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 |
|---|---|---|---|---|---|---|
| Diphenhydramine HCl and Zinc Acetate | EXTRA STRENGTH ITCH RELIEF CONTINUOUS SPRAY | Topco Associates LLC | 8026c7dd-eb7b-ebea-e053-2991aa0a1b0f | 2025-11-06 | Warnings | M017 |
| Diphenhydramine HCl and Zinc Acetate | EXTRA STRENGTH ITCH RELIEF | Walgreen Company | 6057b4ff-6adc-4688-893c-62d237d7d1ae | 2025-11-06 | Warnings | M017 |
| BANPINGHUA Glucosamine Chondroitin Patch | PEPPERMINT, CAMPHOR, BORNEOL | Henan Lijitang Medical Technology Co., Ltd. | 42f8c2ae-50a2-2358-e063-6394a90a5979 | 2025-11-06 | Warnings | M017 |
| PAINGEL | CAMPHOR, MENTHOL | NACOR BUSINESS GROUP LLC | 42fa2397-b61a-3b16-e063-6294a90a5fed | 2025-11-06 | Warnings | M017 |
| PAINGEL UNGUENTO | CAMPHOR, MENTHOL | NACOR BUSINESS GROUP LLC | 42fab525-b0a5-97fb-e063-6394a90aec6c | 2025-11-06 | Warnings | M017 |
| PAINGEL ROLL-ON | MENTHOL | NACOR BUSINESS GROUP LLC | 42fb0bdf-8bbd-bbe3-e063-6294a90a656c | 2025-11-06 | Warnings | M017 |
| Coolexa | CAMPHOR, MENTHOL, METHYL SALICYLATE | Rising Pharma Holdings, Inc. | 38839f29-d4ce-4684-a3c7-0bb4bf1ad594 | 2025-11-06 | Warnings | M017 |
| ItchZap | DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE | Rising Pharma Holdings, Inc. | 245d0afb-19a8-4cfb-968b-d892b18d5f2c | 2025-11-06 | Warnings | M017 |
| Pain Relief Gel-Roll On | LIDOCAINE AND MENTHOL | Bullet point LLC | 42c70681-494b-47c9-e063-6394a90a80be | 2025-11-04 | Warnings | M017 |
| China-Gel Topical Pain Reliever | MENTHOL AND CAMOHOR (SYNTHETIC) | China-Gel, LLC | ba6c7e97-d740-484b-8711-55fa7ab15784 | 2025-11-04 | Warnings | M017 |
| China-Gel | MENTHOL AND CAMOHOR (SYNTHETIC) | China-Gel, Inc. | d7c5cb17-f7a2-7f57-e053-2995a90a40f7 | 2025-11-04 | Warnings | M017 |
| Aulief Topical Pain Reliever | MENTHOL AND CAMOHOR | China-Gel, LLC | 8647dcc3-1dbc-1093-e053-2991aa0a1ab9 | 2025-11-04 | Warnings | M017 |
| China-Gel Topical Pain Reliever | MENTHOL AND CAMOHOR (SYNTHETIC) | China-Gel, LLC | 254abae9-ef1b-5a90-e054-00144ff88e88 | 2025-11-04 | Warnings | M017 |
| Pain Relief Gel-Tube | MENTHOL | Bullet point LLC | 42c93789-9758-54b7-e063-6394a90ac398 | 2025-11-04 | Warnings | M017 |
| Tattoo care | TATTOO CARE CREAM | Perfso (HK) Co., Limited | 42d0f56f-9cb1-8e19-e063-6394a90aa3e0 | 2025-11-04 | Warnings | M017 |
| CORE RELIEF | CAMPHOR, MENTHOL | Copper Joint, LLC | 42d17270-f58d-9d69-e063-6294a90a4078 | 2025-11-04 | Warnings | M017 |
| Lidocaine and Menthol | LIDOCAINE AND MENTHOL | Marcella Health | d25f25ee-79f8-49e7-9715-0aae305b73e5 | 2025-11-03 | Warnings | M017 |
| Calamine Plus Pramoxine HCl | CALAMINE PLUS NO TOUCH SPRAY | Premier Brands of America Inc. | 36481d67-2346-470b-e063-6294a90aae99 | 2025-11-03 | Warnings | M017 |
| Lidocaine Numbing Cream | LIDOCAINE 5% | YYBA Corp | 1319ee69-8b3f-5815-e063-6294a90a5ad5 | 2025-11-03 | Warnings | M017 |
| Goodsense Extra Strength Cold and Hot Medicated | MENTHOL | Geiss, Destin and Dunn, Inc. | 7585d111-775f-4fb6-a485-28cd99d88852 | 2025-10-31 | 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 |