Indications and uses
Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% and 10%, is indicated to dilate the pupil.
PHENYLEPHRINE HYDROCHLORIDE
- Manufacturer
- Leading Pharma, LLC | CAPLIN STERILES LIMITED
- Effective date
- 2024-08-23
- Label type
- HUMAN PRESCRIPTION DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 21:12:06
Label at a glance#
ProductPHENYLEPHRINE HYDROCHLORIDE
Active ingredientPHENYLEPHRINE HYDROCHLORIDE
Label structure15 sections
Dosage and administration
In patients 1 year of age or greater, apply one drop of either phenylephrine hydrochloride ophthalmic solution 2.5% or 10% every 3 to 5 minutes to the conjunctival fornix as required up to a maximum of 3 drops per eye per day. In order to obtain a greater degree of mydriasis, phenylephrine hydrochloride ophthalmic solution 10% may be needed. In pediatric patients less than 1 year of age, one drop of phenylephrine ...
Storage and handling
Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% is supplied as a sterile, aqueous, topical ophthalmic solution in an opaque, white low density polyethylene (LDPE) bottle with a natural LDPE dropper tip and red cap in the following sizes: NDC 69315-323-08 2 mL in 5 mL bottle NDC 69315-323-15 15 mL in 15 mL bottle Phenylephrine Hydrochloride Ophthalmic Solution, USP 10% is sup...
Contacts and useful links#
Websitewww.fda.gov
www.fda.gov/medwatch
www.fda.gov/medwatchLabel contents#
Full prescribing information#
1 INDICATIONS AND USAGE
Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% and 10%, is indicated to dilate the pupil.
2 DOSAGE AND ADMINISTRATION
2.1 General Dosing Recommendations
In patients 1 year of age or greater, apply one drop of either phenylephrine hydrochloride ophthalmic solution 2.5% or 10% every 3 to 5 minutes to the conjunctival fornix as required up to a maximum of 3 drops per eye per day.
In order to obtain a greater degree of mydriasis, phenylephrine hydrochloride ophthalmic solution 10% may be needed.
2.2 Dosing in Pediatric Patients Less Than 1 Year of Age
In pediatric patients less than 1 year of age, one drop of phenylephrine hydrochloride ophthalmic solution 2.5% should be instilled at 3 to 5 minute intervals up to a maximum of 3 drops per eye.
3 DOSAGE FORMS AND STRENGTHS
Phenylephrine hydrochloride ophthalmic solution, USP 2.5% is a clear, colorless to yellow solution, sterile topical ophthalmic solution containing phenylephrine hydrochloride 2.5%: each mL contains 25 mg of phenylephrine hydrochloride.
Phenylephrine hydrochloride ophthalmic solution, USP 10% is a clear, colorless to yellow solution, sterile topical ophthalmic solution containing phenylephrine hydrochloride 10%.: each mL contains 100 mg of phenylephrine hydrochloride.
4 CONTRAINDICATIONS
4.1 Cardiac and Endocrine Disease
Phenylephrine hydrochloride ophthalmic solution 10% is contraindicated in patients with hypertension or thyrotoxicosis. Phenylephrine hydrochloride ophthalmic solution 2.5% should be used in these patients.
4.2 Pediatric Patients Less Than 1 Year of Age
Phenylephrine hydrochloride ophthalmic solution 10% is contraindicated in pediatric patients less than 1 year of age due to the increased risk of systemic toxicity. Phenylephrine hydrochloride ophthalmic solution 2.5% should be used in these patients [SeeDosage and Administration (2.2)].
5 WARNINGS AND PRECAUTIONS
5.1 Topical Ophthalmic Use Only
Phenylephrine hydrochloride ophthalmic solution 2.5% and 10% is not indicated for injection.
5.2 Cardiovascular Reactions
There have been reports of serious cardiovascular reactions, including ventricular arrhythmias and myocardial infarctions, in patients using phenylephrine 10%. These episodes, some fatal, have usually occurred in patients with pre-existing cardiovascular diseases. Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% should be used in these patients.
