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Proparacaine hydrochloride 5 mg/mL Solution/ Drops — NDC 42571-0497-57 package photo

Proparacaine hydrochloride 5 mg/mL Solution/ Drops

by Micro Labs Limited · 1 BOTTLE in 1 CARTON (42571-497-57) / 15 mL in 1 BOTTLE
NDC 42571-0497-57
🏷️ FDA NDC (as labeled) 42571-497-57 billing pads the product segment with a zero
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 42571-497-57
Product NDC 42571-497
11-digit billing NDC 42571049757
RxCUI 1191013
UNII U96OL57GOY
UPC 0342571497576
Application # ANDA219294
SPL Set ID df1af0e8-7d9d-4511-9d86-f0c31a5da2c2
Established class (EPC) Local Anesthetic
Physiologic effect Local Anesthesia
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-02-01
Route OPHTHALMIC
Dosage form SOLUTION/ DROPS
Substance PROPARACAINE HYDROCHLORIDE
TE code (Orange Book) AT · RLD · RS
Why two NDCs? The FDA registers this code as 42571-497-57 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 42571-0497-57. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Local Anesthetic class.

Pharmacologic class Local Anesthetic
Drug family (ATC) Local anesthetics
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerMicro Labs Limited
Application holderMICRO LABS LTD
FDA applicationANDA219294 (ANDA)
Labeler code42571
First marketedFeb 2026
Product typeHuman Prescription Drug
Portfolio190 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII F5UM2KM3W7
    Benzalkonium chloride is a chemical compound that works as a preservative and antimicrobial agent in medications. It prevents bacterial and fungal growth in liquid formulations to keep the product safe during storage and use.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII QTT17582CB
    A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

5 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Proparacaine Hydrochloride 5 mg/mL 24208-0730-06 Bausch 1 bottle $1.550 AT Availability likely —
Proparacaine Hydrochloride 5 mg/mL 61314-0016-01 Sandoz 1 bottle $1.550 AT Availability likely —
Proparacaine Hydrochloride 5 mg/mL 70069-0601-01 Somerset 1 bottle $1.550 AT Availability likely —
Proparacaine hydrochloride 5 mg/mL 70756-0193-35 Lifestar 1 bottle $1.550 AT Availability likely —
Alcaine 5 mg/mL 00998-0016-15 Alcon 1 bottle — AT FDA listed —
Proparacaine hydrochloride 5 mg/mLthis 42571-0497-57 Micro 1 bottle — AT FDA listed —
Proparacaine Hydrochloride 5 mg/mL 50090-1923-00 A-S 1 bottle — AT FDA listed —
Proparacaine Hydrochloride 5 mg/mL 68071-4368-05 NuCare 15 ml — AT FDA listed —
proparacaine hydrochloride 5 mg/mL 68071-5139-05 NuCare 15 ml — AT FDA listed —
Proparacaine Hydrochloride 5 mg/mL 70518-3408-00 REMEDYREPACK 1 bottle — AT FDA listed —
Proparacaine Hydrochloride 5 mg/mL 85766-0039-15 Sportpharm 1 bottle — AT FDA listed —
Proparacaine Hydrochloride 5 mg/mL 85766-0056-15 Sportpharm 1 bottle — AT FDA listed —
Proparacaine Hydrochloride 5 mg/mL 85766-0057-15 Sportpharm 1 bottle — AT FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2026
On the market since
Feb 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Proparacaine hydrochloride — the ingredient across all brands.

Top reported reactions

Conjunctival Hyperaemia66
Eye Pain62
Drug Abuse59
Corneal Oedema55
Hypopyon53
Vision Blurred46
Corneal Epithelium Defect43

Reporter sex

527 reports

Serious outcomes

Hospitalization133
Life-threatening34
Reports over time (by year) — tap or hover for the count & year
2022 2023 2024 2026 53 20
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
42571-0497-57 You're viewing this 1 BOTTLE in 1 CARTON (42571-497-57) / 15 mL in 1 BOTTLE 2026-02-01 Active

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 42571-497-57, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 42571-0497-57, written without dashes as 42571049757. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 42571-0497-57, the first segment (42571) is the labeler code FDA assigned to Micro Labs Limited; the middle segment (0497) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (57) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Micro Labs Limited. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Micro Labs Limited is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description
🎯 Indications and Usage 66 words ▾

INDICATIONS AND USAGE Proparacaine Hydrochloride Ophthalmic solution is indicated for topical anesthesia in ophthalmic practice. Representative ophthalmic procedures in which the preparation provides good local anesthesia include measurement of intraocular pressure (tonometry), removal of foreign bodies and sutures from the cornea, conjunctival scraping in diagnosis and gonioscopic examination; it is also indicated for use as a topical anesthetic prior to surgical operations such as cataract extraction.

⏱️ Dosage and Administration 63 words ▾

DOSAGE AND ADMINISTRATION Deep anesthesia as in cataract extraction : Instill 1 drop every 5 to 10 minutes for 5 to 7 doses. Removal of sutures : Instill 1 or 2 drops 2 or 3 minutes before removal of stitches. Removal of foreign bodies : Instill 1 or 2 drops prior to operating. Tonometry : Instill 1 or 2 drops immediately before measurement

⛔ Contraindications 16 words ▾

CONTRAINDICATIONS This preparation is contraindicated in patients with known hypersensitivity to any component of the solution.

