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 |
|---|---|---|---|---|---|---|
| Signature Care Menthol | MENTHOL 4% | Safeway | 27d3cb47-a6c7-5b7a-e063-6394a90a056f | 2024-12-05 | Warnings | M017 |
| ITCH X | BENZYL ALCOHOL/PRAMOXINE HYDROCHLORIDE | BF ASCHER AND CO INC | 03c16d33-8f59-0184-e054-00144ff8d46c | 2024-12-05 | Warnings | M017 |
| PO First Aid Series BURN | LIDOCAINE HYDROCHLORIDE | Nantong Health & Beyond Hygienic Products Inc. | f1c349a8-216d-4233-922e-c95329a33d1e | 2024-12-05 | Warnings | M017 |
| Post Treatment Balm | HYDROCORTISONE | Allure Labs Inc. | faa803e6-453c-4d86-85dd-5a5dcdd72d02 | 2024-12-05 | Warnings | M017 |
| CBD Pain Relief Cream | TROLAMINE SALICYLATE | Allure Labs | b6b3102a-4154-2da2-e053-2995a90ae99f | 2024-12-05 | Warnings | M017 |
| CVS Health Pain Relieving | CAMPHOR (SYNTHETIC), MENTHOL (UNSPECIFIED FORM), METHYL SALICYLATE | Natural Essentials, Inc. | f7198485-3d68-41d2-b9b9-f932a0649310 | 2024-12-04 | Warnings | M017 |
| Salonpas LIDOCAINE PLUS | BENZYL ALCOHOL, LIDOCAINE HYDROCHLORIDE | Hisamitsu America, Inc. | 364924d3-fac3-4f4e-9b40-decd4ec48245 | 2024-12-03 | Warnings | M017 |
| Bite and Itch | DIPHENHYDRAMINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE | Weeks & Leo Co., Inc. | 0a4d471b-c3f3-0a6a-e063-6394a90ad57b | 2024-12-03 | Warnings | M017 |
| Menthol | AMISH ORIGINS MEDICATED | Amish Origins LLC | 547abe39-3af3-4d70-99dd-caf8d67feda2 | 2024-12-03 | Warnings | M017 |
| Meijer Small Cold-Hot Medicated Patches | MENTHOL | Meijer Distribution Inc | be6012d6-2062-45ba-8fc4-abf14cff5845 | 2024-12-03 | Warnings | M017 |
| Salonpas | CAMPHOR, MENTHOL, METHYL SALICYLATE | Hisamitsu Pharmaceutical Co., Inc. | acdd5622-a9a7-4cc3-877e-57efea23303f | 2024-12-03 | Warnings | M017 |
| Salonpas | CAMPHOR, MENTHOL, METHYL SALICYLATE | Hisamitsu Pharmaceutical Co., Inc. | 5bb6c6a3-7dc0-463d-ab2c-9f3bd3f3eff5 | 2024-12-03 | Warnings | M017 |
| Salonpas DEEP Relieving | CAMPHOR, MENTHOL, METHYL SALICYLATE | Hisamitsu America, Inc. | a4ddb2b9-d023-4c8c-9285-93d51f93207d | 2024-12-03 | Warnings | M017 |
| Salonpas LIDOCAINE PLUS | BENZYL ALCOHOL, LIDOCAINE HYDROCHLORIDE | Hisamitsu America, Inc. | ea5b4a7f-d47d-4dbd-9288-c01329e387e5 | 2024-12-03 | Warnings | M017 |
| Hempvana Ultra Strength Pain Relief - Overnight | LIDOCAINE | Telebrands Corp | 1030d478-6805-6579-e063-6294a90a0c76 | 2024-12-02 | Warnings | M017 |
| Campho-Phenique Cold Sore Treatment | CAMPHOR (SYNTHETIC) AND PHENOL | Foundation Consumer Healthcare LLC | 106c0bb2-f2e2-4255-867d-d09ff6a5a2e6 | 2024-12-02 | Warnings | M017 |
| Campho-Phenique Antiseptic | CAMPHOR (SYNTHETIC) AND PHENOL | Foundation Consumer Healthcare LLC | 82edaef0-0709-4ae1-a664-c9c5adb91ee1 | 2024-12-02 | Warnings | M017 |
| Thermacare Arthritis and Nerve Pain Therapy Capsaicin Roll On | THERMACARE CAPSAICIN ROLL ON | Clarion Brands LLC | 2850f7e7-41dd-f5f9-e063-6394a90ae519 | 2024-12-02 | Warnings | M017 |
| BURN | LIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDE | NINGBO TIANBO FIRST AID PRODUCT CO., LTD. | 2ec1cf79-c341-4b79-9047-ce29f0dff419 | 2024-11-29 | Warnings | M017 |
| TheraCare Pain Relieving Lidocaine Cream | LIDOCAINE HYDROCHLORIDE | Veridian Healthcare | 242204d3-efc7-f7a9-e063-6294a90a5af1 | 2024-11-27 | 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 |