Ketorolac Tromethamine Ophthalmic Solution, 0.4%

Manufacturer: Rebel Distributors Corp
Effective date: 2010-09-29
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 20:10:27

Label at a glance#

ProductKetorolac Tromethamine

Active ingredientketorolac tromethamine

Label structure10 sections

Indications and uses

Ketorolac Tromethamine Ophthalmic Solution, 0.4% is indicated for the reduction of ocular pain and burning/stinging following corneal refractive surgery.

Dosage and administration

The recommended dose of Ketorolac Tromethamine Ophthalmic Solution, 0.4% is one drop four times a day in the operated eye as needed for pain and burning/stinging for up to 4 days following corneal refractive surgery. Ketorolac tromethamine ophthalmic solution has been safely administered in conjunction with other ophthalmic medications such as antibiotics, beta blockers, carbonic anhydrase inhibitors, cycloplegics...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Rx only

DESCRIPTION

DESCRIPTION SECTION

Ketorolac Tromethamine Ophthalmic Solution, 0.4% is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDS) for ophthalmic use.

Chemical Name: (±)-5-Benzoyl-2,3-dihydro-1H-pyrrolizine-l-
carboxylic acid, compound with 2-amino-2-(hydroxymethy1)-l,3-propanediol (1:1)

Contains: Active: ketorolac tromethamine 0.4%.

Preservative: benzalkonium chloride 0.006%. Inactives: edetate disodium 0.015%, octoxynol 40, sodium chloride and purified water. May contain hydrochloric acid and/or sodium hydroxide (to adjust the pH).

Ketorolac Tromethamine Ophthalmic Solution 0.4% is supplied as a sterile isotonic aqueous 0.4% solution, with a pH of approximately 7.4. Ketorolac Ophthalmic Solution is a racemic mixture of R-(+) and S-(-)-ketorolac tromethamine. Ketorolac tromethamine may exist in three crystal forms. All forms are equally soluble in water. The pKa of ketorolac is 3.5. This white to off-white crystalline substance discolors on prolonged exposure to light. The osmolality of Ketorolac Ophthalmic Solution is approximately 290 mOsml/kg.

CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY SECTION

Mechanism of Action

MECHANISM OF ACTION SECTION

Ketorolac Ophthalmic Solution is a nonsteroidal anti-inflammatory drug which, when administered systemically, has demonstrated analgesic, anti-inflammatory, and anti-pyretic activity. The mechanism of its action is thought to be due to its ability to inhibit prostaglandin biosynthesis. Ketorolac tromethamine given systemically does not cause pupil constriction.

Pharmacokinetics

PHARMACOKINETICS SECTION

One drop (0.05 mL) of 0.5% ketorolac tromethamine ophthalmic solution was instilled into one eye and one drop of vehicle into the other eye TID in 26 normal subjects. Only 5 of 26 subjects had a detectable amount of ketorolac in their plasma (range 10.7 to 22.5 ng/mL) at day 10 during topical ocular treatment. When ketorolac tromethamine 10 mg is administered systemically every 6 hours, peak plasma levels at steady state are around 960 ng/mL.

Clinical Studies

CLINICAL STUDIES SECTION

In two double-masked, multi-centered, parallel-group studies, 313 patients who had undergone photorefractive keratectomy received Ketorolac Tromethamine Ophthalmic Solution, 0.4% or its vehicle QID for up to 4 days. Significant differences favored Ketorolac Ophthalmic Solution for the reduction of ocular pain and burning/stinging following photorefractive keratectomy surgery.

Results from clinical studies indicate that ketorolac tromethamine has no significant effect upon intraocular pressure.

The safety and effectiveness of Ketorolac Tromethamine Ophthalmic Solution in post-cataract surgery patients has not been established.

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

Ketorolac Tromethamine Ophthalmic Solution, 0.4% is indicated for the reduction of ocular pain and burning/stinging following corneal refractive surgery.

CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

Ketorolac Tromethamine Ophthalmic Solution, 0.4% is contraindicated in patients with previously demonstrated hypersensitivity to any of the ingredients in the formulation.

