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  5. NDC Package Code: 55758-443-04 Sanatos X Children

NDC Package 55758-443-04 Sanatos X Children

Acetaminophen,Dextromethorphan Hbr,Guaifenesin,Phenylephrine Hci Liquid Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
55758-443-04
Package Description:
1 BOTTLE, PLASTIC in 1 CARTON / 118 mL in 1 BOTTLE, PLASTIC
Product Code:
55758-443
Proprietary Name:
Sanatos X Children
Non-Proprietary Name:
Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hci
Substance Name:
Acetaminophen; Dextromethorphan Hydrobromide; Guaifenesin; Phenylephrine Hydrochloride
Usage Information:
This product does not contain directions or complete warnings for adult use do not give more than directed (see Overdose warning)shake well before usechildren 6 to under 12 years of age: take 10 mL in dosing cup provided every 4 hours, while symptoms persist, up to 5 times a day or as directed by a doctor children under 6 years of age: do not use
11-Digit NDC Billing Format:
55758044304
NDC to RxNorm Crosswalk:
  • RxCUI: 1116572 - acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaiFENesin 400 MG / phenylephrine HCl 10 MG in 20 mL Oral Solution
  • RxCUI: 1116572 - acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution
  • RxCUI: 1116572 - acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG per 10 ML Oral Solution
  • RxCUI: 1116572 - acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine hydrochloride 10 MG per 20 ML Oral Solution
  • RxCUI: 1116572 - APAP 32.5 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / Guaifenesin 20 MG/ML / Phenylephrine Hydrochloride 0.5 MG/ML Oral Solution
Product Type:
Human Otc Drug
Labeler Name:
Pharmadel Llc
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(s):
Oral - Administration to or by way of the mouth.
Active Ingredient(s):
Pharmacologic Class(es):
Sample Package:
No
FDA Application Number:
M012
Marketing Category:
OTC MONOGRAPH DRUG -
Start Marketing Date:
08-01-2024
Listing Expiration Date:
12-31-2025
Exclude Flag:
N
Code Structure:

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 disclaimer below.

Frequently Asked Questions

What is NDC 55758-443-04?

The NDC Packaged Code 55758-443-04 is assigned to a package of 1 bottle, plastic in 1 carton / 118 ml in 1 bottle, plastic of Sanatos X Children, a human over the counter drug labeled by Pharmadel Llc. The product's dosage form is liquid and is administered via oral form.

Is NDC 55758-443 included in the NDC Directory?

Yes, Sanatos X Children with product code 55758-443 is active and included in the NDC Directory. The product was first marketed by Pharmadel Llc on August 01, 2024 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 55758-443-04?

The 11-digit format is 55758044304. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
5-3-255758-443-045-4-255758-0443-04