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 |
|---|---|---|---|---|---|---|
| XtraCare Ice Cold Topical Analgesic Gel | MENTHOL | Rejoice International | d38f3099-d940-44d8-aa7f-404157c5e0e3 | 2023-10-24 | Warnings | M017 |
| Family Wellness | DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE | Zhejiang Jingwei Pharmaceutical Co., Ltd. | fefbe351-1cd9-4a2f-a43d-51e2c4eb180b | 2023-10-24 | Warnings | M017 |
| TheraPlus Plus | MENTHOL | Zhejiang Jingwei Pharmaceutical Co., Ltd. | d4119f84-eb60-4134-b58e-de13d9601199 | 2023-10-24 | Warnings | M017 |
| Family Wellness | HYDROCORTISONE | Zhejiang Jingwei Pharmaceutical Co., Ltd. | cddc9c4a-7c58-4225-921a-05d6afb49178 | 2023-10-24 | Warnings | M017 |
| NUMOTIZINE | MENTHOL | Hobart Laboratories, Inc. | 9a29ad1b-4ba3-403f-90c9-ee7582fe4535 | 2023-10-20 | Warnings | M017 |
| Numfast Tetracaine Green | TETRACAINE | Unit Dose, Ltd. | 77d9e6ea-1cd3-4447-ba74-01cd7143e27c | 2023-10-19 | Warnings | M017 |
| Liprotek | PETROLATUM, LIDOCAINE | Unit Dose, Ltd. | 051cfa27-bd7c-4f8c-b3e6-03ee0b7a3aa5 | 2023-10-19 | Warnings | M017 |
| GENUINE FIRST AID Antiseptic Pain Relieving | BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE | Nantong Health & Beyond Hygienic Products Inc. | bc7c6739-6068-4694-adc9-0c0c5c347df4 | 2023-10-19 | Warnings | M017 |
| CVS Itch relief moisturizing | PRAMOXINE HCL 1% | CVS Health | f3a753fc-f448-6bba-e053-2a95a90a8e1b | 2023-10-18 | Warnings | M017 |
| Zylotrol | LIDOCAINE HCL 4%, MENTHOL 1% | Asclemed USA, Inc. | e13984ea-73a9-2894-e053-2995a90a8ed6 | 2023-10-16 | Warnings | M017 |
| EXOTEN-C | METHYL SALICYLATE, MENTHOL, CAPSAICIN | Asclemed USA, Inc. | 76ed37e0-64b5-4abe-a03c-3dc7084a3919 | 2023-10-16 | Warnings | M017 |
| Calypxo Pain Relief | METHYL SALICYLATE, MENTHOL | Asclemed USA, Inc | bd9d0bc0-5705-4c73-bcd6-f6cdb68e05b6 | 2023-10-16 | Warnings | M017 |
| Calypxo HP Pain Relief | METHYL SALICYLATE, MENTHOL | Asclemed USA, Inc | 89a8c267-bd92-4d0d-8e50-c52224aff9cd | 2023-10-16 | Warnings | M017 |
| Zylotrol | LIDOCAINE HCL 4%, MENTHOL 1% | Whitestone Products LLC | 0e32e9c0-ff5b-4e88-89b1-f5903cd98209 | 2023-10-16 | Warnings | M017 |
| Capsadyn | CAPSAICIN | Chorda Pharma, Inc | 07731045-0d2b-76b7-e063-6294a90af921 | 2023-10-11 | Warnings | M017 |
| WHITE FLOWER STRAIN RELIEF | CAMPHOR, MENTHOL AND METHYL SALICYLATE | HOE HIN PAK FAH YEOW MANUFACTORY LTD | 65282267-de63-453a-a686-f8752c71b9ef | 2023-10-02 | Warnings | M017 |
| WHITE FLOWER ANALGESIC BALM FLORAL SCENTED | CAMPHOR, MENTHOL AND METHYL SALICYLATE | HOE HIN PAK FAH YEOW MANUFACTORY LTD | 4e9cb5aa-b0aa-4a5c-b561-cc38437758d8 | 2023-10-02 | Warnings | M017 |
| NATUREANCE BODY BALM | CAMPHOR | EROS GLOBAL CORP | 05b84fd2-8d8f-9249-e063-6294a90ae29f | 2023-09-19 | Warnings | M017 |
| U ICE COLD | MENTHOL | UNIVERSAL DISTRIBUTION CENTER LLC | 752ef0cd-f12a-3b9e-e053-2991aa0abeb1 | 2023-09-01 | Warnings | M017 |
| Family Wellness Pain Relief with Lidocaine | PAIN RELIEF WITH LIDOCAINE | FAMILY DOLLAR (Family Wellness) | 3a18119f-6c75-4cea-a990-97cb8a9589d4 | 2023-08-29 | 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 |