Drug company (FDA labeler)
Alcon Laboratories, Inc.
NDC labeler codes: 0065, 0998, 70727, 71571
What is a labeler?
The company whose name is on the package and in the FDA’s National Drug Code (NDC) Directory. It may make the medicine itself or sell medicine made by another company. The first part of every NDC code identifies the labeler.
Official FDA data only
Products, approvals and recalls come from the FDA (NDC Directory, Drugs@FDA, enforcement reports). Recalls are linked to this company by the NDC labeler code on the recalled product.
Questions about your medicine: ask your doctor or pharmacist. In an emergency, call 911.
Prescription medicines
- Cyclopentolate hydrochlorideCyclogyl · 3 products
- AtropineAtropen Auto-Injector, Isopto Atropine · 2 products
- PhenylephrineBiorphen, Immphentiv · 2 products
- Balanced salt solutionBss, Balanced Salt · 2 products
- Brinzolamide/brimonidine tartrateSimbrinza · 1 product
- Tetracaine hydrochloride1 product
- Cyclopentolate hydrochloride and phenylephrine hydrochlorideCyclomydril · 1 product
- TropicamideMydriacyl · 1 product
- Proparacaine hydrochlorideAlcaine · 1 product
- CarbacholMiostat · 1 product
- Netarsudil and latanoprost ophthalmic solution, 0.02%/0.005%Rocklatan · 1 product
- AcoltremonTryptyr · 1 product
- Povidone-iodineBetadine · 1 product
- NetarsudilRhopressa · 1 product
- Loteprednol etabonateLotemax, Lotemax Sm, Alrex · 1 product
FDA applications for these products
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| May 28, 2025 | NDA217370 | Acoltremon TRYPTYR | Alcon Labs Inc |
| October 26, 2020 | NDA210933 | Loteprednol etabonate EYSUVIS | Alcon Labs Inc |
| March 12, 2019 | NDA208259 | Netarsudil and latanoprost ophthalmic solution, 0.02%/0.005% ROCKLATAN | Alcon Labs Inc |
| December 18, 2017 | NDA208254 | Netarsudil RHOPRESSA | Alcon Labs Inc |
| December 1, 2016 | NDA208151 | Atropine ISOPTO ATROPINE | Alcon Labs Inc |
| February 29, 2016 | NDA208135 | Tetracaine hydrochloride TETRACAINE HYDROCHLORIDE | Alcon Labs |
| January 15, 2015 | NDA207926 | Phenylephrine PHENYLEPHRINE HYDROCHLORIDE | Alcon |
| April 19, 2013 | NDA204251 | Brinzolamide/brimonidine tartrate SIMBRINZA | Alcon Labs Inc |
| December 10, 1997 | NDA020742 | Balanced salt solution BSS | Alcon |
| December 17, 1986 | NDA018634 | Povidone-iodine BETADINE | Alcon Pharms Ltd |
| September 12, 1975 | ANDA084300 | Cyclopentolate hydrochloride and phenylephrine hydrochloride CYCLOMYDRIL | Alcon Labs Inc |
| December 6, 1974 | ANDA084306 | Tropicamide MYDRIACYL | Alcon Labs Inc |
| July 31, 1974 | ANDA084108 | Cyclopentolate hydrochloride CYCLOGYL | Alcon Labs Inc |
| July 31, 1974 | ANDA084109 | Cyclopentolate hydrochloride CYCLOGYL | Alcon Labs Inc |
| July 31, 1974 | ANDA084110 | Cyclopentolate hydrochloride CYCLOGYL | Alcon Labs Inc |
| September 28, 1972 | NDA016968 | Carbachol MIOSTAT | Alcon |
| December 22, 1971 | ANDA080027 | Proparacaine hydrochloride ALCAINE | Alcon Labs Inc |
The sponsor is the company that holds the FDA application; it can differ from the labeler.
Recall timeline
No recall of these products (by NDC code) appears in the FDA enforcement reports.
Sources
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026