COLD AND HOT MEDICATED LARGE
- Product NDC
- 52000-421
- 11-digit product format
- 520000421
- Labeler code
- 52000
- Product ID
- 52000-421_6e490a04-d32f-4dec-9ced-ab55fae6efb1
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Menthol
- Dosage form
- PATCH
- Route
- TOPICAL
- Labeler
- Universal Distribution Center LLC
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-11-25
- Substance
- MENTHOL, UNSPECIFIED FORM
- Active strength
- .05 g/g
- 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
- COLD AND HOT MEDICATED LARGE
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| MENTHOL, UNSPECIFIED FORM | .05 g/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| L7T10EIP3A | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 420222 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| d6780230-aa96-4055-b054-be41358568b6 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| f52be47f-7aa7-46c0-b1fa-50c18dd50206 | Product name | 1 | 20201029 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 52000-421-41 | COLD AND HOT MEDICATED LARGE | 19 g in 1 PATCH | PATCH | 19 | 7 | |
| 52000-421-41 | COLD AND HOT MEDICATED LARGE | 1 in 1 POUCH | PATCH | 1 | 7 | |
| 52000-421-42 | COLD AND HOT MEDICATED LARGE | 1 in 1 POUCH | PATCH | 1 | 7 | |
| 52000-421-42 | COLD AND HOT MEDICATED LARGE | 24 in 1 BOX | PATCH | 24 | 7 |
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 |
|---|---|---|---|---|---|---|
| Eagle Brand Medicated Roll On Aromatic | CAMPHOR, MENTHOL, METHYL SALICYLATE | PT. EAGLE INDO PHARMA | 0f333f93-bec6-72d5-e063-6394a90a4e3f | 2026-04-27 | Warnings | M017 |
| HIP PAIN RELIEF ROLL-ON | LIDOCAINE AND MENTHOL | Guangzhou Liuquanmiao Import & Export Trade Co., Ltd. | 502f1f9e-8552-ca7b-e063-6394a90a7c53 | 2026-04-24 | Warnings | M017 |
| SOMBRA WARM THERAPY | MENTHOL CAMPHOR | SOMBRA COSMETICS INC. | de78dba9-53b3-4dbd-9dd2-6a692378da34 | 2026-04-24 | Warnings | M017 |
| Rite Aid Itch Relief | DIPHENHYDRAMINE HCL 2%, ZINC ACETATE 0.1% | Rite Aid | e285df43-317c-d862-e053-2a95a90acdce | 2026-04-23 | Warnings | M017 |
| FixMySkin Healing Balm Unflavored | HYDROCORTISONE | Lovely Skin, Inc. | 9ff8db07-ad6d-4865-a534-94bd8312957e | 2026-04-23 | Warnings | M017 |
| DCH Labs Cortisone | HYDROCORTISONE 1% | Derma Care Research Labs | 5025f53a-02e0-0f6a-e063-6394a90adbbf | 2026-04-23 | Warnings | M017 |
| Hydrocortisone 1% | HYDROCORTISONE | Preferred Pharmaceuticals Inc. | e0f46445-64c5-4f5d-90b0-3fa07ed7d1b4 | 2026-04-22 | Warnings | M017 |
| Dr. Carrasco Pain Relief | MENTHOL | Carrasco Enterprises, Inc. | befa8526-f468-428e-a829-422c2ea48612 | 2026-04-21 | Warnings | M017 |
| HealthWise Feminine Anti-itch Cream | BENZOCAINE, RESORCINOL | Veridian Healthcare | 4ff88b9e-5869-a1cb-e063-6294a90a87b7 | 2026-04-21 | Warnings | M017 |
| SOMBRA COOL THERAPY | MENTHOL | SOMBRA COSMETICS INC. | 87e9b16b-1cab-48f7-b9e4-1c3eaeeb3ca3 | 2026-04-21 | Warnings | M017 |
| Careland Lidocaine Pain Relieving | LIDOCAINE | Planet (Anhui) Pharmaceutical Co., Ltd. | c4c86a8f-1d57-49d2-a65f-acb0dccf2f87 | 2026-04-21 | Warnings | M017 |
| KOXUO Arnica Bruise Cream | ARNICA BRUISE CREAM | Guangzhou Jingliang Cosmetics Co., Ltd. | 5003bf83-fa01-b01a-e063-6294a90ad37f | 2026-04-21 | Warnings | M017 |
| KT Pain Relief Cream Magnesium with Arnica and 4% Lidocaine | KT PAIN RELIEF CREAM MAGNESIUM WITH ARNICA AND 4% LIDOCAINE ROLLON | Clarion Brands LLC | 4f82993c-ebc4-5787-e063-6294a90a12d6 | 2026-04-20 | Warnings | M017 |
| KT Pain Relief Cream Magnesium with Cooling 5% Menthol | KT PAIN RELIEF CREAM MAGNESIUM WITH COOLING 5% MENTHOL | Clarion Brands LLC | 4fe64056-f3c6-bc76-e063-6294a90a7e62 | 2026-04-20 | Warnings | M017 |
| Kevo-Prophen | JUNIPER TAR | Faeve, LLC | 4fe773a8-77cd-831e-e063-6294a90ae2ca | 2026-04-20 | Warnings | M017 |
| BeeVenom | METHYL SALICYLATE | Menper Distributors, Inc. | 4fe7a986-336d-ad4e-e063-6294a90a0b8a | 2026-04-20 | Warnings | M017 |
| Benzodent | BENZOCAINE | Focus Consumer Healthcare, LLC | 5fdcb871-d387-6352-e053-2991aa0a09da | 2026-04-20 | Warnings | M017 |
| Tecnu Calagel | DIPHENHYDRAMINE HYDROCHLORIDE | Tec Laboratories Inc. | 8bc9cbfe-1dd4-18ed-e053-2a95a90a7966 | 2026-04-20 | Warnings | M017 |
| Aemerry Numbing Cream | MENTHOL 5% | Da Capo Prima LLC | 4fefddaf-19c8-86b4-e063-6294a90abffc | 2026-04-20 | Warnings | M017 |
| Sting Relief Swab | BENZOCAINE | 4 Visions LLC | 4fc7a356-2f1d-85af-e063-6394a90aec6b | 2026-04-18 | Warnings | M017 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 420222 | menthol 5 % Medicated Patch | PSN | d6780230-aa96-4055-b054-be41358568b6 | 7 |
| 420222 | menthol 0.05 MG/MG Medicated Patch | SCD | d6780230-aa96-4055-b054-be41358568b6 | 7 |
| 420222 | menthol 5 % Medicated Patch | SY | d6780230-aa96-4055-b054-be41358568b6 | 7 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 52000-421-41 | 52000042141 | 1 PATCH in 1 POUCH (52000-421-41) / 19 g in 1 PATCH | 1 patch | 2024-11-25 | No | No | Current |
| 52000-421-42 | 52000042142 | 24 POUCH in 1 BOX (52000-421-42) / 1 PATCH in 1 POUCH / 19 g in 1 PATCH | 24 pouch | 2024-11-25 | No | No | Current |