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Tetracaine Hydrochloride 5 mg/mL Solution — NDC 00065-0741-14 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Tetracaine Hydrochloride 5 mg/mL Solution — NDC 0065-0741-14 (Billing 00065-0741-14)

by Alcon Laboratories, Inc. · 12 BLISTER PACK in 1 CARTON / 1 BOTTLE, DROPPER in 1 BLISTER PACK / 4 mL in 1 BOTTLE, DROPPER

This is a package of Tetracaine Hydrochloride 5 mg/mL Solution from Alcon Laboratories, Inc., marketed since Nov 2016 and currently FDA-listed. It is this product's only package size.

NDC 00065-0741-14
🏷️ FDA NDC (as labeled) 0065-0741-14 billing pads the labeler segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed 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

NDC database record

One package, one record: these facts belong to NDC 0065-0741-14 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0065 labeler · 0741 product · 14 package
Package marketed since
Nov 2, 2016
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0300650741149
Medicaid fills, this package
6,899 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026
Past resolved recalls for this product (1)
Class II · Apr 13, 2022 · Terminated — cGMP deviations: Temperature abuse (Mckesson Medical-Surgical Inc. Corporate Office) · FDA recall D-1113-2022

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0065-0741-14
Product NDC 0065-0741
11-digit billing NDC 00065074114
NCPDP billing unit ML — per mL (volume)
RxCUI 1547771
UNII 5NF5D4OPCI
UPC 0300650741149
Application # NDA208135
SPL Set ID 5c7b1de4-9f55-1d0e-ef6d-b0ba2cbaba79
Established class (EPC) Ester Local Anesthetic
Physiologic effect Local Anesthesia
Chemical class Esters
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2016-11-02
Route OPHTHALMIC
Dosage form SOLUTION
Substance TETRACAINE HYDROCHLORIDE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 86750030102005
GPI class Tetracaine HCl
GCN Seq No 066977
GCN 29417
HICL code 036480
Ingredient (HICL) Tetracaine Hcl/Pf
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q6
Therapeutic class — intermediate (HIC2) Ophthalmic Preparations
HIC3 code Q6H
Therapeutic class — specific (HIC3) Eye Local Anesthetics
AHFS code 52:16.00.00
AHFS class Local Anesthetics (Eent)
FDB label name TETRACAINE 0.5% STERI-UNIT SOL
FDB brand name Tetracaine Hcl
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 066977
  • GCN: 29417
  • GPI-14 (Medi-Span): 86750030102005
  • HICL (First Databank): 036480
  • AHFS class code: 52:16.00.00
  • RxCUI (RxNorm): 1547771
Why two NDCs? The FDA registers this code as 0065-0741-14 — a 4-4-2 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 labeler segment → 00065-0741-14. 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 Ester Local Anesthetic class.

Pharmacologic class Ester Local Anesthetic
Drug family (ATC) Local anesthetics, Anesthetics for topical use, Esters of aminobenzoic acid
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.

Clinical

Label name TETRACAINE 0.5% STERI-UNIT SOL Ingredient Tetracaine Hcl/Pf

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.

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 $9.51 $456.52 / 48 ml
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
00065-0741-14 You're viewing this Main listing 12 BLISTER PACK in 1 CARTON / 1 BOTTLE, DROPPER in 1 BLISTER PACK / 4 mL in 1 BOTTLE, DROPPER 2016-11-02 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Tetracaine Hydrochloride 5 mg/mL 70069-0596-01 Somerset 1 bottle $4.330 AB1 Availability likely —
Tetracaine Hydrochloride 5 mg/mL 82260-0920-05 Bausch 1 bottle $4.330 AB1 Availability likely —
Tetracaine Hydrochloride 5 mg/mLthis 00065-0741-14 Alcon 1 bottle — — FDA listed —
Tetracaine Hydrochloride 5 mg/mL 00187-0920-05 Bausch 1 bottle — AB1 FDA listed —
Tetracaine Hydrochloride 5 mg/mL 24208-0092-05 Bausch 1 bottle — AB1 FDA listed —
Tetracaine Hydrochloride 5 mg/mL 50090-2364-01 A-S 4 ml — — FDA listed —
Tetracaine Hydrochloride 5 mg/mL 68682-0920-05 Oceanside 1 bottle — AB1 FDA listed —
Tetracaine Hydrochloride 5 mg/mL 70069-0597-01 Somerset 1 bottle — AB1 FDA listed —
Tetracaine Hydrochloride 5 mg/mL 70518-4183-00 REMEDYREPACK 12 bottles — — FDA listed —
Tetracaine Hydrochloride 5 mg/mL 85766-0229-05 Sportpharm 1 bottle — AB1 FDA listed —
Tetracaine Hydrochloride 5 mg/mL 85766-0230-15 Sportpharm 1 bottle — AB1 FDA listed —
About this product: this is the brand-name version. FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available.
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

