FDA.reportPublic FDA data

ALLI

Manufacturer
Haleon US Holdings LLC
Effective date
2026-03-18
Label type
HUMAN OTC DRUG LABEL
Version
15
Source
full-release
Hydrated at
2026-06-01 01:50:51

Label at a glance#

ProductALLI
Active ingredientORLISTAT
Label structure9 sections

Dosage and administration

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 mor...

Storage and handling

store at 20 - 25 o C (68 - 77 o F) protect drug from excessive light, humidity and temperatures over 30 o C (86 o F)

Label contents#

Full prescribing information#

Active ingredient (in each sealed capsule)

OTC - ACTIVE INGREDIENT SECTION

Orlistat 60 mg

Purpose

OTC - PURPOSE SECTION

Weight loss aid

Use

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

  • 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

OTC - ASK DOCTOR SECTION

  • gallbladder problems
  • kidney disease or kidney stones
  • pancreatitis

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • 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

OTC - WHEN USING SECTION

  • 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

OTC - STOP USE SECTION

  • 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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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.

Other information

STORAGE AND HANDLING SECTION

  • store at 20 - 25 oC (68 - 77 oF)
  • protect drug from excessive light, humidity and temperatures over 30 oC (86 oF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

edible ink, FD&C blue no. 2, gelatin, iron oxide, microcrystalline cellulose, povidone, sodium lauryl sulfate, sodium starch glycolate, talc, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

1-800-452-0051

Additional information

SPL UNCLASSIFIED SECTION

TAMPER- EVIDENT features for your protection. The package has a security seal on both ends of the carton. The bottle of capsules has a foil seal under the cap imprinted with the words “sealed for your protection”. Each individual capsule is sealed with a dark blue band around the center of the capsule. DO NOT USE THIS PRODUCT IF ANY OF THESE TAMPER-EVIDENT FEATURES ARE MISSING, TORN OR BROKEN.

For more information and to learn more about alli,visit us at www.my alli.com

The Starter Pack includes:

  • Read Me First brochure
  • Up to 20 day supply (60 capsules)

For more information, visit www.myalli.com

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

60 capsules Starter Pack

SEE TOP OF PACKAGE FOR LISTING OF CONTENTS

alli

Orlistat 60 mg Capsules

Weight Loss Aid

60 capsules

FDA approved non-prescription weight loss aid

Helps you lose more weight than dieting alone

60 CAPSULES

Alli 60 ct starter pack
Alli 60 ct starter pack

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
723846Alli 60 MG Oral CapsulePSN15
692876orlistat 60 MG Oral CapsulePSN15
723846orlistat 60 MG Oral Capsule [Alli]SBD15
692876orlistat 60 MG Oral CapsuleSCD15
723846Alli 60 MG Oral CapsuleSY15

