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 |
|---|---|---|---|---|---|---|
| good sense anti itch | HYDROCORTISONE | L. Perrigo Company | b7a896cc-1d78-45c0-a73e-aa1e117f7d3b | 2024-09-29 | Warnings | M017 |
| Topcare Hydrocortisone | HYDROCORTISONE | Topco Associates LLC | b7362f21-f1a3-4edc-b5b6-a16680e05df3 | 2024-09-29 | Warnings | M017 |
| hydrocortisone | HYDROCORTISONE | H E B | 412ca2d1-064b-4438-aee1-fcb5cf27c7db | 2024-09-29 | Warnings | M017 |
| Topcare Antibiotic | NEOMYCIN, POLYMYXIN B, PRAMOXINE HYDROCHLORIDE | Topco Associates LLC | 8c349cac-20e1-4600-9b0a-fcfe929551c5 | 2024-09-26 | Warnings | M017 |
| good sense anti itch | HYDROCORTISONE | A-S Medication Solutions | 072dd455-24a5-4a44-aaef-d3e137d005a6 | 2024-09-26 | Warnings | M017 |
| SYREN Intimate Relief | LIDOCAINE HYDROCHLORIDE | Icon Health Science | 57d5a080-3583-4510-e053-2a91aa0ad589 | 2024-09-25 | Warnings | M017 |
| AOSI HEALTHCARE | HYDROCORTISONE | Nantong Health & Beyond Hygienic Products Inc. | f4db90ad-dd62-44f1-9655-2614ed36581e | 2024-09-25 | Warnings | M017 |
| AOSI HEALTHCARE BURN | LIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDE | Nantong Health & Beyond Hygienic Products Inc. | a28b920c-0bb8-4b5a-addd-26ea164e036e | 2024-09-25 | Warnings | M017 |
| anti itch | DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE | Kroger Company | 067e718a-ec0b-4895-8f9f-82d64ab4c7b4 | 2024-09-24 | Warnings | M017 |
| topcare anti itch | DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE | Topco Associates LLC | e0fb332a-2903-41ef-b35b-7cd3a74cff99 | 2024-09-24 | Warnings | M017 |
| equaline anti itch | HYDROCORTISONE | United Natural Foods, Inc. dba UNFI | 83cd9f60-a4c4-4dea-97a7-cd96aade9e88 | 2024-09-24 | Warnings | M017 |
| good sense itch relief | DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE | L. Perrigo Company | 162fe0a3-3995-4e6f-94ed-f839b2b0c80e | 2024-09-24 | Warnings | M017 |
| Caring Mill Anti-Itch Cream | DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE | Veridian Healthcare | 22ca137a-576c-a13c-e063-6394a90ae7fc | 2024-09-23 | Warnings | M017 |
| Signature Care Anti Itch | HYDROCORTISONE | Safeway | ed0eb068-3ce6-423d-a7f8-c3456b7f6040 | 2024-09-23 | Warnings | M017 |
| members mark hydrocortisone | HYDROCORTISONE | Sam's West Inc | 218f0dcd-fa67-4935-8019-ecbbd53ed2f7 | 2024-09-23 | Warnings | M017 |
| anti itch | HYDROCORTISONE | Meijer, Inc. | a07496e0-6fc2-4190-8a01-f513134ffb92 | 2024-09-23 | Warnings | M017 |
| ZYLOTROL PAIN RELIEVING | LIDOCAINE HCL, MENTHOL | Whitestone Products LLC | 2301fed7-0fa9-450d-8b1b-006f53235be0 | 2024-09-21 | Warnings | M017 |
| Tibetree Cheezheng Joint Analgesic Patch | CAMPHOR | Tibet Cheezheng Tibetan Medicine Co. Ltd | 65a8a63f-1864-473e-be72-7840a6a5dee7 | 2024-09-20 | Warnings | M017 |
| Cold Ice Analgesic Gel | MENTHOL | Dabur India Limited | 22915b2f-5f76-3e38-e063-6394a90a07b4 | 2024-09-20 | Warnings | M017 |
| Exchange Select Hydrocortisone | HYDROCORTISONE | Army & Air Force Exchange Service | 1b709db3-7dc1-4756-a8a0-dddda875dc57 | 2024-09-19 | 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 |