MENTHOL 5%
- Product NDC
- 80425-0543
- 11-digit product format
- 804250543
- Labeler code
- 80425
- Product ID
- 80425-0543_3bdd0c39-8004-0b8f-e063-6394a90aa5f4
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- menthol 5%
- Dosage form
- PATCH
- Route
- TRANSDERMAL
- Labeler
- Advanced Rx of Tennessee, LLC
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-08-08
- Substance
- MENTHOL, (+)-
- Active strength
- 500 mg/10g
- 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
- MENTHOL 5%
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| MENTHOL, (+)- | 500 mg/10g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| C6B1OE8P3W | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 420222 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 3bdd0c52-29d8-ab67-e063-6294a90a9c45 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| f52be47f-7aa7-46c0-b1fa-50c18dd50206 | Product name | 1 | 20201029 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 80425-0543-1 | MENTHOL 5% | 30 in 1 BOX | PATCH | 30 | 1 | |
| 80425-0543-1 | MENTHOL 5% | 11 g in 1 PATCH | PATCH | 11 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 80425-0543-1 | EA - Each | 80425-0543 | 981debb7-91bf-4d39-84b1-9714bfa6ee66 | 1 | 2025-09-12 |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Resinol | PETROLATUM AND RESORCINOL | ResiCal, Inc. | 03f57a4a-f94b-4ba6-b709-41cfb6e16261 | 2025-12-17 | Warnings | M017 |
| HealthWise Maximum Pain Relief | LIDOCAINE | Veridian Healthcare | afc3c16d-0076-44b2-ae7e-5f36d4d8088e | 2025-12-17 | Warnings | M017 |
| HealthWise Max Lidocaine plus Menthol | LIDOCAINE, MENTHOL | Veridian Healthcare | f39a27da-6799-4fc6-97ca-101eac4a9360 | 2025-12-17 | Warnings | M017 |
| HealthWise Original Menthol | MENTHOL | Veridian Healthcare | e4bfb6b0-545e-4fbc-8538-4f41a6be1025 | 2025-12-17 | Warnings | M017 |
| Welly Polka First Aid Kit | HYDROCORTISONE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE | Dongguan Shenglian Tins Products Co., Ltd. | d7c4314c-c4c6-4adf-b384-3ac7a7108319 | 2025-12-17 | Warnings | M017 |
| Frankincense and Myrrh Arthritis Pain Therapy | MENTHOL | Wise Consumer Products | 2410a199-f4a3-da6c-e063-6394a90aaace | 2025-12-17 | Warnings | M017 |
| Lidocaine | LIDOCAINE, MENTHOL | Vive Health LLC | 462d3b24-643e-91da-e063-6394a90a0e1d | 2025-12-17 | Warnings | M017 |
| Teevodar Pain Relieving | MENTHOL | Sod-e Biotech Ltd | 205b0fef-4f00-db2e-e063-6294a90a93b8 | 2025-12-17 | Warnings | M017 |
| Frankincense and Myrrh Arthritis Pain Relief | MENTHOL | WISE CONSUMER PRODUCTS CO. | 116045df-891b-f370-e063-6294a90abe42 | 2025-12-17 | Warnings | M017 |
| Frankincense and Myrrh Intensive Foot Therapy | MENTHOL | Wise Consumer Products | 23e56c6b-0f2b-721f-e063-6394a90a1ed0 | 2025-12-17 | Warnings | M017 |
| Tiger Balm Ultra Strength | CAMPHOR (SYNTHETIC) AND MENTHOL | Haw Par Healthcare Ltd. | f0561804-e0f7-495d-9768-9b86a208c51e | 2025-12-17 | Warnings | M017 |
| Kwan Loong | METHYL SALICYLATE AND MENTHOL | Haw Par Healthcare Ltd. | 54bcb26e-786a-403e-9330-11ae9e3c013a | 2025-12-17 | Warnings | M017 |
| Magsoothium Body Cooling Formula | MENTHOL | Ubu/Elements, Inc. | f7fb6ac9-a920-a440-e053-6394a90aaa35 | 2025-12-16 | Warnings | M017 |
| Magsoothium CBD Body Lavender | MENTHOL | Ubu/Elements, Inc. | f9b87fbe-b889-67a1-e053-6394a90acbcd | 2025-12-16 | Warnings | M017 |
| Aquaphor Itch Relief | HYDROCORTISONE | Beiersdorf Inc | b1d0333f-ba60-35d8-e053-2995a90af932 | 2025-12-16 | Warnings | M017 |
| Magsoothium CBD Body | MENTHOL | Ubu/Elements, Inc. | 00b2ef34-42d7-523c-e063-6294a90a753d | 2025-12-16 | Warnings | M017 |
| GENTLECARE HAND AND SKIN SANITIZER | BENZALKONIUM CHLORIDE | PARAGON SOLUTIONS US, INC. | 16650277-fa62-485e-9a82-7763d2b50168 | 2025-12-16 | Warnings | 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 | 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 | M017 |
| Zestama | CAPSAICIN | V2 Pharma LLC | c9b46759-b8df-4ff4-815e-8e032c2635c0 | 2025-12-15 | Warnings | M017 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 420222 | menthol 5 % Medicated Patch | PSN | 3bdd0c52-29d8-ab67-e063-6294a90a9c45 | 1 |
| 420222 | menthol 0.05 MG/MG Medicated Patch | SCD | 3bdd0c52-29d8-ab67-e063-6294a90a9c45 | 1 |
| 420222 | menthol 5 % Medicated Patch | SY | 3bdd0c52-29d8-ab67-e063-6294a90a9c45 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 80425-0543-1 | 80425054301 | 30 PATCH in 1 BOX (80425-0543-1) / 11 g in 1 PATCH | 30 patch | 2025-08-08 | No | No | Current |