Theraworx PM Nighttime Maximum Strength Pain Relief
- Product NDC
- 61594-044
- 11-digit product format
- 615940044
- Labeler code
- 61594
- Product ID
- 61594-044_5d4f6c02-183f-001e-e063-6294a90a3b80
- 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
- 2024-09-01
- 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 PM Nighttime Maximum Strength Pain Relief
- 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 |
|---|---|---|---|---|---|---|
| 61594-044-00 | Theraworx PM Nighttime Maximum Strength Pain Relief | 1 in 1 CARTON | LIQUID | 1 | 2 | |
| 61594-044-00 | Theraworx PM Nighttime Maximum Strength Pain Relief | 74 mL in 1 BOTTLE | LIQUID | 74 | 2 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 61594-044-00 | ML - Milliliter | 61594-044 | c0b6419a-4f81-47b1-b6ba-bcde30b73862 | 1 | 2024-10-04 |
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 |
|---|---|---|---|---|---|---|
| RELISPRAY NATURAL PAIN RELIEF | MENTHOL | Midas-Care Pharmaceuticals, Pvt. Ltd | adc8a43c-19a1-4eb3-9820-b63f7b5e91ea | 2025-10-30 | Warnings | M017 |
| Aveeno Anti-Itch Concentrated | ZINC OXIDE, FERRIC OXIDE RED, AND PRAMOXINE HYDROCHLORIDE | Kenvue Brands LLC | 07f4d4d0-9cee-46c3-bc71-2024abd31c9e | 2025-10-29 | Warnings | M017 |
| zourunan Relieve itching cream ANTIFUNGAL | RELIEVE ITCHING CREAM | Guchutang Biotechnology (Longyan) Co., Ltd | 41bb9ced-dde4-2998-e063-6394a90a8159 | 2025-10-29 | Warnings | M017 |
| zourunan Intensive healing lotion. for ECZEMA | INTENSIVE HEALING LOTION | Guchutang Biotechnology (Longyan) Co., Ltd | 41bad9f3-f1a7-e92c-e063-6394a90ad0ba | 2025-10-29 | Warnings | M017 |
| Aromalief Pain Relief Cream Orange Ginger | MENTHOL | Marketites LLC | 9e8d3611-ef1b-4ac6-e053-2995a90af28a | 2025-10-29 | Warnings | M017 |
| Aromalief Calming Pain Relief Cream Lavender | MENTHOL | Marketites LLC | b8197d52-ccfb-b008-e053-2995a90a0a53 | 2025-10-29 | Warnings | M017 |
| Aromalief Cozy Vanilla Pain Relief Cream | MENTHOL | Marketites LLC | 3634e55e-8c62-a782-e063-6394a90a6508 | 2025-10-29 | Warnings | M017 |
| BENOVA PAIN AND ITCH RELIEF | MENTHOL, 0.11% | BENOVA RX LLC | 42513ee2-8b40-a9f3-e063-6394a90a9386 | 2025-10-29 | Warnings | M017 |
| Burn Relief | LIDOCAINE | CVS Pharmacy | 7e9285fd-26d5-3eac-e053-2991aa0ae2db | 2025-10-29 | Warnings | M017 |
| Coralite Ultra Strength Pain Relief | CAMPHOR MENTHOL | United Exchange Corp. | 44ecf959-cc07-4adc-a500-075b2ee69548 | 2025-10-29 | Warnings | M017 |
| GoodSense Pain Relief | LIDOCAINE | Geiss, Destin & Dunn, Inc | 826f8da4-8468-ea0a-e053-2991aa0a66cb | 2025-10-28 | Warnings | M017 |
| CALMADOL | CAMPHOR, MENTHOL, METHYL SALICYLATE | GRANDALL DISTRIBUTING, LLC | 31b7f84e-8b66-4d31-8e9c-279d0af2fe64 | 2025-10-28 | Warnings | M017 |
| XRay DOL | CAMPHOR, MENTHOL, AND METHYL SALICYLATE | Genomma Lab USA, Inc. | e07fef46-68d9-769c-e053-2a95a90aa065 | 2025-10-28 | Warnings | M017 |
| CVS Medicated Heat | CAPSICUM EXTRACT | CVS Pharmacy | 81cd1019-93a6-311b-e053-2991aa0a7997 | 2025-10-28 | Warnings | M017 |
| Foster and Thrive | LIDOCAINE | STRATEGIC SOURCING SERVICES, LLC | f950b072-d978-b629-e053-6394a90abfaf | 2025-10-28 | Warnings | M017 |
| Calamine Plus Pramoxine HCl | CALAMINE PLUS SPRAY | Premier Brands of America, Inc. | d3452573-f91f-f157-e053-2a95a90a1ad8 | 2025-10-27 | Warnings | M017 |
| PR | MENTHOL | Amphp, Inc | 6f5b9e08-c445-4fac-e053-2a91aa0aa737 | 2025-10-27 | Warnings | M017 |
| Lidocaine | BURN RELIEF | Foodhold USA | b25dc0df-02d0-41ac-b36c-2c04baa77ef2 | 2025-10-27 | Warnings | M017 |
| Menthol | MAXIMUM STRENGTH MEDICATED FOOT POWDER TALC FREE | FSA Store Inc. | fb3548c8-f202-dc50-e053-6394a90a5b30 | 2025-10-27 | Warnings | M017 |
| Hydrocortisone | HYDROCORTISONE CONTINUOUS SPRAY | Premier Brands of America, Inc. | d344f68b-9b62-3029-e053-2995a90a1665 | 2025-10-27 | Warnings | M017 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1987647 | lidocaine hydrochloride 4 % Topical Solution | PSN | bc8cb476-9a47-47b3-ad78-a6ecec9ee66f | 2 |
| 1987647 | lidocaine hydrochloride 40 MG/ML Topical Solution | SCD | bc8cb476-9a47-47b3-ad78-a6ecec9ee66f | 2 |
| 1987647 | lidocaine hydrochloride 4 % Topical Solution | SY | bc8cb476-9a47-47b3-ad78-a6ecec9ee66f | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 61594-044-00 | 61594004400 | 1 BOTTLE in 1 CARTON (61594-044-00) / 74 mL in 1 BOTTLE | 1 bottle | 2024-09-01 | No | No | Current |