WARNINGS

WARNINGS SECTION

There is the potential for cross-sensitivity to acetylsalicylic acid, phenylacetic acid derivatives, and other nonsteroidal anti-inflammatory agents. Therefore, caution should be used when treating individuals who have previously exhibited sensitivities to these drugs.

With some nonsteroidal anti-inflammatory drugs there exists the potential for increased bleeding time due to interference with thrombocyte aggregation. There have been reports that ocularly applied nonsteroidal anti-inflammatory drugs may cause increased bleeding of ocular tissues (including hyphemas) in conjunction with ocular surgery.

PRECAUTIONS

PRECAUTIONS SECTION

GENERAL PRECAUTIONS SECTION

General: All topical nonsteroidal anti-inflammatory drugs (NSAIDs), including ketorolac tromethamine ophthalmic solution, may slow or delay healing. Topical corticosteroids are also known to slow or delay healing. Concomitant use of topical NSAIDS and topical steroids may increase the potential for healing problems.

Use of topical NSAIDs may result in keratitis. In some susceptible patients, continued use of topical NSAIDs may result in epithelial breakdown, corneal thinning, corneal erosion, corneal ulceration or corneal perforation. These events may be sight threatening. Patients with evidence of corneal epithelial breakdown should immediately discontinue use of topical NSAIDs and should be closely monitored for corneal health.

Postmarketing experience with topical NSAIDs suggests that patients with complicated ocular surgeries, corneal denervation, corneal epithelial defects, diabetes mellitus, ocular surface diseases (e.g., dry eye syndrome), rheumatoid arthritis, or repeat ocular surgeries within a short period of time may be at increased risk for corneal adverse events which may become sight threatening. Topical NSAIDs should be used with caution in these patients.

Postmarketing experience with topical NSAIDs also suggests that use more than 24 hours prior to surgery or use beyond 14 days post-surgery may increase patient risk for the occurrence and severity of corneal adverse events.

It is recommended that Ketorolac Ophthalmic Solution be used with caution in patients with known bleeding tendencies or who are receiving other medications, which may prolong bleeding time.

INFORMATION FOR PATIENTS SECTION

Information for Patients: Ketorolac Ophthalmic Solution should not be administered while wearing contact lenses.

Carcinogenesis, Mutagenesis, Impairment of Fertility:

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION

Ketorolac tromethamine was neither carcinogenic in rats given up to 5 mg/kg/day orally for 24 months (156 times the maximum recommended human topical ophthalmic dose, on a mg/kg basis, assuming 100% absorption in humans and animals) nor in mice given 2 mg/kg/day orally for 18 months (62.5 times the maximum recommended human topical ophthalmic dose, on a mg/kg basis, assuming 100% absorption in humans and animals).

Ketorolac tromethamine was not mutagenic in vitro in the Ames assay or in forward mutation assays. Similarly, it did not result in an in vitro increase in unscheduled DNA synthesis or an in vivo increase in chromosome breakage in mice. However, ketorolac tromethamine did result in an increased incidence in chromosomal aberrations in Chinese hamster ovary cells.

Ketorolac tromethamine did not impair fertility when administered orally to male and female rats at doses up to 280 and 499 times the maximum recommended human topical ophthalmic dose, respectively, on a mg/kg basis, assuming 100% absorption in humans and animals.

Pregnancy:

PREGNANCY SECTION

Teratogenic Effects: Pregnancy Category C:

PREGNANCY SECTION

Ketorolac tromethamine, administered during organogenesis, was not teratogenic in rabbits or rats at oral doses up to 112 times and 312 times the maximum recommended human topical ophthalmic dose, respectively, on a mg/kg basis assuming 100% absorption in humans and animals. When administered to rats after Day 17 of gestation at oral doses up to 46 times the maximum recommended human topical ophthalmic dose on a mg/kg basis, assuming 100% absorption in humans and animals, ketorolac tromethamine resulted in dystocia and increased pup mortality. There are no adequate and well-controlled studies in pregnant women. Ketorolac Ophthalmic Solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nonteratogenic Effects:

NONTERATOGENIC EFFECTS SECTION

Because of the known effects of prostaglandin-inhibiting drugs on the fetal cardiovascular system (closure of the ductus arteriosus), the use of Ketorolac Ophthalmic Solution during late pregnancy should be avoided.

