NDC 10742-8142

Rohto Cool

Naphazoline Hydrochloride, Polysorbate 80

Rohto Cool is a Ophthalmic Liquid in the Human Otc Drug category. It is labeled and distributed by The Mentholatum Company. The primary component is Naphazoline Hydrochloride; Polysorbate 80.

• Product ID: 10742-8142_177c76f0-90d8-4ac1-aee1-b4f181e8df3d
• NDC: 10742-8142
• Product Type: Human Otc Drug
• Proprietary Name: Rohto Cool
• Generic Name: Naphazoline Hydrochloride, Polysorbate 80
• Dosage Form: Liquid
• Route of Administration: OPHTHALMIC
• Marketing Start Date: 2001-08-21
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part349
• Labeler Name: The Mentholatum Company
• Substance Name: NAPHAZOLINE HYDROCHLORIDE; POLYSORBATE 80
• Active Ingredient Strength: 0 mg/mL; mg/mL
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 10742-8142-1

1 BOTTLE, WITH APPLICATOR in 1 CARTON (10742-8142-1) > 13 mL in 1 BOTTLE, WITH APPLICATOR

• Marketing Start Date: 2001-08-21
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 10742-8142-1 [10742814201]

Rohto Cool LIQUID

• Marketing Category: OTC monograph final
• Application Number: part349
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2001-08-21

NDC 10742-8142-2 [10742814202]

Rohto Cool LIQUID

• Marketing Category: OTC monograph final
• Application Number: part349
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2001-08-21
• Marketing End Date: 2017-03-24

Drug Details

Active Ingredients

Ingredient	Strength
NAPHAZOLINE HYDROCHLORIDE	.12 mg/mL

OpenFDA Data

• SPL SET ID: 69166dec-fb86-4c76-9efe-88c3bb12a8f0
• Manufacturer:
  • The Mentholatum Company
• UNII:
  • MZ1131787D
  • 6OZP39ZG8H
• RxNorm Concept Unique ID - RxCUI:
  • 1098362

NDC Crossover Matching brand name "Rohto Cool" or generic name "Naphazoline Hydrochloride, Polysorbate 80"

NDC	Brand Name	Generic Name
10742-8141	Rohto	Naphazoline hydrochloride, Polysorbate 80
10742-8142	Rohto	Naphazoline hydrochloride, Polysorbate 80
10742-8158	Rohto	Naphazoline hydrochloride, Polysorbate 80
10742-8159	Rohto	Naphazoline hydrochloride, Polysorbate 80
10742-8145	Rohto Beauty Secret	Naphazoline hydrochloride, Polysorbate 80