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 |
|---|---|---|---|---|---|---|
| Hydrocortisone Acetate | HYDROCORTISONE ACETATE | Bentlin Products LLC | 4346351c-8e11-46ae-b428-98d17f55beb9 | 2023-10-30 | Warnings | M017 |
| Biofreeze Roll-On | MENTHOL | A-S Medication Solutions | 814b37ea-5441-4cec-8794-71ca01d849ae | 2023-10-30 | Warnings | M017 |
| Dr. Sheffield Hydrocortisone Anti itch | HYDROCORTISONE | Sheffield Pharmaceuticals LLC | 71c9f2f4-2188-45eb-b55e-3856ac78070b | 2023-10-30 | Warnings | M017 |
| Family Wellness | BENZOCAINE, RESORCINOL | Zhejiang Jingwei Pharmaceutic Al Co., Ltd. | df540eb8-6773-4647-9cc2-c3fd14d7355e | 2023-10-27 | Warnings | M017 |
| Family Wellness | HYDROCORTISONE 1% | FRONT PHARMACEUTICAL PLC | ea26265d-f24e-458e-8bf0-287b2d49f4f4 | 2023-10-27 | Warnings | M017 |
| Joint Formula 88 MAX PLUS | CAMPHOR | Sarati International, Inc. | f5d78335-b78d-4909-a88b-9daa3c18ba15 | 2023-10-27 | Warnings | M017 |
| OsmoFlex | MENTHOL | Sarati International, Inc. | 479147c0-4cf4-4d7a-8b8e-1a0de49ed73e | 2023-10-27 | Warnings | M017 |
| Thera plus Anti-itch with aloe Hydrocortisone | HYDROCORTISONE | Fourstar Group USA, Inc. | c69d0670-a65b-1680-e053-2995a90a2ee5 | 2023-10-26 | Warnings | M017 |
| Family Wellness | DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE | FRONT PHARMACEUTICAL PLC | fde2069b-344e-46da-bb95-c5113e0f35d6 | 2023-10-26 | Warnings | M017 |
| MAXIMUM STRENGTH HEMORRHOIDAL RELIEF | LIDOCAINE | CVS PHARMACY, INC | b61424bf-3b23-420b-a7bc-256ddb96aa22 | 2023-10-25 | Warnings | M017 |
| Assured | HYDROCORTISONE | Zhejiang Jingwei Pharmaceutic Al Co., Ltd. | bc97f364-9443-47b8-9c2d-b5dcc00cc9b7 | 2023-10-25 | Warnings | M017 |
| Stopain Clinical | MENTHOL, UNSPECIFIED FORM | Troy Manufacturing, Inc. | b41091b4-0dc0-4a88-8ff6-11979b3d307a | 2023-10-25 | Warnings | M017 |
| Thera Plus | HYDROCORTISONE | Zhejiang Jingwei Pharmaceutical Co., Ltd. | bcc99e5a-2403-46da-9c9d-8411fa4104e0 | 2023-10-25 | Warnings | M017 |
| Assured | LIDOCAINE HYDROCHLORIDE | Zhejiang Jingwei Pharmaceutical Co., Ltd. | ab25c47d-bbe6-4e2b-9e39-dd9f4da3ee8c | 2023-10-25 | Warnings | M017 |
| Red hot | CAPSAICIN | The Hygenic Company, LLC | d100092c-e10b-2063-e053-2995a90aedb2 | 2023-10-25 | Warnings | M017 |
| Stopain Clinical | MENTHOL | Troy Manufacturing, Inc. | c8d4ae28-efc4-6a00-e053-2a95a90a40bf | 2023-10-25 | Warnings | M017 |
| Cryo10 Topical Analgesic | MENTHOL | Element 26 LLC | ff1d2140-9302-918c-e053-6394a90acb9a | 2023-10-25 | Warnings | M017 |
| Stopain Clinical | MENTHOL | Troy Manufacturing, Inc. | 3336cc35-e773-4705-84b5-61040604beef | 2023-10-25 | Warnings | M017 |
| CARMEX Multi-Symptom 3 in 1 COLD Sore treatment External Analgesic Skin Protectant | BENZOCAINE, WHITE PETROLATUM | Carma Laboratories, Inc. | bbf0abcd-b7d6-b5e4-e053-2995a90a5240 | 2023-10-25 | Warnings | M017 |
| Carmex Classic Lip Balm Medicated | CAMPHOR (SYNTHETIC), WHITE PETROLATUM | Carma Laboratories, Inc. | bbee66b9-39ff-4e7e-e053-2995a90a43be | 2023-10-25 | 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 |