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Active ingredient

Proparacaine

13 finished FDA listings contain Proparacaine as their only active ingredient; 1 combination products also contain it.

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FDA NDC Directory

Ingredient names as written by FDA
PROPARACAINE HYDROCHLORIDE
Dosage forms
Solution/ Drops
Routes
Ophthalmic
Manufacturers / labelers
10
Strengths listed
5 mg/ml
Brand names in FDA listings
Alcaine

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 34905

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
ANDA 080027ALCON LABS INC1971-12-225
ANDA 040074BAUSCH AND LOMB INC1995-09-294
ANDA 215816SOMERSET THERAPS LLC2024-08-092
ANDA 219136MANKIND PHARMA2025-05-211
ANDA 219294MICRO LABS2025-10-201

Official labeling on DailyMed

Showing the 12 most recent of 13 labels.

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.