NDC 0065-0348-25 - Profenal

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 0065-0348
Requested NDC: 0065-0348-25
Package NDCs from labels: 0065-0348-25
Manufacturer: Alcon Laboratories, Inc.
Effective date: 2006-02-23
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Profenal® 1% (Suprofen) Sterile Ophthalmic Solution	Alcon Laboratories, Inc.	2006-02-23	Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0065-0348-25	Profenal	2.5 mL in 1 BOTTLE, PLASTIC	SOLUTION	2.5		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0065-0348	PROFENAL (SUPROFEN) SOLUTION [ALCON LABORATORIES, INC.]	1	1 package rows	20080313_8de2c303-5d99-46b6-ad6d-a4caadea3604.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
suprofen	ACTIVE INGREDIENT	988GU2F9PE	PROFENAL (SUPROFEN) SOLUTION [ALCON LABORATORIES, INC.]	1
suprofen	ACTIVE MOIETY	988GU2F9PE	PROFENAL (SUPROFEN) SOLUTION [ALCON LABORATORIES, INC.]	1
caffeine	INACTIVE INGREDIENT	3G6A5W338E	PROFENAL (SUPROFEN) SOLUTION [ALCON LABORATORIES, INC.]	1
dibasic sodium phosphate	INACTIVE INGREDIENT	GR686LBA74	PROFENAL (SUPROFEN) SOLUTION [ALCON LABORATORIES, INC.]	1
edetate disodium	INACTIVE INGREDIENT	7FLD91C86K	PROFENAL (SUPROFEN) SOLUTION [ALCON LABORATORIES, INC.]	1
monobasic sodium phosphate	INACTIVE INGREDIENT	3980JIH2SW	PROFENAL (SUPROFEN) SOLUTION [ALCON LABORATORIES, INC.]	1
sodium chloride	INACTIVE INGREDIENT	451W47IQ8X	PROFENAL (SUPROFEN) SOLUTION [ALCON LABORATORIES, INC.]	1
sodium hydroxide and/or hydrochloric acid	INACTIVE INGREDIENT		PROFENAL (SUPROFEN) SOLUTION [ALCON LABORATORIES, INC.]	1
thimerosal	INACTIVE INGREDIENT	2225PI3MOV	PROFENAL (SUPROFEN) SOLUTION [ALCON LABORATORIES, INC.]	1
water	INACTIVE INGREDIENT	059QF0KO0R	PROFENAL (SUPROFEN) SOLUTION [ALCON LABORATORIES, INC.]	1

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
DC62EB0C-44CF-DE50-5E26-872A270D0F6D			8de2c303-5d99-46b6-ad6d-a4caadea3604	2006-02-23	Warnings, Adverse reactions	Exact identifier spl id: DC62EB0C-44CF-DE50-5E26-872A270D0F6D spl set id: 8de2c303-5d99-46b6-ad6d-a4caadea3604

Reported adverse events (FAERS/openFDA)#

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