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 |
|---|---|---|---|---|---|---|
| equaline anti itch maximum strength | HYDROCORTISONE | United Natural Foods, Inc. dba UNFI | 070000d7-7d4d-439b-9a91-851ba7c027e6 | 2024-10-03 | Warnings | M017 |
| hydrocortisone anti itch | HYDROCORTISONE | H E B | a1a9fed8-4938-48b5-81f1-d3942d534bb8 | 2024-10-03 | Warnings | M017 |
| equaline anti itch | HYDROCORTISONE | United Natural Foods, Inc. dba UNFI | ef9ea069-9b97-4bf5-aaac-deb85334dbd0 | 2024-10-03 | Warnings | M017 |
| Basic Care Hydrocortisone | HYDROCORTISONE | Amazon.com Services LLC | 7fa13ab4-5f2d-4a48-816f-1b22d5f757b2 | 2024-10-03 | Warnings | M017 |
| hydrocortisone | HYDROCORTISONE | A-S Medication Solutions | dc388dc1-0c4f-4bf1-8a12-fa39892317bc | 2024-10-02 | Warnings | M017 |
| Geliga Muscular | MENTHOL, METHYL SALICYLATE | PT. EAGLE INDO PHARMA | fb2beb08-0ad6-a89d-e053-6294a90aa6fe | 2024-10-02 | Warnings | M017 |
| Geliga Muscular Balm | MENTHOL, METHYL SALICYLATE | PT. EAGLE INDO PHARMA | da28097f-4b5c-6159-e053-2a95a90a7d96 | 2024-10-02 | Warnings | M017 |
| Circatrix | CAPSAICIN | PureTek Corporation | cd3b1256-2df8-dc26-e053-2a95a90ad049 | 2024-10-02 | Warnings | M017 |
| DermacinRx Penetral Cream | CAPSAICIN | PureTek Corporation | 1e343a52-6071-3230-e054-00144ff8d46c | 2024-10-02 | Warnings | M017 |
| Eagle Medicated Aromatic | CAMPHOR MENTHOL METHYL SALICYLATE | Borden Company (Private) Limited | 36abfc2c-d424-4df8-968d-866342c96a56 | 2024-10-02 | Warnings | M017 |
| Eagle Balm | CAMPHOR MENTHOL | Eagle Indo Pharma, PT | 87614869-9675-2c76-e053-2a95a90a48a9 | 2024-10-02 | Warnings | M017 |
| Eagle Medicated | MENTHOL METHYL SALICYLATE | Borden Company (Private) Limited | d9a93daa-4e24-6690-e053-2a95a90a147c | 2024-10-02 | Warnings | M017 |
| Eagle Extra Strength | MENTHOL METHYL SALICYLATE | Borden Company (Private) Limited | 5e02fbe3-5bc7-430e-b661-3a760ddd8fe0 | 2024-10-02 | Warnings | M017 |
| Eagle Medicated Oil Refreshing | MENTHOL, METHYL SALICYLATE | Borden Company (Private) Limited | c62a4313-2c07-5f58-e053-2995a90a083a | 2024-10-02 | Warnings | M017 |
| Eagle Medicated Aromatic | CAMPHOR MENTHOL METHYL SALICYLATE | Eagle Indo Pharma, PT | e272ec90-3cd9-5b70-e053-2a95a90a1df4 | 2024-10-02 | Warnings | M017 |
| RUGBY HYDROCORTISONE WITH ALOE | HYDROCORTISONE | A-S Medication Solutions | b2674075-aaa4-4c77-bcaa-a76336b3c321 | 2024-10-02 | Warnings | M017 |
| Herb Street Anti-Itch Stick | HYDROCORTISONE | Balassa Laboratories Inc. | 8717faae-59c3-4c6f-9ef1-285c0d2445ed | 2024-10-01 | Warnings | M017 |
| Herb Street Backache and Sore Muscle Relief | MENTHOL | Balassa Laboratories Inc. | aeac1b64-8689-4b3d-a41c-db41061257b5 | 2024-10-01 | Warnings | M017 |
| Herb Street Arthritis Relief | MENTHOL/CAMPHOR | Balassa Laboratories Inc. | a9d8ceb7-def0-415f-8fc1-ff8dd3e41855 | 2024-10-01 | Warnings | M017 |
| Lido King Lidocaine 4% Pain Relieving Gel-Patch | LIDOCAINE | Galaxy Bio, Inc. | 2243734a-4ea2-a5e5-e063-6294a90aba15 | 2024-10-01 | 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 |