NDC 10742-8159

Rohto Cool Max

Naphazoline Hydrochloride, Polysorbate 80

Rohto Cool Max 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: 10742-8159_b00e427c-0b57-491d-a775-84f029c09657
• NDC: 10742-8159
• Product Type: Human Otc Drug
• Proprietary Name: Rohto Cool Max
• Generic Name: Naphazoline Hydrochloride, Polysorbate 80
• Dosage Form: Liquid
• Route of Administration: OPHTHALMIC
• Marketing Start Date: 2014-05-05
• 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 10742-8159-1

1 BOTTLE, WITH APPLICATOR in 1 CARTON (10742-8159-1) > 13 mL in 1 BOTTLE, WITH APPLICATOR

• Marketing Start Date: 2014-05-05
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 10742-8159-1 [10742815901]

Rohto Cool Max LIQUID

• Marketing Category: OTC monograph final
• Application Number: part349
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2014-05-05

Drug Details

Active Ingredients

Ingredient	Strength
NAPHAZOLINE HYDROCHLORIDE	.3 mg/mL

OpenFDA Data

• SPL SET ID: 20b934af-fe24-44a2-b313-5540a209432c
• Manufacturer:
  • The Mentholatum Company
• UNII:
  • MZ1131787D
  • 6OZP39ZG8H
• RxNorm Concept Unique ID - RxCUI:
  • 1535485

NDC Crossover Matching brand name "Rohto Cool Max" 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