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 |
|---|---|---|---|---|---|---|
| LubeLife Climax Control Delay | BENZOCAINE | CC Wellness LLC | e1a98e6d-0c24-75b8-e053-2a95a90ad136 | 2025-09-09 | Warnings | M017 |
| Blue-Emu Maximum Pain Relief | TROLAMINE SALICYLATE | Kingsway Pharmaceuticals dba NFI, LLC | c863351a-951b-4f7c-a9c0-4289d702054a | 2025-09-09 | Warnings | M017 |
| Tiger Balm Neck and Shoulder Rub | CAMPHOR (SYNTHETIC) AND MENTHOL | Haw Par Healthcare Ltd. | 02a65b25-78b2-4e29-9484-40e2228fb384 | 2025-09-09 | Warnings | M017 |
| Hydrocortisone | HYDROCORTISONE | Unifirst First Aid Corporation | e90df2e5-2ef4-47dd-bd74-be9cea6d9d85 | 2025-09-08 | Warnings | M017 |
| Hydrocortisone | HYDROCORTISONE | Unifirst First Aid Corporation | 69d6645e-db3c-4dc0-a9a5-e2bc963e2f28 | 2025-09-08 | Warnings | M017 |
| SupreH Arnica Bruise Cream | SUPREH ARNICA REMEDY PLUS BRUISE CREAM | Shenzhen Xinxin Yunhai Technology Co., Ltd. | 3e41fc0e-54c3-2622-e063-6294a90a13c9 | 2025-09-07 | Warnings | M017 |
| Menthol | MENTHOL | FlexiGo Inc | 3607c326-6db0-a2cd-e063-6394a90a9eb6 | 2025-09-06 | Warnings | M017 |
| TIDL PAIN RELIEF CRYOTHERAPY MENTHOL Cream | PAIN RELIEF CRYOTHERAPY MENTHOL CREAM | Shenzhen Sam Technology Co., Ltd. | 3e08cc87-2385-0838-e063-6394a90abf9b | 2025-09-05 | Warnings | M017 |
| TIDL CLINICAL CRYOTHERAPY MENTHOL Cream | CLINICAL CRYOTHERAPY MENTHOL CREAM | Shenzhen Sam Technology Co., Ltd. | 3e090b98-1db7-4174-e063-6394a90aa539 | 2025-09-05 | Warnings | M017 |
| ALCEMISTE | LIDOCAINE HCL | Price Team Ventures, LLC | 4383faaa-49cf-47b7-83a6-c2a94b6ff9b5 | 2025-09-05 | Warnings | M017 |
| Lansinoh Pain Relieving | LIDOCAINE HCL | Lansinoh Laboratories Inc | b7cf1fdb-946d-a4e8-e053-2995a90a26a8 | 2025-09-05 | Warnings | M017 |
| Sumifun PLANTAR RELIEF ROLL -ON | 4% LIDOCAINE, 1% MENTHOL | Guangzhou Zhupuyou E-commerce Co., Ltd | 3c9ee60b-548a-979f-e063-6394a90a70b0 | 2025-09-03 | Warnings | M017 |
| Meijer Capsaicin Heat Patch | CAPSAICIN | Meijer Distribution | 3c465557-0a4f-fb72-e063-6294a90a1ef2 | 2025-09-02 | Warnings | M017 |
| Cold Therapy | MENTHOL | AHC Ventures Corp DBA Cryoderm | dd95c682-8ddf-43e7-a277-2fca6ec744cc | 2025-09-02 | Warnings | M017 |
| Pain Relieving | MENTHOL, CAMPHOR, CAPSAICIN | AHC VENTURES CORP DBA CRY | 27679d31-a5f3-417b-b0c5-5f6b001ecff9 | 2025-09-02 | Warnings | M017 |
| Cold Therapy | MENTHOL | AHC VENTURES CORP DBA CRYODERM | 52fff03e-eba2-4604-a71c-2522468f627b | 2025-09-02 | Warnings | M017 |
| Pain Relieving Cold Therapy | MENTHOL | AHC VENTURES CORP DBA CRYODERM | de210c3a-c24e-cefd-e053-2a95a90a93ff | 2025-09-02 | Warnings | M017 |
| Pain Relieving Roll-On | MENTHOL, CAMPHOR, CAPSAICIN | AHC VENTURES CORP DBA CRY | 799751f3-726a-42de-934e-dbc3cd1cb8b8 | 2025-09-02 | Warnings | M017 |
| Pain Relieving Cold Therapy | MENTHOL | AHC VENTURES CORP DBA CRYODERM | de0c9a73-dbc0-599e-e053-2a95a90a7986 | 2025-09-02 | Warnings | M017 |
| Cold Therapy | MENTHOL | AHC VENTURES CORP DBA CRYODERM | 90334420-5f81-4284-9a57-42e134ce362f | 2025-09-02 | 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 |