Rohto Liquid
NDC Package 10742-8158-1

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Rohto (naphazoline hydrochloride, polysorbate 80) liquids is •put 1 or 2 drops in the affected eye(s) up to 4 times daily•tightly snap on cap to sealOther information •do not store above 25°C (77°F). This formulation utilizes a liquid delivery system. Marketed by The Mentholatum Company, this product is identified by NDC 10742-8158 and is authorized under FDA application M018.

Identification & Billing

NDC Package Code
10742-8158-1
Package Description
1 BOTTLE, WITH APPLICATOR in 1 CARTON / 13 mL in 1 BOTTLE, WITH APPLICATOR
Product Code
10742-8158
11-Digit Billing Format
10742815801
RxNorm Crosswalk
  • RxCUI: 1535485 - naphazoline HCl 0.03 % / polysorbate 80 0.2 % Ophthalmic Solution
  • RxCUI: 1535485 - naphazoline hydrochloride 0.3 MG/ML / polysorbate 80 2 MG/ML Ophthalmic Solution

Clinical Specifications

Proprietary Name
Rohto Max Strength
Non-Proprietary Name
Naphazoline Hydrochloride, Polysorbate 80
Substance Name
Naphazoline Hydrochloride; Polysorbate 80
Dosage Form
Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
Administration Route
Ophthalmic - Administration to the external eye.
Active Ingredient(s)
Usage Information
•put 1 or 2 drops in the affected eye(s) up to 4 times daily•tightly snap on cap to sealOther information •do not store above 25°C (77°F)

Regulatory & Marketing

Labeler Name
The Mentholatum Company
Product Type
Human Otc Drug
FDA Application #
M018
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
05-12-2021
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (10742-8158). Click a package code to view its specific billing and regulatory data.

10742-8158-2
2 BOTTLE, WITH APPLICATOR in 1 CARTON / 13 mL in 1 BOTTLE, WITH APPLICATOR

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 10742-8158-1 identifies a specific commercial package of 1 bottle, with applicator in 1 carton / 13 ml in 1 bottle, with applicator of Rohto Max Strength, a human over the counter drug labeled by The Mentholatum Company. This liquid is formulated for ophthalmic use and contains naphazoline hydrochloride; polysorbate 80 as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by The Mentholatum Company on May 12, 2021. The current certification is valid through December 31, 2027.

How is this The Mentholatum Company product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 10742815801. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-4-1)
10742-8158-1
11-Digit CMS (5-4-2)
10742-8158-01

Note: The zero is added to the Package segment to maintain the 5-4-2 structure.