NURSING MOTHERS SECTION

Nursing Mothers: Caution should be exercised when Ketorolac Ophthalmic Solution is administered to a nursing woman.

PEDIATRIC USE SECTION

Pediatric Use: Safety and effectiveness of ketorolac tromethamine in pediatric patients below the age of 3 have not been established.

GERIATRIC USE SECTION

Geriatric Use: No overall differences in safety or effectiveness have been observed between elderly and younger patients.

ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

The most frequently reported adverse reactions for Ketorolac Ophthalmic Solution occurring in approximately 1 to 5% of the overall study population were conjunctival hyperemia, corneal infiltrates, headache, ocular edema and ocular pain.

The most frequent adverse events reported with the use of ketorolac tromethamine ophthalmic solutions have been transient stinging and burning on instillation. These events were reported by 20% - 40% of patients participating in these other clinical trials.

Other adverse events occurring approximately 1%-10% of the time during treatment with ketorolac tromethamine ophthalmic solutions included allergic reactions, corneal edema, iritis, ocular inflammation, ocular irritation, ocular pain, superficial keratitis, and superficial ocular infections.

SPL UNCLASSIFIED SECTION

Clinical Practice: The following events have been identified during postmarketing use of ketorolac tromethamine ophthalmic solutions in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. The events, which have been chosen for inclusion due to either their seriousness, frequency of reporting, possible causal connection to topical ketorolac tromethamine ophthalmic solutions, or a combination of these factors, include corneal erosion, corneal perforation, corneal thinning and epithelial breakdown (see PRECAUTIONS, General).

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Ketorolac tromethamine ophthalmic solution has been safely administered in conjunction with other ophthalmic medications such as antibiotics, beta blockers, carbonic anhydrase inhibitors, cycloplegics, and mydriatics.

HOW SUPPLIED

HOW SUPPLIED SECTION

Ketorolac Tromethamine Ophthalmic Solution, 0.4% is supplied sterile in a white LDPE boston round bottle with a LDPE natural-colored dropper tip and a gray short skirt cap as follows:

5 mL in 10 mL bottle - NDC 21695-624-05

STORAGE AND HANDLING SECTION

Storage: Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature].

Manufactured by: Akorn, Inc.
Lake Forest, IL 60045

KRA0N

Rev. 08/09

Repackaged by:

Rebel Distributors Corp

Thousand Oaks, CA 91320

Ketorolac Tromethamine Ophthalmic Solution 0.4% Container Label Principal Display Panel Text:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 21695-624-05

Ketorolac
Tromethamine
Ophthalmic
Solution

0.4%

Rx only 5mL

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
KETOROLAC Pharmacologic Class Indexing	3	Indexing - Pharmacologic Class	20191108

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6a38bd75-79e3-96c0-1204-08a0282902ae	Product name	4	20250128
4d6e22a5-3693-6edf-0179-2ab93aecbadb	Product name	9	20240724
03452e68-2506-686e-a908-f2381c778fc6	Product name	5	20240307
b5abe2e3-39a1-43eb-9bff-f3c1653fe3df	Product name	2	20190930
bb41bc3a-c643-93c9-055f-a8f48f363af3	Product name	2	20190219
4f6a8082-ae1e-0ff7-4dc0-77f9f0f7b70c	Product name	1	20140508
8d3e992f-8ff7-c106-f7eb-1e2d5eb12025	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
21695-624-05	2019-09-24	C162847	48780-1	934fe258-4c11-48b1-e053-8cdaa90a720a	Ketorolac Tromethamine Ophthalmic Solution, 0.4%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
21695-624-05	Ketorolac Tromethamine	1 in 1 CARTON	SOLUTION	1		1
21695-624-05	Ketorolac Tromethamine	5 mL in 1 BOTTLE, DROPPER	SOLUTION	5		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21695-624	KETOROLAC TROMETHAMINE SOLUTION [REBEL DISTRIBUTORS CORP]	1	Legacy NDC, 2 package rows	20101119_947e29c2-a270-48e0-ba96-c7ed676db871.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
21695-624-05	ML - Milliliter	21695-624	db0f9328-3a5c-400f-bc96-6f26c03b43f1	1	2012-07-24
17478-208-10	ML - Milliliter	17478-208	fad9a3da-d8dc-4883-ba45-674e6df05b73	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
ketorolac tromethamine	ACTIVE INGREDIENT	4EVE5946BQ	1
ketorolac	ACTIVE MOIETY	YZI5105V0L	1
benzalkonium chloride	INACTIVE INGREDIENT	F5UM2KM3W7	1
edetate disodium	INACTIVE INGREDIENT	7FLD91C86K	1
hydrochloric acid	INACTIVE INGREDIENT	QTT17582CB	1
octoxynol-40	INACTIVE INGREDIENT	9T1C662FKS	1
sodium chloride	INACTIVE INGREDIENT	451W47IQ8X	1
sodium hydroxide	INACTIVE INGREDIENT	55X04QC32I	1
water	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

