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
- 2027-12-31
- 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
- 2027-12-31
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 |
|---|---|---|---|---|---|---|
| Burn First Aid | BURN FIRST AID | Dynarex Corporation | 826e08be-dffa-5a27-e053-2a91aa0a8701 | 2024-01-22 | Warnings | M017 |
| Target Up and Up Pain Relief Menthol Topical Analgesic Roll-On | MENTHOL | TARGET CORPORATION | 0f95fc55-8665-9e89-e063-6394a90a7891 | 2024-01-22 | Warnings | M017 |
| CVS Health Lidocaine Pain Relief Plus Menthol | LIDOCAINE, MENTHOL, UNSPECIFIED FORM | Natural Essentials, Inc. | 77978069-a1b4-473e-83c9-8320e00eea89 | 2024-01-19 | Warnings | M017 |
| ZIMS MAX FREEZE LEG CRAMPS | CAMPHOR, MENTHOL | KOBAYASHI Healthcare International, Inc. | ba26635d-95d3-4d88-93cc-1fd4fd29fd79 | 2024-01-18 | Warnings | M017 |
| Burn | LIDOCAINE | HART Health | e95ebdac-9789-41c2-97da-2307e4538794 | 2024-01-18 | Warnings | M017 |
| Medi-First Hydrocortisone 1% | HYDROCORTISONE ACETATE | Unifirst First Aid Corporation | bd216f5d-f304-7d8d-e053-2a95a90aa9ce | 2024-01-17 | Warnings | M017 |
| Green Guard Hydrocortisone 1% | HYDROCORTISONE | Unifirst First Aid Corporation | bd348e2a-57b1-3f17-e053-2a95a90a8bdc | 2024-01-17 | Warnings | M017 |
| Pain Relief | LIDOCAINE, MENTHOL | HUMN Pharmaceuticals Inc | 6c96f94a-e724-eab3-e053-2991aa0aab88 | 2024-01-17 | Warnings | M017 |
| CVS Health Lidocaine Pain Relief | LIDOCAINE | Natural Essentials, Inc. | 52e82e70-53b7-4ecb-be39-fe10c94cc444 | 2024-01-17 | Warnings | M017 |
| CVS Health XL Lidocaine Pain Relief | LIDOCAINE | NATURAL ESSENTIALS, INC. | ec16da91-8244-402b-b8d8-84896094ac2c | 2024-01-17 | Warnings | M017 |
| Anti-itch | DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE | Target Corporation | f444b0a6-2ed3-4236-8206-342150290675 | 2024-01-17 | Warnings | M017 |
| Maximum Strength Hydrocortisone Anti-itch | HYDROCORTISONE 1% | Target Corporation | 4ff39cb8-3a20-4fe7-9829-1e882a484668 | 2024-01-17 | Warnings | M017 |
| Burn | LIDOCAINE HYDROCHLORIDE | Nantong Health & Beyond Hygienic Products Inc. | eca272cb-ac8f-982b-e053-2995a90aa8b2 | 2024-01-15 | Warnings | M017 |
| American Safety and First Aid | HYDROCORTISONE ACETATE | Orazen Inc | eb0cfde0-c463-e9b5-e053-2a95a90a1924 | 2024-01-15 | Warnings | M017 |
| American Safety and First Aid | HYDROCORTISONE ACETATE | Orazen Inc | eb0cce4b-c70a-1b2d-e053-2995a90aa4aa | 2024-01-15 | Warnings | M017 |
| Oral Pain Relief Gel | BENZOCAINE 20% | Sled Distribution, LLC | e7391302-831e-14dc-e053-2a95a90ac236 | 2024-01-15 | Warnings | M017 |
| FIRST SHIELD | LIDOCAINE HCI | Ever Ready First Aid | e022bf8f-3dd8-de22-e053-2995a90a219b | 2024-01-15 | Warnings | M017 |
| Flexigen | MENTHOL 1.25% | Derma Care Research Labs, LLC | e9ae2682-59b4-e796-e053-2995a90af921 | 2024-01-15 | Warnings | M017 |
| Vita-P Oral and Nasal | MENTHOL 1% | Beijing HKKY Medical Tech. Co., Ltd. | 537c3843-1c92-41c6-b724-52701bbddeab | 2024-01-13 | Warnings | M017 |
| Caring mill Lidocaine Aloe Gel Burn and Pain Relief | LIDOCAINE HYDROCHLORIDE | FSA Store Inc. | 0ec20c87-1681-dd23-e063-6394a90a291c | 2024-01-12 | 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 |