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 |
|---|---|---|---|---|---|---|
| 4x Medicated Toothache and Gum Cream | BENZOCAINE | Kroger | a8c5090a-24f9-4e73-e053-2a95a90acca0 | 2025-11-14 | Warnings | M017 |
| PM Toothache Relief | BENZOCAINE | CVS | 0a5a8cd0-d680-8a0f-e063-6294a90aa65c | 2025-11-14 | Warnings | M017 |
| PM Toothache Relief | BENZOCAINE | Walgreens | e816f742-fba9-3c12-e053-2a95a90a192f | 2025-11-14 | Warnings | M017 |
| 4x Medicated Toothache and Gum Cream | BENZOCAINE | Walgreens | a71c2092-4ece-b82e-e053-2995a90ac933 | 2025-11-14 | Warnings | M017 |
| After Bite Outdoor | DIPHENHYDRAMINE HCL | Tender Corporation d/b/a Adventure Ready Brands | 22b891a9-6386-dee1-e063-6394a90a5c2f | 2025-11-14 | Warnings | M017 |
| QR PAIN | ANALGESIC | MARYHELENE ENTERPRISES INC | 8f8f53e3-fe31-e7b5-e053-2995a90a710d | 2025-11-14 | Warnings | M017 |
| QR PAIN | ANALGESIC | MARYHELENE ENTERPRISES INC | 9984a510-30be-4013-e053-2995a90a841e | 2025-11-14 | Warnings | M017 |
| Anti-Itch Cream | DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE | Kroger | 3f881349-fcdd-e276-e063-6394a90ae49e | 2025-11-13 | Warnings | M017 |
| Rapid Relief | PLANTAR FASCIITIS PAIN RELIEF LIDOCAINE 4% MENTHOL 1% | RAPID AID VIET NAM COMPANY LIMITED | 434cb8b2-a996-5360-e063-6394a90ada03 | 2025-11-13 | Warnings | M017 |
| Rapid Relief | COLD RELIEF PATCH 5% MENTHOL | RAPID AID VIET NAM COMPANY LIMITED | 4360e3ec-7a4b-b28e-e063-6294a90a0bd6 | 2025-11-13 | Warnings | M017 |
| Rapid Relief | PAIN RELIEF PATCH CAMPHOR 110MG MENTHOL 33MG CAPSICUM EXTRACT 22MG | RAPID AID VIET NAM COMPANY LIMITED | 4360e3be-0ec4-cd57-e063-6394a90aca63 | 2025-11-13 | Warnings | M017 |
| Rapid Relief | PAIN RELIEF PATCH LIDOCAINE 4% MENTHOL 1% | RAPID AID VIET NAM COMPANY LIMITED | 43616ad7-58bb-e5ad-e063-6394a90a192b | 2025-11-13 | Warnings | M017 |
| 4x Medicated Severe Toothache and Gum Gel | BENZALKONIUM CHLORIDE | Meijer | 97ce7890-5093-1763-e053-2a95a90afae7 | 2025-11-13 | Warnings | M017 |
| Pain Reliever | CAMPHOR, MENTHOL | Kool 'N Fit Inc. | 2253f6bd-5707-b993-e063-6394a90aa74a | 2025-11-13 | Warnings | M017 |
| Rapid Relief | PLANTAR FASCIITIS PAIN RELIEF LIDOCAINE 4% MENTHOL 1% | RAPID AID VIET NAM COMPANY LIMITED | 4360e0d1-46cd-ab4b-e063-6394a90a55e1 | 2025-11-12 | Warnings | M017 |
| CVS Itch Relief | DIPHENHYDRAMINE HCL, ZINC ACETATE | CVS | 8723e097-296f-784a-e053-2991aa0a552e | 2025-11-12 | Warnings | M017 |
| Dragon Pain Relieving Balm | CAMPHOR, MENTHOL | Americanna Wellness, Inc. | 154d8821-3e76-b0e2-e063-6294a90ae077 | 2025-11-12 | Warnings | M017 |
| Good neighbor Pharmacy Itch Relief | DIPHENHYDRAMINE HCL, ZINC ACETATE | AMERISOURCEBERGEN DRUG CORPORATION | 87395273-380c-7cef-e053-2991aa0a54c6 | 2025-11-12 | Warnings | M017 |
| Quality Choice Itch Relief | DIPHENHYDRAMINE HCL, ZINC ACETATE | Chain Drug Marketing Association | 8735b298-83f3-0b5d-e053-2a91aa0a8292 | 2025-11-12 | Warnings | M017 |
| Dragon Pain Relieving Balm | CAMPHOR, MENTHOL | Americanna Wellness, Inc. | 1550e794-b3c0-4769-e063-6294a90a8c2d | 2025-11-12 | 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 |