🏛️
2016
On the market since
Nov 2016
📍
2026
Currently FDA-listed
10 years listed
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

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.

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 Q40Q9N063P
    Acetic acid is a weak organic acid commonly used in medicines as a buffer and pH adjuster. It helps maintain the proper acidity level to ensure the drug remains stable and effective in its formulation.
  • UNII 4550K0SC9B
    Sodium acetate is a salt derived from acetic acid. It acts as a buffer to help maintain the medicine's pH stability and may serve as a preservative or solubilizer in liquid formulations.
  • UNII 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • 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.

4 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.

Manufacturer & labeler

LabelerAlcon Laboratories, Inc.
Application holderALCON LABORATORIES LTD
FDA applicationNDA208135 (NDA)
Labeler code00065
First marketedNov 2016
Product typeHuman Prescription Drug
Portfolio55 products on file

More NDCs from Alcon Laboratories, Inc. labeler code 00065

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.

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 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 45 words ▾

1 INDICATIONS AND USAGE Tetracaine Hydrochloride Ophthalmic Solution 0.5% is indicated for procedures requiring a rapid and short-acting topical ophthalmic anesthetic. Tetracaine Hydrochloride Ophthalmic Solution 0.5% is an ester local anesthetic indicated for procedures requiring a rapid and short-acting topical ophthalmic anesthetic. ( 1 )

⏱️ Dosage and Administration 70 words ▾

2 DOSAGE AND ADMINISTRATION One drop topically in the eye(s) as needed. Discard unused portion. ( 2.1 )

2.1Topical Administration One drop topically in the eye as needed. Discard unused portion.

2.2Sterile Field Administration Open package using standard aseptic technique. The DROP‑TAINER ® dispenser may then be allowed to fall upon a sterile surface. The entire outer surface of the DROP‑TAINER ® dispenser and its contents are sterile.

💊 Dosage Forms and Strengths 28 words ▾

3 DOSAGE FORMS AND STRENGTHS Sterile ophthalmic solution containing 0.5% w/v tetracaine hydrochloride equivalent to tetracaine 0.44% w/v. Sterile ophthalmic solution containing 0.5% tetracaine hydrochloride ( 3 )

⛔ Contraindications 7 words ▾

4 CONTRAINDICATIONS None. None ( 4 )

⚠️ Warnings and Cautions ~1 min read ▾

5 WARNINGS AND PRECAUTIONS Do not use intracamerally since use may damage corneal endothelial cells ( 5.1 ) Prolonged use or abuse may lead to corneal epithelial toxicity and may manifest as epithelial defects which may progress to permanent corneal damage. ( 5.2 ) Patients should not touch the eye for at least 10-20 minutes after using anesthetic as accidental injuries can occur due to insensitivity of the eye. ( 5.3 ) For Administration by Healthcare Provider: Tetracaine Hydrochloride Ophthalmic Solution 0.5% is not intended for patient self-administration.

( 5.4 )

5.1Corneal injury with Intracameral Use Not for injection or intraocular use. Do not use intracamerally because use of TetracaineHydrochloride Ophthalmic Solution 0.5% may lead to damage of the corneal endothelial cells.

5.2Corneal Toxicity Prolonged use or abuse may lead to corneal epithelial toxicity and may manifest as epithelial defects which may progress to permanent corneal damage.

5.3Corneal Injury due to Insensitivity Patients should not touch the eye for at least 10-20 minutes after using anesthetic as accidental injuries can occur due to insensitivity of the eye.

5.4For Administration by Healthcare Provider Tetracaine Hydrochloride Ophthalmic Solution 0.5% is indicated for administration under the direct supervision of a healthcare provider. Tetracaine Hydrochloride Ophthalmic Solution 0.5% is not intended for patient self-administration [ see Warnings and Precautions ( 5.2 )].

