Tropicamide Ophthalmic Solution, USP

Manufacturer: Akorn
Effective date: 2022-07-01
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 8
Source: full-release
Hydrated at: 2026-05-31 20:42:13

Label at a glance#

ProductTropicamide

Active ingredientTropicamide

Label structure14 sections

Indications and uses

For mydriasis and cycloplegia for diagnostic procedures.

Dosage and administration

For refraction, instill one or two drops of 1% solution in the eye(s), repeated in five minutes. If patient is not seen within 20 to 30 minutes, an additional drop may be instilled to prolong mydriatic effect. For examination of fundus, instill one or two drops of 0.5% solution 15 to 20 minutes prior to examination. Individuals with heavily pigmented irides may require higher strength or more doses. Mydriasis will...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Rx only

DESCRIPTION:

DESCRIPTION SECTION

Tropicamide Ophthalmic Solution, USP is an anticholinergic prepared as a sterile topical ophthalmic solution in two strengths. The active ingredient is represented by the structural formula:

C₁₇H₂₀N₂O₂ MW=284.36

Established name: Tropicamide

Chemical name: Benzeneacetamide, N-ethyl-α-(hydroxymethyl)-N-(4-pyridinylmethyl)-.

Each mL contains: Active: Tropicamide 0.5% (5 mg) or 1% (10 mg). Inactives: Edetate Disodium, Sodium Chloride, Hydrochloric Acid and/or Sodium Hydroxide (to adjust pH), Water for Injection. pH range 4.0 to 5.8. Preservative: Benzalkonium Chloride 0.01%.

CLINICAL PHARMACOLOGY:

CLINICAL PHARMACOLOGY SECTION

This anticholinergic preparation blocks the responses of the sphincter muscle of the iris and the ciliary muscle to cholinergic stimulation, dilating the pupil (mydriasis). The stronger preparation (1%) also paralyzes accommodation. This preparation acts in 15-30 minutes and the duration of activity is approximately 3-8 hours. Complete recovery from mydriasis in some individuals may require 24 hours. The weaker strength may be useful in producing mydriasis with only slight cycloplegia. Heavily pigmented irides may require more doses than lightly pigmented irides.

INDICATIONS AND USAGE:

INDICATIONS & USAGE SECTION

For mydriasis and cycloplegia for diagnostic procedures.

CONTRAINDICATIONS:

CONTRAINDICATIONS SECTION

Contraindicated in persons showing hypersensitivity to any component of this preparation.

WARNINGS:

WARNINGS SECTION

For topical use only — not for injection.

This preparation may cause CNS disturbances which may be dangerous in pediatric patients. The possibility of psychotic reactions and behavioral disturbances due to hypersensitivity to anticholinergic drugs should be considered.

Mydriatics may produce a transient elevation of intraocular pressure.

Remove contact lenses before using.

PRECAUTIONS:

PRECAUTIONS SECTION

GENERAL PRECAUTIONS SECTION

General: The lacrimal sac should be compressed by digital pressure for two to three minutes after instillation to avoid excessive systemic absorption.

INFORMATION FOR PATIENTS SECTION

Information for Patients: Do not touch dropper tip to any surface, as this may contaminate the solution. Patient should be advised not to drive or engage in potentially hazardous activities while pupils are dilated. Patient may experience sensitivity to light and should protect eyes in bright illumination during dilation. Parents should be warned not to get this preparation in their child's mouth and to wash their own hands and the child's hands following administration.

DRUG INTERACTIONS SECTION

Drug Interactions: Tropicamide may interfere with the antihypertensive action of carbachol, pilocarpine, or ophthalmic cholinesterase inhibitors.

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION

Carcinogenesis, Mutagenesis, Impairment of Fertility: There have been no long-term studies done using tropicamide in animals to evaluate carcinogenic potential.

PREGNANCY SECTION

Pregnancy: Pregnancy Category C. Animal reproduction studies have not been conducted with tropicamide. It is also not known whether tropicamide can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Tropicamide should be given to a pregnant woman only if clearly needed.

