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 |
|---|---|---|---|---|---|---|
| Itch Eraser | DIPHENHYDRAMINE HCL | Tender Corporation d/b/a Adventure Ready Brands | 2204e135-6a23-68a2-e063-6394a90ac019 | 2025-11-18 | Warnings | M017 |
| Analgesic Balm | MENTHOL 10%, METHYL SALICYLATE 15% | Geri-Care Pharmaceuticals, Corp | c8594e10-661f-6ff3-e053-2995a90ab4fc | 2025-11-18 | Warnings | M017 |
| Mag 5 PT Cooling Formula Recovery Cream | MENTHOL | RENU LABORATORIES, LLC | a45cde67-64ec-643b-e053-2a95a90a10b6 | 2025-11-18 | Warnings | M017 |
| After Ivy Wipe | CAMPHOR | Tender Corporation d/b/a Adventure Ready Brands | 21d98018-826a-1d0d-e063-6294a90a0a71 | 2025-11-17 | Warnings | M017 |
| Itch Eraser Gel | DIPHENHYDRAMINE HCL | Tender Corporation d/b/a Adventure Ready Brands | 223c7cfd-6dc5-140a-e063-6394a90a8332 | 2025-11-17 | Warnings | M017 |
| Calamine Plus Pramoxine HCl | CALAMINE PLUS SPRAY | Kroger Co. | 6b3e7aac-395f-48cf-9c5e-f7e163724aef | 2025-11-17 | Warnings | M017 |
| Calamine Plus Pramoxine HCl | CALAMINE PLUS SPRAY | HY-VEE, INC | 415ecfe9-3145-f23e-e063-6394a90adfd8 | 2025-11-17 | Warnings | M017 |
| AY BENDITO - CBD | CAMPHOR, MENTHOL | AY BENDITO INTERNATIONAL, INC | 04b1d605-60aa-56f4-e063-6294a90ae760 | 2025-11-17 | Warnings | M017 |
| AY BENDITO - CBD | CAMPHOR, MENTHOL | AY BENDITO INTERNATIONAL, INC | 0f1406fe-3a2f-bf36-e063-6294a90a7e5e | 2025-11-17 | Warnings | M017 |
| AY BENDITO CBD | MENTHOL, CAMPHOR | AY BENDITO INTERNATIONAL, INC | 30a1c6b7-e37e-32c2-e063-6394a90aa354 | 2025-11-17 | Warnings | M017 |
| ETERNAL SPIRIT BEAUTY PAINLESS WITH CBD 3000 | MENTHOL, CAMPHOR | Worldwide Cosmetics, Inc | 0816cc8f-8d0b-de27-e063-6294a90a8a9d | 2025-11-17 | Warnings | M017 |
| JUST CBD ROLL-ON COOLING | MENTHOL | Just Brands LLC | f6538e3e-4663-679c-e053-2995a90a87b5 | 2025-11-17 | Warnings | M017 |
| JUST CBD ROLL-ON WARMING | CAMPHOR | Just Brands LLC | f65455d7-04a9-6217-e053-2995a90a7c90 | 2025-11-17 | Warnings | M017 |
| JUST CBD - CBD AND THC ULTRA RELIEF | MENTHOL, CAMPHOR | Just Brands LLC | f664eb79-8897-3a49-e053-2995a90a37b4 | 2025-11-17 | Warnings | M017 |
| JUST CBD RELIEF SOOTHING | LIDOCAINE HCL | Just Brands LLC | f9aff6e7-5702-f61c-e053-6294a90aa66f | 2025-11-17 | Warnings | M017 |
| JUST CBD SOOTHING | MENTHOL, CAMPHOR | Just Brands LLC | 0abece07-976c-4881-e063-6294a90a5c1b | 2025-11-17 | Warnings | M017 |
| Blue-Emu Thrive Pain Relief Cream | TRIPELENNAMINE 0.5% | Kingsway Pharmaceuticals dba NFI, LLC | a4ba6787-c99b-4bf2-9f8f-e923ef976212 | 2025-11-14 | Warnings | M017 |
| CVS Cooling Patch | MENTHOL | CVS Pharmacy | 42d97e29-f32d-a31b-e063-6394a90a88d8 | 2025-11-14 | Warnings | M017 |
| Lidocaine | LIDOCAINE | Marlex Pharmaceuticals Inc | 4de2bc60-dc4a-4417-984f-eabab0e926a6 | 2025-11-14 | Warnings | M017 |
| EXTREME EMU | MENTHOL, METHYL SALICYLATE | Renu Laboratories, LLC | 4393b57b-1e70-b8dd-e063-6294a90ae748 | 2025-11-14 | 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 |