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 |
|---|---|---|---|---|---|---|
| Magsoothium Body | MENTHOL, CAPSAICIN | Ubu/Elements, Inc. | f604d30c-b17c-ec01-e053-2a95a90aa304 | 2025-12-15 | Warnings | M017 |
| Salonpas pain relieving JET | MENTHOL, METHYL SALICYLATE | Hisamitsu Pharmaceutical Co., Inc. | dd1ea3bf-891a-402e-8f43-14302bc9c3e5 | 2025-12-15 | Warnings | M017 |
| Herbal Tendon Bone Relief | CAMPHOR MINT | Guchutang Biotechnology (Longyan) Co., Ltd. | 45cf4040-9751-d24b-e063-6294a90aff27 | 2025-12-13 | Warnings | M017 |
| ElixirLidoFast | LIDOCAINE 5% CREAM | ELIXIR HEALTHCARE USA, LLC. | 45de5a3d-06c2-aa02-e063-6294a90a63d3 | 2025-12-13 | Warnings | M017 |
| MEDI FIRST PLUS | HYDROCORTISONE ACETATE | Orazen Inc | 5781124a-60f4-4a64-80b7-ce5f28d495b5 | 2025-12-12 | Warnings | M017 |
| MEDI-FIRST | HYDROCORTISONE ACETATE | Orazen Inc | aeffd85c-58a7-4d64-bf94-977b6fbbe713 | 2025-12-12 | Warnings | M017 |
| Joint and Muscle Relief | MENTHOL | Smart Cookie Solutions Inc. | 45c24d56-4dc9-2884-e063-6294a90a52cc | 2025-12-12 | Warnings | M017 |
| Popstar | DELAY SPRAY | Pineapple Brands LLC | 293b2da9-1261-0358-e063-6394a90aa08c | 2025-12-12 | Warnings | M017 |
| Careland Pain Relief Plus | CAMPHOR, MENTHOL, METHYL SALICYLATE | Planet (Anhui) Pharmaceutical Co., Ltd. | d9e63ddd-d003-45fa-b156-7f4452c28cbd | 2025-12-12 | Warnings | M017 |
| Glucosamine Cream EXTRA STRENGTH | HISTAMINE DIHYDROCHLORIDE | IDEAZ, LLC | f4d414b7-89e7-ad65-e053-2a95a90a25d4 | 2025-12-12 | Warnings | M017 |
| ARTHRITIS | MENTHOL | Smith Amish, LLC | 20c36972-b695-1241-e063-6394a90adf63 | 2025-12-12 | Warnings | M017 |
| FOOT | MENTHOL | Smith Amish, LLC | 20c48537-f55f-c10f-e063-6394a90a4cca | 2025-12-12 | Warnings | M017 |
| Joint Ease | MENTHOL | Smith Amish, LLC | 20c4a0f8-bdc6-d89a-e063-6294a90aa8d8 | 2025-12-12 | Warnings | M017 |
| Toast Screamin Hot | CAPSAICIN | IDEAZ, LLC | 331207e6-b8ac-b169-e063-6394a90ac169 | 2025-12-12 | Warnings | M017 |
| Pain Relief Gel-Patch | LIDOCAINE | KORVIA GLOBAL Inc. | 45ccfcae-a307-1c5f-e063-6294a90acf89 | 2025-12-12 | Warnings | M017 |
| Lidospot patch | LIDOCAINE AND MENTHOL | Fabrication Enterprises Inc | 3a6e94c4-1ca6-e77a-e063-6394a90a4bfc | 2025-12-12 | Warnings | M017 |
| LETEBEE LIGHT neuropathy pain relief cream for feet | MENTHOL | Guangdong Aimu Biological Technology Co., Ltd | 45a99afc-15ec-76c2-e063-6294a90a2220 | 2025-12-11 | Warnings | M017 |
| Cinthera | LIDOCAINE | Strand Health Group | 2746e5b2-be2d-f2d2-e063-6394a90a3690 | 2025-12-11 | Warnings | M017 |
| Equate Cool and Heat Pain Relieving Liquid | COOL AND HEAT PAIN RELIEF | Walmart, Inc. | ad156685-3bd5-6837-e053-2995a90ac788 | 2025-12-11 | Warnings | M017 |
| HUMCO Camphor Spirit | CAMPHOR 10% | Humco Holding Group, Inc. | 9a0ef0a3-3c79-41b2-8193-424a3ef9886f | 2025-12-11 | 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 |