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 |
|---|---|---|---|---|---|---|
| LIDOGUARD | LIDOCAINE 4% | ViolaCare, Inc. | d8b021b6-cf71-4f7e-9d27-92d0982bd34f | 2026-03-25 | Warnings | M017 |
| LactiGo | MENTHOL | LactiGo, Inc. | 4dda6ac4-d849-69a6-e063-6394a90a3c54 | 2026-03-25 | Warnings | M017 |
| Alocane Max | LIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDE | Quest Products LLC | 0a33f9a9-1fdc-7cdf-e063-6294a90adca1 | 2026-03-25 | Warnings | M017 |
| EjaGuard | LIDOCAINE | MOLANSPACE INC | 475f64ef-d636-7e87-e063-6294a90ae32f | 2026-03-25 | Warnings | M017 |
| Hydrocortisone 1% | HYDROCORTISONE | ProStat First Aid | 4e53d29c-ed3c-f481-e063-6294a90a3181 | 2026-03-25 | Warnings | M017 |
| Topicaine Ultra | TOPICAINE ULTRA | Oncora Pharma, LLC | e052f718-700a-44e0-8770-65451b812ee1 | 2026-03-24 | Warnings | M017 |
| Hot Pap Cataplasma | METHYL SALICYLATE, VANILLYL NONYLAMIDE | Masaem Company | 4dbeda13-b198-0cf0-e063-6294a90a8180 | 2026-03-24 | Warnings | M017 |
| Barmicil Anti-itch | HYDROCORTISONE | OPMX LLC | 850084c3-1dd4-eb8d-e053-2a91aa0a130b | 2026-03-24 | Warnings | M017 |
| Jeil Hangbang Paff Soo S Cataplasma | GLYCOL SALICYLATE, L-MENTHOL | Masaem Company | 4dd040db-07cf-361a-e063-6394a90a8001 | 2026-03-24 | Warnings | M017 |
| Zenol Double Action | METHYL SALICYLATE, L-MENTHOL | BA TRADE INC | 4da998fc-75a3-583f-e063-6394a90a59c7 | 2026-03-23 | Warnings | M017 |
| Ultra Strength Topical Pain Relief Cream | CAMPHOR, MENTHOL, METHYL SALICYLATE | J C UDEOZOR & SONS GLOBAL INDUSTRIES LTD | 4db9ae57-4ab4-8fe4-e063-6394a90a7e51 | 2026-03-23 | Warnings | M017 |
| DR. SANA ALIVIO TOTAL ALIVIO TOTAL ROLL ON | ALIVIO TOTAL ROLL ON | EVI LABS | 4da01338-8739-08a8-e063-6294a90ae157 | 2026-03-22 | Warnings | M017 |
| DR SANA ALIVIO TOTAL ALIVIO TOTAL | ALIVIO TOTAL | EVI LABS | 4da1c3b8-9af2-6e9f-e063-6394a90a86ae | 2026-03-22 | Warnings | M017 |
| SORE NO MORE | MENTHOL CAMPHOR | SOMBRA COSMETICS INC. | 80d97c80-bdc0-4d5d-b6e2-86dfdb15d7bd | 2026-03-20 | Warnings | M017 |
| CVS Health Antiseptic Wound Wash | LIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDE | CVS Pharmacy | 53ac017a-eccb-3b24-e054-00144ff88e88 | 2026-03-20 | Warnings | M017 |
| Tecnu Diphenhydramine HCl Pain Relieving Anti Itch Gel 2% | ANTI ITCH GEL | Walgreens | 3d6e8c62-2fcc-51c2-e063-6394a90a33f7 | 2026-03-20 | Warnings | M017 |
| ANIXIKE Numbing | MENTHOL 5% NUMBING | Jiangxi Yudexi Pharmaceutical Co., LTD | 4d5c52d7-8e81-b62f-e063-6394a90ad03e | 2026-03-19 | Warnings | M017 |
| SYLVIRENE NUMBING | MENTHOL 5% NUMBING | Jiangxi Yudexi Pharmaceutical Co., LTD | 4d47e8c7-d293-bf63-e063-6294a90a5fd9 | 2026-03-18 | Warnings | M017 |
| Antibiotic and Pain Relief | NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE | STRATEGIC SOURCING SERVICES LLC | f7aa9330-c47c-4d2f-b784-11b831d919d6 | 2026-03-18 | Warnings | M017 |
| hydrocortisone | HYDROCORTISONE | Bryant Ranch Prepack | 99726aa3-3b45-4175-8471-279419af5457 | 2026-03-18 | 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 |