NURSING MOTHERS SECTION

Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when tropicamide is administered to a nursing woman.

PEDIATRIC USE SECTION

Pediatric Use: Tropicamide may rarely cause CNS disturbances which may be dangerous in pediatric patients. Psychotic reactions, behavioral disturbances, and vasomotor or cardiorespiratory collapse in children have been reported with the use of anticholinergic drugs (See WARNINGS). Keep this and all medications out of the reach of children.

ADVERSE REACTIONS:

ADVERSE REACTIONS SECTION

SPL UNCLASSIFIED SECTION

Ocular: Transient stinging, blurred vision, photophobia and superficial punctate keratitis have been reported with the use of tropicamide. Increased intraocular pressure has been reported following the use of mydri-atics.

SPL UNCLASSIFIED SECTION

Non-Ocular: Dryness of the mouth, tachycardia, headache, allergic reactions, nausea, vomiting, pallor, central nervous system disturbances and muscle rigidity have been reported with the use of tropicamide. Psychotic reactions, behavioral disturbances, and vasomotor or cardiorespiratory collapse in children have been reported with the use of anticholinergic drugs.

DOSAGE AND ADMINISTRATION:

DOSAGE & ADMINISTRATION SECTION

HOW SUPPLIED:

HOW SUPPLIED SECTION

Tropicamide Ophthalmic Solution USP, 0.5% and 1% are supplied as sterile solutions in plastic dropper bottles.

0.5% NDC 17478-101-12 (15 mL)
1% NDC 17478-102-12 (15 mL)
1% NDC 17478-102-20 (2 mL)

STORAGE AND HANDLING SECTION

STORAGE: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Do not refrigerate or store at high temperatures. Keep container tightly closed.

Akorn

Distributed by:
Akorn Operating Company LLC
Gurnee, IL 60031
TC00N Rev. 03/22

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Container Label:

NDC 17478-101-12

Tropicamide

Ophthalmic

Solution, USP

0.5%

Sterile

15 mL

Rx only

For Topical Ophthalmic Use Only

Principal Display Panel Text for Container Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Carton Label:

NDC 17478-101-12

Tropicamide

Ophthalmic

Solution, USP

0.5%

For Topical Ophthalmic

Use only.

Sterile

15 mL

Rx only [Akorn logo]

Principal Display Panel Text for Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Container Label:

NDC 17478-102-12

Tropicamide

Ophthalmic

Solution, USP

Sterile

15 mL

Rx only

For Topical Ophthalmic Use Only

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Carton Label:

NDC 17478-102-12

Tropicamide

Ophthalmic

Solution, USP

For Topical Ophthalmic

Use only.

Sterile

15 mL

Rx only [Akorn logo]

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
313521	tropicamide 0.5 % Ophthalmic Solution	PSN	8
314238	tropicamide 1 % Ophthalmic Solution	PSN	8
314238	tropicamide 10 MG/ML Ophthalmic Solution	SCD	8
313521	tropicamide 5 MG/ML Ophthalmic Solution	SCD	8
313521	tropicamide 0.5 % Ophthalmic Solution	SY	8
314238	tropicamide 1 % Ophthalmic Solution	SY	8

