NDC 54799-904

Tears Again

Benzalkonium Chloride, Sodium Phosphate, Dibasic, Edetate Disodium,sodium Phosphate, Monobasic, Sodium Chloride, Water, Phosphoric Acid, Sodium Hydroxide

Tears Again is a Intraocular Solution in the Human Otc Drug category. It is labeled and distributed by Ocusoft, Inc.. The primary component is Polyvinyl Alcohol, Unspecified.

• Product ID: 54799-904_4e25be00-7f71-4e7d-bf29-5ddb4c8a5471
• NDC: 54799-904
• Product Type: Human Otc Drug
• Proprietary Name: Tears Again
• Generic Name: Benzalkonium Chloride, Sodium Phosphate, Dibasic, Edetate Disodium,sodium Phosphate, Monobasic, Sodium Chloride, Water, Phosphoric Acid, Sodium Hydroxide
• Dosage Form: Solution
• Route of Administration: INTRAOCULAR
• Marketing Start Date: 2010-08-01
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part349
• Labeler Name: OCuSOFT, Inc.
• Substance Name: POLYVINYL ALCOHOL, UNSPECIFIED
• Active Ingredient Strength: 14 mg/mL
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 54799-904-15

1 BOTTLE, DROPPER in 1 CARTON (54799-904-15) > 15 mL in 1 BOTTLE, DROPPER

• Marketing Start Date: 2010-08-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 54799-904-15 [54799090415]

Tears Again SOLUTION

• Marketing Category: OTC monograph final
• Application Number: part349
• Product Type: HUMAN OTC DRUG
• Billing Unit: ML
• Marketing Start Date: 2010-08-01

NDC 54799-904-30 [54799090430]

Tears Again SOLUTION

• Marketing Category: OTC monograph final
• Application Number: part349
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2018-08-01

Drug Details

Active Ingredients

Ingredient	Strength
POLYVINYL ALCOHOL, UNSPECIFIED	14 mg/mL

OpenFDA Data

• SPL SET ID: eac4e03d-93c4-49ae-bcf7-32f1a6e59b4c
• Manufacturer:
  • OCuSOFT, Inc.
• UNII:
  • 532B59J990

NDC Crossover Matching brand name "Tears Again" or generic name "Benzalkonium Chloride, Sodium Phosphate, Dibasic, Edetate Disodium,sodium Phosphate, Monobasic, Sodium Chloride, Water, Phosphoric Acid, Sodium Hydroxide"

NDC	Brand Name	Generic Name
54799-904	Tears Again	Benzalkonium Chloride, Sodium Phosphate, Dibasic, Edetate Disodium,Sodium Phosphate, Monobasic, Sodium Chloride, Water, Phosphoric Acid, Sodium Hydroxide
54799-906	Tears Again	Mineral oil, White petrolatum