Thera Plus Cold Therapy Pain Relieving Menthol
- Product NDC
- 80684-101
- 11-digit product format
- 806840101
- Labeler code
- 80684
- Product ID
- 80684-101_0b23e32c-9248-271c-e063-6294a90a1f5c
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- MENTHOL
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Fourstar Group USA, Inc.
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-02-01
- Substance
- MENTHOL
- Active strength
- 40 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 Cold Therapy Pain Relieving Menthol
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| MENTHOL | 40 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| L7T10EIP3A | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 415974 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 0a462c91-5300-e282-e063-6394a90a4cc2 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 6c13b22c-b3ba-4127-b768-0132dd5ab0d1 | Product name | 1 | 20230829 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 80684-101-00 | Thera Plus Cold Therapy Pain Relieving Menthol | 74 mL in 1 BOTTLE | GEL | 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 |
|---|---|---|---|---|---|---|
| Sheffield Arthritis and Muscle Pain Relief | CAPSICUM OLEORESIN | Sheffield Pharmaceuticals LLC | 724b9870-e86a-4087-ba78-8c944ce3baa6 | 2023-11-28 | Warnings | M017 |
| Dr Sheffield Muscle Rub Cream | MUSCLE RUB CREAM | Sheffield Pharmaceuticals LLC | 60d1d826-a53e-42e5-bc30-1b2c2690445b | 2023-11-28 | Warnings | M017 |
| Thera Plus Cold Therapy Pain Relieving Menthol | MENTHOL | Fourstar Group USA, Inc. | 0a462c91-5300-e282-e063-6394a90a4cc2 | 2023-11-27 | Warnings | M017 80684-101 |
| UtaSpray | MENTHOL AND METHYL SALICYLATE | Big 5 Nutrition LLC | c641ab11-cd00-4e23-ace7-8178739084f0 | 2023-11-21 | Warnings | M017 |
| Top Medicated Oil | CAMPHOR, MENTHOL, METHYL SALICYLATE | Big 5 Nutrition LLC | b2f0d1e1-7d03-434e-be39-9f980459690c | 2023-11-21 | Warnings | M017 |
| BT Pain Relief Balm | METHYL SALICYLATE, MENTHOL, CAMPHOR | Big 5 Nutrition LLC | 50112419-c934-4d3a-9ea6-9b089f516a6d | 2023-11-21 | Warnings | M017 |
| BT Pain Relief | MENTHOL, METHYL SALICYLATE | Big 5 Nutrition LLC | 91324910-27cf-424f-9e9b-6173f2d7acbf | 2023-11-21 | Warnings | M017 |
| Dit Da Shui | MENTHOL AND METHYL SALICYLATE | Big 5 Nutrition LLC | 5d45cb48-3e88-4d58-81d2-6f88d7a82134 | 2023-11-20 | Warnings | M017 |
| Herbal Balm | METHYL SALICYLATE, MENTHOL AND | Big 5 Nutrition LLC | 09b3b86d-3434-428b-b0a8-e8dfd7c0b52a | 2023-11-20 | Warnings | M017 |
| Hydrocortisone | ANTIPRURITIC (ANTI-ITCH) | BluePoint Laboratories | b505769e-9c46-3cf3-e053-2a95a90a4df9 | 2023-11-17 | Warnings | M017 |
| Hydrocortisone | ANTIPRURITIC (ANTI-ITCH) | BluePoint Laboratories | d6523993-d781-cdbc-e053-2a95a90af191 | 2023-11-17 | Warnings | M017 |
| ZIMS MAX FREEZE PRO FORMULA | MENTHOL, UNSPECIFIED FORM | KOBAYASHI Healthcare International, Inc. | 4d91baf3-9655-4786-93b8-aa0d93fe0bf9 | 2023-11-16 | Warnings | M017 |
| ZIMS MAX FREEZE LEG CRAMP | MENTHOL | KOBAYASHI Healthcare International, Inc. | 7ef03298-6623-4cf4-b21f-74b2ffc11c6e | 2023-11-16 | Warnings | M017 |
| ZIMS MAX FREEZE PRO FORMULA | MENTHOL, UNSPECIFIED FORM | KOBAYASHI Healthcare International, Inc. | 436e8578-b609-4b45-8f84-0d111140fda6 | 2023-11-16 | Warnings | M017 |
| ZIMS MAX FREEZE PRO FORMULA | MENTHOL | KOBAYASHI Healthcare International, Inc. | 08dcfa78-7332-4f19-90d7-fdd7d446848a | 2023-11-16 | Warnings | M017 |
| Totally Fun After Sun | LIDOCAINE HCL | MJ Products Association, LLC | 965a2a29-914c-4ad0-b25f-5df3c30da393 | 2023-11-15 | Warnings | M017 |
| Universal Ice Cold Analgesic | MENTHOL | Universal Distribution Center LLC | 4fdf61d8-a9e0-4cd2-9e3f-0bdedc47a52f | 2023-11-15 | Warnings | M017 |
| ZIMS MAX FREEZE PRO FORMULA | MENTHOL, UNSPECIFIED FORM | KOBAYASHI Healthcare International, Inc. | b44beac3-1d20-434f-9a79-4fab1ac68791 | 2023-11-15 | Warnings | M017 |
| Universal Ice Cold Analgesic | MENTHOL | Universal Distribution Center LLC | 79ad55eb-b59d-4bb8-88e3-3b51e10a7f28 | 2023-11-15 | Warnings | M017 |
| PURE EASE Joint Muscle lnstant Pain Relief | CAPSAICIN, MENTHOL | SERENU, INC. | 42bf129c-5c84-4331-b6d0-78e3be71a985 | 2023-11-13 | Warnings | M017 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 415974 | menthol 4 % Topical Gel | PSN | 0a462c91-5300-e282-e063-6394a90a4cc2 | 2 |
| 415974 | menthol 0.04 MG/MG Topical Gel | SCD | 0a462c91-5300-e282-e063-6394a90a4cc2 | 2 |
| 415974 | menthol 4 % Topical Gel | SY | 0a462c91-5300-e282-e063-6394a90a4cc2 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 80684-101-00 | 80684010100 | 74 mL in 1 BOTTLE (80684-101-00) | 74 ml | 2024-02-01 | No | No | Current |