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 |
|---|---|---|---|---|---|---|
| PAIN RELIEF Gel-Tube | MENTHOL | Shanghai Chuangshi Medical Technology (Group) Co., Ltd. | f0bec1d4-2e18-4519-e053-2a95a90a1bbb | 2024-04-29 | Warnings | M017 |
| THERAPLEX AIM Anti-Itch Moisturizing | HYDROCORTISONE | THERAPLEX, LLC | d1b231b6-cc9f-488a-9121-501831473772 | 2024-04-27 | Warnings | M017 |
| HYDROCORTISONE | HYDROCORTISONE ACETATE | JHK Inc dba American Safety & First Aid | 64adc8d0-7ca4-4c1a-813f-f1df47e916f2 | 2024-04-25 | Warnings | M017 |
| HealthWise Lidocaine Plus Cream | BENZYL ALCOHOL, LIDOCAINE HYDROCHLORIDE | Veridian Healthcare | 16f26249-b508-2c6e-e063-6394a90a265b | 2024-04-25 | Warnings | M017 |
| Hydrocortisone Cream with Aloe | HYDROCORTISONE | Cardinal Health 110 dba LEADER | 16f2f3cb-4611-5867-e063-6394a90af107 | 2024-04-25 | Warnings | M017 |
| Burn | LIDOCAINE HYDROCHLORIDE | JHK Inc | 5a4ac4cc-015a-48e7-81f8-93a895049afd | 2024-04-25 | Warnings | M017 |
| Cold Therapy Pain Relief | MENTHOL, UNSPECIFIED FORM | Walgreen Co. | ede15818-5d17-477d-a8be-7b36bb0770a6 | 2024-04-22 | Warnings | M017 |
| Anti Itch | HYDROCORTISONE | Neilmed Pharmaceuticals Inc. | 14b4f066-fde4-ac97-e063-6394a90ae64c | 2024-04-20 | Warnings | M017 |
| Walgreens Cold Therapy Pain Relief Patch | MENTHOL 5% | Walgreens Company | e33c90d1-2729-970f-e053-2995a90ad97a | 2024-04-18 | Warnings | M017 |
| HealthWise Cold Therapy Pain Relief Patch | MENTHOL | Veridian Healthcare | 0ce356e0-90a3-ad52-e063-6294a90a404a | 2024-04-18 | Warnings | M017 |
| Walgreens Scalp Relief External analgesic | HYDROCORTISONE | Walgreen Company | da0a24c7-9295-4f22-b2c7-40000dad4b81 | 2024-04-18 | Warnings | M017 |
| HealthWise 3x Medicated Pain Relief Patch | CAMPHOR,MENTHOL, METHYL SALICYLATE | Veridian Healthcare | 164d4d62-00c0-e06d-e063-6294a90abd73 | 2024-04-17 | Warnings | M017 |
| TIGER Balm PAIN RELIEVING HYDROGEL | CAMPHOR (SYNTHETIC), LEVOMENTHOL, AND CAPSICUM | Haw Par Healthcare Ltd. | ca601b02-e9be-4d8d-a384-c62553302ceb | 2024-04-16 | Warnings | M017 |
| Lidocaine Pain Relief Patch | LIDOCAINE PAIN RELIEF PATCH | Henan Enokon Medical Instrument Co., Ltd. | 1592a40a-a647-34bd-e063-6394a90a0a10 | 2024-04-08 | Warnings | M017 |
| Menticam | CAMPHOR, MENTHOL, METHYL SALICYLATE | PureTek Corporation | 081837a8-9669-be1f-e063-6394a90a9d20 | 2024-04-05 | Warnings | M017 |
| Pain Relieving Liniment | CAMPHOR (NATURAL) AND MENTHOL, UNSPECIFIED FORM | J.R. Watkins, LLC. | 97a0c839-0927-4e54-aee2-ded2016ac4a0 | 2024-04-02 | Warnings | M017 |
| HealthWise Capsaicin Heat Patch | CAPSAICIN | Veridian Healthcare | 150c1f09-8aa7-67ea-e063-6294a90a950a | 2024-04-01 | Warnings | M017 |
| HealthWise Roll-On Lidocaine Pain Relief Liquid Lavender Scent | LIDOCAINE HCI | Veridian Healthcare | 150d3e54-5c8d-19ef-e063-6394a90a70c2 | 2024-04-01 | Warnings | M017 |
| Meijer Pain Relief Cream | LIDOCAINE | Meijer Distribution | 07ecee44-387a-cdce-e063-6294a90ab9c9 | 2024-03-27 | Warnings | M017 |
| Hydrocortisone Cream | HYDROCORTISONE | Trifecta Pharmaceuticals USA | 141aa2a7-8789-1127-e063-6294a90a2d23 | 2024-03-20 | 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 |