5.3 Elevation of Blood Pressure
A significant elevation in blood pressure is not common but has been reported following conjunctival instillation of recommended doses of phenylephrine 10%. The risk is less with phenylephrine 2.5%. Caution should be exercised with the use of phenylephrine 10% in pediatric patients less than 5 years of age and patients with hyperthyroidism, or cardiovascular disease. The post-treatment blood pressure of patients with cardiac and endocrine diseases and any patients who develop symptoms should be carefully monitored.
5.4. Rebound Miosis
Rebound miosis has been reported one day after receiving phenylephrine hydrochloride ophthalmic solution, and re-instillation of the drug produced a lesser mydriatic effect.
6 ADVERSE REACTIONS
The following serious adverse reactions are described below and elsewhere in the labeling:
- Cardiovascular Effects [SeeWarnings and Precautions (5.2)]
- Elevation in Blood Pressure [SeeWarnings and Precautions (5.3)]
The following adverse reactions have been identified following use of phenylephrine hydrochloride ophthalmic solution. 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.
6.1 Ocular Adverse Reactions
Eye pain and stinging on instillation, temporary blurred vision and photophobia, and conjunctival sensitization may occur.
6.2 Systemic Adverse Reactions
A marked increase in blood pressure has been reported particularly, but not limited to low weight premature neonates, infants and hypertensive patients.
Cardiovascular effects which have been seen primarily in hypertensive patients following topical ocular use of phenylephrine hydrochloride ophthalmic solution 10% include marked increase in blood pressure, syncope, myocardial infarction, tachycardia, arrhythmia and subarachnoid hemorrhage [SeeWarnings and Precautions (5.2 and 5.3) ].
7 DRUG INTERACTIONS
7.1 Agents That May Exaggerate Pressor Responses
Concomitant use of phenylephrine and atropine may enhance the pressor effects and induce tachycardia in some patients. Phenylephrine may potentiate the cardiovascular depressant effects of some inhalation anesthetic agents.
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Animal reproduction studies have not been conducted with topical phenylephrine. It is also not known whether phenylephrine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Phenylephrine hydrochloride should be given to a pregnant woman only if clearly needed.
8.3 Nursing Mothers
It is not known whether this drug is excreted in human breast milk. Because many drugs are excreted in human milk, caution should be exercised when phenylephrine hydrochloride ophthalmic solution 2.5% and 10% is administered to a nursing woman.
8.4 Pediatric Use
Phenylephrine hydrochloride ophthalmic solution 10% is contraindicated in pediatric patients less than 1 year of age [See Contraindications (4.2)].
8.5 Geriatric Use
No overall differences in safety and effectiveness have been observed between elderly and younger adult patients.
10 OVERDOSAGE
Overdosage of phenylephrine may cause a rapid rise in blood pressure. It may also cause headache, anxiety, nausea, and vomiting, and ventricular arrhythmias. Prompt injection of a rapidly acting alpha-adrenergic blocking agent such as phentolamine has been recommended.
11 DESCRIPTION
Phenylephrine Hydrochloride Ophthalmic Solution, USP is a sterile, clear, colorless, topical α- adrenergic agonist for ophthalmic use. The active ingredient is represented by the chemical structure
Chemical Name: (R)-3-hydroxy-α[(methylamino)methyl]benzenemethanol hydrochloride.
Molecular Formula: C9H13NO2.HCl
Molecular Weight: 203.67 g/mol
Each mL of Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% contains: ACTIVE: Phenylephrine Hydrochloride 25 mg (2.5%); INACTIVES: Sodium Phosphate Dibasic, Sodium Phosphate Monobasic, Water for Injection. Phosphoric Acid and/or Sodium Hydroxide may be added to adjust pH (4.0 to 7.5). The solution has a tonicity of 340 mOsm/kg; PRESERVATIVE: Benzalkonium Chloride 0.1 mg (0.01%).
