincense and Myrrh Arthritis Pain Relief MENTHOL WISE CONSUMER PRODUCTS CO. 116045df-891b-f370-e063-6294a90abe42 2025-12-17 Warnings Exact identifier application number: M017 Frankincense and Myrrh Intensive Foot Therapy MENTHOL Wise Consumer Products 23e56c6b-0f2b-721f-e063-6394a90a1ed0 2025-12-17 Warnings Exact identifier application number: M017 Tiger Balm Ultra Strength CAMPHOR (SYNTHETIC) AND MENTHOL Haw Par Healthcare Ltd. f0561804-e0f7-495d-9768-9b86a208c51e 2025-12-17 Warnings Exact identifier application number: M017 Kwan Loong METHYL SALICYLATE AND MENTHOL Haw Par Healthcare Ltd. 54bcb26e-786a-403e-9330-11ae9e3c013a 2025-12-17 Warnings Exact identifier application number: M017 Magsoothium Body Cooling Formula MENTHOL Ubu/Elements, Inc. f7fb6ac9-a920-a440-e053-6394a90aaa35 2025-12-16 Warnings Exact identifier application number: M017 Magsoothium CBD Body Lavender MENTHOL Ubu/Elements, Inc. f9b87fbe-b889-67a1-e053-6394a90acbcd 2025-12-16 Warnings Exact identifier application number: M017 Aquaphor Itch Relief HYDROCORTISONE Beiersdorf Inc b1d0333f-ba60-35d8-e053-2995a90af932 2025-12-16 Warnings Exact identifier application number: M017 Magsoothium CBD Body MENTHOL Ubu/Elements, Inc. 00b2ef34-42d7-523c-e063-6294a90a753d 2025-12-16 Warnings Exact identifier application number: M017 GENTLECARE HAND AND SKIN SANITIZER BENZALKONIUM CHLORIDE PARAGON SOLUTIONS US, INC. 16650277-fa62-485e-9a82-7763d2b50168 2025-12-16 Warnings Exact identifier application number: M017 Welly First Aid Kit Refill HYDROCORTISONE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, LIDOCAINE Dongguan Shenglian Tins Products Co., Ltd. 4bc93855-4009-4b49-9fb4-e5864054153d 2025-12-16 Warnings Exact identifier application number: M017 LidocainePain pain reliving gel-patch PAIN RELIVING GEL-PATCH Shenzhen Yuetai Electronic Commerce Co., Ltd 461ebbdd-0f26-a333-e063-6394a90a7a3e 2025-12-16 Warnings Exact identifier application number: M017 Zestama CAPSAICIN V2 Pharma LLC c9b46759-b8df-4ff4-815e-8e032c2635c0 2025-12-15 Warnings Exact identifier application number: M017 equate hydrocortisone HYDROCORTISONE Wal-Mart Stores Inc 70f4636d-4137-498b-ab81-0330de883e53 2025-12-15 Warnings Exact identifier application number: M017 SALONPAS-HOT CAPSICUM CAPSAICIN Hisamitsu Pharmaceutical Co., Inc. ef5373aa-9857-4d01-95af-2d7716e54ae4 2025-12-15 Warnings Exact identifier application number: M017 First Aid Burn Cream FIRST AID BURN CREAM ProStat First Aid LLC f70a442e-7ba7-4860-e053-6394a90ac2bd 2025-12-15 Warnings Exact identifier application number: M017 Burn Ease, 3.5g BURN EASE, 3.5G ProStat First Aid LLC 004aa18f-3a97-f454-e063-6394a90afcff 2025-12-15 Warnings Exact identifier application number: M017 PS-3866 Burn Ease, 0.9g PS-3866 BURN EASE, 0.9G ProStat First Aid LLC 004d00a5-9cff-29ff-e063-6294a90aeb8c 2025-12-15 Warnings Exact identifier application number: M017
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 54155-052-01 54155005201 1 BOTTLE, GLASS in 1 CAN (54155-052-01) / 30 mL in 1 BOTTLE, GLASS 2026-08-27 2030-09-02 No No Current