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 |
|---|---|---|---|---|---|---|
| DZUL - LIDO CREME | LIDOCAINE HCL, MENTHOL | Caball Sales, Inc. | 063387e4-a1b1-a467-e063-6294a90a6cbd | 2026-01-08 | Warnings | M017 |
| TOPICAINE | LIDOCAINE 4% | ESBA LABORATORIES INC. | 7f96e980-891e-743d-e053-2a91aa0aea5f | 2026-01-08 | Warnings | M017 |
| LUBRICAINE | LIDOCAINE 4% | ESBA LABORATORIES INC. | 9d7416b1-607d-34e0-e053-2a95a90aa3c3 | 2026-01-08 | Warnings | M017 |
| 0.5% LIDOCAINE BURN RELIEF | LIDOCAINE HYDROCHLORIDE | Universal Distribution Center LLC | 0a1aeff0-bade-457b-a0ac-099d646c0b2e | 2026-01-08 | Warnings | M017 |
| 4% MENTHOL COLD THERAPY | MENTHOL | Universal Distribution Center LLC | 66892993-a755-4584-b2a8-2e8d7ac70593 | 2026-01-08 | Warnings | M017 |
| Private Label Antifungal Barrier Cream | 2% MICONAZOLE NITRATE CREAM | Swiss-American CDMO, LLC | e74bddea-c1ac-4e4e-84bd-5a9defb85b2d | 2026-01-08 | Warnings | M017 |
| 2.0% LIDOCAINE BURN | LIDOCAINE HYDROCHLORIDE | Universal Distribution Center LLC | e1911279-85f7-4053-b6da-8f4e991347a2 | 2026-01-08 | Warnings | M017 |
| POMG PAIN RELIEF ROLLER | LIDOCAINE HYDROCHLORIDE, MENTHOL | POMG LLC | 1fa980fb-fc0e-fdd0-e063-6394a90adc13 | 2026-01-07 | Warnings | M017 |
| Artridon Glucosamine | MENTHOL, METHYL SALICYLATE | Pharmadel LLC | 73572156-4cce-0669-e053-2991aa0aaecc | 2026-01-07 | Warnings | M017 |
| HealthWise Cooling Pain Relief | MENTHOL | Veridian Healthcare | 6e2ad0ab-e3a8-4e3a-8f1d-2cd6351185bd | 2026-01-07 | Warnings | M017 |
| Hydrocortisone 1% Anti-Itch Cream | HYDROCORTISONE | DLC Laboratories, Inc. | 16eeec2c-065d-4da0-e063-6294a90a3873 | 2026-01-07 | Warnings | M017 |
| Maximum Strength Hydrocortisone | HYDROCORTISONE | DLC Laboratories, Inc | caf50f12-f35c-4e9e-8ef7-3b0c84e225ee | 2026-01-07 | Warnings | M017 |
| EARTHS CARE MUSCLE AND JOINT RUB | CAMPHOR | DLC Laboratories, Inc. | 71e33e06-4dc3-4ead-a122-ff89d93a64de | 2026-01-07 | Warnings | M017 |
| Amour CBD | PAIN RELIEF CREAM | SVD Premium Products | 95b45e79-b1e7-17b2-e053-2995a90a8836 | 2026-01-07 | Warnings | M017 |
| Tiger Balm Active Muscle | METHYL SALICYLATE AND MENTHOL, UNSPECIFIED FORM | Haw Par Healthcare Ltd. | 845a4ead-f9c0-4009-bcae-b17cd388439b | 2026-01-07 | Warnings | M017 |
| 3X Medicated Toothache and Gum Gel | BENZOCAINE | Rite Aid | 996f7989-17ce-5b28-e053-2995a90af8b8 | 2026-01-06 | Warnings | M017 |
| QNTAMAX Muscle and Joint Pain Relieving | CAMPHOR (SYNTHETIC), MENTHOL | Qntamax LLC | 6622b94c-824e-4e84-a8d8-b60bb0b866e2 | 2026-01-06 | Warnings | M017 |
| Winco Muscle and Joint Pain Relief Gel 2oz | WINCO BENGAY VANISHING SCENT MUSCLE AND JOINT PAIN RELIEF | WINCO FOODS, LLC | 47bedf4e-4036-cf43-e063-6394a90a91d6 | 2026-01-06 | Warnings | M017 |
| Pain Relief Hot Patch | MENTHOL AND CAPSAICIN | Universal Distribution Center LLC | 110bcb16-ef0b-4bc8-8877-173a0494e1ad | 2026-01-06 | Warnings | M017 |
| WOFANLI Quit Smoking Nicotine Patches | NICOTINE PATCHES | Shenzhen Paxi Trading Co., Ltd. | 4582b4e9-0c24-069d-e063-6394a90a6f4b | 2026-01-05 | 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 |