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ORLISTAT Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b3f93084-d1af-0d2d-125b-736522e0a7a2Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0135-0461-012020-11-09C16284748780-19d75b9d0-7d53-f424-e053-dadaa90a57ceDrug Facts
0135-0461-022020-11-09C16284748780-19d75b9d0-7d53-f424-e053-dadaa90a57ceDrug Facts
0135-0461-032020-11-09C16284748780-19d75b9d0-7d53-f424-e053-dadaa90a57ceDrug Facts
0135-0461-052020-11-09C16284748780-19d75b9d0-7d53-f424-e053-dadaa90a57ceDrug Facts
0135-0461-062020-11-09C16284748780-19d75b9d0-7d53-f424-e053-dadaa90a57ceDrug Facts
0135-0461-072020-11-09C16284748780-19d75b9d0-7d53-f424-e053-dadaa90a57ceDrug Facts
0135-0461-082020-11-09C16284748780-19d75b9d0-7d53-f424-e053-dadaa90a57ceDrug Facts
0135-0461-012020-01-31C16284748780-19d75b9d0-7d53-f424-e053-dadaa90a57ceDrug Facts
0135-0461-022020-01-31C16284748780-19d75b9d0-7d53-f424-e053-dadaa90a57ceDrug Facts
0135-0461-032020-01-31C16284748780-19d75b9d0-7d53-f424-e053-dadaa90a57ceDrug Facts
0135-0461-052020-01-31C16284748780-19d75b9d0-7d53-f424-e053-dadaa90a57ceDrug Facts
0135-0461-062020-01-31C16284748780-19d75b9d0-7d53-f424-e053-dadaa90a57ceDrug Facts
0135-0461-072020-01-31C16284748780-19d75b9d0-7d53-f424-e053-dadaa90a57ceDrug Facts
0135-0461-082020-01-31C16284748780-19d75b9d0-7d53-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0135-0461-01ALLI60 in 1 BOTTLECAPSULE6015
0135-0461-02ALLI90 in 1 BOTTLECAPSULE9015
0135-0461-03ALLI120 in 1 BOTTLECAPSULE12015
0135-0461-05ALLI120 in 1 BOTTLECAPSULE12015
0135-0461-06ALLI170 in 1 BOTTLECAPSULE17015
0135-0461-07ALLI21 in 1 BOTTLECAPSULE2115
0135-0461-08ALLI2 in 1 CARTONCAPSULE215
0135-0461-08ALLI60 in 1 BOTTLECAPSULE6015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0135-0461-01EA - Each0135-0461060dcda2-78a0-40a4-9c3b-e21127b35e6312021-05-05
0135-0461-02EA - Each0135-0461b587d8e8-bdf7-455b-a8dd-f9538f9cf31712012-07-24
0135-0461-05EA - Each0135-046161e49d90-2834-484b-b6cb-3acf721107ed12012-07-24
0135-0461-06EA - Each0135-046162c7e670-db2d-4367-b445-42e246996c2112012-07-24
0135-0461-07EA - Each0135-046159c364d2-2aa2-497a-8993-7ff5e80e723f12024-04-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ORLISTATACTIVE INGREDIENT95M8R751W86
ORLISTATACTIVE MOIETY95M8R751W86
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61U6
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQK6
FERROUS OXIDEINACTIVE INGREDIENTG7036X8B5H6
GELATININACTIVE INGREDIENT2G86QN327L6
POVIDONESINACTIVE INGREDIENTFZ989GH94E6
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141J6
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A26
TALCINACTIVE INGREDIENT7SEV7J4R1U6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JP6

