Childrens Ibuprofen Bubblegum Dye Free Suspension/ Drops
NDC 53041-811
Ibuprofen 100 mg/5mL · Suspension/ Drops (oral)
Product Information
This code was recently added to the official NDC directory and the product has entered commercial distribution.
Childrens Ibuprofen Bubblegum Dye Free (ibuprofen) is a ANDA-approved product labeled by Guardian Drug Company. This medication is typically used as a anti-inflammatory agents. It is supplied as a suspension/ drops for oral administration. This product entry covers the primary NDC 53041-811 and 2 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
53041-811
Proprietary Name:
Childrens Ibuprofen Bubblegum Dye Free
Non-Proprietary Name: [1]
Ibuprofen
Substance Name: [2]
Ibuprofen
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:
Clinical Specifications
Dosage Form:
Suspension/ Drops
- A suspension which is usually administered in a dropwise fashion.
Administration Route(s): [4]
Oral - Administration to or by way of the mouth.
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
53041
Product Label ID:
FDA Application Number: [6]
ANDA210149
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Marketing Timeline
Start Marketing Date: [9]
11-02-2026
Listing Expiration Date: [11]
12-31-2027
Exclude Flag: [12]
N
Code Structure Chart
Product Details
What is NDC 53041-811?
The NDC code 53041-811 is assigned by the FDA to the product Childrens Ibuprofen Bubblegum Dye Free. It is commonly known by its generic name, ibuprofen. This pharmaceutical product is labeled by Guardian Drug Company and is currently categorized as listed product. The medication is a suspension/ drops administered via oral route. In terms of distribution, this product is available in 2 different package configurations. The associated package NDC(s) include: 53041-811-03, 53041-811-04. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.
What are the uses of this product?
This product does not contain directions or complete warnings for adult usedo not give more than directedshake well before usingmL=milliliterfind right dose on chart. If possible, use weight to dose; otherwise use age.use only enclosed dosing cup. Do not use any other dosing device.if needed, repeat dose every 6-8 hoursdo not use more than 4 times a dayreplace original bottle cap to maintain child resistanceDosing ChartWeight (lb) Age (yr) Dose (mL)* under 24 under 2 years ask a doctor 24-35 lbs 2-3 years 5 mL 36-47 lbs 4-5 years 7.5 mL 48-59 lbs 6-8 years 10 mL 60-71 lbs 9-10 years 12.5 mL 72-95 lbs 11 years 15 mL *or as directed by a doctor
What are Active Ingredients of this product?
An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
- IBUPROFEN 100 mg/5mL - A non-steroidal anti-inflammatory agent with analgesic, antipyretic, and anti-inflammatory properties
Which are the Pharmacologic Classes of this product?
A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.
* Please review the full disclaimer at the bottom of this page.
Product & Regulatory Definitions
What is the Non-Proprietary Name? The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
What is the Substance Name? An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
What kind of product is this? Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the FDA Application Number? This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the Listing Expiration Date? This is the date when the listing record will expire if not updated or certified by the product labeler.
What is the NDC Exclude Flag? This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".
