Vonaflex
- Product NDC
- 36590-6461
- 11-digit product format
- 365906461
- Labeler code
- 36590
- Product ID
- 36590-6461_ec2347e5-d690-1f60-e053-2a95a90aa6ea
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Lidocaine Lotion
- Dosage form
- LOTION
- Route
- CUTANEOUS; RECTAL; TOPICAL; VAGINAL
- Labeler
- Cymbiotics, Inc
- Application
- M015
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2022-08-25
- Marketing end
- 0000-00-00
- Substance
- LIDOCAINE
- Active strength
- 4 g/100g
- 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 product | product | 36590-6461 | D | Discontinued by firm | 2026-10-16 | ||
| excluded package | package | 36590-6461 | 36590-6461-1 | D | Discontinued by firm | 2026-10-16 | |
| excluded package | package | 36590-6461 | 36590-6461-2 | D | Discontinued by firm | 2026-10-16 | |
| excluded package | package | 36590-6461 | 36590-6461-3 | D | Discontinued by firm | 2026-10-16 | |
| excluded package | package | 36590-6461 | 36590-6461-4 | D | Discontinued by firm | 2026-10-16 | |
| excluded package | package | 36590-6461 | 36590-6461-5 | D | Discontinued by firm | 2026-10-16 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Dataset | Scope | Package NDC |
|---|---|---|
| excluded product | product | |
| excluded package | package | 36590-6461-3 |
| excluded package | package | 36590-6461-4 |
| excluded package | package | 36590-6461-5 |
| excluded package | package | 36590-6461-2 |
| excluded package | package | 36590-6461-1 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 36590-6461 | VONAFLEX (LIDOCAINE LOTION) LOTION [CYMBIOTICS, INC] | 5 | Legacy NDC | 20241215_dd30ccaf-d239-9d82-e053-2a95a90a6e84.zip |
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.
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 36590-6461-3 | 36590646103 | 100 g in 1 BOTTLE, PUMP (36590-6461-3) | 100 g | 2022-08-26 | 0000-00-00 | No | No | Current |
| 36590-6461-4 | 36590646104 | 150 g in 1 BOTTLE, PUMP (36590-6461-4) | 150 g | 2022-08-26 | 0000-00-00 | No | No | Current |