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 |
|---|---|---|---|---|---|---|
| AleveX | CAMPHOR AND MENTHOL | Bayer HealthCare LLC | bc66bc1b-c0d5-2481-e053-2a95a90a75de | 2025-12-04 | Warnings | M017 |
| AleveX | CAMPHOR AND MENTHOL | Bayer HealthCare LLC | bafd199a-e198-d5d1-e053-2995a90ad1cb | 2025-12-04 | Warnings | M017 |
| AleveX | CAMPHOR AND MENTHOL | Bayer HealthCare LLC | bafdf06b-25f5-e29e-e053-2a95a90a5e1b | 2025-12-04 | Warnings | M017 |
| Milagroso | METHYL SALICYLATE | Pharmadel LLC | fdcc8f44-afa0-3af0-e053-6394a90aa46d | 2025-12-04 | Warnings | M017 |
| Alocane Max | LIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDE | Quest Products LLC | 0a35221a-2fcb-2735-e063-6294a90a88ca | 2025-12-04 | Warnings | M017 |
| Pain Relieving | TROLAMINE SALICYLATE | CARDINAL HEALTH 110, LLC. DBA LEADER | b813262e-57c6-4d2c-8cc0-7a17f6f59343 | 2025-12-04 | Warnings | M017 |
| Gold Bond Medicated Extra Strength Body | MENTHOL | Gold Bond Co LLC | 7b75b7de-9c0b-4edf-b923-320f7d2bb1e6 | 2025-12-04 | Warnings | M017 |
| Lidocaine Patch | LIDOCAINE | Shenzhen Finona Information Technology Co., Ltd | 38767081-7011-6602-e063-6394a90a2784 | 2025-12-03 | Warnings | M017 |
| 4% Lidocaine Maximum Strength Pain Relief | LIDOCAINE | Shenzhen Finona Information Technology Co., Ltd | 3e5a5165-a773-0501-e063-6294a90ae2f4 | 2025-12-03 | Warnings | M017 |
| Leader Lidocaine | LIDOCAINE HCL | CARDINAL HEALTH | cece6765-0e2f-5ce9-e053-2995a90a3758 | 2025-12-03 | Warnings | M017 |
| Westlake Lidocaine | LIDOCAINE HCL | Westlake Pharma LLC | 0c586a14-1a2a-9f42-e063-6294a90a16c1 | 2025-12-03 | Warnings | M017 |
| CVS Lidocaine Maximum Strength | LIDOCAINE HCL | CVS Pharmacy | 87490c0f-a4d9-740e-e053-2a95a90a4724 | 2025-12-03 | Warnings | M017 |
| CVS Maximum Strength Burn | LIDOCAINE HYDROCHLORIDE 4% | CVS Pharmacy | 4510f379-c5a4-92c3-e063-6294a90a0a32 | 2025-12-03 | Warnings | M017 |
| LidoPatch Pain Relief | LIDOCAINE, MENTHOL | JAR Laboratories | 07289aa1-43ed-df31-e063-6394a90a764a | 2025-12-03 | Warnings | M017 |
| Equate Pain Relief Cream | 4% LIDOCAINE HCL | Walmart, Inc | 7d8e8a9a-5474-4c7b-e053-2991aa0a29f5 | 2025-12-03 | Warnings | M017 |
| Solarcaine Burn Pain Relief 4oz | SOLARCAINE BURN PAIN RELIEF 4OZ | WellSpring Pharmaceutical Corporation | 14f23c28-c713-4868-9f46-66363bf94b2c | 2025-12-03 | Warnings | M017 |
| ElixirCortiRelief | HYDROCORTISONE | ELIXIR HEALTHCARE USA, LLC. | a6ca66f3-9759-4c98-a758-45700bc08352 | 2025-12-02 | Warnings | M017 |
| Pain Relief Gel-Patch | LIDOCAINE 4% | Trifecta Pharmaceuticals USA, LLC. | 12a27ce7-c547-7134-e063-6394a90a94bd | 2025-12-02 | Warnings | M017 |
| 5Kind DMSO | MENTHOL, METHYL SALICYLATE | 5KIND TRADING LTD | 6a6c7241-f544-4784-9581-f5b172fdbec7 | 2025-12-02 | Warnings | M017 |
| PEDIADERMICS ECZEMA 2 | HYDROCORTISONE | RENU LABORATORIES, LLC | da840bf6-ed65-bafc-e053-2a95a90a92d5 | 2025-12-02 | 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 |