Ketorolac Tromethamine
ketorolac
benzalkonium chloride
edetate disodium
octoxynol-40
sodium chloride
hydrochloric acid
sodium hydroxide
water

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
21695-624	21695-624-05
17478-208

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ketorolac tromethamine	4EVE5946BQ	ACTIB
benzalkonium chloride	F5UM2KM3W7	IACT
edetate disodium	7FLD91C86K	IACT
octoxynol-40	9T1C662FKS	IACT
sodium chloride	451W47IQ8X	IACT
hydrochloric acid	QTT17582CB	IACT
sodium hydroxide	55X04QC32I	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 10 · 559 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
hydrochloric acid	HYDROCHLORIC ACID	QTT17582CB	INJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SOLUTION / INTRAVASCULAR	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION / OPHTHALMIC		10 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS	0.68 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	POWDER / INTRAVENOUS	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
hydrochloric acid	HYDROCHLORIC ACID	QTT17582CB	SOLUTION / INTRAVENOUS	18.25 mg		Exact identifier — unii candidate 148 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION / EPIDURAL		3535 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SUSPENSION / INTRALESIONAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRATUMOR	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
hydrochloric acid	HYDROCHLORIC ACID	QTT17582CB	INJECTION / INTRACAVITARY	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
hydrochloric acid	HYDROCHLORIC ACID	QTT17582CB	INJECTION / ENDOTRACHEAL	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	POWDER / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 134 equally ranked IID candidates
hydrochloric acid	HYDROCHLORIC ACID	QTT17582CB	SOLUTION / NASAL	91.7 mg/100ml		Exact identifier — unii candidate 148 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	SUSPENSION/ DROPS / OPHTHALMIC	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	INJECTION / SUBCUTANEOUS		6 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
benzalkonium chloride	BENZALKONIUM CHLORIDE	F5UM2KM3W7	GEL / OPHTHALMIC	0.01 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
hydrochloric acid	HYDROCHLORIC ACID	QTT17582CB	INJECTION, POWDER, FOR SOLUTION / PARENTERAL	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRAVITREAL	10 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	TABLET, ORALLY DISINTEGRATING / ORAL		10 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
hydrochloric acid	HYDROCHLORIC ACID	QTT17582CB	INJECTION, SOLUTION / SUBMUCOSAL	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	LOTION / TOPICAL		21 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	TABLET, COATED / ORAL	0.21 mg		Exact identifier — unii candidate 77 equally ranked IID candidates
benzalkonium chloride	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SUSPENSION / AURICULAR (OTIC)	0.01 %w/v		Exact identifier — unii candidate 24 equally ranked IID candidates
hydrochloric acid	HYDROCHLORIC ACID	QTT17582CB	SOLUTION / RECTAL	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
hydrochloric acid	HYDROCHLORIC ACID	QTT17582CB	SOLUTION / SUBCUTANEOUS	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION / PERINEURAL		648 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SOLUTION / INTRA-ARTICULAR	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	INJECTION, SOLUTION / INTRAMUSCULAR		4 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
