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 |
|---|---|---|---|---|---|---|
| Nighttime 4X Medicated Cream | BENZOCAINE | Rite Aid | 21645ed1-2dc0-223a-e063-6394a90ab021 | 2025-11-21 | Warnings | M017 |
| 4x Medicated Gum Cream | BENZOCAINE | Albertsons | b81a308c-9c30-0e3d-e053-2a95a90a15d2 | 2025-11-21 | Warnings | M017 |
| MENTHOL, CAMPHOR | MENTHOL, CAMPHOR | SUNSET NOVELTIES, INC | b0edd9d9-951f-d3dd-e053-2995a90a8d5a | 2025-11-21 | Warnings | M017 |
| Up up | LIDOCAINE PAIN RELIEF MAXIMUM STRENGTH PATCHES | Target Corporation | 44121d40-86e1-0df6-e063-6294a90aedaf | 2025-11-20 | Warnings | M017 |
| Up up | PAIN RELIEF ADVANCED HYDROGEL PATCHES | Target Corporation | 44128b70-3172-ee37-e063-6294a90a705f | 2025-11-20 | Warnings | M017 |
| MENTHOL, CAMPHOR | MENTHOL, CAMPHOR | SUNSET NOVELTIES, INC | f03090fa-f7e6-f53a-e053-2a95a90aa819 | 2025-11-20 | Warnings | M017 |
| HEATING PAIN RELIEF | METHYL SALICYLATE, MENTHOL | SUNSET NOVELTIES, INC | ff073e47-3107-e17e-e053-6294a90a58fa | 2025-11-20 | Warnings | M017 |
| MENTHOL, CAMPHOR | MENTHOL, CAMPHOR | SUNSET NOVELTIES, INC | fc8a8f20-97ab-481e-e053-6394a90a3525 | 2025-11-20 | Warnings | M017 |
| MENTHOL | MENTHOL | SUNSET PAIN RELIEF ROLL-ON 3OZ | 934d4638-b47b-187d-e053-2995a90ae69d | 2025-11-20 | Warnings | M017 |
| FOOT PAIN RELIEF ROLL-ON | LIDOCAINE, MENTHOL | Guangzhou Zhupuyou E-commerce Co., Ltd | 43edcea0-ab04-f368-e063-6294a90a817a | 2025-11-19 | Warnings | M017 |
| Absolut Skin Corticosoothe Anti-Itch | HYDROCORTISONE | Absolut Skin Incorporated | deb52218-9176-4aaa-a22f-b66dada6690f | 2025-11-19 | Warnings | M017 |
| Maximum Strength 4% Lidocaine Patch Good Neighbor Pharmacy | LIDOCAINE | InterMed Laboratories Private Limited | 43f3d189-f6b7-02ed-e063-6394a90afd73 | 2025-11-19 | Warnings | M017 |
| Maximum Strength 4% Lidocaine Patch HealthA2Z | LIDOCAINE | InterMed Laboratories Private Limited | 43f3e288-e828-8130-e063-6394a90a6d44 | 2025-11-19 | Warnings | M017 |
| Maximum Strength 4% Lidocaine Patch Leader | LIDOCAINE | InterMed Laboratories Private Limited | 42f06914-c8b8-ea9c-e063-6294a90a79e6 | 2025-11-19 | Warnings | M017 |
| CVS Anti-Itch | CAMPHOR, MENTHOL | CVS | 87715662-c788-9a8d-e053-2a95a90acb53 | 2025-11-19 | Warnings | M017 |
| Walgreen Anti Itch | CAMPHOR, MENTHOL | Walgreens | b4f47a8d-d4a6-9233-e053-2a95a90afd90 | 2025-11-19 | Warnings | M017 |
| Leader Anti-Itch | CAMPHOR, MENTHOL | LEADER/Cardinal Helath 110, Inc. | 9ca985c6-5017-0558-e053-2995a90a8202 | 2025-11-19 | Warnings | M017 |
| CVS Anti-Itch | PRAMOXINE HCL | CVS | 87fc476a-5b12-7383-e053-2995a90a530b | 2025-11-19 | Warnings | M017 |
| Walgreen Anti-Itch | PRAMOXINE HCL | Walgreens | b5f9d1c5-891e-4377-e053-2995a90aa281 | 2025-11-19 | Warnings | M017 |
| MENTHOL, CAMPHOR | MENTHOL, CAMPHOR | SUNSET PAIN RELIEF | 89f5f688-856f-f2df-e053-2995a90a73cf | 2025-11-19 | 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 |