ALLI — Capsule

Overview

Brand name

ALLI

Generic name

orlistat

Dosage form

Capsule

Route

Oral

Marketing category

NDA · NDA

Labeler

Aphena Pharma Solutions - Tennessee, LLC

Product type

Human Otc Drug

DEA schedule

Not scheduled

Active ingredients

1

NDC product codes

2

Packages

4

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
Orlistat	60 mg/1	692876	View

Forms, strengths and routes

Source: NDC Directory

Dosage form

Capsule

Route of administration

Oral

Presentations

6

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
Intestinal Lipase Inhibitor [EPC]	EPC	2 members — no class page
Lipase Inhibitors [MoA]	MoA	2 members — no class page

Regulatory status

Source: Drugs@FDA NDC Directory

Application number

021887

Application type

NDA · New Drug Application

Approval date

February 7, 2007

Sponsor

HALEON US HOLDINGS

Products on application

1

Submissions recorded

8

Products approved under application 021887.
Product	Trade name	Form	Strength	Ingredient	Status	TE	Flags
021887-001	ALLI	CAPSULE		ORLISTAT	Over-the-counter	—	RLD RS

Therapeutic equivalence

Source: Orange Book

TE code

—

Reference Listed Drug

Yes

Reference Standard

Yes

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Approval history

Source: Drugs@FDA

Most recent submissions on application 021887.
Type	No.	Action	Status	Date	Review
Supplement	13	Labeling	Approved	March 27, 2026	Standard
Supplement	9	Labeling	Approved	May 15, 2017	Standard
Supplement	8	Labeling	Approved	May 25, 2016	Standard
Supplement	6	Labeling	Approved	June 13, 2014	Standard
Supplement	5	Labeling	Approved	March 10, 2011	Unknown
Supplement	4	Labeling	Approved	February 4, 2011	Standard
Supplement	2	Labeling	Approved	September 22, 2010	Unknown
Original application	1	Type 5 - New Formulation or New Manufacturer	Approved	February 7, 2007	Standard

Review documents

0 · Supplement · March 31, 2026
0 · Supplement · March 31, 2026
0 · Supplement · May 17, 2017
0 · Supplement · May 17, 2017
0 · Supplement · May 27, 2016
0 · Supplement · May 26, 2016
0 · Supplement · August 5, 2014
0 · Supplement · June 18, 2014
0 · Supplement · March 14, 2011
0 · Supplement · February 14, 2011
0 · Supplement · September 27, 2010
0 · Original application · April 10, 2007
0 · Original application · February 12, 2007
0 · Original application · February 8, 2007

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260318). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20260318

Indications and Usage

openFDA Drug Labeling

Use for weight loss in overweight adults, 18 years and older, when used along with a reduced-calorie and low-fat diet

Purpose

openFDA Drug Labeling

Purpose Weight loss aid

Dosage and Administration

openFDA Drug Labeling

Directions read the enclosed brochure for other important information diet and exercise are the starting points for any weight loss program. Try these first before adding orlistat. Check with your doctor before starting any exercise program. to see if orlistat capsules are right for you, find your height on the chart to the right. You may consider starting a weight loss program with orlistat if your weight is the same or more than the weight shown for your height. for overweight adults 18 years and older: take 1 capsule with each meal containing fat do not take more than 3 capsules daily use with a reduced-calorie, low-fat diet and exercise program until you reach your weight loss goal. Most weight loss occurs in the first 6 months. if you stop taking orlistat, continue with your diet and exercise program if you start to regain weight after you stop taking orlistat, you may need to start taking orlistat again along with your diet and exercise program take a multivitamin once a day, at bedtime, when using orlistat Ht. / Wt. 4’10” 129 lbs. 4’11” 133 lbs. 5’0” 138 lbs. 5’1” 143 lbs. 5’2” 147 lbs. 5’3” 152 lbs. 5’4” 157 lbs. 5’5” 162 lbs. 5’6” 167 lbs. 5’7” 172 lbs. 5’8” 177 lbs. 5’9” 182 lbs. 5’10” 188 lbs. 5’11” 193 lbs. 6’0” 199 lbs. 6’1” 204 lbs. 6’2” 210 lbs. 6’3” 216 lbs. 6’4” 221 lbs. 6’5” 227 lbs.