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0135-04610135-0461-02, 0135-0461-03, 0135-0461-05, 0135-0461-06, 0135-0461-07, 0135-0461-08, 0135-0461-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
FD&C BLUE NO. 2L06K8R7DQKIACT
GELATIN, UNSPECIFIED2G86QN327LIACT
FERROUS OXIDEG7036X8B5HIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
SODIUM LAURYL SULFATE368GB5141JIACT
SODIUM STARCH GLYCOLATE TYPE AH8AV0SQX4DIACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
ORLISTAT95M8R751W8ACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 2 · 80 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
FERROUS OXIDEFERROUS OXIDEG7036X8B5HTABLET, DELAYED RELEASE / ORALNAExact identifier — unii+route
24 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UCAPSULE / ORAL2169 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ECAPSULE / ORAL300 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
GELATINGELATIN2G86QN327LCAPSULE / ORAL10932 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
FERROUS OXIDEFERROUS OXIDEG7036X8B5HTABLET / ORALNAExact identifier — unii+route
24 equally ranked IID candidates
TALCTALC7SEV7J4R1UCAPSULE / ORAL729 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
GELATINGELATIN2G86QN327LCAPSULE / ORAL10932 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
GELATINGELATIN2G86QN327LCAPSULE / ORAL10932 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
FERROUS OXIDEFERROUS OXIDEG7036X8B5HTABLET / ORALNAExact identifier — unii+route
24 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ECAPSULE / ORAL300 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
FD&C BLUE NO. 2FD&C BLUE NO. 2L06K8R7DQKCAPSULE / ORAL4 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE / ORAL72 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
TALCTALC7SEV7J4R1UCAPSULE / ORAL729 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ECAPSULE / ORAL300 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ECAPSULE / ORAL300 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
GELATINGELATIN2G86QN327LCAPSULE / ORAL10932 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UCAPSULE / ORAL2169 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UCAPSULE / ORAL2169 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
GELATINGELATIN2G86QN327LCAPSULE / ORAL10932 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JCAPSULE / ORAL600 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE / ORAL72 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
FERROUS OXIDEFERROUS OXIDEG7036X8B5HTABLET, EXTENDED RELEASE / ORALNAExact identifier — unii+route
24 equally ranked IID candidates
TALCTALC7SEV7J4R1UCAPSULE / ORAL729 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
FD&C BLUE NO. 2FD&C BLUE NO. 2L06K8R7DQKCAPSULE / ORAL4 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE / ORAL72 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
GELATINGELATIN2G86QN327LCAPSULE / ORAL10932 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
FERROUS OXIDEFERROUS OXIDEG7036X8B5HTABLET / ORALNAExact identifier — unii+route
24 equally ranked IID candidates
FERROUS OXIDEFERROUS OXIDEG7036X8B5HTABLET, DELAYED RELEASE / ORALNAExact identifier — unii+route
24 equally ranked IID candidates
FERROUS OXIDEFERROUS OXIDEG7036X8B5HTABLET / ORALNAExact identifier — unii+route
24 equally ranked IID candidates
FD&C BLUE NO. 2FD&C BLUE NO. 2L06K8R7DQKCAPSULE / ORAL4 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
GELATINGELATIN2G86QN327LCAPSULE / ORAL10932 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
FERROUS OXIDEFERROUS OXIDEG7036X8B5HTABLET, EXTENDED RELEASE / ORALNAExact identifier — unii+route
24 equally ranked IID candidates
FD&C BLUE NO. 2FD&C BLUE NO. 2L06K8R7DQKCAPSULE / ORAL4 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ECAPSULE / ORAL300 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
FERROUS OXIDEFERROUS OXIDEG7036X8B5HTABLET / ORALNAExact identifier — unii+route
24 equally ranked IID candidates
FD&C BLUE NO. 2FD&C BLUE NO. 2L06K8R7DQKCAPSULE / ORAL4 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
FERROUS OXIDEFERROUS OXIDEG7036X8B5HTABLET, DELAYED RELEASE / ORALNAExact identifier — unii+route
24 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JCAPSULE / ORAL600 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
TALCTALC7SEV7J4R1UCAPSULE / ORAL729 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE / ORAL72 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
TALCTALC7SEV7J4R1UCAPSULE / ORAL729 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE / ORAL72 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
FERROUS OXIDEFERROUS OXIDEG7036X8B5HTABLET, EXTENDED RELEASE / ORALNAExact identifier — unii+route
24 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UCAPSULE / ORAL2169 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE / ORAL72 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JCAPSULE / ORAL600 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ECAPSULE / ORAL300 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
TALCTALC7SEV7J4R1UCAPSULE / ORAL729 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
FERROUS OXIDEFERROUS OXIDEG7036X8B5HTABLET, DELAYED RELEASE / ORALNAExact identifier — unii+route
24 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ECAPSULE / ORAL300 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UCAPSULE / ORAL2169 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
FERROUS OXIDEFERROUS OXIDEG7036X8B5HTABLET, DELAYED RELEASE / ORALNAExact identifier — unii+route
24 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UCAPSULE / ORAL2169 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ECAPSULE / ORAL300 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
GELATINGELATIN2G86QN327LCAPSULE / ORAL10932 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JCAPSULE / ORAL600 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
FERROUS OXIDEFERROUS OXIDEG7036X8B5HTABLET, DELAYED RELEASE / ORALNAExact identifier — unii+route
24 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE / ORAL72 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
FD&C BLUE NO. 2FD&C BLUE NO. 2L06K8R7DQKCAPSULE / ORAL4 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
FERROUS OXIDEFERROUS OXIDEG7036X8B5HTABLET, DELAYED RELEASE / ORALNAExact identifier — unii+route
24 equally ranked IID candidates

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021887-001ALLIORLISTAT60MGCAPSULE / ORALRLD, RS2007-02-07

