LidoPro
- Product NDC
- 53225-1020
- Requested package NDC
- 53225-1020-1
- 11-digit product format
- 532251020
- Labeler code
- 53225
- Product ID
- 53225-1020_e3a1e298-fa88-4d16-e053-2995a90acabd
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Capsaicin, Lidocaine, Menthol, and Methyl Salicylate
- Dosage form
- OINTMENT
- Route
- TOPICAL
- Labeler
- Terrain Pharmaceuticals
- Application
- part348
- Marketing category
- OTC MONOGRAPH NOT FINAL
- Marketing start
- 2022-07-08
- Marketing end
- 0000-00-00
- Substance
- CAPSAICIN; LIDOCAINE HYDROCHLORIDE; MENTHOL; METHYL SALICYLATE
- Active strength
- 0 g/g; g/g; g/g; g/g
- Pharmacologic classes
- Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 53225-1020 | 53225-1020-1 | D | Discontinued by firm | 2026-10-05 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 53225-1020-1 | GM - Gram | 53225-1020 | 90722ca5-1b77-4826-84a4-3015f50099aa | 1 | 2022-11-07 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 53225-1020 | LIDOPRO (CAPSAICIN, LIDOCAINE, MENTHOL, AND METHYL SALICYLATE) OINTMENT [TERRAIN PHARMACEUTICALS] | 4 | Legacy NDC | 20240829_e3a1e298-fa87-4d16-e053-2995a90acabd.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1601095 | capsaicin 0.0325 % / lidocaine HCl 4 % / menthol 10 % / methyl salicylate 27.5 % Topical Ointment | PSN | 3b5ea9b4-6a5b-4ee8-b4d8-ece9b840adfd | 3 |
| 1601097 | LidoPro 0.0325 % / 4 % / 10 % / 27.5 % Topical Ointment | PSN | 3b5ea9b4-6a5b-4ee8-b4d8-ece9b840adfd | 3 |
| 1601097 | capsaicin 0.000325 MG/MG / lidocaine hydrochloride 0.04 MG/MG / menthol 0.1 MG/MG / methyl salicylate 0.275 MG/MG Topical Ointment [LidoPro] | SBD | 3b5ea9b4-6a5b-4ee8-b4d8-ece9b840adfd | 3 |
| 1601095 | capsaicin 0.000325 MG/MG / lidocaine hydrochloride 0.04 MG/MG / menthol 0.1 MG/MG / methyl salicylate 0.275 MG/MG Topical Ointment | SCD | 3b5ea9b4-6a5b-4ee8-b4d8-ece9b840adfd | 3 |
| 1601095 | capsaicin 0.0325 % / lidocaine HCl 4 % / menthol 10 % / methyl salicylate 27.5 % Topical Ointment | SY | 3b5ea9b4-6a5b-4ee8-b4d8-ece9b840adfd | 3 |
| 1601097 | LidoPro (capsaicin 0.0325 % / lidocaine HCl 4 % / menthol 10 % / methyl salicylate 27.5 % ) Topical Ointment | SY | 3b5ea9b4-6a5b-4ee8-b4d8-ece9b840adfd | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 53225-1020-1 | 53225102001 | 92 g in 1 BOTTLE (53225-1020-1) | 92 g | 2022-07-08 | 0000-00-00 | No | No | Current |