Theraworx Pain Relief Roll- On- Lidocaine
- Product NDC
- 61594-028
- 11-digit product format
- 615940028
- Labeler code
- 61594
- Product ID
- 61594-028_5d4f768e-8acc-1d1c-e063-6394a90ac0ae
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- LIDOCAINE HYDROCHLORIDE
- Dosage form
- LIQUID
- Route
- TOPICAL
- Labeler
- AVADIM HOLDINGS, INC.
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-01-15
- Substance
- LIDOCAINE HYDROCHLORIDE
- Active strength
- 40 mg/mL
- Pharmacologic classes
- Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
- 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
- Theraworx Pain Relief Roll- On- Lidocaine
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| LIDOCAINE HYDROCHLORIDE | 40 mg/mL |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 860a93dc-4863-49cc-b284-6bbe8191bc48 | Product name | 4 | 20250214 |
| 9b4cf230-fd05-41d5-98c6-5db9ecb27b86 | Product name | 1 | 20230117 |
| 68ed98f8-24c2-44a0-944a-6d36e82ce25a | Product name | 1 | 20141222 |
| 1cd42bc2-a430-c72b-636d-991b235fbf80 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 61594-028-00 | Theraworx Pain Relief Roll- On- Lidocaine | 1 in 1 CARTON | LIQUID | 1 | 1 | |
| 61594-028-00 | Theraworx Pain Relief Roll- On- Lidocaine | 74 mL in 1 BOTTLE | LIQUID | 74 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 61594-028-00 | ML - Milliliter | 61594-028 | 0d447cd4-8d89-4f96-b2ad-82f8ca3183b1 | 1 | 2024-05-16 |
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 |
|---|---|---|---|---|---|---|
| MENTHOL, CAMPHOR | MENTHOL, CAMPHOR | SUNSET PAIN RELIEF | 4a7f92d3-dd35-44a3-e063-6294a90ae004 | 2026-02-10 | Warnings | M017 |
| NICOVITO HEMORRHOID MASTER | LIDOCAINE 4% PHENYLEPHRINE HCL 0.25% HEMORRHOID MASTER | Jiangxi Yudexi Pharmaceutical Co., LTD | 4a5e24fa-959e-79b4-e063-6294a90a8f68 | 2026-02-09 | Warnings | M017 |
| Tiger Balm Active Muscle Rub | METHYL SALICYLATE, MENTHOL, UNSPECIFIED FORM, AND CAMPHOR (SYNTHETIC) | Haw Par Healthcare Ltd. | 2e7638c6-e1ce-4e2f-bd50-52fbce5a138e | 2026-02-09 | Warnings | M017 |
| Tiger Balm Neck and Shoulder Rub | CAMPHOR (SYNTHETIC) AND MENTHOL | Haw Par Healthcare Ltd. | 2f272d12-7b34-430e-817e-1005f57ed9e9 | 2026-02-09 | Warnings | M017 |
| Welmate Lidocaine Pain Relieving Patch | LIDOCAINE | YYBA CORP | 4303fd30-0d35-3671-e063-6394a90a2aee | 2026-02-09 | Warnings | M017 |
| Pain Relief Lidocaine | LIDOCAINE | Kroger Company | 4098756e-3d9f-317a-e063-6394a90af04c | 2026-02-09 | Warnings | M017 |
| Aquanil HC | HYDROCORTISONE | Person and Covey | 4a698246-05a6-d01f-e063-6294a90a3401 | 2026-02-09 | Warnings | M017 |
| Hemorrhoid Master | LIDOCAINE, PHENYLEPHRINE | Ebanel Laboratories, Inc | 41292d65-dabe-4bc3-872f-34a3912aa342 | 2026-02-09 | Warnings | M017 |
| DERMFREE NEUROPATHY | ARNICA MONTANA 1X HPUS 7% NEUROPATHY | Jiangxi Yudexi Pharmaceutical Co., LTD | 4a5c232d-5d29-2504-e063-6394a90ac9de | 2026-02-08 | Warnings | M017 |
| ASSIELF NUMBING Topical Anorectal | LIDOCAINE | Shenzhen Yuanbang International Logistics Co., Ltd | 4a5cb477-57ef-2a1d-e063-6394a90ac9ed | 2026-02-08 | Warnings | M017 |
| Lidocaine Pain Relieve Gel-Patch | PAIN RELIEVE GEL-PATCH | Henan Kangdi Medical Devices Co., Ltd | 1e31b950-e990-e255-e063-6394a90a7d23 | 2026-02-07 | Warnings | M017 |
| Herbal Knee Patch | HERBAL KNEE PATCH | Henan Kangdi Medical Devices Co., Ltd | 2a009059-b515-8214-e063-6294a90a4ed3 | 2026-02-07 | Warnings | M017 |
| Flocean ANTI-ITCH | BENZOCAINE 5%ANTI-ITCH | Jiangxi Yudexi Pharmaceutical Co., LTD | 4a493911-a846-5aa0-e063-6294a90a65ac | 2026-02-07 | Warnings | M017 |
| daily solutions Ice Blue Analgesic | MENTHOL, UNSPECIFIED FORM | Garcoa, Inc. | 4d8c8c14-ecaa-43de-a07f-c73ca0d1e3e6 | 2026-02-06 | Warnings | M017 |
| Lidocaine Pain Relief Gel-Patch | LIDOCAINE | Shenzhen Wankelai E-commerce Co., Ltd. | 4a22562b-601e-97d7-e063-6394a90a5bca | 2026-02-06 | Warnings | M017 |
| hydrocortisone | HYDROCORTISONE | Sportpharm LLC | ee64ad1e-78db-4553-a3cf-b539b770fa26 | 2026-02-06 | Warnings | M017 |
| Pain Relief Gel-Patch | LIDOCAINE 4% | Sportpharm LLC | 1dd022b9-88ae-4737-88cc-fdb0ce0a83a3 | 2026-02-06 | Warnings | M017 |
| Camphor plus Lidocaine Pain Relief | CAMPHOR, LIDOCAINE | Veridian Healthcare | 4a2b73a8-c10c-85f9-e063-6294a90ac52c | 2026-02-06 | Warnings | M017 |
| Aloe Vera Gel | LIDOCAINE HCL, MENTHOL | Retail Business Services, LLC | 073c72fe-3171-4a4f-913a-d1b9630a1af3 | 2026-02-06 | Warnings, Adverse reactions | M017 |
| HealthWise Soothing Lidocaine Pain Relief | LIDOCAINE HCI 0.5% | Veridian Healthcare | 4a2ec73e-7332-6f13-e063-6294a90a8506 | 2026-02-06 | Warnings | M017 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1987647 | lidocaine hydrochloride 4 % Topical Solution | PSN | b4ce3876-f9e3-43ca-810b-75fbe6f887b6 | 1 |
| 1987647 | lidocaine hydrochloride 40 MG/ML Topical Solution | SCD | b4ce3876-f9e3-43ca-810b-75fbe6f887b6 | 1 |
| 1987647 | lidocaine hydrochloride 4 % Topical Solution | SY | b4ce3876-f9e3-43ca-810b-75fbe6f887b6 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 61594-028-00 | 61594002800 | 1 BOTTLE in 1 CARTON (61594-028-00) / 74 mL in 1 BOTTLE | 1 bottle | 2024-01-15 | No | No | Current |