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 |
|---|---|---|---|---|---|---|
| LenzaPro Flex | LIDOCAINE/MENTHOL | SOLA Pharmaceuticals | ba498f1d-460b-f4e6-e053-2995a90a5755 | 2025-12-08 | Warnings | M017 |
| LidaFlex | LIDOCAINE | SOLA Pharmaceuticals | b9e49529-13b4-1b0b-e053-2995a90adc7a | 2025-12-08 | Warnings | M017 |
| Rugby Menthol Hot Cold Patch | MENTHOL | RUGBY LABORATORIES | c68d29c2-9b56-4994-e053-2a95a90ae60e | 2025-12-08 | Warnings | M017 |
| Neuracin Topical Gel | NEURACIN TOPICAL ANALGESIC GEL | SOLA Pharmaceuticals | c3166926-30c2-2128-e053-2a95a90a0bf2 | 2025-12-08 | Warnings | M017 |
| Triceptin | LIDOCAINE / MENTHOL / METHYL SALICYLATE | SOLA Pharmaceuticals | ef1b98ab-d2db-038c-e053-2995a90a94b4 | 2025-12-08 | Warnings | M017 |
| SynoFlex Patch | SYNOFLEX PATCH | Sola Pharmaceuticals | de2042c4-6c5e-7365-e053-2a95a90ada2a | 2025-12-08 | Warnings | M017 |
| AROAMAS COT NICOTINE TRANSDERMAL PATCHES STEP 1 | NICOTINE TRANSDERMAL PATCHES | PCHEERY LLC | 457c860b-091d-8350-e063-6294a90a2f98 | 2025-12-08 | Warnings | M017 |
| AY BENDITO HEMP | MENTHOL, CAMPHOR | AY BENDITO INTERNATIONAL, INC | 457c9bd6-2e72-03e5-e063-6394a90a558c | 2025-12-08 | Warnings | M017 |
| AY BENDITO HEMP ROLL-ON | CAMPHOR, MENTHOL | AY BENDITO INTERNATIONAL, INC | 3e552afc-9305-8825-e063-6294a90a1afe | 2025-12-08 | Warnings | M017 |
| AY BENDITO HEMP | CAMPHOR, MENTHOL | AY BENDITO INTERNATIONAL, INC | 457d89aa-4a84-94a6-e063-6294a90a20c0 | 2025-12-08 | Warnings | M017 |
| Gold Bond Medicated Anti-Itch | PRAMOXINE HYDROCHLORIDE, MENTHOL | Gold Bond Co LLC | 4a2bd277-47dd-4ae6-9b4b-e0ae9aad226b | 2025-12-05 | Warnings | M017 |
| Orajel for Cold Sores Double Medicated, Cream | BENZOCAINE AND WHITE PETROLATUM | Church & Dwight Co., Inc. | b8699a40-8464-ca02-e053-2995a90a4260 | 2025-12-05 | Warnings | M017 |
| Thompson Hydrocortisone 1% | HYDROCORTISONE | Thompson | f8740314-7e1f-815e-e053-6294a90a6eae | 2025-12-05 | Warnings | M017 |
| JUST CBD SOOTHING UNSCENTED | LIDOCAINE HCL | Just Brands LLC | 453f44e2-9e5b-8695-e063-6394a90a4389 | 2025-12-05 | Warnings | M017 |
| JUST CBD ROLL-ON COOLING | MENTHOL | Just Brands LLC | 453fa1a7-368c-ae50-e063-6294a90a5507 | 2025-12-05 | Warnings | M017 |
| JUST CBD ROLL-ON WARMING | CAMPHOR | Just Brands LLC | 4540221f-cf9f-9b6a-e063-6294a90adec3 | 2025-12-05 | Warnings | M017 |
| Gold Bond Extra Strength | MENTHOL | Gold Bond Co LLC | 3e84375f-95d3-420c-b222-02a757412592 | 2025-12-04 | Warnings | M017 |
| Alocane Plus | LIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDE | Quest Products LLC | b3ec09b9-7511-0895-e053-2a95a90a7840 | 2025-12-04 | Warnings | M017 |
| Gold Bond Medicated Pain and Itch Relief | LIDOCAINE HYDROCHLORIDE | Gold Bond Co LLC | d240e9b8-3506-42ab-8a50-05e8d3fac4ff | 2025-12-04 | Warnings | M017 |
| BLT Skin Cream | BENZOCAINE, LIDOCAINE, TETRACAINE | M2B Pharma LLC | 9dc5db9d-9e0a-cd28-e053-2995a90a6bf7 | 2025-12-04 | 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 |