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0f7ae452-206d-4fc4-868d-56fc47074084	Product name	1	20231011
6e36a95f-fcff-e2d1-3f9b-17d0b7f9e28c	Product name	2	20200603
41722ce4-2429-80d8-5977-d735f8eca6d6	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
17478-101-12	2024-01-30	C162847	48780-1	1030e365-5cef-111a-e063-dadaa90a10e2	Tropicamide Ophthalmic Solution, USP
17478-102-12	2024-01-30	C162847	48780-1	1030e365-5cef-111a-e063-dadaa90a10e2	Tropicamide Ophthalmic Solution, USP
17478-102-20	2024-01-30	C162847	48780-1	1030e365-5cef-111a-e063-dadaa90a10e2	Tropicamide Ophthalmic Solution, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
17478-101-12	Tropicamide	1 in 1 CARTON	SOLUTION/ DROPS	1	8
17478-101-12	Tropicamide	15 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	15	8
17478-102-12	Tropicamide	1 in 1 CARTON	SOLUTION/ DROPS	1	8
17478-102-12	Tropicamide	15 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	15	8
17478-102-20	Tropicamide	1 in 1 CARTON	SOLUTION/ DROPS	1	8
17478-102-20	Tropicamide	2 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	2	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
17478-101	TROPICAMIDE SOLUTION/ DROPS [AKORN]	8	Legacy NDC, 2 package rows	20220706_329a3382-3718-4311-890f-97c6b7e0077c.zip
17478-102	TROPICAMIDE SOLUTION/ DROPS [AKORN]	8	Legacy NDC, 4 package rows	20220706_329a3382-3718-4311-890f-97c6b7e0077c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
17478-102-12	ML - Milliliter	17478-102	a40716e4-abb9-40f2-9f35-a8165d94b395	1	2012-07-24
17478-101-12	ML - Milliliter	17478-101	ea016d61-973f-447f-9aea-5c6074d56b62	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Tropicamide	ACTIVE INGREDIENT	N0A3Z5XTC6	2
Tropicamide	ACTIVE MOIETY	N0A3Z5XTC6	2
benzalkonium chloride	INACTIVE INGREDIENT	F5UM2KM3W7	2
edetate disodium	INACTIVE INGREDIENT	7FLD91C86K	2
hydrochloric acid	INACTIVE INGREDIENT	QTT17582CB	2
sodium chloride	INACTIVE INGREDIENT	451W47IQ8X	2
sodium hydroxide	INACTIVE INGREDIENT	55X04QC32I	2
water	INACTIVE INGREDIENT	059QF0KO0R	2

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

Tropicamide
benzalkonium chloride
edetate disodium
sodium chloride
sodium hydroxide
hydrochloric acid
water

