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
- 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 |
|---|---|---|---|---|---|---|
| Medicated Herbal Lip Balm | MENTHOL | Earth Mama Angel Baby LLC | 1cc2391e-6a7a-609c-e063-6394a90a6305 | 2024-10-01 | Warnings | M017 |
| CVS Health Lidocaine Plus Pain Relieving | LIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOL | NATURAL ESSENTIALS, INC. | 1adb9b74-4a01-4461-b845-f3aedcb3f810 | 2024-10-01 | Warnings | M017 |
| Circata | CAPSAICIN | PureTek Corporation | b67161d7-cc5c-e971-e053-2995a90acbe7 | 2024-10-01 | Warnings | M017 |
| Menticam | CAMPHOR,MENTHOL, METHYL SALICYLATE | PureTek Corporation | ffea2e97-777f-434b-e053-6394a90a3a63 | 2024-10-01 | Warnings | M017 |
| Herb Street Sore Muscle Relief | METHYL SALICYLATE | Balassa Laboratories Inc. | e43943c2-d4cd-44c5-a0ff-403a8d42860f | 2024-10-01 | Warnings | M017 |
| hydrocortisone | HYDROCORTISONE | Kroger Company | 68dab606-0385-48b7-9a7b-a2cf83d20393 | 2024-09-29 | Warnings | M017 |
| kirkland signature hydrocortisone plus maximum strength | HYDROCORTISONE | Costco Wholesale Company | 481341c5-db1f-43fb-aed7-f40495a4eab8 | 2024-09-29 | Warnings | M017 |
| Care One hydrocortisone maximum strength | HYDROCORTISONE | American Sales Company | 32593229-d0ac-4d6c-831a-089fc6e76152 | 2024-09-29 | Warnings | M017 |
| good sense anti itch | HYDROCORTISONE | L. Perrigo Company | b7a896cc-1d78-45c0-a73e-aa1e117f7d3b | 2024-09-29 | Warnings | M017 |
| Topcare Hydrocortisone | HYDROCORTISONE | Topco Associates LLC | b7362f21-f1a3-4edc-b5b6-a16680e05df3 | 2024-09-29 | Warnings | M017 |
| hydrocortisone | HYDROCORTISONE | H E B | 412ca2d1-064b-4438-aee1-fcb5cf27c7db | 2024-09-29 | Warnings | M017 |
| Topcare Antibiotic | NEOMYCIN, POLYMYXIN B, PRAMOXINE HYDROCHLORIDE | Topco Associates LLC | 8c349cac-20e1-4600-9b0a-fcfe929551c5 | 2024-09-26 | Warnings | M017 |
| good sense anti itch | HYDROCORTISONE | A-S Medication Solutions | 072dd455-24a5-4a44-aaef-d3e137d005a6 | 2024-09-26 | Warnings | M017 |
| SYREN Intimate Relief | LIDOCAINE HYDROCHLORIDE | Icon Health Science | 57d5a080-3583-4510-e053-2a91aa0ad589 | 2024-09-25 | Warnings | M017 |
| AOSI HEALTHCARE | HYDROCORTISONE | Nantong Health & Beyond Hygienic Products Inc. | f4db90ad-dd62-44f1-9655-2614ed36581e | 2024-09-25 | Warnings | M017 |
| AOSI HEALTHCARE BURN | LIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDE | Nantong Health & Beyond Hygienic Products Inc. | a28b920c-0bb8-4b5a-addd-26ea164e036e | 2024-09-25 | Warnings | M017 |
| anti itch | DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE | Kroger Company | 067e718a-ec0b-4895-8f9f-82d64ab4c7b4 | 2024-09-24 | Warnings | M017 |
| topcare anti itch | DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE | Topco Associates LLC | e0fb332a-2903-41ef-b35b-7cd3a74cff99 | 2024-09-24 | Warnings | M017 |
| equaline anti itch | HYDROCORTISONE | United Natural Foods, Inc. dba UNFI | 83cd9f60-a4c4-4dea-97a7-cd96aade9e88 | 2024-09-24 | Warnings | M017 |
| good sense itch relief | DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE | L. Perrigo Company | 162fe0a3-3995-4e6f-94ed-f839b2b0c80e | 2024-09-24 | 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 |