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 |
|---|---|---|---|---|---|---|
| Good Neighbor Pharmacy Hydrocortisone with Aloe | HYDROCORTISONE | AmerisourceBergen | 0c544792-63d9-400c-9888-207c44fdc75e | 2025-07-08 | Warnings | M017 |
| Good Neighbor Pharmacy Hydrocortisone | HYDROCORTISONE | AmerisourceBergen | 58b0b7ba-e547-4e0f-b04d-8e1e6a5d4fcf | 2025-07-08 | Warnings | M017 |
| Publix Hydro | HYDROCORTISONE | Publix Super Markets Inc | 29296b0f-0eed-4bb9-8727-c25c2bcf9fd6 | 2025-07-08 | Warnings | M017 |
| Publix hydro plus | HYDROCORTISONE | Publix Super Markets Inc | a00d82c1-6b09-424a-be78-2603eee3fb9d | 2025-07-08 | Warnings | M017 |
| Tattoo | TATTOO CREAM | Perfso (HK) Co., Limited | 39773cab-12df-4520-e063-6294a90abc5b | 2025-07-08 | Warnings | M017 |
| Neutrogena Sun Rescue After Sun Medicated Relief | CAMPHOR (SYNTHETIC) | Kenvue Brands LLC | c95c5b64-b90f-1143-e053-2a95a90aa03c | 2025-07-07 | Warnings | M017 |
| sunmark Hydrocortisone | HYDROCORTISONE | Strategic Sourcing Services LLC | 210079e9-3d2f-4489-b468-b96b145034ed | 2025-07-07 | Warnings | M017 |
| Relief Gel | LIDOCAINE HCL | Good Clean Love, Inc. | e5fa2265-ccb7-750c-e053-2995a90aa51e | 2025-07-07 | Warnings | M017 |
| Hydrocortisone Plus 12 Moisturizers | HYDROCORTISONE | Sun Pharmaceutical Industries, Inc. | 09ac2749-a60f-4039-8c80-a0d2eaf50c34 | 2025-07-07 | Warnings | M017 |
| Hydrocortisone | HYDROCORTISONE | Sun Pharmaceutical Industries, Inc. | 2ada9ec2-1c28-4da2-8639-07b3193ffb32 | 2025-07-03 | Warnings | M017 |
| Hydrocortisone with Aloe | HYDROCORTISONE | Sun Pharmaceutical Industries, Inc. | caa2fd64-e262-4d7c-ad8a-69f506feba8c | 2025-07-03 | Warnings | M017 |
| Stopain Extra Strength | MENTHOL | Troy Manufacturing, Inc. | 07e9a235-6d10-4407-8729-beaf936e97ad | 2025-07-03 | Warnings | M017 |
| Blue Ice Topical Analgesic Gel | ICE GEL | International Wholesale | 397cd306-078d-5b7d-e063-6294a90a8bbc | 2025-07-03 | Warnings | M017 |
| LIDOCAINE | LIDOCAINE, MENTHOL | Vive Health LLC | 236ccc6d-21b7-6153-e063-6394a90a4634 | 2025-07-02 | Warnings | M017 |
| AsperFlex MAX | LIDOCAINE 4% WITH MENTHOL 1% | Akron Pharma Inc. | ccf6172b-350a-4b78-b844-f84bf17c491f | 2025-07-02 | Warnings | M017 |
| METHYL SALICYLATE 25% | METHYL SALICYLATE | Oncora Pharma, LLC | 3766e3a9-94a8-4c3e-e063-6394a90aa24a | 2025-07-01 | Warnings | M017 |
| Diphenhydramine Hydrochloride and Zinc Acetate | DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE | Sun Pharmaceutical Industries, Inc. | c89e3de8-7d71-485c-8fc5-2832d6024f16 | 2025-07-01 | Warnings | M017 |
| Westlake Outdoor Pain and Itch Relieving | LIDOCAINE 4% PAIN AND ITCH RELIEVING | WESTLAKE HB PHARMA | 3c563b28-4f4f-9d0c-e063-6294a90adf73 | 2025-07-01 | Warnings | M017 |
| Cortizone 10 Water Resistant | HYDROCORTISONE | Chattem, Inc. | 118e55e7-241f-44c4-959e-09bf6221bd77 | 2025-07-01 | Warnings | M017 |
| Quit Smoking Nicotine Patches | NICOTINE TRANSDERMAL PATCHES | Shenzhen Paxi Trading Co., Ltd. | 38c1616e-3b09-0669-e063-6294a90a2c86 | 2025-06-29 | 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 |