dye-free pain relief — Capsule, Liquid Filled

Overview

Brand name

dye-free pain relief

Generic name

Ibuprofen

Dosage form

Capsule, Liquid Filled

Route

Oral

Marketing category

ANDA · ANDA

Labeler

Bionpharma Inc.

Product type

Human Otc Drug

DEA schedule

Not scheduled

Active ingredients

2

NDC product codes

2

Packages

2

Data completeness

76% of corroborating sources present

Active ingredients

Source: NDC Directory

Active ingredients and strengths as listed in the NDC Directory.
Ingredient	Strength	RxCUI	Monograph
Ibuprofen	200 mg/1	310965	View
Ibuprofen	200 mg/1201	310965	View

Forms, strengths and routes

Source: NDC Directory

Dosage form

Capsule, Liquid Filled

Route of administration

Oral

Presentations

4

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory

Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class	Type	Browse
Anti-Inflammatory Agents	EPC	All 251 members
Cyclooxygenase Inhibitors [MoA]	MoA	All 251 members
Non-Steroidal [CS]	CS	All 251 members
Nonsteroidal Anti-inflammatory Drug [EPC]	EPC	All 251 members

Regulatory status

Source: Drugs@FDA NDC Directory

Application number

078682

Application type

ANDA · Abbreviated New Drug Application

Approval date

March 24, 2009

Sponsor

BIONPHARMA

Products on application

1

Submissions recorded

7

Products approved under application 078682.
Product	Trade name	Form	Strength	Ingredient	Status	TE	Flags
078682-001	IBUPROFEN	CAPSULE		IBUPROFEN	Over-the-counter	—

Approval history

Source: Drugs@FDA

Most recent submissions on application 078682.
Type	No.	Action	Status	Date	Review
Supplement	20	Manufacturing (CMC)	Approved	November 12, 2019	Unknown
Supplement	21	Labeling	Approved	February 21, 2019	Standard
Supplement	16	Labeling	Approved	February 21, 2019	Standard
Supplement	12	Labeling	Approved	July 31, 2013	Standard
Supplement	3	Labeling	Approved	March 12, 2013	—
Supplement	7	Manufacturing (CMC)	Approved	April 27, 2012	—
Original application	1		Approved	March 24, 2009	—

Review documents

0 · Supplement · January 7, 2021
0 · Supplement · January 7, 2021
0 · Supplement · January 7, 2021
0 · Original application · September 19, 2011
0 · Original application · April 14, 2009

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260623). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20260623 HUMAN OTC DRUG · 20260623

Indications and Usage

openFDA Drug Labeling

Uses ■ temporarily relieves minor aches and pains due to: ■ headache ■ toothache ■ backache ■ menstrual cramps ■ the common cold ■ muscular aches ■ minor pain of arthritis ■ temporarily reduces fever

Purpose

openFDA Drug Labeling

Purpose Pain reliever/Fever reducer

Dosage and Administration

openFDA Drug Labeling

Directions do not take more than directed the smallest effective dose should be used adults and children 12 years and over: take 1 capsule every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 capsule, 2 capsules may be used do not exceed 6 capsules in 24 hours, unless directed by a doctor children under 12 years: ask a doctor

Warnings

openFDA Drug Labeling

Warnings Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: ■ hives ■ facial swelling ■ asthma (wheezing) ■ shock ■ skin reddening ■ rash ■ blisters If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you ■ are age 60 or older ■ have had stomach ulcers or bleeding problems ■ take a blood thinning (anticoagulant) or steroid drug ■ take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] ■ have 3 or more alcoholic drinks every day while using this product ■ take more or for a longer time than directed Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.

Do Not Use

openFDA Drug Labeling

Do not use ■ if you have ever had an allergic reaction to any other pain reliever/fever reducer ■ right before or after heart surgery

Ask a Doctor

openFDA Drug Labeling

Ask a doctor before use if ■ stomach bleeding warning applies to you ■ you have problems or serious side effects from taking pain relievers or fever reducers ■ you have a history of stomach problems, such as heartburn ■ you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke ■ you are taking a diuretic

Stop Use

openFDA Drug Labeling

Stop use and ask a doctor if ■ you experience any of the following signs of stomach bleeding: ■ feel faint ■ vomit blood ■ have bloody or black stools ■ have stomach pain that does not get better ■ you have symptoms of heart problems or stroke: ■ chest pain ■ trouble breathing ■ weakness in one part or side of body ■ slurred speech ■ leg swelling ■ pain gets worse or lasts more than 10 days ■ fever gets worse or lasts more than 3 days ■ redness or swelling is present in the painful area ■ any new symptoms appear

Active Ingredient

openFDA Drug Labeling

Active ingredient (in each capsule) Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)* (present as the free acid and potassium salt) *nonsteroidal anti-inflammatory drug

Adverse event reports

Source: openFDA FAERS

283,546

FAERS reports mentioning this drug

as of 2026-09-25T03:42:24+00:00

A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: IBUPROFEN. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory

Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC	Product NDC	Labeler	Description	Marketing start
69452-302-25	69452-302	Bionpharma Inc.	180 CAPSULE, LIQUID FILLED in 1 BOTTLE (69452-302-25)	March 5, 2021
69452-513-81	69452-513	Bionpharma Inc.	400 CAPSULE, LIQUID FILLED in 1 BOTTLE (69452-513-81)	October 27, 2025
69452-302	69452-302	Bionpharma Inc.	—	March 5, 2021
69452-513	69452-513	Bionpharma Inc.	—	October 27, 2025

Sources for this page

Every dataset that contributed a fact to this page.
Dataset	Agency	Used for
NDC Directory	FDA	Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA	FDA	Application, sponsor, submissions, review documents, marketing status
Drug Labeling	FDA / NLM	Prescribing information reproduced above
FAERS	FDA	Adverse event report counts

Generated September 25, 2026 · 10 sections on this page.