Warnings

openFDA Drug Labeling

Warnings Organ transplant alert: do not use if you have had an organ transplant. Orlistat interferes with the medicines used to prevent transplant rejection. Allergy alert: do not use if you are allergic to any of the ingredients in orlistat capsules Do not use if you are taking cyclosporine if you have been diagnosed with problems absorbing food if you are not overweight Ask a doctor before use if you have ever had gallbladder problems kidney disease or kidney stones pancreatitis Ask a doctor or pharmacist before use if you are taking any of the following prescription medications. Some prescription doses may need to be adjusted, or some medications may not work as well when used with orlistat. anticoagulants (blood thinning medicine) amiodarone (heart medicine) diabetes medicine thyroid disease medicine seizure medicine antiretrovirals (HIV medicine) taking any other weight loss products When using this product take a multivitamin once a day, at bedtime . Orlistat can reduce the absorption of some vitamins. follow a well-balanced, reduced-calorie, low-fat diet. Try starting this diet before taking orlistat. orlistat works by preventing the absorption of some of the fat you eat. The fat passes out of your body, so you may have bowel changes. You may get: gas with oily spotting loose stools more frequent stools that may be hard to control eating a low-fat diet lowers the chance of having these bowel changes for every 5 pounds you lose from diet alone, orlistat can help you lose 2-3 pounds more. In studies, most people lost 5-10 pounds over 6 months. Stop use and ask a doctor if you develop itching, yellow eyes or skin, dark urine or loss of appetite. There have been rare reports of liver injury in people taking orlistat. you develop severe pain in the back or groin, painful urination, blood in your urine, swelling of the legs or feet, or are urinating less often than normal. There have been rare reports of kidney injury in people taking orlistat. severe or continuous abdominal pain occurs. This may be a sign of a serious medical condition. you are taking medicine for seizures and your seizures happen more often or get worse If pregnant or breast-feeding, do not use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Do Not Use

openFDA Drug Labeling

Do not use if you are taking cyclosporine if you have been diagnosed with problems absorbing food if you are not overweight

Ask a Doctor

openFDA Drug Labeling

Ask a doctor before use if you have ever had gallbladder problems kidney disease or kidney stones pancreatitis

Stop Use

openFDA Drug Labeling

Stop use and ask a doctor if you develop itching, yellow eyes or skin, dark urine or loss of appetite. There have been rare reports of liver injury in people taking orlistat. you develop severe pain in the back or groin, painful urination, blood in your urine, swelling of the legs or feet, or are urinating less often than normal. There have been rare reports of kidney injury in people taking orlistat. severe or continuous abdominal pain occurs. This may be a sign of a serious medical condition. you are taking medicine for seizures and your seizures happen more often or get worse

Active Ingredient

openFDA Drug Labeling

Active ingredient (in each sealed capsule) Orlistat 60 mg

Adverse event reports

Source: openFDA FAERS

25,755

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: ORLISTAT. 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
71610-805-34	71610-805	Aphena Pharma Solutions - Tennessee, LLC	2280 CAPSULE in 1 BOTTLE (71610-805-34)	March 22, 2024
0135-0461-01	0135-0461	Haleon US Holdings LLC	60 CAPSULE in 1 BOTTLE (0135-0461-01)	September 1, 2016
0135-0461-05	0135-0461	Haleon US Holdings LLC	120 CAPSULE in 1 BOTTLE (0135-0461-05)	February 7, 2007
0135-0461-06	0135-0461	Haleon US Holdings LLC	170 CAPSULE in 1 BOTTLE (0135-0461-06)	February 7, 2007
71610-805	71610-805	Aphena Pharma Solutions - Tennessee, LLC	—	February 7, 2007
0135-0461	0135-0461	Haleon US Holdings LLC	—	February 7, 2007

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 · 11 sections on this page.