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 |
|---|---|---|---|---|---|---|
| A Health Itch Relief Gel | ITCH RELIEF GEL | Bionpharma, Inc. | 38040732-48c9-3533-e063-6394a90af10a | 2025-06-20 | Warnings | M017 |
| SCHOELIF Numbing Cream | NUMBING CREAM | Guangzhou Qiexiran Cosmetics Co., Ltd. | 37eaabb7-884e-0bd5-e063-6294a90ae063 | 2025-06-19 | Warnings | M017 |
| Re-Lieved Lidocaine Patch | LIDOCAINE PATCH 4% | Transfer Technology | 37ee539c-df7e-511d-e063-6394a90a4469 | 2025-06-19 | Warnings | M017 |
| Re-Lieved Lidocaine Patch | LIDOCAINE PATCH 4% | Transfer Technology | 37eef80a-556f-b090-e063-6294a90a151b | 2025-06-19 | Warnings | M017 |
| Re-Lieved Lidocaine Patch | LIDOCAINE PATCH 4% | Transfer Technology | 37ef02d4-2ff5-cb23-e063-6294a90a68af | 2025-06-19 | Warnings | M017 |
| Post-Treatment Repair Cream | HYDROCORTISONE | Vi Medical Products Inc. | ab8885a9-0778-28ff-e053-2995a90a2e12 | 2025-06-19 | Warnings | M017 |
| MyDerm | LIDOCAINE | Inspec Solutions LLC. | 82d075d1-c92e-2097-e053-2991aa0ab131 | 2025-06-18 | Warnings | M017 |
| Walgreens Extra Small Lidocaine | LIDOCAINE | Walgreen Co. | dc838e47-d234-4ba5-9449-f645e99be923 | 2025-06-18 | Warnings | M017 |
| CLn Body Moisturizer | COLLOIDAL OAT MOISTURIZER | TopMD Skin Care, Inc. | 2de3d68d-a540-d456-e063-6394a90a4b57 | 2025-06-18 | Warnings | M017 |
| Aloe UP SPF 30 Mineral | ZINC OXIDE, TITANIUM DIOXIDE | Aloe Care International, LLC | 35967b33-bdfb-ee3c-e063-6294a90a75f6 | 2025-06-18 | Warnings | M017 |
| Aloe Up SPF 50 Mineral | ZINC OXIDE, TITANIUM DIOXIDE | Aloe Care International, LLC | 35b9dcfa-05f3-3d7b-e063-6394a90a18f1 | 2025-06-18 | Warnings | M017 |
| Aloe Up SPF 50 Mineral | ZINC OXIDE | Aloe International, LLC | 35bc3621-f4e4-42d3-e063-6394a90a7aad | 2025-06-18 | Warnings | M017 |
| Aloe Up SPF 50 Kids Mineral | ZINC OXIDE, TITANIUM DIOXIDE | Aloe Care International, LLC | 35cd16b0-bd81-8f68-e063-6294a90a3d8c | 2025-06-18 | Warnings | M017 |
| Aloe Up SPF 50 Kids Mineral | ZINC OXIDE | Aloe International, LLC | 35cd5542-947d-a042-e063-6394a90a13f8 | 2025-06-18 | Warnings | M017 |
| Relieve Your Pain | MENTHOL | Proximity Capital Partners LLC dba Asutra | c12369dd-8305-edaf-e053-2995a90a0d3d | 2025-06-18 | Warnings | M017 |
| Melt Pain Away | CAPSAICIN | Proximity Capital Partners LLC dba Asutra | a95a11d7-a2ae-6654-e053-2a95a90a802c | 2025-06-18 | Warnings | M017 |
| Recovery Roll-On | MENTHOL, CAMPHOR | PROXIMITY CAPITAL PARTNERS LLC DBA ASUTRA | ebc9630f-6d8b-e4f0-e053-2995a90a0b49 | 2025-06-18 | Warnings | M017 |
| ProCure Hydrocortisone 1% | HYDROCORTISONE | Twin Med LLC | 37cdfabc-1fdb-246a-e063-6394a90a008a | 2025-06-17 | Warnings | M017 |
| ProCure Hydrocortisone 1% | HYDROCORTISONE | Twin Med LLC | 37ce6c35-b211-43de-e063-6294a90ab773 | 2025-06-17 | Warnings | M017 |
| Hydrocortisone with Aloe | HYDROCORTISONE CREAM 1% | Sun Pharmaceutical Industries, Inc. | 312ddc8d-100e-cfac-e063-6294a90acd09 | 2025-06-16 | 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 |