NDC 58697-064

Optimis7

Dextran 70, Polyethylene Glycol 400, Povidone, Tetrahydrozoline Hcl

Optimis7 is a Ophthalmic Liquid in the Human Otc Drug category. It is labeled and distributed by Pacific Health Collaborative, Inc.. The primary component is Tetrahydrozoline Hydrochloride; Dextran 70; Polyethylene Glycol 400; Povidone.

• Product ID: 58697-064_2d80ae24-1f9c-43d2-e054-00144ff88e88
• NDC: 58697-064
• Product Type: Human Otc Drug
• Proprietary Name: Optimis7
• Generic Name: Dextran 70, Polyethylene Glycol 400, Povidone, Tetrahydrozoline Hcl
• Dosage Form: Liquid
• Route of Administration: OPHTHALMIC
• Marketing Start Date: 2011-08-11
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part349
• Labeler Name: Pacific Health Collaborative, Inc.
• Substance Name: TETRAHYDROZOLINE HYDROCHLORIDE; DEXTRAN 70; POLYETHYLENE GLYCOL 400; POVIDONE
• Active Ingredient Strength: 1 mg/mL; mg/mL; mg/mL; mg/mL
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 58697-064-05

1 BOTTLE in 1 BOX (58697-064-05) > 15 mL in 1 BOTTLE

• Marketing Start Date: 2011-08-11
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 58697-064-05 [58697006405]

Optimis7 LIQUID

• Marketing Category: OTC monograph final
• Application Number: part349
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2011-08-11
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
TETRAHYDROZOLINE HYDROCHLORIDE	.5 mg/mL

OpenFDA Data

• SPL SET ID: 2d80ae24-1f9b-43d2-e054-00144ff88e88
• Manufacturer:
  • Pacific Health Collaborative, Inc.
• UNII:
  • 7SA290YK68
  • B697894SGQ
  • 0YZT43HS7D
  • FZ989GH94E
• RxNorm Concept Unique ID - RxCUI:
  • 1741538
  • 996202

NDC Crossover Matching brand name "Optimis7" or generic name "Dextran 70, Polyethylene Glycol 400, Povidone, Tetrahydrozoline Hcl"

NDC	Brand Name	Generic Name
58697-064	Optimis7	dextran 70, polyethylene glycol 400, povidone, tetrahydrozoline HCl
67091-282	Advance Relief Eye Drops	DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCl
41520-532	Advanced relief	dextran 70, polyethylene glycol 400, povidone, tetrahydrozoline HCl
51134-0064	Advanced relief	dextran 70, polyethylene glycol 400, povidone, tetrahydrozoline HCl
67510-0064	Advanced Relief	dextran 70, polyethylene glycol 400, povidone, tetrahydrozoline HCl
33992-8376	ASSURED ADVANCED RELIEF EYE	DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL
55910-361	DG Health Advanced Relief Eye Drops	dextran 70, polyethylene glycol 400, povidone, tetrahydrozoline HCl
55301-177	Exchange Select Eye Drops Advanced Relief Moisturizer	dextran 70, polyethylene glycol 400, povidone, tetrahydrozoline HCl
55315-118	FREDS ADVANCED EYE DROPS	DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL
70000-0456	Leader Advanced Relief Eye Drops	DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCl
55038-002	OPTICAL ADVANCED EYE	DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL
63868-376	Quality Choice Eye Drops Moisturizing Relief	dextran 70, polyethylene glycol 400, povidone, tetrahydrozoline HCl
58988-0018	Redness reliever and Lubricant	dextran 70, polyethylene glycol 400, povidone, tetrahydrozoline HCl
21130-704	Signature Care Eye Drops Advanced Relief	DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCl
81772-005	SK Advanced Relief Eye Drops	dextran 70, polyethylene glycol 400, povidone, tetrahydrozoline HCl
67510-0652	Soundbody Advanced relief	dextran 70, polyethylene glycol 400, povidone, tetrahydrozoline HCl
36800-856	TopCare Health Advanced Moisturizing Plus Redness Relief	dextran 70, polyethylene glycol 400, povidone, tetrahydrozoline HCl