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
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 |
|---|---|---|---|---|---|---|
| Itch Relief | DIPHENHYDRAMINE HCL, ZINC ACETATE | Cardinal Health, 110 dba Leader | 3ed7b8a1-012f-459d-878c-813b93d4673c | 2026-08-06 | Warnings, Adverse reactions | M017 |
| Gel Cooling Pain Relief | MENTHOL | The Kroger Co. | 6fb0acc8-8dab-452c-b09e-de97306e1c32 | 2026-08-06 | Warnings, Adverse reactions | M017 |
| Lidocaine Tattoo Wipe | LIDOCAINE HYDROCHLORIDE | MD Tattoo Company | 369c1d16-597c-e1dc-e063-6394a90a3104 | 2026-08-06 | Warnings | M017 |
| Point Relief Coldspot Pain Relieving | MENTHOL | Fabrication Enterprises Inc | 479fb728-4aeb-42e3-b238-f04255514baa | 2026-08-05 | Warnings | M017 |
| Lidocaine HCl | LIDOCAINE HCL | Topco Associates LLC | 584e1f35-4d99-9c85-e063-6294a90ab3d0 | 2026-08-05 | Warnings, Adverse reactions | M017 |
| tuiwaro LIDOCAINE Cream | LIDOCAINE CREAM | Guangzhou Jingliang Cosmetics Co., Ltd. | 56e36592-a935-61d4-e063-6294a90a6e4c | 2026-08-04 | Warnings | M017 |
| Mineral Ice Extreme Menthol Pain Relief | MENTHOL | Carlin Consumer Health LLC | 584f5c6e-3385-3221-e063-6294a90aabae | 2026-08-04 | Warnings | M017 |
| hydrocortisone | HYDROCORTISONE | Bryant Ranch Prepack | 484fe5e4-a058-49c0-a382-c8fc3e20c3b2 | 2026-08-04 | Warnings | M017 |
| procure | HYDROCORTISONE ACETATE | TWIN MED, LLC | 2670c9c4-66ad-40e8-a08a-582b160de39d | 2026-08-03 | Warnings | M017 |
| Icy Hot Original Nighttime Recovery Pain Relief No Mess Roll On | MENTHOL | Chattem, Inc. | aa40c907-eeb5-4fda-b35e-439cbecc178c | 2026-07-31 | Warnings | M017 |
| Alphamale Delay Cream | BENZOCAINE | Prodigy Media Inc | 53d682ee-0802-a16d-e063-6394a90aeee1 | 2026-07-31 | Warnings | M017 |
| Pure Primal Delay Cream | BENZOCAINE | Prodigy Media Inc | 57e9e894-c14f-d806-e063-6394a90ab8e5 | 2026-07-31 | Warnings | M017 |
| Satohap | DL-CAMPHOR, L-MENTHOL, METHYL SALICYLATE | Sato Pharmaceutical Co., Ltd. | df0e2b83-8f61-4ed8-bcc4-55e4ea782090 | 2026-07-31 | Warnings | M017 |
| Satogesic | DL-CAMPHOR, L-MENTHOL, METHYL SALICYLATE | Sato Pharmaceutical Co., Ltd. | cb000134-92a4-4304-8ef0-0347190e1414 | 2026-07-31 | Warnings | M017 |
| Satogesic Hot | CAPSAICIN | Sato Pharmaceutical Co., Ltd. | 16b47cb5-ea5f-4514-9a89-141ee4cc60f8 | 2026-07-31 | Warnings | M017 |
| Satohap Cool and Hot Pads | CAMPHOR, CAPSAICIN, MENTHOL | Sato Pharmaceutical Co., Ltd. | b6bf1eab-4ab9-f500-e053-2995a90a8d7b | 2026-07-31 | Warnings, Adverse reactions | M017 |
| SATOHAP COOL and HOT | CAMPHOR, CAPSAICIN, MENTHOL | Sato Pharmaceuticals Co., Ltd. | 232a4c76-1a0c-2f4b-e063-6394a90a8849 | 2026-07-31 | Warnings, Adverse reactions | M017 |
| Cortizone 10 Itch Relief Massaging Rollerball | HYDROCORTISONE | Chattem, Inc. | 1e27682c-f856-41f1-9935-37540960a4c7 | 2026-07-31 | Warnings | M017 |
| Aspercreme with Lidocaine Dry | LIDOCAINE | Chattem, Inc. | 008abaaa-5e12-4246-a7f5-66f3966acf28 | 2026-07-30 | Warnings | M017 |
| ACOLYE Lidocaine Cream Topical Analgesia Cream | LIDOCAINE,MENTHOL | Guangdong Aimu Biological Technology Co., Ltd | 57deebf7-52f1-4256-e063-6294a90a75d5 | 2026-07-30 | 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 |