🤒 Adverse Reactions 133 words ▾

6 ADVERSE REACTIONS The following serious ocular adverse reactions are described elsewhere in the labeling: Corneal injury with Intracameral Use [See Warnings and Precautions (5.1) ] Corneal Toxicity [See Warnings and Precautions (5.2) ] Corneal Injury due to Insensitivity [ See Warnings and Precautions (5.3) ] The following adverse reactions have been identified following use of Tetracaine Hydrochloride Ophthalmic Solution 0.5%. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Ocular Adverse Reactions Transient stinging, burning, and conjunctival redness, eye irritation, eye pain, ocular discomfort. Ocular adverse events: stinging, burning, conjunctival redness ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Alcon Laboratories, Inc., at 1-800-757-9195 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

👥 Use in Specific Populations 199 words ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary There are no adequate and well-controlled studies with Tetracaine Hydrochloride Ophthalmic Solution 0.5% in pregnant women. Animal developmental and reproductive toxicity studies with tetracaine hydrochloride have not been reported in the published literature.

8.2Lactation Risk Summary There are no data to assess whether Tetracaine Hydrochloride Ophthalmic Solution 0.5% is excreted in human milk or to assess its effects on milk production/excretion. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Tetracaine Hydrochloride Ophthalmic Solution 0.5% and any potential adverse effects on the breastfed child from Tetracaine Hydrochloride Ophthalmic Solution 0.5% or from the underlying maternal condition.

8.3Females and Males of Reproductive Potential No human data on the effect of Tetracaine Hydrochloride Ophthalmic Solution 0.5% on fertility are available.

8.4Pediatric Use Safety in the pediatric population has been demonstrated in clinical trials. Efficacy of tetracaine hydrochloride ophthalmic solution for use in pediatric patients has been extrapolated from adequate and well controlled clinical trials in the adult population.

8.5Geriatric Use No overall differences in safety or effectiveness of tetracaine hydrochloride ophthalmic solution have been observed between elderly and younger patients.

🤰 Pregnancy 37 words ▾

8.1Pregnancy Risk Summary There are no adequate and well-controlled studies with Tetracaine Hydrochloride Ophthalmic Solution 0.5% in pregnant women. Animal developmental and reproductive toxicity studies with tetracaine hydrochloride have not been reported in the published literature.

🧒 Pediatric Use 39 words ▾

8.4Pediatric Use Safety in the pediatric population has been demonstrated in clinical trials. Efficacy of tetracaine hydrochloride ophthalmic solution for use in pediatric patients has been extrapolated from adequate and well controlled clinical trials in the adult population.

🧓 Geriatric Use 23 words ▾

8.5Geriatric Use No overall differences in safety or effectiveness of tetracaine hydrochloride ophthalmic solution have been observed between elderly and younger patients.

🆘 Overdosage 40 words ▾

10 OVERDOSAGE Prolonged use of a topical ocular anesthetic including TetracaineHydrochloride Ophthalmic Solution 0.5% may produce permanent corneal opacification and ulceration with accompanying visual loss. Symptoms related to systemic toxicity consist mainly of effects on the neurologic and cardiovascular systems.

🧬 Clinical Pharmacology 59 words ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Tetracaine blocks sodium ion channels required for the initiation and conduction of neuronal impulses thereby affecting local anesthesia.

12.3Pharmacokinetics The systemic exposure to tetracaine following topical ocular administration of Tetracaine Hydrochloride Ophthalmic Solution 0.5% has not been studied. Tetracaine hydrochloride is metabolized by plasma pseudocholinesterases and nonspecific esterases in ocular tissues.

🧬 Mechanism of Action 22 words ▾

12.1Mechanism of Action Tetracaine blocks sodium ion channels required for the initiation and conduction of neuronal impulses thereby affecting local anesthesia.

📦 How Supplied / Storage and Handling 95 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Tetracaine Hydrochloride Ophthalmic Solution 0.5% STERI-UNITS ® is supplied as single patient use, 4 mL filled in 4-mL natural medium- or low-density polyethylene plastic DROP-TAINER ® dispensers and natural low-density polyethylene tips with white polypropylene caps in a carton of 12. Each sterilized DROP-TAINER ® dispenser is packaged in a clear PVC and Tyvek blister. This product does not contain a preservative; discard unused portion.