⚠️ Warnings 49 words ▾

WARNINGS For topical ophthalmic use only. Prolonged use of a topical ocular anesthetic may produce permanent corneal opacification with accompanying loss of visual. Proparacaine hydrochloride ophthalmic solution is indicated for administration under the direct supervision of a healthcare provider. Proparacaine hydrochloride ophthalmic solution is not intended for patient self-administration.

🤒 Adverse Reactions 157 words ▾

ADVERSE REACTIONS Pupillary dilation or cycloplegic effects have rarely been observed with proparacaine hydrochloride. The drug appears to be safe for use in patients sensitive to other local anesthetics, but local or systemic sensitivity occasionally occurs. Instillation of proparacaine in the eye at recommended concentration and dosage usually produces little or no initial irritation, stinging, burning, conjunctival redness, lacrimation or increased winking.

However, some local irritation and stinging may occur several hours after the instillation. Rarely, a severe, immediate-type, apparently hyperallergic corneal reaction may occur which includes acute, intense and diffuse epithelial keratitis; a gray, ground-glass appearance; sloughing of large areas of necrotic epithelium; corneal filaments and, sometimes, iritis with descemetitis. Allergic contact dermatitis with drying and fissuring of the fingertips has been reported.

Softening and erosion of the corneal epithelium and conjunctival congestion and hemorrhage have been reported. To report SUSPECTED ADVERSE REACTIONS, contact Micro Labs USA, Inc., at 1-855-839-8195 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🤰 Pregnancy 50 words ▾

Pregnancy Animal reproduction studies have not been conducted with proparacaine hydrochloride ophthalmic solution, 0.5%. It is also not known whether proparacaine hydrochloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Proparacaine hydrochloride should be administered to a pregnant woman only if clearly needed.

🧒 Pediatric Use 47 words ▾

Pediatric Use Safety and effectiveness of proparacaine hydrochloride ophthalmic solution in pediatric patients have been established. Use of proparacaine hydrochloride is supported by evidence from adequate and well-controlled studies in adults and children over the age of twelve, and safety information in neonates and other pediatric patients.

🧓 Geriatric Use 20 words ▾

Geriatric Use No overall clinical differences in safety or effectiveness have been observed between the elderly and other adult patients.

🧬 Clinical Pharmacology 170 words ▾

CLINICAL PHARMACOLOGY Proparacaine hydrochloride ophthalmic solution is a rapid acting local anesthetic suitable for ophthalmic use. With a single drop, the onset of anesthesia occurs in approximately 13 seconds and persists for 15 minutes or longer. The main site of anesthetic action is the nerve cell membrane where proparacaine interferes with the large transient increase in the membrane permeability to sodium ions that is normally produced by a slight depolarization of the membrane.

As the anesthetic action progressively develops in a nerve, the threshold for electrical stimulation gradually increases and the safety factor for conduction decreases; when this action is sufficiently well developed, block of conduction is produced. The exact mechanism whereby proparacaine and other local anesthetics influence the permeability of the cell membrane is unknown; however, several studies indicate that local anesthetics may limit sodium ion permeability by closing the pores through which the ions migrate in the lipid layer of the nerve cell membrane.

This limitation prevents the fundamental change necessary for the generation of the action potential.

📦 How Supplied / Storage and Handling 105 words ▾

HOW SUPPLIED Proparacaine hydrochloride ophthalmic solution USP, 0.5% is supplied in a 3-piece white low density polyethylene S design container with natural low density polyethylene S design open nozzle and white color high density polyethylene S design cap with TSTR- tear off ring. 15 mL fill in 15 mL Container NDC 42571-497-57 Storage: Refrigerate at 2° to 8° C. Keep bottle tightly closed.

Store bottles in carton until empty to protect from light. If solution shows more than a faint yellow color, it should not be used. Manufactured by: Micro Labs Limited Bangalore-560099, INDIA Manufactured for: Micro Labs USA, Inc.

Somerset, NJ 08873 Rev. 01/2025

📋 Description 93 words ▾

DESCRIPTION Proparacaine hydrochloride ophthalmic solution USP, 0.5% is a local anesthetic for ophthalmic instillation. Each mL of sterile aqueous solution contains active ingredient: proparacaine hydrochloride 5 mg (0.5%) and inactive ingredients: glycerin (tonicity agent), benzalkonium chloride, 0.01% (preservative) and water for injection (vehicle). The pH may be adjusted with hydrochloric acid and/or sodium hydroxide.

At the time of manufacture, the air in the container is replaced by nitrogen. Proparacaine hydrochloride is designated chemically as 2-(Diethylamino) ethyl 3-amino-4-propoxybenzoate monohydrochloride. Graphic formula: C 16 H 26 N 2 O 3 •HCl MW 330.85 CAS-5875-06-9 proparacaine-stru

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 42571-0477-47 · Micro 42571-0499-06 · Micro →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.