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
17478-102	17478-102-12, 17478-102-20
17478-101	17478-101-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Tropicamide	N0A3Z5XTC6	ACTIB
benzalkonium chloride	F5UM2KM3W7	IACT
edetate disodium	7FLD91C86K	IACT
sodium chloride	451W47IQ8X	IACT
sodium hydroxide	55X04QC32I	IACT
hydrochloric acid	QTT17582CB	IACT
water	059QF0KO0R	IACT
Tropicamide	N0A3Z5XTC6	ACTIB
benzalkonium chloride	F5UM2KM3W7	IACT
edetate disodium	7FLD91C86K	IACT
sodium chloride	451W47IQ8X	IACT
sodium hydroxide	55X04QC32I	IACT
hydrochloric acid	QTT17582CB	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 · 557 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 / INTRA-ARTICULAR	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
hydrochloric acid	HYDROCHLORIC ACID	QTT17582CB	EMULSION / OPHTHALMIC	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
hydrochloric acid	HYDROCHLORIC ACID	QTT17582CB	INJECTION, POWDER, FOR SOLUTION / INTRA-ARTERIAL	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	POWDER, FOR SUSPENSION / ORAL		285 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	SOLUTION / NASAL	100 mg/100ml		Exact identifier — unii candidate 77 equally ranked IID candidates
hydrochloric acid	HYDROCHLORIC ACID	QTT17582CB	INJECTION / SUBMUCOSAL	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRALESIONAL	0.9 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRA-ARTICULAR		26 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
hydrochloric acid	HYDROCHLORIC ACID	QTT17582CB	INJECTION / INTRADERMAL	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, POWDER, FOR SOLUTION / INTRADISCAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
hydrochloric acid	HYDROCHLORIC ACID	QTT17582CB	INJECTION, POWDER, FOR SOLUTION / INTRATUMOR	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
benzalkonium chloride	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SUSPENSION/ DROPS / OPHTHALMIC	0.02 %w/v		Exact identifier — unii candidate 24 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION / INTRATYMPANIC		2 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
benzalkonium chloride	BENZALKONIUM CHLORIDE	F5UM2KM3W7	CLOTH / TOPICAL	NA		Exact identifier — unii candidate 24 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	SUSPENSION / ENDOTRACHEAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	CREAM / TOPICAL	0.4 %w/w		Exact identifier — unii candidate 134 equally ranked IID candidates
hydrochloric acid	HYDROCHLORIC ACID	QTT17582CB	SOLUTION / SUBCUTANEOUS	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
hydrochloric acid	HYDROCHLORIC ACID	QTT17582CB	INJECTION / INTRALESIONAL	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
hydrochloric acid	HYDROCHLORIC ACID	QTT17582CB	INJECTION / SOFT TISSUE	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
hydrochloric acid	HYDROCHLORIC ACID	QTT17582CB	POWDER, FOR SUSPENSION / ORAL		125 mg	Exact identifier — unii candidate 148 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	SUSPENSION / AURICULAR (OTIC)	0.01 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		27 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS		19 mg	Exact identifier — unii candidate 77 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	INJECTION / SOFT TISSUE	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	SOLUTION / RESPIRATORY (INHALATION)		43 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SUSPENSION, LIPOSOMAL / INTRAVENOUS	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
hydrochloric acid	HYDROCHLORIC ACID	QTT17582CB	SOLUTION / DENTAL	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	POWDER, DENTIFRICE / DENTAL	0.03 mg/mg		Exact identifier — unii candidate 134 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SOLUTION / INTRA-ARTICULAR	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
hydrochloric acid	HYDROCHLORIC ACID	QTT17582CB	JELLY / TOPICAL	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	GEL / VAGINAL		5 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
hydrochloric acid	HYDROCHLORIC ACID	QTT17582CB	INJECTION / INTRA-ARTERIAL		840 mg	Exact identifier — unii candidate 148 equally ranked IID candidates
hydrochloric acid	HYDROCHLORIC ACID	QTT17582CB	INJECTION, EMULSION / SUBCUTANEOUS	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	DROPS / NASAL	0.1 mg/1ml		Exact identifier — unii candidate 77 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRABURSAL	0.01 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
hydrochloric acid	HYDROCHLORIC ACID	QTT17582CB	EMULSION / TOPICAL	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	TABLET, COATED / ORAL	54.7 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
benzalkonium chloride	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SHAMPOO / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	DROPS / OPHTHALMIC	0.05 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVITARY	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SUSPENSION / INTRAVITREAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	NA		Exact identifier — unii candidate 174 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	ELIXIR / ORAL	1.3 mg/5ml		Exact identifier — unii candidate 77 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	SOLUTION/ DROPS / OPHTHALMIC		55 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / INTRAVENOUS		90 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SUSPENSION / INTRAMUSCULAR		26 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
hydrochloric acid	HYDROCHLORIC ACID	QTT17582CB	INJECTION / INTRACARDIAC	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	POWDER, FOR SUSPENSION / ENDOTRACHEAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SUSPENSION / SUBCUTANEOUS	0.8 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	SPRAY / NASAL		30 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / RECTAL	NA		Exact identifier — unii candidate 174 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	SOLUTION/ DROPS / OPHTHALMIC	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	DROPS / ORAL	NA		Exact identifier — unii candidate 134 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	GEL / TOPICAL		70 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
hydrochloric acid	HYDROCHLORIC ACID	QTT17582CB	SOLUTION / URETERAL	ADJ PH		Exact identifier — unii candidate 148 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 · 2 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
A040314-001	TROPICACYL	TROPICAMIDE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT		2000-09-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A040314-001	AT

