Tetracaine Hydrochloride

Manufacturer: Alcon Laboratories, Inc. | Siegfried Evionnaz SA | Alcon Research LLC
Effective date: 2024-01-19
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 14
Source: full-release
Hydrated at: 2026-05-31 20:58:29

Label at a glance#

ProductTetracaine Hydrochloride

Active ingredientTetracaine Hydrochloride

Label structure15 sections

Indications and uses

Tetracaine Hydrochloride Ophthalmic Solution 0.5% is indicated for procedures requiring a rapid and short-acting topical ophthalmic anesthetic.

Dosage and administration

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

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 preservati...

Contacts and useful links#

PhoneLabel contact1-800-757-9195

PhoneFDA MedWatch1-800-FDA-1088

Websitewww.fda.gov

www.fda.gov/medwatch

Label contents#

Full prescribing information#

1 INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

Tetracaine Hydrochloride Ophthalmic Solution 0.5% is indicated for procedures requiring a rapid and short-acting topical ophthalmic anesthetic.

2 DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

2.1 Topical Administration

SPL UNCLASSIFIED SECTION

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

2.2 Sterile Field Administration

SPL UNCLASSIFIED SECTION

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.

3 DOSAGE FORMS AND STRENGTHS

DOSAGE FORMS & STRENGTHS SECTION

Sterile ophthalmic solution containing 0.5% w/v tetracaine hydrochloride equivalent to tetracaine 0.44% w/v.

4 CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

None.

5 WARNINGS AND PRECAUTIONS

WARNINGS AND PRECAUTIONS SECTION

5.1 Corneal injury with Intracameral Use

SPL UNCLASSIFIED SECTION

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.

5.2 Corneal Toxicity

SPL UNCLASSIFIED SECTION

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

5.3 Corneal Injury due to Insensitivity

SPL UNCLASSIFIED SECTION

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.

5.4 For Administration by Healthcare Provider

SPL UNCLASSIFIED SECTION

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 )].

6 ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

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.

8 USE IN SPECIFIC POPULATIONS

USE IN SPECIFIC POPULATIONS SECTION

8.1 Pregnancy

PREGNANCY SECTION

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.

8.2 Lactation

LACTATION SECTION

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.

8.3 Females and Males of Reproductive Potential

SPL UNCLASSIFIED SECTION

No human data on the effect of Tetracaine Hydrochloride Ophthalmic Solution 0.5% on fertility are available.

8.4 Pediatric Use

PEDIATRIC USE SECTION

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.

8.5 Geriatric Use

GERIATRIC USE SECTION

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

10 OVERDOSAGE

OVERDOSAGE SECTION

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.

11 DESCRIPTION

DESCRIPTION SECTION

Tetracaine hydrochloride is chemically designated as benzoic acid, 4-(butylamino)-,2-(dimethylamino) ethyl ester, monohydrochloride. Its chemical formula is C₁₅H₂₄N₂O₂ • 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

12 CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY SECTION

12.1 Mechanism of Action

MECHANISM OF ACTION SECTION

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

12.3 Pharmacokinetics

PHARMACOKINETICS SECTION

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.

13 NONCLINICAL TOXICOLOGY

NONCLINICAL TOXICOLOGY SECTION

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION

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.

14 CLINICAL STUDIES

CLINICAL STUDIES SECTION

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)].

16 HOW SUPPLIED/STORAGE AND HANDLING

HOW SUPPLIED SECTION

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.

17 PATIENT COUNSELING INFORMATION

INFORMATION FOR PATIENTS SECTION

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

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.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.:

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1547771	tetracaine HCl 0.5 % Ophthalmic Solution	PSN	14
1547771	tetracaine hydrochloride 5 MG/ML Ophthalmic Solution	SCD	14
1547771	tetracaine hydrochloride 0.5 % Ophthalmic Solution	SY	14

