Medicine
Lidocaine 20 mg/mL oral solution
Lidocaine 20 mg/mL oral solution is a generic prescription medicine for oral use, made by 3 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Lidocaine Hydrochloride Oral Topical Solution, USP 2% (Viscous) is a clear…
Key facts
- Active ingredient (INN)
- Lidocaine
- Brand
- Sold under the generic name
- Strength
- 20 mg/mL
- Dosage form
- Oral solution
- Route
- Oral
- Packs
- 12 bottles, 4 trays, 100 mL and 1 more
- Manufacturers
- PAI PharmaMajor PharmaceuticalsPreferred Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Lidocaine Hydrochloride Oral Topical Solution, USP 2% (Viscous) is a clear colorless viscous liquid with cherry flavor available as: 0121-0950-03: 100 mL polyethylene squeeze bottles. 0121-4950-15: 15 mL unit dose cup 0121-4950-40: Case contains 40 unit dose cups of 15 mL packaged in 4 trays of 10 unit dose cups each The solutions should be stored at controlled room temperature 20° to 25°C (68°…
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- C01BB01 Lidocaine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 20 February 2024
- Identifiers
- RxCUI 1010739DailyMed set ID d5e23ede-957c-4a32-b1c6-268acb773c31, abf60c5c-66df-4894-aa8f-bf770a6e9d00, 04e8dd94-93a8-427d-81ab-a95793d86c36NDC 0121-0950, 68788-8847, 0904-7644 +1Application ANDA218138
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 12 bottle in 1 case / 100 mL in 1 bottle | 0121-0950-03 | PAI Pharma | 20 February 2024 |
| 4 tray in 1 case / 10 cup, unit-dose in 1 tray / 15 mL in 1 cup, unit-dose | 0121-4950-40 | PAI Pharma | 20 February 2024 |
| 4 tray in 1 case / 10 cup, unit-dose in 1 tray / 15 mL in 1 cup, unit-dose | 0904-7644-87 | Major Pharmaceuticals | 21 August 2026 |
| 100 mL in 1 bottle | 68788-8847-1 | Preferred Pharmaceuticals | 24 March 2025 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 19 November 1948 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Other strengths and forms of Lidocaine
Clinical summary
Lidocaine is an amide local anesthetic. It is available as injection, ointment and patches for infiltration, perineural and topical use. MedsAcross supplies Lidocaine for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about LidocaineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Xylocaine prescribing information (Fresenius Kabi) · U.S. National Library of Medicine, DailyMed
Need Lidocaine 20 mg/mL oral solution for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.