NDC 0065-0741-14 Storage: Store at 2°C to 25°C (36°F to 77°F). Protect from light. Do not use if solution contains crystals, is cloudy, or discolored.

📋 Description 93 words ▾

11 DESCRIPTION Tetracaine hydrochloride is chemically designated as benzoic acid, 4-(butylamino)-,2-(dimethylamino) ethyl ester, monohydrochloride. Its chemical formula is C 15 H 24 N 2 O 2 • HCl and it is represented by the chemical structure: Tetracaine hydrochloride is a fine, white, crystalline, odorless powder and has a molecular weight of 300.82. Tetracaine Hydrochloride Ophthalmic Solution 0.5% has a pH of 3.7 to 5.5.

Active ingredient: tetracaine hydrochloride 0.5% w/v (equivalent to 0.44% w/v tetracaine) Inactive ingredients: sodium chloride, sodium acetate trihydrate, acetic acid (to adjust pH approximately 4.5), Water for Injection, USP

💬 Information for Patients 53 words ▾

17 PATIENT COUNSELING INFORMATION Eye Care Precaution Advise patients that, due to the effect of the anesthetic, their eyes will be insensitive up to 20 minutes and that care should be taken to avoid accidental injuries. ALCON ® Distributed by: ALCON LABORATORIES, INC. Fort Worth, Texas 76134 USA © 2022 Alcon Inc. 300055204-1121

🧬 Pharmacokinetics 34 words ▾

12.3Pharmacokinetics The systemic exposure to tetracaine following topical ocular administration of Tetracaine Hydrochloride Ophthalmic Solution 0.5% has not been studied. Tetracaine hydrochloride is metabolized by plasma pseudocholinesterases and nonspecific esterases in ocular tissues.

🔬 Clinical Studies 47 words ▾

14 CLINICAL STUDIES Topical administration of tetracainehydrochloride ophthalmic solution results in localized temporary anesthesia. The maximum effect is achieved within 10–20 seconds after instillation, with efficacy lasting 10–20 minutes. Duration of effect can be extended with repeated dosing. [see Corneal toxicity (5.2) and Overdosage (10) ] .

🧪 Nonclinical Toxicology 59 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Studies to assess the genotoxicity of tetracaine hydrochloride have not been reported in the published literature. Long-term animal studies have not been conducted to evaluate the carcinogenic potential of tetracaine hydrochloride. Animal studies to assess the effects of tetracaine hydrochloride on fertility have not been reported in the published literature.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 56 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Studies to assess the genotoxicity of tetracaine hydrochloride have not been reported in the published literature. Long-term animal studies have not been conducted to evaluate the carcinogenic potential of tetracaine hydrochloride. Animal studies to assess the effects of tetracaine hydrochloride on fertility have not been reported in the published literature.

📄 Recent Major Changes 7 words ▾

Warnings and Precautions ( 5.4 ) 2/2022

📄 Package Label / Principal Display Panel ~1 min read ▾

PRINCIPAL DISPLAY PANEL NDC 0065-0741-14 Tetracaine Hydrochloride Ophthalmic Solution, 0.5% STERi-UNITS Single Dose DROP-TAINER® dispensers for topical use.See package insert for directions. Rx Only 12 x 4mL STERILE Alcon Alcon Laboratories, Inc. Fort Worth, Texas 76134 USA Printed in USA NDC 0065-0741-14 TETRACAINE HYDROCHLORIDE Ophthalmic Solution 0.5% INGREDIENTS: Each mL contains: Active: Tetracaine Hydrochloride 0.5%.

(equivalent to tetracaine (0.44%) Inactive: Sodium Chloride, Sodium Acetate Trihydrate, Acetic Acid (to adjust pH), Water for Injection. USUAL DOSAGE: One drop topically in the eye(s) as needed. Discard unused portion.

STORAGE: Store at 2°C to 25°C (36°F to 77°F). Protect from Light. Do not use if discolored Printed in USA 300057714-0622 GTIN: 10300650741146 SN: LOT: EXP: PRINCIPAL DISPLAY PANEL NDC 0065-0741-14 Tetracaine Hydrochloride Ophthalmic Solution, 0.5% STERi-UNITS Single Dose DROP-TAINER® dispensers for topical use.See package insert for directions.

