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 |
|---|---|---|---|---|---|---|
| Pain Relieving | MENTHOL, CAMPHOR, CAPSAICIN | AHC VENTURES CORP DBA CRY | 27679d31-a5f3-417b-b0c5-5f6b001ecff9 | 2025-09-02 | Warnings | M017 |
| Cold Therapy | MENTHOL | AHC VENTURES CORP DBA CRYODERM | 52fff03e-eba2-4604-a71c-2522468f627b | 2025-09-02 | Warnings | M017 |
| Pain Relieving Cold Therapy | MENTHOL | AHC VENTURES CORP DBA CRYODERM | de210c3a-c24e-cefd-e053-2a95a90a93ff | 2025-09-02 | Warnings | M017 |
| Pain Relieving Roll-On | MENTHOL, CAMPHOR, CAPSAICIN | AHC VENTURES CORP DBA CRY | 799751f3-726a-42de-934e-dbc3cd1cb8b8 | 2025-09-02 | Warnings | M017 |
| Pain Relieving Cold Therapy | MENTHOL | AHC VENTURES CORP DBA CRYODERM | de0c9a73-dbc0-599e-e053-2a95a90a7986 | 2025-09-02 | Warnings | M017 |
| Cold Therapy | MENTHOL | AHC VENTURES CORP DBA CRYODERM | 90334420-5f81-4284-9a57-42e134ce362f | 2025-09-02 | Warnings | M017 |
| KNEE PAIN RELIRF Patch | CAMPHOR, MENTHOL | Shenzhen Finona Information Technology Co., Ltd | 3db971ef-d7fa-0171-e063-6294a90aa58b | 2025-09-01 | Warnings | M017 |
| Bikini Zone Medicated Creme | LIDOCAINE | Kingsway Pharmaceuticals dba NFI, LLC | 300ac57e-844a-4840-b285-41ff5518e6b6 | 2025-08-29 | Warnings | M017 |
| Bikini Zone Medicated Gel | LIDOCAINE | Kingsway Pharmaceuticals dba NFI, LLC | 30b85890-e72d-4af7-bda9-e7744abc92af | 2025-08-29 | Warnings | M017 |
| Sumifun Lidocaine Pain Relief Gel-Patch | LIDOCAINE | Guangzhou Zhupuyou E-commerce Co., Ltd | 3d7dc8cc-0680-d94d-e063-6394a90ac8e8 | 2025-08-29 | Warnings | M017 |
| TKTALKER NUMBING | NUMBING | Shenzhen Shandian Jingling Technology Co., Ltd. | 3d7e6757-f183-2a68-e063-6294a90ae4ca | 2025-08-29 | Warnings | M017 |
| PBZ OTC | TRIPELENNAMINE HCL 1% | Kingsway Pharmaceuticals dba NFI, LLC | 12f72d74-018f-4bc6-acd4-175ca3af4c6d | 2025-08-29 | Warnings | M017 |
| else. | LIDOCAINE | Else Co. | 3d6c7b10-ed03-bbde-e063-6294a90ae92f | 2025-08-28 | Warnings | M017 |
| Mountain Ice Pain Relief | MENTHOL | Mountainside Medical Equipment, Inc. | c79fdd91-16f4-4ae0-bee4-d37c05ed2074 | 2025-08-28 | Warnings | M017 |
| HealthWise 4% Lidocaine Cream 2.7 oz | LIDOCAINE HYDROCHLORIDE | Veridian Healthcare | f39eb3d0-e153-4f50-85b1-ad5c677d176c | 2025-08-28 | Warnings | M017 |
| HealthWise Overnight Menthol Patch | MENTHOL | Veridian Healthcare | 6379f50d-2878-46ca-8acb-71c4554585e9 | 2025-08-28 | Warnings | M017 |
| Capsaicin | CAPSAICIN | PHARMACURE LLC | 119bab58-f129-4ff0-8d81-9c6a7b508dd6 | 2025-08-28 | Warnings | M017 |
| Anti Itch Maximum Relief | PRAMOXINE HYDROCHLORIDE AND MENTHOL | Natureplex LLC | 75de3d5e-ecbe-4d04-a39d-792200e6ee32 | 2025-08-28 | Warnings | M017 |
| NicDuic Quit Smoking Nicotine Patches | NICOTINE TRANSDERMAL PATCHES | Shenzhen Paxi Trading Co., Ltd. | 3d5718f3-c175-6b64-e063-6394a90aa6f1 | 2025-08-27 | Warnings | M017 |
| ARCTIC HEAT | MENTHOL, METHYL SALICYLATE | Renu Laboratories, LLC | 402df5c1-b8cb-17a2-e054-00144ff8d46c | 2025-08-27 | 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 |