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
TETRACAINE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a26f29b9-6919-4f09-a354-491df8d2b97d	Product name	1	20251021
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
122d1fa8-7b9e-49b4-89ce-b062ffd1d947	Product name	1	20181030
48747306-602a-42cc-957b-5b0c69158eee	Product name	1	20180604
a993dfc5-f219-4460-bde6-30dd724d9ef0	Product name	1	20160818
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
4d7ae718-ed00-bae8-2abe-9eaec1eef7ff	Product name	1	20140508
9137811f-f279-8640-5aeb-99fa2145d64d	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578b	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0065-0741-12	Tetracaine Hydrochloride	2 mL in 1 BOTTLE, DROPPER	SOLUTION	2	14
0065-0741-12	Tetracaine Hydrochloride	12 in 1 CARTON	SOLUTION	12	14
0065-0741-14	Tetracaine Hydrochloride	1 in 1 BLISTER PACK	SOLUTION	1	14
0065-0741-14	Tetracaine Hydrochloride	12 in 1 CARTON	SOLUTION	12	14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0065-0741	TETRACAINE HYDROCHLORIDE SOLUTION [ALCON LABORATORIES, INC.]	14	Current NDC, Legacy NDC, 4 package rows	20240120_5c7b1de4-9f55-1d0e-ef6d-b0ba2cbaba79.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0065-0741-12	ML - Milliliter	0065-0741	8dd61beb-f100-4e9d-a05b-1b036f9db54d	1	2013-02-13
0065-0741-14	ML - Milliliter	0065-0741	aaeddbd8-1c36-4b91-af31-25bf6c63a1dc	1	2016-11-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Tetracaine Hydrochloride	ACTIVE INGREDIENT	5NF5D4OPCI	2
Tetracaine	ACTIVE MOIETY	0619F35CGV	2
Acetic Acid	INACTIVE INGREDIENT	Q40Q9N063P	2
Sodium Acetate	INACTIVE INGREDIENT	4550K0SC9B	2
Sodium Chloride	INACTIVE INGREDIENT	451W47IQ8X	2
Water	INACTIVE INGREDIENT	059QF0KO0R	2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

Tetracaine Hydrochloride
Tetracaine
Sodium Chloride
Sodium Acetate
Acetic Acid
Water

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0065-0741	0065-0741-12, 0065-0741-14

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Tetracaine Hydrochloride	5NF5D4OPCI	ACTIB
Sodium Chloride	451W47IQ8X	IACT
Sodium Acetate	4550K0SC9B	IACT
Acetic Acid	Q40Q9N063P	IACT
Water	059QF0KO0R	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 9 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Maximum daily exposure	Match
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / OPHTHALMIC	13 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
Sodium Acetate	SODIUM ACETATE	4550K0SC9B	SOLUTION / OPHTHALMIC	2 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
Sodium Acetate	SODIUM ACETATE	4550K0SC9B	SOLUTION / OPHTHALMIC	2 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / OPHTHALMIC	13 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
Acetic Acid	ACETIC ACID	Q40Q9N063P	SOLUTION / OPHTHALMIC	3 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
Acetic Acid	ACETIC ACID	Q40Q9N063P	SOLUTION / OPHTHALMIC	3 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
Sodium Acetate	SODIUM ACETATE	4550K0SC9B	SOLUTION / OPHTHALMIC	2 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
Acetic Acid	ACETIC ACID	Q40Q9N063P	SOLUTION / OPHTHALMIC	3 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / OPHTHALMIC	13 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N208135-001	TETRACAINE HYDROCHLORIDE	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC		RLD, RS	2016-02-29

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N208135-001	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION / OPHTHALMIC	RLD, RS	2016-02-29	`f41ea6bd6efb…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tetracaine Hydrochloride	TETRACAINE HYDROCHLORIDE	Alcon Laboratories, Inc.	5c7b1de4-9f55-1d0e-ef6d-b0ba2cbaba79	2024-01-19	Warnings, Adverse reactions	Exact identifier ndc (package): 0065-0741-12 ndc (package): 0065-0741-14 ndc (product): 0065-0741 ndc11 (package): 00065074112 ndc11 (package): 00065074114 spl id: e5c0f202-3d32-4b47-8d45-e1d031ff7ce9 spl set id: 5c7b1de4-9f55-1d0e-ef6d-b0ba2cbaba79

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.