octoxynol-40	OCTOXYNOL-40	9T1C662FKS	SOLUTION / OPHTHALMIC	0.05 %w/v		Exact identifier — unii candidate 2 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	TABLET, FILM COATED / ORAL	4 mg		Exact identifier — unii candidate 77 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	LIQUID / TOPICAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SOLUTION / SUBCUTANEOUS	1 %w/v		Exact identifier — unii candidate 174 equally ranked IID candidates
benzalkonium chloride	BENZALKONIUM CHLORIDE	F5UM2KM3W7	OINTMENT / TOPICAL	0.03 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
hydrochloric acid	HYDROCHLORIC ACID	QTT17582CB	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRATHECAL	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	SOLUTION/ DROPS / AURICULAR (OTIC)		18 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SUSPENSION / INTRAVENOUS	0.9 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	GEL / TRANSDERMAL		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION, CONCENTRATE / INTRAMUSCULAR	0.86 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
benzalkonium chloride	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SOLUTION / OPHTHALMIC	2 %w/v		Exact identifier — unii candidate 24 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION / INFILTRATION		3535 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
hydrochloric acid	HYDROCHLORIC ACID	QTT17582CB	INJECTION / INTRAVENOUS		720 mg	Exact identifier — unii candidate 148 equally ranked IID candidates
hydrochloric acid	HYDROCHLORIC ACID	QTT17582CB	SUSPENSION/ DROPS / AURICULAR (OTIC)	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INFILTRATION	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
hydrochloric acid	HYDROCHLORIC ACID	QTT17582CB	AEROSOL, METERED / RESPIRATORY (INHALATION)	0.7 %w/w		Exact identifier — unii candidate 148 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SUSPENSION / SOFT TISSUE	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	SPRAY / NASAL		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
hydrochloric acid	HYDROCHLORIC ACID	QTT17582CB	AEROSOL, FOAM / TOPICAL	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
hydrochloric acid	HYDROCHLORIC ACID	QTT17582CB	TABLET / ORAL	2.32 mg		Exact identifier — unii candidate 148 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SOLUTION / INTRA-ARTERIAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / INTRAOCULAR		320 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
hydrochloric acid	HYDROCHLORIC ACID	QTT17582CB	INJECTION, SUSPENSION / SUBCUTANEOUS	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	SUSPENSION / ORAL		30 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / INTRATHECAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	SUSPENSION / ENDOTRACHEAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
hydrochloric acid	HYDROCHLORIC ACID	QTT17582CB	INJECTION, SUSPENSION / SOFT TISSUE	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	INJECTION, EMULSION / INTRAVENOUS		59 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	LOTION / TOPICAL		22 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
benzalkonium chloride	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SPRAY, METERED / NASAL		1 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
hydrochloric acid	HYDROCHLORIC ACID	QTT17582CB	INJECTION / RETROBULBAR	ADJ PH		Exact identifier — unii candidate 148 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
A078399-001	KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	0.4%	SOLUTION/DROPS / OPHTHALMIC			2009-11-05

