Gel Cooling Pain Relief
- Product NDC
- 11344-894
- 11-digit product format
- 113440894
- Labeler code
- 11344
- Product ID
- 11344-894_5b86bd3c-493e-70b8-e063-6294a90a1225
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Menthol
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Nice-Pak Products, LLC
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2021-01-13
- Substance
- MENTHOL
- Active strength
- 40 mg/mL
- 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
- Gel Cooling Pain Relief
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| MENTHOL | 40 mg/mL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 11344-894-18 | Gel Cooling Pain Relief | 74 mL in 1 BOTTLE, WITH APPLICATOR | GEL | 74 | 4 |
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| terrasil Bruise and Pain Relief Maximum Strength | CAMPHOR, MENTHOL | Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions | 240b231d-a8b2-c64c-e063-6394a90a7440 | 2024-10-09 | Warnings | M017 |
| Muscle Freeze Relief | MENTHOL | NATURAL ESSENTIALS, INC. | 815c534b-096d-49f2-b5f2-8c885d45a5e6 | 2024-10-09 | Warnings | M017 |
| HYDROCORTISONE | HYDROCORTISONE | VIVE HEALTH LLC | 2410dc2f-9332-19fa-e063-6394a90a2835 | 2024-10-09 | Warnings | M017 |
| CVS Health Lidocaine Pain-Relieving | LIDOCAINE | Natural Essentials, Inc. | fc23b2e2-4abc-4119-b8bd-305b4327f1dd | 2024-10-09 | Warnings | M017 |
| KERACARE | MENTHOL 1% | Avlon Industries, Inc. | f72eec6d-1204-4e03-8aed-d5bcf8d3bbce | 2024-10-09 | Warnings | M017 |
| Eagle Medicated | MENTHOL METHYL SALICYLATE | Eagle Indo Pharma, PT | da338796-de9c-be51-e053-2a95a90a2509 | 2024-10-07 | Warnings | M017 |
| Eagle Medicated | MENTHOL METHYL SALICYLATE | Eagle Indo Pharma | e2c5f821-cdd5-190d-e053-2a95a90a9159 | 2024-10-07 | Warnings | M017 |
| NanoXtreme Pain Relieving | MENTHOL, METHYL SALICYLATE | MG Science Technologies LLC | c1490c30-a9db-4120-adaf-9e8000169e46 | 2024-10-07 | Warnings | M017 |
| CAREALL Hydrocortisone Maximum Strength | HYDROCORTISONE | New World Imports, Inc | ea656cf8-cad5-4fa5-82e7-daec77a0bb04 | 2024-10-07 | Warnings | M017 |
| Eagle Medicated Oil Refreshing | MENTHOL, METHYL SALICYLATE | Eagle Indo Pharma, PT | e2729023-d689-7ae2-e053-2a95a90a78dc | 2024-10-06 | Warnings | M017 |
| Flanax Back Pain Relief | LIDOCAINE | Belmora LLC | 46d33346-e582-4af1-b81a-feca7033dceb | 2024-10-04 | Warnings | M017 |
| Muscle Balm | MENTHOL, UNSPECIFIED FORM, CAMPHOR (SYNTHETIC) | Natural Essentials, Inc. | 16918ba3-2e07-4232-9ed3-4c7751796cd2 | 2024-10-04 | Warnings | M017 |
| Fast Freeze Pain Relieving Continuous | MENTHOL, UNSPECIFIED FORM | Natural Essentials, Inc. | 998a4824-9ed9-4fe0-b45b-72e52861fcd3 | 2024-10-04 | Warnings | M017 |
| Fast Freeze Lidocaine Roll-On | LIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOL | Natural Essentials, Inc. | 74b06366-5eb4-4eba-aa2b-2b672828294d | 2024-10-04 | Warnings | M017 |
| Fast Freeze Lidocaine | LIDOCAINE | Natural Essentials, Inc. | 029bd3fb-1b5b-48e0-b9af-d91d548b5b0f | 2024-10-04 | Warnings | M017 |
| Fast Freeze | MENTHOL | Natural Essentials Inc. | a96e3e41-871c-4cf3-93b6-af2a6246ded8 | 2024-10-04 | Warnings | M017 |
| CVS Pain Relief | MENTHOL 4% | CVS | 20234356-5e80-b79e-e063-6294a90a2ee3 | 2024-10-04 | Warnings | M017 |
| FLANAX BACK PAIN RELIEF | LIDOCAINE | Belmora Llc | af4bf57c-f250-4506-83eb-e0f253e96062 | 2024-10-04 | Warnings | M017 |
| topcare hydrocortisone | HYDROCORTISONE | Topco Associates LLC | 11a30ec9-ebc2-4a00-8a8d-431d0d973b37 | 2024-10-03 | Warnings | M017 |
| pain relief patch | LIDOCAINE 4% | Bionpharma Inc. | 19c69983-4e78-8ec5-e063-6394a90a84be | 2024-10-03 | Warnings | M017 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 415974 | menthol 4 % Topical Gel | PSN | 696f678d-8f76-4087-a52e-efe3c9f814d0 | 4 |
| 415974 | menthol 0.04 MG/MG Topical Gel | SCD | 696f678d-8f76-4087-a52e-efe3c9f814d0 | 4 |
| 415974 | menthol 4 % Topical Gel | SY | 696f678d-8f76-4087-a52e-efe3c9f814d0 | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 11344-894-18 | 11344089418 | 74 mL in 1 BOTTLE, WITH APPLICATOR (11344-894-18) | 74 ml | 2021-01-13 | No | No | Current |