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 |
|---|---|---|---|---|---|---|
| Mountain Ice Sports Pain Relief | MENTHOL, CAMPHOR | Mountainside Medical Equipment, Inc. | c1f5512c-67b1-4ff0-b1a5-616e883d436f | 2025-07-21 | Warnings | M017 |
| Stopain Clinical Roll-On | MENTHOL, UNSPECIFIED FORM | Troy Manufacturing, Inc. | 27703209-fdac-4620-a445-d89a84bc853d | 2025-07-21 | Warnings | M017 |
| Hydrocortisone | HYDROCORTISONE | STRATEGIC SOURCING SERVICES LLC | 9bac1869-8072-49bd-8568-a87a184d2200 | 2025-07-21 | Warnings | M017 |
| Dr Kevin Khalili Pain Relief Cream | MENTHOL | DR. KHALILI LLC | 3a79b38c-9adc-60dd-e063-6394a90a5b30 | 2025-07-21 | Warnings | M017 |
| ARTHRITIS PAIN RELIEF | CAMPHOR, CAPSAICIN, METHYL SALICYLATE | YUNNAN BAIYAO GROUP CO., LTD. | 671c57f0-3c6f-4416-bc81-f6930fef327b | 2025-07-21 | Warnings | M017 |
| GoodSense Cooling Pain Relief | MENTHOL | Geiss, Destin & Dunn, Inc | 2e5e1375-df07-9a43-e063-6394a90a9938 | 2025-07-20 | Warnings | M017 |
| Benadryl Extra Strength Itch Cooling | DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE | Kenvue Brands LLC | a7eae5dc-9db6-4bdf-9179-76060e75e044 | 2025-07-18 | Warnings | M017 |
| Nicotine Patches | NICOTINE PATCHES | Shenzhen TeLaFaErJiaLuo Technology Co., Ltd. | 3a1abd26-c0aa-8a65-e063-6294a90ab66e | 2025-07-17 | Warnings | M017 |
| Aouiv 4% Lidocaine Numbing Cream | 4% LIDOCAINE NUMBING CREAM | Guangzhou Qiexiran Cosmetics Co., Ltd. | 3a221dd2-e945-bd0e-e063-6294a90a8fb9 | 2025-07-17 | Warnings | M017 |
| Alocane Plus | LIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDE | Quest Products, Inc. | 24538037-1d74-48a0-b909-98ecc57651fe | 2025-07-17 | Warnings | M017 |
| Hydrocortisone anti-itch plus | HYDROCORTISONE | Wal-Mart Stores, Inc. | a0c6e180-b385-4a9b-a9cf-84a551f533d0 | 2025-07-16 | Warnings | M017 |
| OTC Rescue Lidocaine Pain Relief Patch | LIDOCAINE | Veridian Healthcare | 0e742fc6-5f76-d202-e063-6394a90acf31 | 2025-07-16 | Warnings | M017 |
| Itch Relief | HYDROCORTISONE | STRATEGIC SOURCING SERVICES LLC | ae4b7cd6-8b5d-4d25-86f9-72260638bb94 | 2025-07-16 | Warnings | M017 |
| Freds Hydrocortisone Plus 12 Moisturizers | HYDROCORTISONE | FRED'S, INC. | 7502eebe-11c5-4e9e-b427-b87180a84349 | 2025-07-16 | Warnings | M017 |
| PROINNATE Numbing Cream | MENTHOL | Guangzhou Haishi Biological Technology Co., Ltd. | 39688b2b-c1fe-cd86-e063-6394a90a5345 | 2025-07-16 | Warnings | M017 |
| Methyl Salicylate | METHYL SALICYLATE | ViolaCare, Inc. | 8f0ba6e7-8aa4-443e-99ae-a255085ddfec | 2025-07-15 | Warnings | M017 |
| TopCare Hydrocortisone Intensive Healing Formula | HYDROCORTISONE | Topco Associates LLC | 7daafc44-e2a4-4f1b-bfca-3309a8e9a920 | 2025-07-15 | Warnings | M017 |
| Hydrocortisone Plus 12 Moisturizers | HYDROCORTISONE | TARGET Corporation | 72c3889c-b743-4728-a315-6e4063e00200 | 2025-07-15 | Warnings | M017 |
| Shopko Hydrocortisone Maximum Strength | HYDROCORTISONE | Shopko Stores Operating Co., LLC | 0431a6af-4c9a-4bbd-a535-cba31a5e53cc | 2025-07-15 | Warnings | M017 |
| Freds Hydrocortisone with Aloe | HYDROCORTISONE | FRED'S, INC. | 076503bf-8238-4739-bb1c-c385e72f8a96 | 2025-07-15 | 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 |