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	A040314-001	TROPICACYL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2000-09-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040314-001	TROPICACYL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2000-09-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040314-001	TROPICACYL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2000-09-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040314-001	TROPICACYL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2000-09-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040314-001	TROPICACYL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2000-09-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040314-001	TROPICACYL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2000-09-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040314-001	TROPICACYL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2000-09-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040314-001	TROPICACYL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2000-09-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040314-001	TROPICACYL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2000-09-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040314-001	TROPICACYL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2000-09-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040314-001	TROPICACYL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2000-09-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040314-001	TROPICACYL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2000-09-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040314-001	TROPICACYL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2000-09-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040314-001	TROPICACYL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2000-09-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040314-001	TROPICACYL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2000-09-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040314-001	TROPICACYL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2000-09-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040314-001	TROPICACYL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2000-09-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040314-001	TROPICACYL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2000-09-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040314-001	TROPICACYL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2000-09-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040314-001	TROPICACYL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2000-09-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040314-001	TROPICACYL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2000-09-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040314-001	TROPICACYL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2000-09-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040314-001	TROPICACYL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2000-09-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040314-001	TROPICACYL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2000-09-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040314-001	TROPICACYL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2000-09-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040314-001	TROPICACYL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2000-09-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040314-001	TROPICACYL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2000-09-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040314-001	TROPICACYL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2000-09-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040314-001	TROPICACYL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2000-09-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040314-001	TROPICACYL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2000-09-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040314-001	TROPICACYL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2000-09-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040314-001	TROPICACYL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2000-09-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040314-001	TROPICACYL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2000-09-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040314-001	TROPICACYL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2000-09-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040314-001	TROPICACYL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2000-09-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040314-001	TROPICACYL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2000-09-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040314-001	TROPICACYL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2000-09-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040314-001	TROPICACYL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2000-09-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040314-001	TROPICACYL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2000-09-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040314-001	TROPICACYL	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2000-09-29	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A040314-001	AT	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040314-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040314-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040314-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040314-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040314-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040314-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040314-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040314-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040314-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040314-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040314-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040314-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040314-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040314-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040314-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040314-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040314-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040314-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040314-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040314-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040314-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040314-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040314-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040314-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040314-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040314-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040314-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040314-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040314-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040314-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040314-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040314-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040314-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040314-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040314-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040314-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040314-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040314-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040314-001	AT	1	`f41ea6bd6efb…`

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
A040315-001	TROPICACYL	TROPICAMIDE	1%	SOLUTION/DROPS / OPHTHALMIC	AT		2000-09-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A040315-001	AT

