Theraworx Pain Relief Roll- On- Lidocaine
- Product NDC
- 61594-028
- 11-digit product format
- 615940028
- Labeler code
- 61594
- Product ID
- 61594-028_5d4f768e-8acc-1d1c-e063-6394a90ac0ae
- 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
- 2024-01-15
- 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 Pain Relief Roll- On- Lidocaine
- 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 |
|---|---|---|---|---|---|---|
| 61594-028-00 | Theraworx Pain Relief Roll- On- Lidocaine | 1 in 1 CARTON | LIQUID | 1 | 1 | |
| 61594-028-00 | Theraworx Pain Relief Roll- On- Lidocaine | 74 mL in 1 BOTTLE | LIQUID | 74 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 61594-028-00 | ML - Milliliter | 61594-028 | 0d447cd4-8d89-4f96-b2ad-82f8ca3183b1 | 1 | 2024-05-16 |
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 |
|---|---|---|---|---|---|---|
| Methyl Salicylate | METHYL SALICYLATE | PHARMACURE LLC | 66b13044-69d2-4559-9e65-8a4c601c077a | 2025-10-06 | Warnings | M017 |
| Methyl Salicylate | METHYL SALICYLATE | PHARMACURE LLC | f119a1bd-095f-41f5-86d5-c0ee4f19fd2c | 2025-10-06 | Warnings | M017 |
| LIDOCAINE | LIDOCAINE | PHARMACURE LLC | 31d5e5c9-6ec4-4496-8a4c-cca39a2cbe32 | 2025-10-06 | Warnings | M017 |
| Tempo cool | MENTHOL | The Egyptian Saudi Co. For Medical Manufacturing (Masco-Mid) S.A.E | bd642389-6d03-4e09-a71c-312fb90eae89 | 2025-10-06 | Warnings | M017 |
| Menthopatch Hot | MENTHOL , CAPSICUM EXTRACT | THE EGYPTIAN SAUDI CO FOR MEDICAL MANUFACTURING MASCOMID | 3d289be3-c237-4065-a8ac-e8c2e51b76a5 | 2025-10-06 | Warnings | M017 |
| Mentho patch cool | MENTHOL | THE EGYPTIAN SAUDI CO FOR MEDICAL MANUFACTURING MASCOMID | 02251a4a-fc6f-42c9-a244-6f4835de5edd | 2025-10-06 | Warnings | M017 |
| Feminine Anti-Itch Creme | BENZOCAINE, RESORCINOL | Quality Choice (CHAIN DRUG MARKETING ASSOCIATION) | aa6cc963-dc60-5222-e053-2995a90acaf6 | 2025-10-06 | Warnings | M017 |
| TheraCare 2% Diphenhydramine Anti-Itch Cream | DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE | Veridian Healthcare | 5999b677-63dd-49c6-b5b8-7b3c117ecc5c | 2025-10-06 | Warnings | M017 |
| HealthWise Pain Relief | MENTHOL | Veridian Healthcare | 06be5331-7a1e-4ab3-9f17-2d350bd4b890 | 2025-10-02 | Warnings | M017 |
| equate Burn Relief | LIDOCAINE HYDROCHLORIDE | Walmart Inc | a90cbd92-80a5-4463-8152-b83165121a6f | 2025-10-02 | Warnings | M017 |
| AsperFlex HOT | CAMPHOR, MENTHOL, METHYL SALICYLATE | Akron Pharma Inc. | a6cb0656-8866-44ff-b40c-73655ff68721 | 2025-10-02 | Warnings | M017 |
| AsperFlex Original Maximum Strength | MENTHOL | Akron Pharma Inc. | d766c61e-c48b-4aff-97b0-678159479e03 | 2025-10-02 | Warnings | M017 |
| HealthWise Feminine Anti-Itch Cream | BENZOCAINE, RESORCINOL | Veridian Healthcare | 1f9110da-f448-8e20-e063-6294a90a4275 | 2025-10-02 | Warnings | M017 |
| PROSTAT FIRST AID Burn Ease, 0.9g | LIDOCAINE | ProStat First Aid LLC | dc704403-e2aa-47f7-a7f4-f6afe1547ca8 | 2025-10-01 | Warnings | M017 |
| PROSTAT FIRST AID Burn Ease, 0.9g | LIDOCAINE | ProStat First Aid LLC | e02558a9-fe2b-4f28-9fd3-7308f859d759 | 2025-10-01 | Warnings | M017 |
| FL Burn Ease, 0.9g | LIDOCAINE | ProStat First Aid LLC | 4dc0d579-ab42-4ea5-9788-5e54d7d318a3 | 2025-10-01 | Warnings | M017 |
| Carmex Classic Lip Balm Medicated | CAMPHOR (SYNTHETIC), WHITE PETROLATUM | Carma Laboratories, Inc. | c7a7626c-cf82-4301-af79-c5e85367e777 | 2025-10-01 | Warnings | M017 |
| Viaderma Calm Anti-Itch | HYDROCORTISONE | ViaDerma Distribution, Inc. | 7afa2ccd-bfc6-48fc-9a14-a0c6d645844e | 2025-10-01 | Warnings | M017 |
| AsperFlex Advance | CAMPHOR, MENTHOL, METHYL SALICYLATE | Akron Pharma Inc. | d23d7f2b-4dcd-4c31-9d12-340f233018b4 | 2025-10-01 | Warnings | M017 |
| HEATING PAIN RELIEF | METHYL SALICYLATE, MENTHOL | SUNSET NOVELTIES, INC | 4024d604-c8c7-2d73-e063-6294a90a2e80 | 2025-10-01 | Warnings | M017 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1987647 | lidocaine hydrochloride 4 % Topical Solution | PSN | b4ce3876-f9e3-43ca-810b-75fbe6f887b6 | 1 |
| 1987647 | lidocaine hydrochloride 40 MG/ML Topical Solution | SCD | b4ce3876-f9e3-43ca-810b-75fbe6f887b6 | 1 |
| 1987647 | lidocaine hydrochloride 4 % Topical Solution | SY | b4ce3876-f9e3-43ca-810b-75fbe6f887b6 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 61594-028-00 | 61594002800 | 1 BOTTLE in 1 CARTON (61594-028-00) / 74 mL in 1 BOTTLE | 1 bottle | 2024-01-15 | No | No | Current |