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 |
|---|---|---|---|---|---|---|
| Numbing Cream | LIDOCAINE | 100 KARMA INC | 359884d6-188a-e503-e063-6294a90acab4 | 2025-05-20 | Warnings | M017 |
| AY BENDITO - THERMOACTIVE | CAMPHOR, MENTHOL | AY BENDITO - THERMOACTIVE LOTION | 835abc66-680f-be06-e053-2a91aa0a309e | 2025-05-19 | Warnings | M017 |
| Numbing Cream | LIDOCAINE | 100 KARMA INC | 35884644-d017-eda3-e063-6394a90a1f6c | 2025-05-19 | Warnings | M017 |
| QUIT SMOKING Proven Patches | NICOTINE | Jiashen International Trade Limited | 35570155-c769-dc4c-e063-6394a90a019d | 2025-05-17 | Warnings | M017 |
| VBBV Tattoo Numbing | LIDOCAINE | Jiashen International Trade Limited | 3557859e-f8b3-1049-e063-6394a90ad737 | 2025-05-17 | Warnings | M017 |
| Bliss Republic Lidocaine Numbing Cream | LIDOCAINE NUMBING CREAM | Sargass Group Limited Liability Company | 35415851-beba-5bb4-e063-6294a90a35c0 | 2025-05-16 | Warnings | M017 |
| Cold Hot Chinese Red Tiger Pain Relief Gel Roll-On | MENTHOL | Guangzhou Zhupuyou E-commerce Co., Ltd | 352798e1-1e09-3d47-e063-6394a90ad404 | 2025-05-15 | Warnings | M017 |
| Plantar Fasciitis Chinese Red Tiger Pain Relief Gel Roll-On | MENTHOL | Guangzhou Zhupuyou E-commerce Co., Ltd | 35285d62-c660-a056-e063-6294a90aabc8 | 2025-05-15 | Warnings | M017 |
| SionBiotext Hydrocortisone | HYDROCORTISONE ACETATE 1% | Sion Biotext Medical Ltd | 35073eae-26fe-2bb5-e063-6294a90ab56a | 2025-05-13 | Warnings | M017 |
| Bliss Republic Lidocaine Numbing Cream | LIDOCAINE NUMBING CREAM | Sargass Group Limited Liability Company | 3508ae14-d9c9-3c85-e063-6294a90a0098 | 2025-05-13 | Warnings | M017 |
| SORE NO MORE WARM THERAPY | MENTHOL AND CAMPHOR | SOMBRA COSMETICS INC. | cd86b56e-9b4c-4aca-9740-c8793cb12055 | 2025-05-12 | Warnings | M017 |
| SORE NO MORE COOL THERAPY | MENTHOL | SOMBRA COSMETICS INC. | 9aa1f0ac-3baf-4e45-9e3a-c28a99b22909 | 2025-05-12 | Warnings | M017 |
| Calm and Correct Serum with Lidocaine | LIDOCAINE 3 PERCENT | Renu Laboratories, LLC | ddcf1c2e-2f67-44d7-e053-2a95a90a812b | 2025-05-09 | Warnings | M017 |
| Mqupin Knee Patch | KNEE PATCH | Zhengzhou Miaoqi Pharmaceutical Technology Co., Ltd | 09772e4b-8193-3771-e063-6394a90a9516 | 2025-05-08 | Warnings | M017 |
| Hydrocortisone Cream | HYDROCORTISONE | Trifecta Pharmaceuticals USA | d57a59fb-c8f2-f73b-e053-2995a90a4cdb | 2025-05-08 | Warnings | M017 |
| Hydrocortisone Cream | HYDROCORTISONE | Trifecta Pharmaceuticals USA | 4c96ec41-841c-322b-e054-00144ff8d46c | 2025-05-08 | Warnings | M017 |
| GNP Extra Strength Anti-Itch Cream | DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE | Amerisource Bergen | 34a66224-ef3c-e36e-e063-6394a90ac99d | 2025-05-08 | Warnings | M017 |
| Good Neighbor Muscle Rub Cream | CAMPHOR 4.0%, MENTHOL 10.0%, METHYL SALICYLATE 30.0%, | Amerisource Bergen | 34924bb9-e3e8-70e6-e063-6294a90aaa8c | 2025-05-07 | Warnings | M017 |
| DermaRad Relief Post Radiation Calming | LIDOCAINE 3 PERCENT | Renu Laboratories, LLC | e5d64929-fb9c-7ebc-e053-2995a90a9318 | 2025-05-07 | Warnings | M017 |
| Cold Hot Medicated Patch 5% Menthol | MENTHOL | InterMed Laboratories Private Limited | 33ee0235-5a6e-0ea1-e063-6394a90a89a5 | 2025-05-06 | 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 |