Each mL of Phenylephrine Hydrochloride Ophthalmic Solution, USP 10% contains: ACTIVE: Phenylephrine Hydrochloride 100 mg (10%); INACTIVES: Sodium Phosphate Dibasic, Sodium Phosphate Monobasic, Water for Injection. Phosphoric Acid and/or Sodium Hydroxide may be added to adjust pH (4.0 to 7.5). The solution has a tonicity of 985 mOsm/kg; PRESERVATIVE: Benzalkonium Chloride 0.1 mg (0.01%).
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Phenylephrine hydrochloride is an α-1 adrenergic agonist drug that is used in ophthalmology mainly for its mydriatic effect. After topical application to the conjunctiva, phenylephrine acts directly on α-adrenergic receptors in the eye, producing contraction of the dilator muscle of the pupil and constriction of the arterioles in the conjunctiva.
12.2 Pharmacodynamics
Maximal mydriasis occurs in 20 to 90 minutes with recovery after 3 to 8 hours.
Systemic absorption of sufficient quantities of phenylephrine may lead to systemic α-adrenergic effects, such as rise in blood pressure which may be accompanied by a reflex atropine-sensitive bradycardia.
12.3 Pharmacokinetics
The systemic exposure following topical administration of phenylephrine hydrochloride ophthalmic solution has not been studied. A higher systemic absorption is expected for the 10% solution than the 2.5% solution and when the corneal barrier function is compromised.
14 CLINICAL STUDIES
Pupillary dilation following topical administration of phenylephrine hydrochloride ophthalmic solution has been demonstrated in controlled clinical studies in adults and pediatric patients with different levels of iris pigmentation. Pupil movement is generally seen within 15 minutes, maximal mydriasis between 20 to 90 minutes and recovery after 3 to 8 hours. Darker irides tend to dilate slower than lighter irides.
16 HOW SUPPLIED/STORAGE AND HANDLING
Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% is supplied as a sterile, aqueous, topical ophthalmic solution in an opaque, white low density polyethylene (LDPE) bottle with a natural LDPE dropper tip and red cap in the following sizes:
NDC 69315-323-08 2 mL in 5 mL bottle
NDC 69315-323-15 15 mL in 15 mL bottle
Phenylephrine Hydrochloride Ophthalmic Solution, USP 10% is supplied as a sterile, aqueous, topical ophthalmic solution in an opaque, white low density polyethylene (LDPE) bottle with a natural LDPE dropper tip and red cap in the following sizes:
NDC 69315-324-05 5 mL in 10 mL bottle
After opening, Phenylephrine Hydrochloride Ophthalmic Solution, USP can be used until the expiration date on the bottle.
Storage: Store at 20° to 25°C (68° to 77°F).
Keep container tightly closed.
Protect from light and excessive heat.
Do not use if solution is brown or contains precipitate.
17 PATIENT COUNSELING INFORMATION
Advise patients not to touch the dropper tip to any surface as this may contaminate the solution.
Inform patients that they may experience sensitivity to light and should protect their eyes in bright illumination while their pupils are dilated.
Manufactured by:
Caplin Steriles Limited,
Gummidipoondi – 601 201,
India.
Distributed by:
Leading Pharma, LLC
Fairfield, NJ 07004,
USA.