Rx Only 12 x 4mL STERILE Alcon Alcon Laboratories, Inc. Fort Worth, Texas 76134 USA Product of Switzerland Printed in USA NDC 0065-0741-14 TETRACAINE HYDROCHLORIDE Ophthalmic Solution 0.5% INGREDIENTS: Each mL contains: Active: Tetracaine Hydrochloride 0.5%. (equivalent to tetracaine (0.44%) Inactive: Sodium Chloride, Sodium Acetate Trihydrate, Acetic Acid (to adjust pH), Water for Injection.

USUAL DOSAGE: One drop topically in the eye(s) as needed. Discard unused portion. STORAGE: Store at 2°C to 25°C (36°F to 77°F).

Protect from Light. Do not use if discolored Printed in USA GTIN: 10300650741146 SN: LOT: EXP: 300057715-0622 NDC 0065-0741-14 TETRACAINE HYDROCHLORIDE Ophthalmic Solution 0.5% 4mL Rx Only SINGLE DOSE UNIT –DISCARD UNUSED PORTION H14660-0916 LOT: EXP : TETRACAINE HYDROCHLORIDE OPHTHALMIC SOLUTION 0.5% 4mL STERILE UNTIL OPENED PROTECT FROM LIGHT Rx Only NDC 0065-0741-14 300065025-1223 Alcon Laboratories, Inc. Fort Worth, Texas 76134 USA Alcon LOT: EXP.:

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
6.9K
Units reimbursed last 4 qtrs
11.5K
Gross reimbursed last 4 qtrs
$109.7K
Avg / prescription
$15.90
Avg / unit
$9.5108
Latest quarter Q1 2026
1.2KRx
Fee-for-service vs managed care ⓘ
22% FFS 78% MCO
Fee-for-service · 1,541 Rx Managed care · 5,358 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: 276 units · 24.4 per 100k residents MT North Dakota: 55 units · 7.0 per 100k residents ND Minnesota: 146 units · 2.5 per 100k residents MN Wisconsin: no data reported WI Michigan: no data reported MI New York: no data reported NY Vermont: no data reported VT New Hampshire: 1,006 units · 71.8 per 100k residents NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: 132 units · 14.4 per 100k residents SD Iowa: 72 units · 2.2 per 100k residents IA Illinois: no data reported IL Indiana: 167 units · 2.4 per 100k residents IN Ohio: no data reported OH Pennsylvania: 775 units · 6.0 per 100k residents PA New Jersey: no data reported NJ Massachusetts: 589 units · 8.4 per 100k residents MA California: 1,254 units · 3.2 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: 3,464 units · 55.9 per 100k residents MO Kentucky: 2,550 units · 56.3 per 100k residents KY West Virginia: no data reported WV Virginia: 176 units · 2.0 per 100k residents VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: 122 units · 5.8 per 100k residents NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: 514 units · 7.2 per 100k residents TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: 83 units · 1.8 per 100k residents LA Mississippi: 71 units · 2.4 per 100k residents MS Alabama: no data reported AL Georgia: no data reported GA D.C.: 84 units · 12.4 per 100k residents DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
1.871.8
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 New Hampshire 71.8 /100k
2 Kentucky 56.3 /100k
3 Missouri 55.9 /100k
4 Montana 24.4 /100k
5 South Dakota 14.4 /100k
6 D.C. 12.4 /100k
7 Massachusetts 8.4 /100k
8 Tennessee 7.2 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

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 Tetracaine hydrochloride — the ingredient across all brands.

Top reported reactions

Toxic Anterior Segment Syndrome27
Nausea15
Syncope15
Aqueous Fibrin14
Inflammation14
Abdominal Discomfort12
Oropharyngeal Pain12

Age at onset

Neonate1
Adult6
Elderly14

Reporter sex

156 reports
Male · 32%
Female · 68%

Serious outcomes

Life-threatening20
Death19
Disabling10
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 14 0
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.

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 — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
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) ✓ Available
“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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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 Alcon Laboratories, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Alcon Laboratories, Inc. 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.
← 00065-0518-01 · Alcon 00065-0795-15 · Alcon →
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.