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 |
|---|---|---|---|---|---|---|
| COOL BREEZE Pain Relief | MENTHOL | COOL BREEZE US LLC | 14dcf4ee-6778-49d4-8601-9205737432ea | 2023-11-01 | Warnings | M017 |
| Lidozen | LIDOCAINE HYDROCHLORIDE, MENTHOL | Proficient Rx LP | 1ebb45e5-4541-4c95-abe1-661ef763a610 | 2023-11-01 | Warnings | M017 |
| Walgreens Pain Relieving Cream | LIDOCAINE 4% | Walgreens | ce1b55ed-f5c5-ea8b-e053-2a95a90acd40 | 2023-10-31 | Warnings | M017 |
| Walgreens pain relieving | LIDOCAINE 4% | Walgreens | ce2b9e57-749d-715c-e053-2995a90aaf8d | 2023-10-31 | Warnings | M017 |
| Walgreens Cool n heat | LIDOCAINE 4% MENTHOL 1% | Walgreens | ce168ab7-ec4a-daea-e053-2995a90af829 | 2023-10-31 | Warnings | M017 |
| Methyl Salicylate 40 Percent | METHYL SALICYLATE | Alexso, Inc | 53407aab-094c-4393-a2b9-54fd85321e3e | 2023-10-31 | Warnings | M017 |
| 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 |
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 |