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 |
|---|---|---|---|---|---|---|
| DCH Calaspray Itch Relief | PRAMOXINE HCL 1%, ZINC ACETATE 0.1% | Derma Care Research Labs, LLC | fda2afaf-3cd0-92b3-e053-6394a90a7493 | 2024-12-19 | Warnings | M017 |
| DCH Nerve Pain Relief Roll-On | LIDOCAINE HCL 4%, MENTHOL 1% | Derma Care Research Labs, LLC | ff32cbb2-79eb-9158-e053-6394a90ac357 | 2024-12-19 | Warnings | M017 |
| DCH Burn Relief | LIDOCAINE, 0.5% | Derma Care Research Labs | ffd7be08-0510-dfcb-e053-6394a90ad286 | 2024-12-19 | Warnings | M017 |
| DCH Arthritis Pain Relief Roll-On | CAPSAISIN 0.1% | Derma Care Research Labs, LLC | fda0d359-95eb-8b38-e053-6294a90a7b88 | 2024-12-19 | Warnings | M017 |
| DCH Pain Relieving | MENTHOL 2% | Derma Care Research Labs, LLC | ff49ee63-6a87-c7a7-e053-6294a90a77a3 | 2024-12-19 | Warnings | M017 |
| Warrior Pain Relief Roll-On Maximum Strength | LIDOCAINE HCL 4% | Derma Care Research Labs, LLC | dd80e560-6467-2166-e053-2995a90a88a8 | 2024-12-19 | Warnings | M017 |
| DCH Labs Cool and Heat Roll-On | MENTHOL 16% | Derma Care Research Labs, LLC | d35d7720-44ce-3624-e053-2995a90a7fb4 | 2024-12-19 | Warnings | M017 |
| Dr Goldsons Pain | MENTHOL 8%, METHYL SALICYLATE 30% | Derma Care Research Labs, LLC | fb34b0d3-ccc0-305e-e053-6394a90a231d | 2024-12-19 | Warnings | M017 |
| Warrior Pain Relieving | CAMPHOR 4%, MENTHOL 10%, METHYL SALICYLATE 30% | Derma Care Research Labs, LLC | dd06af3c-5452-9759-e053-2a95a90afc21 | 2024-12-19 | Warnings | M017 |
| Warrior Burn Relief Aloe Maximum Strength | LIDOCAINE HCL 4% | Derma Care Research Labs, LLC | ec6efa4b-dcbe-1c2b-e053-2995a90ae043 | 2024-12-19 | Warnings | M017 |
| DCH Arthritis Relief | TROLAMIN SALICYLATE 10% | Derma Care Research Labs, LLC | ff31e515-5780-b77d-e053-6394a90af6b9 | 2024-12-19 | Warnings | M017 |
| DCH Pain Relief | LIDOCAINE 4% | Derma Care Research Labs, LLC | 00efda74-d434-04be-e063-6294a90a6d98 | 2024-12-19 | Warnings | M017 |
| Dollar General Cold Therapy Pain Relief | MENTHOL 5% | Dolgencorp, LLC | ff3284d1-e73c-93bf-e053-6294a90aaf4e | 2024-12-19 | Warnings | M017 |
| Dollar General Pain Relieving Patch with Lidocaine | LIDOCAINE | DOLGENCORP, LLC | 55828cd1-3a1e-48ac-bb01-4c50b96d09a2 | 2024-12-19 | Warnings | M017 |
| DCH Nerve Pain Relief | LIDOCAINE 4%, MENTHOL 1% | Derma Care Research Labs, LLC | 00db480a-e510-a64d-e063-6394a90a4695 | 2024-12-19 | Warnings | M017 |
| Pain, Burn, and Itch Relief | BENZOCAINE 20%, MENTHOL 0.5% | Derma Care Research Labs, LLC | fd9fe09f-3ae9-c5f5-e053-6394a90ad691 | 2024-12-19 | Warnings | M017 |
| DCH Cooling Pain Relief | MENTHOL 4% | Derma Care Research Labs, LLC | 00ed3175-c3ba-6545-e063-6394a90acfd1 | 2024-12-19 | Warnings | M017 |
| DCH Pain Relief | LIDOCAINE HCL 4% | Derma Care Research Labs, LLC | 00dd70f3-ecc3-33ba-e063-6294a90a4f32 | 2024-12-19 | Warnings | M017 |
| Walgreens Kinesiology Pain Relief | LIDOCAINE, MENTHOL | Walgreen Co. | 0fdbb310-8e65-4e0c-b413-a093964324a2 | 2024-12-19 | Warnings | M017 |
| Signature Care Medicated Cold and Hot Patch | MENTHOL | Safeway | 0335f1b3-5c8a-67b8-e063-6294a90a9847 | 2024-12-19 | 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 |