Code:TN/Drugs/TN00003457
Revised: 12/2023
22200702
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 69315-323-08
Phenylephrine Hydrochloride
Ophthalmic
Solution, USP
2.5%
For eye use only
2 mL
Rx only
NDC 69315-323-15
Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5%
For eye use only
15 mL
Rx only
NDC 69315-324-05
Phenylephrine Hydrochloride Ophthalmic Solution, USP 10%
For eye use only
5 mL
Rx only
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1234571 | phenylephrine HCl 10 % Ophthalmic Solution | PSN | 1 |
| 1234579 | phenylephrine HCl 2.5 % Ophthalmic Solution | PSN | 1 |
| 1234571 | phenylephrine hydrochloride 100 MG/ML Ophthalmic Solution | SCD | 1 |
| 1234579 | phenylephrine hydrochloride 25 MG/ML Ophthalmic Solution | SCD | 1 |
| 1234571 | phenylephrine hydrochloride 10 % Ophthalmic Solution | SY | 1 |
| 1234579 | phenylephrine hydrochloride 2.5 % Ophthalmic Solution | SY | 1 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| PHENYLEPHRINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e4e263da-1c53-440f-bb80-b7a575843b5a | Product name | 1 | 20260313 |
| d2168cac-a261-415a-9c78-3522859fa720 | Product name | 3 | 20251124 |
| 05a8cdd1-eeb8-409e-b938-0778225eca7d | Product name | 4 | 20250221 |
| e5b5c132-b15d-435b-9faa-2f74e5cadcf9 | Product name | 8 | 20250220 |
| f489e8f3-5c9e-4818-b539-a73587edcfc7 | Product name | 2 | 20240229 |
| 0f7ae452-206d-4fc4-868d-56fc47074084 | Product name | 1 | 20231011 |
| b5abe2e3-39a1-43eb-9bff-f3c1653fe3df | Product name | 2 | 20190930 |
| e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814 | Product name | 3 | 20150910 |
| 42f3c020-f1b3-89bc-7bdc-e1f10e680485 | Product name | 1 | 20140508 |
| e949165d-714d-e548-2b76-0cb5def16f30 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69315-323-08 | PHENYLEPHRINE HYDROCHLORIDE | 1 in 1 CARTON | SOLUTION | 1 | 1 | |
| 69315-323-08 | PHENYLEPHRINE HYDROCHLORIDE | 2 mL in 1 BOTTLE, DROPPER | SOLUTION | 2 | 1 | |
| 69315-323-15 | PHENYLEPHRINE HYDROCHLORIDE | 15 mL in 1 BOTTLE, DROPPER | SOLUTION | 15 | 1 | |
| 69315-323-15 | PHENYLEPHRINE HYDROCHLORIDE | 1 in 1 CARTON | SOLUTION | 1 | 1 | |
| 69315-324-05 | PHENYLEPHRINE HYDROCHLORIDE | 1 in 1 CARTON | SOLUTION | 1 | 1 | |
| 69315-324-05 | PHENYLEPHRINE HYDROCHLORIDE | 5 mL in 1 BOTTLE, DROPPER | SOLUTION | 5 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 69315-323 | PHENYLEPHRINE HYDROCHLORIDE SOLUTION [LEADING PHARMA, LLC] | 1 | Current NDC, 4 package rows | 20240906_7543f7e8-fd5f-46d5-a310-ebae71becf44.zip |
| 69315-324 | PHENYLEPHRINE HYDROCHLORIDE SOLUTION [LEADING PHARMA, LLC] | 1 | Current NDC, 2 package rows | 20240906_7543f7e8-fd5f-46d5-a310-ebae71becf44.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 69315-323-08 | ML - Milliliter | 69315-323 | 53d321c4-050e-472e-a1fc-4d204fac5304 | 1 | 2024-10-04 |
| 69315-323-15 | ML - Milliliter | 69315-323 | 3e23c429-42bd-4a41-a842-cff522259fc7 | 1 | 2024-10-04 |
| 69315-324-05 | ML - Milliliter | 69315-324 | 404c4303-f595-4181-8185-c10caeaeb3d4 | 1 | 2024-10-04 |
Products#
Every source-derived product name is available through these pages.
