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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020485
Company: KENVUE BRANDS

Products on NDA 020485

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VISINE	NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE	0.025%;0.3%	SOLUTION/DROPS;OPHTHALMIC	Over-the-counter	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020485

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/31/1996	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/22/2025	SUPPL-21	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020485Orig1s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/020485Orig1s021ltr.pdf
10/17/2018	SUPPL-13	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020485Orig1s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020485Orig1s013ltr.pdf
01/06/2017	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
08/26/2016	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020485Orig1s011lbl.pdf
03/10/2016	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
12/18/2012	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020485Orig1s009Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020485Orig1s009ltr.pdf
10/15/2004	SUPPL-7	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20485s007ltr.pdf
09/15/2003	SUPPL-6	Manufacturing (CMC)	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20485scm006_visine_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20485scm006ltr.pdf
06/14/2002	SUPPL-5	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20485s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20485s005ltr.pdf
03/11/1999	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.
11/19/1998	SUPPL-3	Labeling		Label is not available on this site.
09/26/1996	SUPPL-2	Labeling		Label is not available on this site.
12/26/1996	SUPPL-1	Manufacturing (CMC)-Packaging		Label is not available on this site.

Labels for NDA 020485

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/22/2025	SUPPL-21	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020485Orig1s021lbl.pdf
10/17/2018	SUPPL-13	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020485Orig1s013lbl.pdf
08/26/2016	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020485Orig1s011lbl.pdf
12/18/2012	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020485Orig1s009Lbl.pdf
09/15/2003	SUPPL-6	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20485scm006_visine_lbl.pdf
06/14/2002	SUPPL-5	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20485s005lbl.pdf

Other OTC Drugs with the Same Active Ingredient, Strength and Dosage Form/Route

VISINE

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

SOLUTION/DROPS;OPHTHALMIC; 0.025%;0.3%

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE	NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE	0.025%;0.3%	SOLUTION/DROPS;OPHTHALMIC	Over-the-counter	No	202795	RISING
NAPHCON-A	NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE	0.025%;0.3%	SOLUTION/DROPS;OPHTHALMIC	Over-the-counter	Yes	020226	ALCON
VISINE	NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE	0.025%;0.3%	SOLUTION/DROPS;OPHTHALMIC	Over-the-counter	Yes	020485	KENVUE BRANDS

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