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 |
|---|---|---|---|---|---|---|
| 4x Medicated Toothache and Gum Cream | BENZOCAINE | Kroger | a8c5090a-24f9-4e73-e053-2a95a90acca0 | 2025-11-14 | Warnings | M017 |
| PM Toothache Relief | BENZOCAINE | CVS | 0a5a8cd0-d680-8a0f-e063-6294a90aa65c | 2025-11-14 | Warnings | M017 |
| PM Toothache Relief | BENZOCAINE | Walgreens | e816f742-fba9-3c12-e053-2a95a90a192f | 2025-11-14 | Warnings | M017 |
| 4x Medicated Toothache and Gum Cream | BENZOCAINE | Walgreens | a71c2092-4ece-b82e-e053-2995a90ac933 | 2025-11-14 | Warnings | M017 |
| After Bite Outdoor | DIPHENHYDRAMINE HCL | Tender Corporation d/b/a Adventure Ready Brands | 22b891a9-6386-dee1-e063-6394a90a5c2f | 2025-11-14 | Warnings | M017 |
| QR PAIN | ANALGESIC | MARYHELENE ENTERPRISES INC | 8f8f53e3-fe31-e7b5-e053-2995a90a710d | 2025-11-14 | Warnings | M017 |
| QR PAIN | ANALGESIC | MARYHELENE ENTERPRISES INC | 9984a510-30be-4013-e053-2995a90a841e | 2025-11-14 | Warnings | M017 |
| Anti-Itch Cream | DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE | Kroger | 3f881349-fcdd-e276-e063-6394a90ae49e | 2025-11-13 | Warnings | M017 |
| Rapid Relief | PLANTAR FASCIITIS PAIN RELIEF LIDOCAINE 4% MENTHOL 1% | RAPID AID VIET NAM COMPANY LIMITED | 434cb8b2-a996-5360-e063-6394a90ada03 | 2025-11-13 | Warnings | M017 |
| Rapid Relief | COLD RELIEF PATCH 5% MENTHOL | RAPID AID VIET NAM COMPANY LIMITED | 4360e3ec-7a4b-b28e-e063-6294a90a0bd6 | 2025-11-13 | Warnings | M017 |
| Rapid Relief | PAIN RELIEF PATCH CAMPHOR 110MG MENTHOL 33MG CAPSICUM EXTRACT 22MG | RAPID AID VIET NAM COMPANY LIMITED | 4360e3be-0ec4-cd57-e063-6394a90aca63 | 2025-11-13 | Warnings | M017 |
| Rapid Relief | PAIN RELIEF PATCH LIDOCAINE 4% MENTHOL 1% | RAPID AID VIET NAM COMPANY LIMITED | 43616ad7-58bb-e5ad-e063-6394a90a192b | 2025-11-13 | Warnings | M017 |
| 4x Medicated Severe Toothache and Gum Gel | BENZALKONIUM CHLORIDE | Meijer | 97ce7890-5093-1763-e053-2a95a90afae7 | 2025-11-13 | Warnings | M017 |
| Pain Reliever | CAMPHOR, MENTHOL | Kool 'N Fit Inc. | 2253f6bd-5707-b993-e063-6394a90aa74a | 2025-11-13 | Warnings | M017 |
| Rapid Relief | PLANTAR FASCIITIS PAIN RELIEF LIDOCAINE 4% MENTHOL 1% | RAPID AID VIET NAM COMPANY LIMITED | 4360e0d1-46cd-ab4b-e063-6394a90a55e1 | 2025-11-12 | Warnings | M017 |
| CVS Itch Relief | DIPHENHYDRAMINE HCL, ZINC ACETATE | CVS | 8723e097-296f-784a-e053-2991aa0a552e | 2025-11-12 | Warnings | M017 |
| Dragon Pain Relieving Balm | CAMPHOR, MENTHOL | Americanna Wellness, Inc. | 154d8821-3e76-b0e2-e063-6294a90ae077 | 2025-11-12 | Warnings | M017 |
| Good neighbor Pharmacy Itch Relief | DIPHENHYDRAMINE HCL, ZINC ACETATE | AMERISOURCEBERGEN DRUG CORPORATION | 87395273-380c-7cef-e053-2991aa0a54c6 | 2025-11-12 | Warnings | M017 |
| Quality Choice Itch Relief | DIPHENHYDRAMINE HCL, ZINC ACETATE | Chain Drug Marketing Association | 8735b298-83f3-0b5d-e053-2a91aa0a8292 | 2025-11-12 | Warnings | M017 |
| Dragon Pain Relieving Balm | CAMPHOR, MENTHOL | Americanna Wellness, Inc. | 1550e794-b3c0-4769-e063-6294a90a8c2d | 2025-11-12 | 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 |