Thera Plus Cool and Heat Pain Relieving Gel Menthol
- Product NDC
- 80684-097
- 11-digit product format
- 806840097
- Labeler code
- 80684
- Product ID
- 80684-097_0b61ea71-e589-bff5-e063-6394a90a2e50
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- MENTHOL
- Dosage form
- LIQUID
- Route
- TOPICAL
- Labeler
- Fourstar Group USA, Inc.
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-02-01
- Substance
- MENTHOL
- Active strength
- 160 mg/mL
- 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
- Thera Plus Cool and Heat Pain Relieving Gel Menthol
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| MENTHOL | 160 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| L7T10EIP3A | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 253056 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 0a225714-ccb1-4676-e063-6294a90aeeb2 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 473d070d-1c38-488e-b991-c4d1bf45aab8 | Product name | 1 | 20210201 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 80684-097-00 | Thera Plus Cool and Heat Pain Relieving Gel Menthol | 74 mL in 1 BOTTLE | LIQUID | 74 | 2 |
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| 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 |
| KNEE PAIN RELIRF Patch | CAMPHOR, MENTHOL | Shenzhen Finona Information Technology Co., Ltd | 3db971ef-d7fa-0171-e063-6294a90aa58b | 2025-09-01 | Warnings | M017 |
| Bikini Zone Medicated Creme | LIDOCAINE | Kingsway Pharmaceuticals dba NFI, LLC | 300ac57e-844a-4840-b285-41ff5518e6b6 | 2025-08-29 | Warnings | M017 |
| Bikini Zone Medicated Gel | LIDOCAINE | Kingsway Pharmaceuticals dba NFI, LLC | 30b85890-e72d-4af7-bda9-e7744abc92af | 2025-08-29 | Warnings | M017 |
| Sumifun Lidocaine Pain Relief Gel-Patch | LIDOCAINE | Guangzhou Zhupuyou E-commerce Co., Ltd | 3d7dc8cc-0680-d94d-e063-6394a90ac8e8 | 2025-08-29 | Warnings | M017 |
| TKTALKER NUMBING | NUMBING | Shenzhen Shandian Jingling Technology Co., Ltd. | 3d7e6757-f183-2a68-e063-6294a90ae4ca | 2025-08-29 | Warnings | M017 |
| PBZ OTC | TRIPELENNAMINE HCL 1% | Kingsway Pharmaceuticals dba NFI, LLC | 12f72d74-018f-4bc6-acd4-175ca3af4c6d | 2025-08-29 | Warnings | M017 |
| else. | LIDOCAINE | Else Co. | 3d6c7b10-ed03-bbde-e063-6294a90ae92f | 2025-08-28 | Warnings | M017 |
| Mountain Ice Pain Relief | MENTHOL | Mountainside Medical Equipment, Inc. | c79fdd91-16f4-4ae0-bee4-d37c05ed2074 | 2025-08-28 | Warnings | M017 |
| HealthWise 4% Lidocaine Cream 2.7 oz | LIDOCAINE HYDROCHLORIDE | Veridian Healthcare | f39eb3d0-e153-4f50-85b1-ad5c677d176c | 2025-08-28 | Warnings | M017 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 253056 | menthol 16 % Topical Gel | PSN | 0a225714-ccb1-4676-e063-6294a90aeeb2 | 2 |
| 253056 | menthol 0.16 MG/MG Topical Gel | SCD | 0a225714-ccb1-4676-e063-6294a90aeeb2 | 2 |
| 253056 | menthol 16 % Topical Gel | SY | 0a225714-ccb1-4676-e063-6294a90aeeb2 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 80684-097-00 | 80684009700 | 74 mL in 1 BOTTLE (80684-097-00) | 74 ml | 2024-02-01 | No | No | Current |