- PHENYLEPHRINE HYDROCHLORIDE
- SODIUM PHOSPHATE, DIBASIC
- SODIUM PHOSPHATE, MONOBASIC
- WATER
- PHOSPHORIC ACID
- SODIUM HYDROXIDE
- BENZALKONIUM CHLORIDE
- PHENYLEPHRINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 69315-323 | 69315-323-08, 69315-323-15 |
| 69315-324 | 69315-324-05 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A215183-001 | PHENYLEPHRINE HYDROCHLORIDE | PHENYLEPHRINE HYDROCHLORIDE | 2.5% | SOLUTION/DROPS / OPHTHALMIC | AT | 2024-05-23 | |
| A215183-002 | PHENYLEPHRINE HYDROCHLORIDE | PHENYLEPHRINE HYDROCHLORIDE | 10% | SOLUTION/DROPS / OPHTHALMIC | AT | 2024-05-23 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A215183-001 | AT |
| A215183-002 | 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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A215183-001 | PHENYLEPHRINE HYDROCHLORIDE | 2.5% | SOLUTION/DROPS / OPHTHALMIC | AT | 2024-05-23 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A215183-002 | PHENYLEPHRINE HYDROCHLORIDE | 10% | SOLUTION/DROPS / OPHTHALMIC | AT | 2024-05-23 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A215183-001 | PHENYLEPHRINE HYDROCHLORIDE | 2.5% | SOLUTION/DROPS / OPHTHALMIC | AT | 2024-05-23 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A215183-002 | PHENYLEPHRINE HYDROCHLORIDE | 10% | SOLUTION/DROPS / OPHTHALMIC | AT | 2024-05-23 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A215183-001 | PHENYLEPHRINE HYDROCHLORIDE | 2.5% | SOLUTION/DROPS / OPHTHALMIC | AT | 2024-05-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A215183-002 | PHENYLEPHRINE HYDROCHLORIDE | 10% | SOLUTION/DROPS / OPHTHALMIC | AT | 2024-05-23 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215183-001 | PHENYLEPHRINE HYDROCHLORIDE | 2.5% | SOLUTION/DROPS / OPHTHALMIC | AT | 2024-05-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215183-002 | PHENYLEPHRINE HYDROCHLORIDE | 10% | SOLUTION/DROPS / OPHTHALMIC | AT | 2024-05-23 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A215183-001 | PHENYLEPHRINE HYDROCHLORIDE | 2.5% | SOLUTION/DROPS / OPHTHALMIC | AT | 2024-05-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A215183-002 | PHENYLEPHRINE HYDROCHLORIDE | 10% | SOLUTION/DROPS / OPHTHALMIC | AT | 2024-05-23 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A215183-001 | PHENYLEPHRINE HYDROCHLORIDE | 2.5% | SOLUTION/DROPS / OPHTHALMIC | AT | 2024-05-23 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A215183-002 | PHENYLEPHRINE HYDROCHLORIDE | 10% | SOLUTION/DROPS / OPHTHALMIC | AT | 2024-05-23 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A215183-001 | PHENYLEPHRINE HYDROCHLORIDE | 2.5% | SOLUTION/DROPS / OPHTHALMIC | AT | 2024-05-23 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A215183-002 | PHENYLEPHRINE HYDROCHLORIDE | 10% | SOLUTION/DROPS / OPHTHALMIC | AT | 2024-05-23 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A215183-001 | PHENYLEPHRINE HYDROCHLORIDE | 2.5% | SOLUTION/DROPS / OPHTHALMIC | AT | 2024-05-23 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A215183-002 | PHENYLEPHRINE HYDROCHLORIDE | 10% | SOLUTION/DROPS / OPHTHALMIC | AT | 2024-05-23 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A215183-001 | PHENYLEPHRINE HYDROCHLORIDE | 2.5% | SOLUTION/DROPS / OPHTHALMIC | AT | 2024-05-23 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A215183-002 | PHENYLEPHRINE HYDROCHLORIDE | 10% | SOLUTION/DROPS / OPHTHALMIC | AT | 2024-05-23 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A215183-001 | PHENYLEPHRINE HYDROCHLORIDE | 2.5% | SOLUTION/DROPS / OPHTHALMIC | AT | 2024-05-23 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A215183-002 | PHENYLEPHRINE HYDROCHLORIDE | 10% | SOLUTION/DROPS / OPHTHALMIC | AT | 2024-05-23 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A215183-001 | PHENYLEPHRINE HYDROCHLORIDE | 2.5% | SOLUTION/DROPS / OPHTHALMIC | AT | 2024-05-23 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A215183-002 | PHENYLEPHRINE HYDROCHLORIDE | 10% | SOLUTION/DROPS / OPHTHALMIC | AT | 2024-05-23 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A215183-001 | PHENYLEPHRINE HYDROCHLORIDE | 2.5% | SOLUTION/DROPS / OPHTHALMIC | AT | 2024-05-23 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A215183-002 | PHENYLEPHRINE HYDROCHLORIDE | 10% | SOLUTION/DROPS / OPHTHALMIC | AT | 2024-05-23 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A215183-001 | PHENYLEPHRINE HYDROCHLORIDE | 2.5% | SOLUTION/DROPS / OPHTHALMIC | AT | 2024-05-23 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A215183-002 | PHENYLEPHRINE HYDROCHLORIDE | 10% | SOLUTION/DROPS / OPHTHALMIC | AT | 2024-05-23 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A215183-001 | PHENYLEPHRINE HYDROCHLORIDE | 2.5% | SOLUTION/DROPS / OPHTHALMIC | AT | 2024-05-23 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A215183-002 | PHENYLEPHRINE HYDROCHLORIDE | 10% | SOLUTION/DROPS / OPHTHALMIC | AT | 2024-05-23 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A215183-001 | PHENYLEPHRINE HYDROCHLORIDE | 2.5% | SOLUTION/DROPS / OPHTHALMIC | AT | 2024-05-23 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A215183-002 | PHENYLEPHRINE HYDROCHLORIDE | 10% | SOLUTION/DROPS / OPHTHALMIC | AT | 2024-05-23 | 1e350fbaab3a… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A215183-001 | PHENYLEPHRINE HYDROCHLORIDE | 2.5% | SOLUTION/DROPS / OPHTHALMIC | AT | 2024-05-23 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A215183-002 | PHENYLEPHRINE HYDROCHLORIDE | 10% | SOLUTION/DROPS / OPHTHALMIC | AT | 2024-05-23 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A215183-001 | AT | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A215183-002 | AT | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A215183-001 | AT | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A215183-002 | AT | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A215183-001 | AT | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A215183-002 | AT | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215183-001 | AT | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215183-002 | AT | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A215183-001 | AT | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A215183-002 | AT | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A215183-001 | AT | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A215183-002 | AT | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A215183-001 | AT | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A215183-002 | AT | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A215183-001 | AT | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A215183-002 | AT | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A215183-001 | AT | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A215183-002 | AT | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A215183-001 | AT | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A215183-002 | AT | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A215183-001 | AT | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A215183-002 | AT | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A215183-001 | AT | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A215183-002 | AT | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A215183-001 | AT | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A215183-002 | AT | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A215183-001 | AT | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A215183-002 | AT | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A215183-001 | AT | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A215183-002 | AT | 1 | 1e350fbaab3a… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A215183-001 | AT | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A215183-002 | AT | 1 | a50c72e98297… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| PHENYLEPHRINE HYDROCHLORIDE | PHENYLEPHRINE HYDROCHLORIDE | Leading Pharma, LLC | 7543f7e8-fd5f-46d5-a310-ebae71becf44 | 2024-08-23 | Warnings, Adverse reactions | 69315-323-08 69315-323-15 69315-324-05 69315-323 69315-324 69315032315 69315032405 69315032308 a73191de-c6e0-455f-8e26-f90a529cac56 7543f7e8-fd5f-46d5-a310-ebae71becf44 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.