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 |
|---|---|---|---|---|---|---|
| ActivICE | MENTHOL | Medline Industries, LP | 834adeb9-38ad-0cfe-e053-2991aa0af82f | 2026-09-01 | Warnings | M017 |
| La Vaquita New Extra | METHYL SALICYLATE, MENTHOL | Delon Laboratories (1990) Ltd | 3097a01b-cee5-492f-b65a-63992fb28e3a | 2026-09-01 | Warnings | M017 |
| Terramed Just Think Comfort Hydrocortisone 1% Cream | HYDROCORTISONE | Rida LLC | 0d2c0c2c-370f-4adb-b0ea-1e218c927f8b | 2026-09-01 | Warnings | M017 |
| Itch Stopping | DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE | HyVee Inc | 53157137-b980-45d2-aa10-8c111c0ec2f4 | 2026-08-31 | Warnings | M017 |
| EAYONYUMT NECK PAIN RELIEF | MENTHOL | Wuhan Ruihengjie Technology Co., Ltd. | 5a450e68-07a7-a4bb-e063-6294a90a97c9 | 2026-08-30 | Warnings | M017 |
| EAYONYUM BACK PAIN RELIEVING | MENTHOL | Wuhan Ruihengjie Technology Co., Ltd. | 5a458280-4f9c-5af6-e063-6394a90acb2e | 2026-08-30 | Warnings | M017 |
| EAYONYUM KNEE PAIN RELIEVING | MENTHOL | Wuhan Ruihengjie Technology Co., Ltd. | 5a45d19f-c753-71eb-e063-6294a90a4805 | 2026-08-30 | Warnings | M017 |
| Good Neighbor Pharmacy Hydrocortisone With Aloe for Sensitive Skin | HYDROCORTISONE | AmerisourceBergen | c5c5b5ca-b4d4-4fa8-b647-b3ccb2966495 | 2026-08-30 | Warnings | M017 |
| Olu Pain Management | LIDOCAINE AND CAMPHOR | HAWAII REPACK, INC. | 31ed3d82-ba12-46b2-b0ec-7e5e019efc10 | 2026-08-28 | Warnings | M017 |
| 4% Lidocaine Patches | 4% LIDOCAINE PATCHES | Shenzhen Chaoxiji Technology Co.,Ltd. | 5a177987-7c05-f07f-e063-6394a90aa9ba | 2026-08-28 | Warnings | M017 |
| Relieved Pro Wrap | 4% LIDOCAINE PATCH | Transfer Technology | 5a1c6ebf-ad3f-c47b-e063-6294a90aa19a | 2026-08-28 | Warnings | M017 |
| Sinsinpas Arex Pain Relieving Patch, Medium | CAMPHOR, MENTHOL, METHYL SALICYLATE | Sinsin Pharmaceutical Co., Ltd. | 46453ef2-512b-4852-e063-6394a90a8912 | 2026-08-28 | Warnings | M017 |
| Sinsinpas arex patch large | CAMPHOR, MENTHOL, METHYL SALICYLATE | Sinsin Pharmaceutical Co., Ltd. | 47c242da-56cd-bea1-e063-6394a90a41de | 2026-08-28 | Warnings | M017 |
| 4% Lidocaine Patches | 4% LIDOCAINE PATCHES | Shenzhen Chaoxiji Technology Co.,Ltd. | 5a16c6aa-3ab0-3e46-e063-6294a90a6d8f | 2026-08-27 | Warnings | M017 |
| Lidocaine Patch 4% | LIDOCAINE 4% | Global America Group LLC | 1eec782d-0e56-43d2-b842-da0ae47c5dc9 | 2026-08-26 | Warnings | M017 |
| Careland Lidocaine Plus Menthol Pain Relieving | LIDOCAINE, MENTHOL | Planet (Anhui) Pharmaceutical Co., Ltd | 0f928b5b-60f5-4a45-a409-c601eb330487 | 2026-08-26 | Warnings | M017 |
| PARCHE CALIENTE | CAPSAICINA AND MENTOL | DW SUPPORT LLC | 59f2708e-295a-ccb3-e063-6394a90ad395 | 2026-08-26 | Warnings | M017 |
| CVS Pain Relief | LIDOCAINE | CVS Pharmacy | 4ecbc263-e0d4-18d5-e063-6294a90a72e9 | 2026-08-26 | Warnings | M017 |
| CVS Pain Relief Lidocaine XL | LIDOCAINE | CVS Pharmacy | 4aa286e3-e274-8095-e063-6394a90ae871 | 2026-08-26 | Warnings | M017 |
| TERAPIA DE DIA Y NOCHE | PAIN RELIEVING PATCH | DW SUPPORT LLC | 59f44135-865b-9d7d-e063-6294a90a9dd9 | 2026-08-26 | 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 |