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 |
|---|---|---|---|---|---|---|
| Kalaya Extra Strength Pain Relief Cream with Hemp Seed Oil | METHYL SALICYLATE, MENTHOL, CAMPHOR | Avaria Health & Beauty Corp | 2eccf23c-fae2-423c-9cae-549bc4194104 | 2025-10-08 | Warnings | M017 |
| KALAYA BACK AND NECK PAIN RELIEF | METHYL SALICYLATE, MENTHOL, CAMPHOR | Avaria Health & Beauty Corp | 48fd73e7-1443-4ac7-bf7c-d99bf2449f51 | 2025-10-08 | Warnings | M017 |
| Lidocaine Pain Relieving Patch | LIDOCAINE 4% | BluePoint Laboratories | 3117273d-e006-2726-e063-6294a90a9c33 | 2025-10-08 | Warnings | M017 |
| EQUATE PAIN RELIEVING PATCHES | LIDOCAINE 4% | WALMART, INC | 01e1cc0e-e1c9-d274-e063-6294a90a409e | 2025-10-08 | Warnings | M017 |
| Equate Pain Relief Balm | MENTHOL 11%, CAMPHOR 11% OINTMENT | WALMART, INC | d8ddf835-f008-ce1f-e053-2a95a90aa9b3 | 2025-10-08 | Warnings | M017 |
| TheraCare Pain Relieving Menthol Gel | MENTHOL 2% | Veridian Healthcare | 9d2ccb02-746c-4cb9-905d-280987778f4d | 2025-10-08 | Warnings | M017 |
| COOLING PAIN RELIEF | MENTHOL, CAMPHOR | SUNSET NOVELTIES, INC | 3a9019b1-8798-1ef9-e063-6394a90a09a4 | 2025-10-08 | Warnings | M017 |
| Coralite Capsaicin Heat Patch 2ct | CAPSAICIN | United Exchange Corp. | 4128b1ac-f540-2611-e063-6294a90ac98b | 2025-10-08 | Warnings | M017 |
| Ombre Men overtime wipes | BENZOCAINE | Sambria Pharmaceuticals, LLC | 405f23ca-99c1-4db4-aba1-2fd7f93f55ee | 2025-10-07 | Warnings | M017 |
| Pain free IV | LIDOCAINE | Sambria Pharmaceuticals, LLC | 7aa4cb20-d452-417f-afdb-307df754ed75 | 2025-10-07 | Warnings | M017 |
| HYDROCORTISONE | HYDROCORTISONE | CVS PHARMACY, INC | b3bdff5e-37fe-442a-a370-7b19799ea781 | 2025-10-07 | Warnings | M017 |
| HealthWise Pain Relief Patch | MENTHOL, METHYL SALICYLATE | Veridian Healthcare | b65932fd-ee9f-4fa2-b842-01e0f54133c9 | 2025-10-07 | Warnings | M017 |
| AREX SINSIN PAS | CAMPHOR, MENTHA OIL, MENTHOL, METHYL SALICYLATE, ZINC OXIDE | Sinsin Pharmaceutical Co., Ltd. | 2013ea44-e2ea-4b36-bddb-7f64163284b6 | 2025-10-07 | Warnings | M017 |
| SINSINPAS LIDOCAINE PAIN RELIEVING | LIDOCAINE | Sinsin Pharmaceutical Co., Ltd. | 82c0a036-8750-5b3d-e053-2a91aa0a1815 | 2025-10-07 | Warnings | M017 |
| SINSIN MULPAS | L-MENTHOL, METHYL SALICYLATE, DL-CAMPHOR, CHLORPHENIRAMINE MALEATE, THYMOL | Sinsin Pharmaceutical Co., Ltd. | 81baffcb-c08e-4616-e053-2a91aa0aaf15 | 2025-10-07 | Warnings | M017 |
| Arex Sinsin Pas | CAMPHOR, MENTHA OIL, MENTHOL, METHYL SALICYLATE, ZINC OXIDE | Sinsin Pharmaceutical Co., Ltd. | a851854a-5dfe-4bd5-95f6-67c3f13f1187 | 2025-10-07 | Warnings | M017 |
| Sinsinpas Arex Flex Gel Pain Relieving Patch | L-MENTHOL | Sinsin Pharmaceutical Co., Ltd. | 1758ef9b-4fac-4066-e063-6394a90a8cc3 | 2025-10-07 | Warnings | M017 |
| SINSINPAS CORN REMOVER | SALICYLIC ACID | Sinsin Pharmaceutical Co., Ltd. | e2771dfc-ee57-553f-e053-2a95a90af281 | 2025-10-07 | Warnings | M017 |
| Capsaicin | CAPSAICIN | PHARMACURE LLC | 05a09ee5-e7a4-4758-8b16-f60b945a7d82 | 2025-10-06 | Warnings | M017 |
| Lidocanna | LIDOCAINE | PHARMACURE LLC | b28ebbb6-1112-4750-a2bb-f96b03fabe6e | 2025-10-06 | 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 |