Sanatos X Liquid
NDC Package 55758-311-06

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

Package Information

Sanatos X (acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hci) liquids is do not take more than directeddosing cup includeddo not take more than 6 doses in any 24-hour periodthis product is not intended for use in children under 12 years of ageagedoseadults & children 12 years of age & over20 mL every 4 hourschildren under 12 years of agedo not use. This formulation utilizes a liquid delivery system. Marketed by Pharmadel Llc, this product is identified by NDC 55758-311 and is authorized under FDA application M013.

Identification & Billing

NDC Package Code
55758-311-06
Package Description
1 BOTTLE, WITH APPLICATOR in 1 BOX / 1 LIQUID in 1 BOTTLE, WITH APPLICATOR
Product Code
55758-311
11-Digit Billing Format
55758031106
RxNorm Crosswalk
  • RxCUI: 1593450 - acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG in 10 mL Oral Suspension
  • RxCUI: 1593450 - acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Suspension
  • RxCUI: 1593450 - acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG per 10 ML Oral Suspension
  • RxCUI: 1593450 - acetaminophen 650 MG / dextromethorphan hydrobromide 20 MG / guaifenesin 400 MG / phenylephrine hydrochloride 10 MG per 20 ML Oral Suspension
  • RxCUI: 1593450 - APAP 32.5 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / Guaifenesin 20 MG/ML / Phenylephrine Hydrochloride 0.5 MG/ML Oral Suspension

Clinical Specifications

Proprietary Name
Sanatos X
Non-Proprietary Name
Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hci
Substance Name
Acetaminophen; Dextromethorphan Hydrobromide; Guaifenesin; Phenylephrine Hydrochloride
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
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Do not take more than directeddosing cup includeddo not take more than 6 doses in any 24-hour periodthis product is not intended for use in children under 12 years of ageagedoseadults & children 12 years of age & over20 mL every 4 hourschildren under 12 years of agedo not use

Regulatory & Marketing

Labeler Name
Pharmadel Llc
Product Type
Human Otc Drug
FDA Application #
M013
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
12-03-2018
Listing Expiration
12-31-2026
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 55758-311-06 identifies a specific commercial package of 1 bottle, with applicator in 1 box / 1 liquid in 1 bottle, with applicator of Sanatos X, a human over the counter drug labeled by Pharmadel Llc. This liquid is formulated for oral use and contains acetaminophen; dextromethorphan hydrobromide; guaifenesin; phenylephrine hydrochloride 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 Pharmadel Llc on December 03, 2018. The current certification is valid through December 31, 2026.

How is this Pharmadel Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 55758031106. 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 (5-3-2)
55758-311-06
11-Digit CMS (5-4-2)
55758-0311-06

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