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 |
|---|---|---|---|---|---|---|
| LIDOGUARD | LIDOCAINE 4% | ViolaCare, Inc. | d8b021b6-cf71-4f7e-9d27-92d0982bd34f | 2026-03-25 | Warnings | M017 |
| LactiGo | MENTHOL | LactiGo, Inc. | 4dda6ac4-d849-69a6-e063-6394a90a3c54 | 2026-03-25 | Warnings | M017 |
| Alocane Max | LIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDE | Quest Products LLC | 0a33f9a9-1fdc-7cdf-e063-6294a90adca1 | 2026-03-25 | Warnings | M017 |
| EjaGuard | LIDOCAINE | MOLANSPACE INC | 475f64ef-d636-7e87-e063-6294a90ae32f | 2026-03-25 | Warnings | M017 |
| Hydrocortisone 1% | HYDROCORTISONE | ProStat First Aid | 4e53d29c-ed3c-f481-e063-6294a90a3181 | 2026-03-25 | Warnings | M017 |
| Topicaine Ultra | TOPICAINE ULTRA | Oncora Pharma, LLC | e052f718-700a-44e0-8770-65451b812ee1 | 2026-03-24 | Warnings | M017 |
| Hot Pap Cataplasma | METHYL SALICYLATE, VANILLYL NONYLAMIDE | Masaem Company | 4dbeda13-b198-0cf0-e063-6294a90a8180 | 2026-03-24 | Warnings | M017 |
| Barmicil Anti-itch | HYDROCORTISONE | OPMX LLC | 850084c3-1dd4-eb8d-e053-2a91aa0a130b | 2026-03-24 | Warnings | M017 |
| Jeil Hangbang Paff Soo S Cataplasma | GLYCOL SALICYLATE, L-MENTHOL | Masaem Company | 4dd040db-07cf-361a-e063-6394a90a8001 | 2026-03-24 | Warnings | M017 |
| Zenol Double Action | METHYL SALICYLATE, L-MENTHOL | BA TRADE INC | 4da998fc-75a3-583f-e063-6394a90a59c7 | 2026-03-23 | Warnings | M017 |
| Ultra Strength Topical Pain Relief Cream | CAMPHOR, MENTHOL, METHYL SALICYLATE | J C UDEOZOR & SONS GLOBAL INDUSTRIES LTD | 4db9ae57-4ab4-8fe4-e063-6394a90a7e51 | 2026-03-23 | Warnings | M017 |
| DR. SANA ALIVIO TOTAL ALIVIO TOTAL ROLL ON | ALIVIO TOTAL ROLL ON | EVI LABS | 4da01338-8739-08a8-e063-6294a90ae157 | 2026-03-22 | Warnings | M017 |
| DR SANA ALIVIO TOTAL ALIVIO TOTAL | ALIVIO TOTAL | EVI LABS | 4da1c3b8-9af2-6e9f-e063-6394a90a86ae | 2026-03-22 | Warnings | M017 |
| SORE NO MORE | MENTHOL CAMPHOR | SOMBRA COSMETICS INC. | 80d97c80-bdc0-4d5d-b6e2-86dfdb15d7bd | 2026-03-20 | Warnings | M017 |
| CVS Health Antiseptic Wound Wash | LIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDE | CVS Pharmacy | 53ac017a-eccb-3b24-e054-00144ff88e88 | 2026-03-20 | Warnings | M017 |
| Tecnu Diphenhydramine HCl Pain Relieving Anti Itch Gel 2% | ANTI ITCH GEL | Walgreens | 3d6e8c62-2fcc-51c2-e063-6394a90a33f7 | 2026-03-20 | Warnings | M017 |
| ANIXIKE Numbing | MENTHOL 5% NUMBING | Jiangxi Yudexi Pharmaceutical Co., LTD | 4d5c52d7-8e81-b62f-e063-6394a90ad03e | 2026-03-19 | Warnings | M017 |
| SYLVIRENE NUMBING | MENTHOL 5% NUMBING | Jiangxi Yudexi Pharmaceutical Co., LTD | 4d47e8c7-d293-bf63-e063-6294a90a5fd9 | 2026-03-18 | Warnings | M017 |
| Antibiotic and Pain Relief | NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE | STRATEGIC SOURCING SERVICES LLC | f7aa9330-c47c-4d2f-b784-11b831d919d6 | 2026-03-18 | Warnings | M017 |
| hydrocortisone | HYDROCORTISONE | Bryant Ranch Prepack | 99726aa3-3b45-4175-8471-279419af5457 | 2026-03-18 | 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 |