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	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A078399-001	KETOROLAC TROMETHAMINE	0.4%	SOLUTION/DROPS / OPHTHALMIC		2009-11-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078399-001	KETOROLAC TROMETHAMINE	0.4%	SOLUTION/DROPS / OPHTHALMIC		2009-11-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078399-001	KETOROLAC TROMETHAMINE	0.4%	SOLUTION/DROPS / OPHTHALMIC		2009-11-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078399-001	KETOROLAC TROMETHAMINE	0.4%	SOLUTION/DROPS / OPHTHALMIC		2009-11-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078399-001	KETOROLAC TROMETHAMINE	0.4%	SOLUTION/DROPS / OPHTHALMIC		2009-11-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078399-001	KETOROLAC TROMETHAMINE	0.4%	SOLUTION/DROPS / OPHTHALMIC		2009-11-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078399-001	KETOROLAC TROMETHAMINE	0.4%	SOLUTION/DROPS / OPHTHALMIC		2009-11-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078399-001	KETOROLAC TROMETHAMINE	0.4%	SOLUTION/DROPS / OPHTHALMIC		2009-11-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078399-001	KETOROLAC TROMETHAMINE	0.4%	SOLUTION/DROPS / OPHTHALMIC		2009-11-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078399-001	KETOROLAC TROMETHAMINE	0.4%	SOLUTION/DROPS / OPHTHALMIC		2009-11-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078399-001	KETOROLAC TROMETHAMINE	0.4%	SOLUTION/DROPS / OPHTHALMIC		2009-11-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078399-001	KETOROLAC TROMETHAMINE	0.4%	SOLUTION/DROPS / OPHTHALMIC		2009-11-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078399-001	KETOROLAC TROMETHAMINE	0.4%	SOLUTION/DROPS / OPHTHALMIC		2009-11-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078399-001	KETOROLAC TROMETHAMINE	0.4%	SOLUTION/DROPS / OPHTHALMIC		2009-11-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078399-001	KETOROLAC TROMETHAMINE	0.4%	SOLUTION/DROPS / OPHTHALMIC		2009-11-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078399-001	KETOROLAC TROMETHAMINE	0.4%	SOLUTION/DROPS / OPHTHALMIC		2009-11-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078399-001	KETOROLAC TROMETHAMINE	0.4%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078399-001	KETOROLAC TROMETHAMINE	0.4%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078399-001	KETOROLAC TROMETHAMINE	0.4%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078399-001	KETOROLAC TROMETHAMINE	0.4%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078399-001	KETOROLAC TROMETHAMINE	0.4%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078399-001	KETOROLAC TROMETHAMINE	0.4%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078399-001	KETOROLAC TROMETHAMINE	0.4%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078399-001	KETOROLAC TROMETHAMINE	0.4%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078399-001	KETOROLAC TROMETHAMINE	0.4%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078399-001	KETOROLAC TROMETHAMINE	0.4%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078399-001	KETOROLAC TROMETHAMINE	0.4%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078399-001	KETOROLAC TROMETHAMINE	0.4%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078399-001	KETOROLAC TROMETHAMINE	0.4%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078399-001	KETOROLAC TROMETHAMINE	0.4%	SOLUTION/DROPS / OPHTHALMIC		2009-11-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078399-001	KETOROLAC TROMETHAMINE	0.4%	SOLUTION/DROPS / OPHTHALMIC		2009-11-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078399-001	KETOROLAC TROMETHAMINE	0.4%	SOLUTION/DROPS / OPHTHALMIC		2009-11-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078399-001	KETOROLAC TROMETHAMINE	0.4%	SOLUTION/DROPS / OPHTHALMIC		2009-11-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078399-001	KETOROLAC TROMETHAMINE	0.4%	SOLUTION/DROPS / OPHTHALMIC		2009-11-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078399-001	KETOROLAC TROMETHAMINE	0.4%	SOLUTION/DROPS / OPHTHALMIC		2009-11-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078399-001	KETOROLAC TROMETHAMINE	0.4%	SOLUTION/DROPS / OPHTHALMIC		2009-11-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078399-001	KETOROLAC TROMETHAMINE	0.4%	SOLUTION/DROPS / OPHTHALMIC		2009-11-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078399-001	KETOROLAC TROMETHAMINE	0.4%	SOLUTION/DROPS / OPHTHALMIC		2009-11-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078399-001	KETOROLAC TROMETHAMINE	0.4%	SOLUTION/DROPS / OPHTHALMIC		2009-11-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078399-001	KETOROLAC TROMETHAMINE	0.4%	SOLUTION/DROPS / OPHTHALMIC		2009-11-05	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078399-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078399-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078399-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078399-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078399-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078399-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078399-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078399-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078399-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078399-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078399-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078399-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078399-001	AT	1	`ea99ee380514…`

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
947e29c2-a270-48e0-ba96-c7ed676db871			947e29c2-a270-48e0-ba96-c7ed676db871	2010-09-29	Warnings, Adverse reactions	Exact identifier spl id: 947e29c2-a270-48e0-ba96-c7ed676db871 spl set id: 947e29c2-a270-48e0-ba96-c7ed676db871

Reported adverse events (FAERS/openFDA)#

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