DIRT Pain Relieving Gel
- Product NDC
- 83067-463
- 11-digit product format
- 830670463
- Labeler code
- 83067
- Product ID
- 83067-463_097705c5-f169-19a5-e063-6294a90acfaf
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- MENTHOL
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- PURIVITAE, LLC
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2023-10-03
- Substance
- MENTHOL
- Active strength
- 40 mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- 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
- DIRT Pain Relieving Gel
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| MENTHOL | 40 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| L7T10EIP3A | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 415974 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| e43e2cbd-d114-4b11-8baf-7a775881cd97 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 83067-463-00 | DIRT Pain Relieving Gel | 88 mL in 1 BOTTLE | GEL | 88 | 2 |
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 |
|---|---|---|---|---|---|---|
| OWELL NATURALS Deep Penetrating Pain Relief | MENTHOL | OWELL NATURALS BRAND, LLC | b36eb017-ed8d-476e-994b-22b275e00543 | 2024-01-02 | Warnings | M017 |
| Dibucaine | DIBUCAINE 1% | Trifecta Pharmaceuticals USA LLC | e8a56651-a292-7609-e053-2a95a90a7c36 | 2024-01-02 | Warnings | M017 |
| Anti-Itch Cream | DIPHENHYDRAMINE HYDROCHLORIDE 2%, ZINC ACETATE 0.1% | Trifecta Pharmaceuticals USA, LLC. | 44d17651-a31b-64ca-e054-00144ff8d46c | 2024-01-02 | Warnings | M017 |
| Muscle Rub Cream | MENTHOL 10%, METHYL SALICYLATE 15% | Trifecta Pharmaceuticals USA, LLC. | e0a13344-5493-eb51-e053-2995a90a8183 | 2024-01-02 | Warnings | M017 |
| Sumifun Knee Relieve Patch | KNEE RELIEVE PATCH | Zhengzhou Miaoqi Pharmaceutical Technology Co., Ltd | 0e031aa5-edf4-8c9d-e063-6394a90afee3 | 2024-01-02 | Warnings | M017 |
| OKeeffes Healthy Feet | ALLANTOIN, LIDOCAINE | The Gorilla Glue Company/O'Keeffe's Company | d73709db-3932-3c56-e053-2995a90a7d0a | 2024-01-01 | Warnings | M017 |
| PERSONAL CARE ICE COLD | MENTHOL | NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD. | 1994356c-e347-5b7d-e063-6394a90a476c | 2024-01-01 | Warnings | M017 |
| Dendracin Neurodendraxcin | METHYL SALICYLATE, MENTHOL AND CAPSAICIN | Proficient Rx LP | 7e765fc1-74c6-4af3-a9cf-05b57011d7d8 | 2024-01-01 | Warnings | M017 |
| CeraVe Developed with Dermatologists Itch Relief Moisturizing | PRAMOXINE HYDROCHLORIDE | L'Oreal USA Products Inc | c6a0880e-fc16-46e9-8314-c56c9d15bf31 | 2023-12-31 | Warnings | M017 |
| CeraVe Developed with Dermatologists Anti Itch | HYDROCORTISONE | L'Oreal USA Products Inc. | 8d65e945-2557-486f-9279-ecbaa08f31c4 | 2023-12-31 | Warnings | M017 |
| Nighttime Sleep-Aid Non-Habit Forming | DIPHENHYDRAMINE HCI | AptaPharma Inc. | ed0ba7aa-e794-43da-b576-6b9945bf7477 | 2023-12-30 | Warnings | M017 |
| Sting-Kill | BENZOCAINE AND MENTHOL | RANDOB LABS, LTD. DBA CROSSINGWELL CONSUMER HEALTH | b8bd9280-f20a-4b2a-aef7-a0ba7b3b8701 | 2023-12-29 | Warnings | M017 |
| Maybelline New York Baby Lips Dr Rescue Medicated Balm | MENTHOL | L'Oreal USA Products Inc | 2f7b8221-66f6-4aed-8359-318cfc656a72 | 2023-12-28 | Warnings | M017 |
| Equate Cortisone | HYDROCORTISONE 1% | Walmart Inc | 027fae33-93a0-a61f-e063-6294a90a990f | 2023-12-27 | Warnings | M017 |
| Walgreens Cool n Heat Lidocaine | LIDOCAINE HCL 4% | Walgreens Co | 0681c6c5-5a8b-ea9e-e063-6394a90a83bc | 2023-12-27 | Warnings | M017 |
| EXTRA STRENGTH WAL-DRYL ITCH RELIEF | DIPHENHYDRAMINE, ZINC ACETATE | WALGREEN CO | 681cf1af-2cc3-4e6d-b76f-f00731ea3e12 | 2023-12-27 | Warnings | M017 |
| XRay Pain Relief | MENTHOL, (PLUS)-, CAMPHOR, (-)-, AND METHYL SALICYLATE | Genomma Lab USA | 5244ddee-fd9e-4df3-8fb3-b16aa321a316 | 2023-12-27 | Warnings | M017 |
| Camphor Spirit | CAMPHOR 10% | Pharma Nobis, LLC | e42fbe63-b01c-4f85-e053-2a95a90a5143 | 2023-12-26 | Warnings | M017 |
| Equate Calaspray | PRAMOXINE HCL 1%, ZINC ACETATE 0.1% | Walmart Inc | 027ed5ab-05ec-569f-e063-6394a90abbc3 | 2023-12-26 | Warnings | M017 |
| EXTERNAL ANALGESIC | CAMPHOR, CAPSICUM, MENTHOL | Hmong 21 | 3b6155a5-51aa-2780-e054-00144ff8d46c | 2023-12-26 | Warnings | M017 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 415974 | menthol 4 % Topical Gel | PSN | e43e2cbd-d114-4b11-8baf-7a775881cd97 | 2 |
| 415974 | menthol 0.04 MG/MG Topical Gel | SCD | e43e2cbd-d114-4b11-8baf-7a775881cd97 | 2 |
| 415974 | menthol 4 % Topical Gel | SY | e43e2cbd-d114-4b11-8baf-7a775881cd97 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 83067-463-00 | 83067046300 | 88 mL in 1 BOTTLE (83067-463-00) | 88 ml | 2023-10-03 | No | No | Current |