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 |
|---|---|---|---|---|---|---|
| AMRUTANJAN RELIEF PAIN BALM | CAMPHOR , MENTHOL, METHYL SALICYLATE | AMRUTANJAN HEALTH CARE LIMITED | ddee6714-8b18-4d87-944b-8467fda22e6b | 2025-07-23 | Warnings | M017 |
| Stopain Extra Strength Gel | MENTHOL | Troy Manufacturing, Inc. | 8bb89002-d7a2-4bee-b5a5-1fd1949273ef | 2025-07-22 | Warnings | M017 |
| Hielo Ardiente | MENTHOL | Menper Distributors, Inc. | 97ec516c-d2bc-47ce-82fe-bd68445d9570 | 2025-07-22 | Warnings | M017 |
| La Flecha Japonesa | METHYL SALICYLATE | Menper Distributors, Inc. | 08819ad0-97c2-49bd-b923-535b94a27167 | 2025-07-22 | Warnings | M017 |
| Veneno de Abeja Aceite De Vibora Brand | METHYL SALICYLATE | Menper Distributors Inc. | ad940dc8-9403-44cf-aed3-6e538cbe488b | 2025-07-22 | Warnings | M017 |
| Balsamo de Vaca Mascura | METHYL SALICYLATE | Menper Distributors Inc. | 321b6f1f-c802-4b96-99d3-e77217da11a3 | 2025-07-22 | Warnings | M017 |
| Abejas y Viboras Roll On | METHYL SALICYLATE | Menper Distributors Inc. | bedf3b36-7def-099f-e053-2a95a90ac15b | 2025-07-22 | Warnings | M017 |
| HealthWise Flexible 4% Lidocaine Patch | LIDOCAINE 4% | Veridian Healthcare | 3869cc18-5494-6142-e063-6394a90a75e5 | 2025-07-22 | Warnings | M017 |
| Arthcal 4% Lidocaine Patches | LIDOCAINE | Beijing JUNGE Technology Co., Ltd. | 2e531194-67ad-c645-e063-6394a90a916c | 2025-07-22 | Warnings | M017 |
| AMRUTANJAN RELIEF STRONG PAIN BALM | MENTHOL, METHYL SALICYLATE | AMRUTANJAN HEALTH CARE LIMITED | 206d8c1e-eb5b-4ec7-a54e-8defc9fb9d27 | 2025-07-22 | Warnings | M017 |
| Cold Sore Fast-Acting Pain Relief | GLYCERIN AND LIDOCAINE | Blistex Inc. | c7511322-dd6c-441c-bf7d-ad4f0c14956a | 2025-07-22 | Warnings | M017 |
| Mountain Ice Sports Pain Relief | MENTHOL, CAMPHOR | Mountainside Medical Equipment, Inc. | c1f5512c-67b1-4ff0-b1a5-616e883d436f | 2025-07-21 | Warnings | M017 |
| Stopain Clinical Roll-On | MENTHOL, UNSPECIFIED FORM | Troy Manufacturing, Inc. | 27703209-fdac-4620-a445-d89a84bc853d | 2025-07-21 | Warnings | M017 |
| Hydrocortisone | HYDROCORTISONE | STRATEGIC SOURCING SERVICES LLC | 9bac1869-8072-49bd-8568-a87a184d2200 | 2025-07-21 | Warnings | M017 |
| Dr Kevin Khalili Pain Relief Cream | MENTHOL | DR. KHALILI LLC | 3a79b38c-9adc-60dd-e063-6394a90a5b30 | 2025-07-21 | Warnings | M017 |
| ARTHRITIS PAIN RELIEF | CAMPHOR, CAPSAICIN, METHYL SALICYLATE | YUNNAN BAIYAO GROUP CO., LTD. | 671c57f0-3c6f-4416-bc81-f6930fef327b | 2025-07-21 | Warnings | M017 |
| GoodSense Cooling Pain Relief | MENTHOL | Geiss, Destin & Dunn, Inc | 2e5e1375-df07-9a43-e063-6394a90a9938 | 2025-07-20 | Warnings | M017 |
| Benadryl Extra Strength Itch Cooling | DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE | Kenvue Brands LLC | a7eae5dc-9db6-4bdf-9179-76060e75e044 | 2025-07-18 | Warnings | M017 |
| Nicotine Patches | NICOTINE PATCHES | Shenzhen TeLaFaErJiaLuo Technology Co., Ltd. | 3a1abd26-c0aa-8a65-e063-6294a90ab66e | 2025-07-17 | Warnings | M017 |
| Aouiv 4% Lidocaine Numbing Cream | 4% LIDOCAINE NUMBING CREAM | Guangzhou Qiexiran Cosmetics Co., Ltd. | 3a221dd2-e945-bd0e-e063-6294a90a8fb9 | 2025-07-17 | 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 |