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 |
|---|---|---|---|---|---|---|
| TheraCare 4% Lidocaine Cream | LIDOCAINE HYDROCHLORIDE | Veridian Healthcare | c808aa05-9d49-cc9f-e053-2a95a90a50f3 | 2024-05-21 | Warnings | M017 |
| TheraCare 4% Lidocaine and 1% Menthol Cream | MENTHOL AND LIDOCAINE | Veridian Healthcare | c80ba251-91a5-0858-e053-2995a90a9cff | 2024-05-21 | Warnings | M017 |
| HealthWise Menthol Roll-On | MENTHOL | Veridian Healthcare | 102d57a5-6449-f825-e063-6294a90a8844 | 2024-05-21 | Warnings | M017 |
| SAFLY Burn | LIDOCAINE HYDROCHLORIDE | Nantong Health & Beyond Hygienic Products Inc. | 3aca2568-d10f-4b14-861b-6c741c106829 | 2024-05-17 | Warnings | M017 |
| HealthWise Menthol 4% Roll-On | MENTHOL | Veridian Healthcare | 1894ef00-ba05-0e02-e063-6394a90ab982 | 2024-05-16 | Warnings | M017 |
| Leader Poison Ivy Wash | PRAMOXINE HYDROCHLORIDE LOTION | Cardinal Health, 110 dba Leader | 81f2ecb0-c3ce-d2f8-e053-2a91aa0add0c | 2024-05-13 | Warnings | M017 |
| Eagle Brand Medicated Oil Aromatic | CAMPHOR, MENTHOL, METHYL SALICYLATE | Borden Company (Private) Limited | 0e808f89-62dc-3790-e063-6394a90a2351 | 2024-05-13 | Warnings | M017 |
| Walgreens Lidocaine Plus Cream | BENZYL ALCOHOL AND LIDOCAINE HYDROCHLORIDE | Walgreens Company | e33e0097-31d6-8083-e053-2a95a90af5d2 | 2024-05-09 | Warnings | M017 |
| Professional Therapy MuscleCare Pro Pain Relieving Cold Gel | CAMPHOR, MENTHOL | ACTIVE AND INNOVATIVE, LLC | 1794c512-5f42-4ec3-e063-6394a90a87cd | 2024-05-03 | Warnings | M017 |
| Professional Therapy MuscleCare Pro | MENTHOL AND CAMPHOR | ACTIVE AND INNOVATIVE, LLC | 17961a84-6bee-c75f-e063-6394a90af576 | 2024-05-03 | Warnings | M017 |
| Aspercreme with Lidocaine Pain Relieving Creme | LIDOCAINE HYDROCHLORIDE | Chattem, Inc. | d5da67c3-c2ec-4e3e-abe9-cc862dcfc8bd | 2024-05-01 | Warnings | M017 |
| Lidocaine HCl 4 Percent | LIDOCAINE HYDROCHLORIDE | ARI BRANDS, LLC | 81aff5c5-91c0-4173-a432-d20115613580 | 2024-04-30 | Warnings | M017 |
| HealthWise 3x Medicated Pain Relief Patch 120 Bulk | CAMPHOR,MENTHOL, METHYL SALICYLATE | Veridian Healthcare | 17545078-05e1-9338-e063-6394a90a678c | 2024-04-30 | Warnings | M017 |
| Professional Therapy MuscleCare Pro Roll-on | CAMPHOR, MENTHOL | ACTIVE AND INNOVATIVE, LLC | 1755ec89-c404-1c17-e063-6394a90ab9fb | 2024-04-30 | Warnings | M017 |
| PAIN RELIEF Gel-Roll On | MENTHOL | Shanghai Chuangshi Medical Technology (Group) Co., Ltd. | f0bc2a14-6bda-428c-e053-2995a90a4ced | 2024-04-29 | Warnings | M017 |
| PAIN RELIEF Gel-Tube | MENTHOL | Shanghai Chuangshi Medical Technology (Group) Co., Ltd. | f0bec1d4-2e18-4519-e053-2a95a90a1bbb | 2024-04-29 | Warnings | M017 |
| THERAPLEX AIM Anti-Itch Moisturizing | HYDROCORTISONE | THERAPLEX, LLC | d1b231b6-cc9f-488a-9121-501831473772 | 2024-04-27 | Warnings | M017 |
| HYDROCORTISONE | HYDROCORTISONE ACETATE | JHK Inc dba American Safety & First Aid | 64adc8d0-7ca4-4c1a-813f-f1df47e916f2 | 2024-04-25 | Warnings | M017 |
| HealthWise Lidocaine Plus Cream | BENZYL ALCOHOL, LIDOCAINE HYDROCHLORIDE | Veridian Healthcare | 16f26249-b508-2c6e-e063-6394a90a265b | 2024-04-25 | Warnings | M017 |
| Hydrocortisone Cream with Aloe | HYDROCORTISONE | Cardinal Health 110 dba LEADER | 16f2f3cb-4611-5867-e063-6394a90af107 | 2024-04-25 | 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 |