Childrens Acetaminophen Suspension
NDC Package 81522-285-04

11-digit billing NDC: 81522028504
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Childrens Acetaminophen (acetaminophen) suspension is this product does not contain directions or complete warnings for adult usedo not take more than directed (see Overdose warning)shake well before usingmL = milliliteruse only the enclosed dosing cup designed for use with this product. This formulation utilizes a suspension delivery system. Marketed by Fsa Store Inc. (caring Mills), this product is identified by NDC 81522-285 and is authorized under FDA application M013.

Identification & Billing

NDC Package Code
81522-285-04
Package Description
1 BOTTLE, PLASTIC in 1 CARTON / 118 mL in 1 BOTTLE, PLASTIC
Product Code
81522-285
11-Digit Billing Format
81522028504
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Childrens Acetaminophen Dye Free Grape
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
This product does not contain directions or complete warnings for adult usedo not take more than directed (see Overdose warning)shake well before usingmL = milliliteruse only the enclosed dosing cup designed for use with this product. Do not use any other dosing device.  if needed, repeat dose every 4 hours while symptoms last  do not give more than 5 times in 24 hours  do not give more than 5 days unless directed by a doctor find the right dose on chart below. If possible, use weight to dose; otherwise, use age.Weight (lb)Age (year)Dose (mL)* under 24under 2 ask a doctor24-352-3 5 mL 36-474-5 7.5 mL 48-596-8 10 mL 60-719-10 12.5 mL72-9511 15 mL*or as directed by a doctor

Regulatory & Marketing

Labeler Name
Fsa Store Inc. (caring Mills)
Product Type
Human Otc Drug
FDA Application #
M013
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
04-18-2022
End Marketing Date
03-28-2027
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 81522-285-04 identifies a specific commercial package of 1 bottle, plastic in 1 carton / 118 ml in 1 bottle, plastic of Childrens Acetaminophen Dye Free Grape, a human over the counter drug labeled by Fsa Store Inc. (caring Mills). 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 Fsa Store Inc. (caring Mills) on April 18, 2022.

How is this Fsa Store Inc. (caring Mills) product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 81522028504. 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)
81522-285-04
11-Digit CMS (5-4-2)
81522-0285-04

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