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09N021887-001ALLI60MGCAPSULE / ORALRLD, RS2007-02-07c2088c7a36db…
2026-09-14 22:38:342026-08N021887-001ALLI60MGCAPSULE / ORALRLD, RS2007-02-0784e616aacf4f…
2026-08-18 06:07:402026-07N021887-001ALLI60MGCAPSULE / ORALRLD, RS2007-02-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021887-001ALLI60MGCAPSULE / ORALRLD, RS2007-02-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021887-001ALLI60MGCAPSULE / ORALRLD, RS2007-02-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08N021887-001ALLI60MGCAPSULE / ORALRLD, RS2007-02-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021887-001ALLI60MGCAPSULE / ORALRLD, RS2007-02-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021887-001ALLI60MGCAPSULE / ORALRLD, RS2007-02-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021887-001ALLI60MGCAPSULE / ORALRLD, RS2007-02-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021887-001ALLI60MGCAPSULE / ORALRLD, RS2007-02-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021887-001ALLI60MGCAPSULE / ORALRLD, RS2007-02-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021887-001ALLI60MGCAPSULE / ORALRLD, RS2007-02-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021887-001ALLI60MGCAPSULE / ORALRLD, RS2007-02-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021887-001ALLI60MGCAPSULE / ORALRLD, RS2007-02-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021887-001ALLI60MGCAPSULE / ORALRLD, RS2007-02-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021887-001ALLI60MGCAPSULE / ORALRLD, RS2007-02-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021887-001ALLI60MGCAPSULE / ORALRLD, RS2007-02-078072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021887-001ALLI60MGCAPSULE / ORALRLD, RS2007-02-075c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021887-001ALLI60MGCAPSULE / ORALRLD, RS2007-02-075d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021887-001ALLI60MGCAPSULE / ORALRLD, RS2007-02-074b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021887-001ALLI60MGCAPSULE / ORALRLD, RS2007-02-0774a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021887-001ALLI60MGCAPSULE / ORALRLD, RS2007-02-07bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021887-001ALLI60MGCAPSULE / ORALRLD, RS2007-02-07782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021887-001ALLI60MGCAPSULE / ORALRLD, RS2007-02-0787673890dc5c…
2021-03-12 10:30 UTC2021-03N021887-001ALLI60MGCAPSULE / ORALRLD, RS2007-02-075aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021887-001ALLI60MGCAPSULE / ORALRLD, RS2007-02-078869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021887-001ALLI60MGCAPSULE / ORALRLD, RS2007-02-07c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021887-001ALLI60MGCAPSULE / ORALRLD, RS2007-02-073f01610625f2…
2019-09-15 20:21 UTC2019-09N021887-001ALLI60MGCAPSULE / ORALRLD, RS2007-02-07b00525d2431f…
2019-07-19 19:46 UTC2019-07N021887-001ALLI60MGCAPSULE / ORALRLD, RS2007-02-07ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021887-001ALLI60MGCAPSULE / ORALRLD, RS2007-02-076a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021887-001ALLI60MGCAPSULE / ORALRLD, RS2007-02-071c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021887-001ALLI60MGCAPSULE / ORALRLD, RS2007-02-07ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021887-001ALLI60MGCAPSULE / ORALRLD, RS2007-02-07a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021887-001ALLI60MGCAPSULE / ORALRLD, RS2007-02-079b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021887-001ALLI60MGCAPSULE / ORALRLD, RS2007-02-07a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021887-001ALLI60MGCAPSULE / ORALRLD, RS2007-02-073f0d92c62455…
2023-05-13 08:27 UTC2023-05N021887-001ALLI60MGCAPSULE / ORALRLD, RS2007-02-07053a50430f4f…
2023-01-26 05:58 UTC2023-01N021887-001ALLI60MGCAPSULE / ORALRLD, RS2007-02-073bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021887-001ALLI60MGCAPSULE / ORALRLD, RS2007-02-073a93d1ddd44b…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ALLIORLISTATHaleon US Holdings LLCa2d3bd73-f3af-4ea5-a57c-66b0004cfe4f2026-03-18WarningsExact identifier
ndc (package): 0135-0461-08
ndc (package): 0135-0461-03
ndc (package): 0135-0461-06
ndc (package): 0135-0461-05
ndc (package): 0135-0461-02
ndc (package): 0135-0461-07
ndc (package): 0135-0461-01
ndc (product): 0135-0461
ndc11 (package): 00135046105
ndc11 (package): 00135046106
ndc11 (package): 00135046103
ndc11 (package): 00135046107
ndc11 (package): 00135046101
ndc11 (package): 00135046102
ndc11 (package): 00135046108
spl id: 4d51b8f1-a819-7ff6-e063-6294a90a82bc
spl set id: a2d3bd73-f3af-4ea5-a57c-66b0004cfe4f

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.