Medicine
Phenylephrine 100 mg/mL eye drops
Phenylephrine 100 mg/mL eye drops is a generic prescription medicine for ophthalmic use, made by 9 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
Store at 20°C to 25°C (68°F to 77°F). Protect from light and excessive heat.
Key facts
- Active ingredient (INN)
- Phenylephrine
- Brand
- Sold under the generic name
- Strength
- 100 mg/mL
- Dosage form
- Eye drops
- Route
- Ophthalmic
- Packs
- 1 bottle and 6 more
- Manufacturers
- Caplin SterilesIndiaDr. Reddy's LaboratoriesIndiaGland PharmaIndiaLifestar PharmaIndiaAlcon LaboratoriesFirst Nation GroupNorthStar RxLLCParagon BioTeckSOLA Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20°C to 25°C (68°F to 77°F). Protect from light and excessive heat.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- C01CA06 Phenylephrine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 15 April 2013
- Identifiers
- RxCUI 1234571, 1234579DailyMed set ID cacbb3fd-1c03-4523-a1bf-0ccc4be102ef, 2ba80bb2-24f3-4bce-bc04-a6ff4c54fefb, ea70aafe-f3ba-471a-8c8f-f533c0a3c27c +6NDC 0065-0343, 68083-594, 72603-530 +6Application NDA207926, ANDA218129, ANDA216496 +2
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 |
|---|---|---|---|
| 1 bottle, dropper in 1 carton / 5 mL in 1 bottle, dropper | 65145-150-01 | Caplin SterilesIndia | 23 January 2025 |
| 1 bottle, dropper in 1 carton / 5 mL in 1 bottle, dropper | 75907-130-23 | Dr. Reddy's LaboratoriesIndia | 14 January 2025 |
| 1 bottle, dropper in 1 carton / 5 mL in 1 bottle, dropper | 68083-594-01 | Gland PharmaIndia | 18 December 2024 |
| 1 bottle, dropper in 1 carton / 5 mL in 1 bottle, dropper | 70756-614-30 | Lifestar PharmaIndia | 18 January 2023 |
| 1 bottle, dropper in 1 carton / 5 mL in 1 bottle, dropper | 0065-0343-02 | Alcon Laboratories | 30 April 2025 |
| 1 bottle, dropper in 1 carton / 5 mL in 1 bottle, dropper | 81469-169-05 | First Nation Group | 1 September 2026 |
| 1 bottle, dropper in 1 carton / 5 mL in 1 bottle, dropper | 42702-103-05 | Paragon BioTeck | 15 April 2013 |
| 1 bottle, dropper in 1 carton / 5 mL in 1 bottle, dropper | 70512-866-05 | SOLA Pharmaceuticals | 1 June 2024 |
| 1 bottle, dropper in 1 carton / 5 mL in 1 bottle, dropper | 72603-530-01 | NorthStar RxLLC | 1 October 2024 |
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 20 December 2012 | 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 Phenylephrine
Clinical summary
Phenylephrine is an alpha-1 adrenergic agonist indicated for increasing blood pressure in adults with clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia, among other approved uses. MedsAcross supplies Phenylephrine 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 PhenylephrineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Phenylephrine Hydrochloride prescribing information (Hikma Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Phenylephrine 100 mg/mL eye drops 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.