Observed Orange Book product history#

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	A040315-001	TROPICACYL	1%	SOLUTION/DROPS / OPHTHALMIC	AT	2000-09-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040315-001	TROPICACYL	1%	SOLUTION/DROPS / OPHTHALMIC	AT	2000-09-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040315-001	TROPICACYL	1%	SOLUTION/DROPS / OPHTHALMIC	AT	2000-09-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040315-001	TROPICACYL	1%	SOLUTION/DROPS / OPHTHALMIC	AT	2000-09-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040315-001	TROPICACYL	1%	SOLUTION/DROPS / OPHTHALMIC	AT	2000-09-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040315-001	TROPICACYL	1%	SOLUTION/DROPS / OPHTHALMIC	AT	2000-09-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040315-001	TROPICACYL	1%	SOLUTION/DROPS / OPHTHALMIC	AT	2000-09-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040315-001	TROPICACYL	1%	SOLUTION/DROPS / OPHTHALMIC	AT	2000-09-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040315-001	TROPICACYL	1%	SOLUTION/DROPS / OPHTHALMIC	AT	2000-09-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040315-001	TROPICACYL	1%	SOLUTION/DROPS / OPHTHALMIC	AT	2000-09-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040315-001	TROPICACYL	1%	SOLUTION/DROPS / OPHTHALMIC	AT	2000-09-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040315-001	TROPICACYL	1%	SOLUTION/DROPS / OPHTHALMIC	AT	2000-09-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040315-001	TROPICACYL	1%	SOLUTION/DROPS / OPHTHALMIC	AT	2000-09-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040315-001	TROPICACYL	1%	SOLUTION/DROPS / OPHTHALMIC	AT	2000-09-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040315-001	TROPICACYL	1%	SOLUTION/DROPS / OPHTHALMIC	AT	2000-09-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040315-001	TROPICACYL	1%	SOLUTION/DROPS / OPHTHALMIC	AT	2000-09-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040315-001	TROPICACYL	1%	SOLUTION/DROPS / OPHTHALMIC	AT	2000-09-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040315-001	TROPICACYL	1%	SOLUTION/DROPS / OPHTHALMIC	AT	2000-09-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040315-001	TROPICACYL	1%	SOLUTION/DROPS / OPHTHALMIC	AT	2000-09-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040315-001	TROPICACYL	1%	SOLUTION/DROPS / OPHTHALMIC	AT	2000-09-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040315-001	TROPICACYL	1%	SOLUTION/DROPS / OPHTHALMIC	AT	2000-09-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040315-001	TROPICACYL	1%	SOLUTION/DROPS / OPHTHALMIC	AT	2000-09-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040315-001	TROPICACYL	1%	SOLUTION/DROPS / OPHTHALMIC	AT	2000-09-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040315-001	TROPICACYL	1%	SOLUTION/DROPS / OPHTHALMIC	AT	2000-09-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040315-001	TROPICACYL	1%	SOLUTION/DROPS / OPHTHALMIC	AT	2000-09-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040315-001	TROPICACYL	1%	SOLUTION/DROPS / OPHTHALMIC	AT	2000-09-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040315-001	TROPICACYL	1%	SOLUTION/DROPS / OPHTHALMIC	AT	2000-09-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040315-001	TROPICACYL	1%	SOLUTION/DROPS / OPHTHALMIC	AT	2000-09-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040315-001	TROPICACYL	1%	SOLUTION/DROPS / OPHTHALMIC	AT	2000-09-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040315-001	TROPICACYL	1%	SOLUTION/DROPS / OPHTHALMIC	AT	2000-09-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040315-001	TROPICACYL	1%	SOLUTION/DROPS / OPHTHALMIC	AT	2000-09-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040315-001	TROPICACYL	1%	SOLUTION/DROPS / OPHTHALMIC	AT	2000-09-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040315-001	TROPICACYL	1%	SOLUTION/DROPS / OPHTHALMIC	AT	2000-09-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040315-001	TROPICACYL	1%	SOLUTION/DROPS / OPHTHALMIC	AT	2000-09-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040315-001	TROPICACYL	1%	SOLUTION/DROPS / OPHTHALMIC	AT	2000-09-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040315-001	TROPICACYL	1%	SOLUTION/DROPS / OPHTHALMIC	AT	2000-09-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040315-001	TROPICACYL	1%	SOLUTION/DROPS / OPHTHALMIC	AT	2000-09-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040315-001	TROPICACYL	1%	SOLUTION/DROPS / OPHTHALMIC	AT	2000-09-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040315-001	TROPICACYL	1%	SOLUTION/DROPS / OPHTHALMIC	AT	2000-09-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040315-001	TROPICACYL	1%	SOLUTION/DROPS / OPHTHALMIC	AT	2000-09-29	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A040315-001	AT	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040315-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040315-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040315-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040315-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040315-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040315-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040315-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040315-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040315-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040315-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040315-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040315-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040315-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040315-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040315-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040315-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040315-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040315-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040315-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040315-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040315-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040315-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040315-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040315-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040315-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040315-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040315-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040315-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040315-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040315-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040315-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040315-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040315-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040315-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040315-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040315-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040315-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040315-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040315-001	AT	1	`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
b8946687-fd16-4405-8320-85fdb1f8d68b			329a3382-3718-4311-890f-97c6b7e0077c	2022-07-01	Warnings, Adverse reactions	Exact identifier spl id: b8946687-fd16-4405-8320-85fdb1f8d68b spl set id: 329a3382-3718-4311-890f-97c6b7e0077c

Reported adverse events (FAERS/openFDA)#

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