Mommys Bliss Infants Pain And Fever Suspension
NDC Package 71444-893-01

11-digit billing NDC: 71444089301
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Mommys Bliss Infants Pain And Fever (acetaminophen) suspension is directions ▪ this product does not contain directions or complete warnings for adult use ▪ do not give more than directed (see overdose warning) ▪ shake well before using ▪ mL=milliliter ▪ find right dose on chart below ▪ if possible, use weight to dose; otherwise, use age ▪ remove cap and seal, then insert the adapter plug by pushing down firmly until a tight seal is formed ▪ top of plug should be flush with bottle neck and not removeable ▪ push air out of syringe and insert syringe tip into adapter plug opening ▪ flip bottle upside down ▪ pull plunger of syringe up to correct dose ▪ dispense liquid slowly into child’s mouth, toward inner cheek ▪ repeat dose every 4 hours while symptoms last ▪ do not give more than 5 times in 24 hours ▪ replace cap tightly to maintain child resistance Weight (lb) Age (yr) Dose (mL)* under 24 lbs under 2 years ask a doctor 24-35 lbs 2-3 years 5 mL *or as directed by a doctor Attention: use only enclosed syringe specifically designed for use with this product. This formulation utilizes a suspension delivery system. Marketed by Mom Enterprises, Llc., this product is identified by NDC 71444-893 and is authorized under FDA application M013.

Identification & Billing

NDC Package Code
71444-893-01
Package Description
59 mL in 1 BOTTLE
Product Code
71444-893
11-Digit Billing Format
71444089301
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Mommys Bliss Infants Pain And Fever
Non-Proprietary Name
Acetaminophen
Substance Name
Acetaminophen
Dosage Form
Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
ACETAMINOPHEN 160 mg/5mL
Usage Information
Directions ▪ this product does not contain directions or complete warnings for adult use ▪ do not give more than directed (see overdose warning) ▪ shake well before using ▪ mL=milliliter ▪ find right dose on chart below ▪ if possible, use weight to dose; otherwise, use age ▪ remove cap and seal, then insert the adapter plug by pushing down firmly until a tight seal is formed ▪ top of plug should be flush with bottle neck and not removeable ▪ push air out of syringe and insert syringe tip into adapter plug opening ▪ flip bottle upside down ▪ pull plunger of syringe up to correct dose ▪ dispense liquid slowly into child’s mouth, toward inner cheek ▪ repeat dose every 4 hours while symptoms last ▪ do not give more than 5 times in 24 hours ▪ replace cap tightly to maintain child resistance Weight (lb) Age (yr) Dose (mL)* under 24 lbs under 2 years ask a doctor 24-35 lbs 2-3 years 5 mL *or as directed by a doctor Attention: use only enclosed syringe specifically designed for use with this product. Do not use any other dosing device.

Regulatory & Marketing

Labeler Name
Mom Enterprises, Llc.
Product Type
Human Otc Drug
FDA Application #
M013
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
02-19-2024
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 71444-893-01 identifies a specific commercial package of 59 ml in 1 bottle of Mommys Bliss Infants Pain And Fever, a human over the counter drug labeled by Mom Enterprises, Llc.. This suspension is formulated for oral use and contains acetaminophen 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 Mom Enterprises, Llc. on February 19, 2024. The current certification is valid through December 31, 2026.

How is this Mom Enterprises, Llc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71444089301. 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)
71444-893-01
11-Digit CMS (5-4-2)
71444-0893-01

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