Nexium 24HR ClearMinis

Manufacturer
Haleon US Holdings LLC
Effective date
2024-03-19
Label type
HUMAN OTC DRUG LABEL
Version
30
Source
full-release
Hydrated at
2026-06-01 00:10:01

Label at a glance#

ProductNexium 24HR
Active ingredientESOMEPRAZOLE MAGNESIUM
Label structure10 sections

Storage and handling

Other Information read the directions and warnings before use keep the carton. It contains important information. store at 20-25°C (68-77°F)

Label contents#

Full prescribing information#

Active ingredient (in each capsule)

OTC - ACTIVE INGREDIENT SECTION

Esomeprazole 20 mg

(Each delayed-release capsule corresponds to 22.3 mg

esomeprazole magnesium trihydrate)

Purpose

OTC - PURPOSE SECTION

Acid reducer

INDICATIONS & USAGE SECTION

Uses

  • treats frequent heartburn (occurs 2 or moredays a week)
  • not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect

WARNINGS SECTION

Warnings

Allergy alert:

SPL UNCLASSIFIED SECTION

  • Do not use if you are allergic to esomeprazole
  • Esomeprazole may cause severe skin reactions. Symptoms include:
  • skin reddening
  • blisters
  • rash

If an allergic reaction occurs, stop use and seek medical attention right away.

Do not use if you have

OTC - DO NOT USE SECTION

  • trouble or pain swallowing food, vomiting with blood, or bloody or black stools
  • heartburn with lightheadedness, sweating or dizziness
  • chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness
  • frequent chest pain

These may be signs of a serious condition. See your doctor.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • had heartburn over 3 months. This may be a sign of a more serious condition.
  • frequent wheezing, particularly with heartburn
  • unexplained weight loss
  • nausea or vomiting
  • stomach pain

OTC - ASK DOCTOR/PHARMACIST SECTION

  1. Ask a doctor or pharmacist before use if you are
  2. taking a prescription drug. Acid reducers may interact with certain prescription drugs.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • your heartburn continues or worsens
  • you need to take this product for more than 14 days
  • you need to take more than 1 course of treatment every 4 months
  • you get diarrhea
  • you develop a rash or joint pain

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding,ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

Directions

  • adults 18 years of age and older
  • this product is to be used once a day (every 24 hours), every day for 14 days
  • may take 1 to 4 days for full effect
    14-Day Course of Treatment Repeated 14-Day Courses (if needed)
    • swallow 1 capsule with a glass of water before eating in the morning
    • take every day for 14 days
    • do not take more than 1 capsule a day
    • swallow whole. Do not crush or chew capsules.
    • do not use for more than 14 days unless directed by your doctor
    • you may repeat a 14-day course every 4 months
    • do not take for more than 14 days or more often than every 4 months unless directed by a doctor
  • children under 18 years of age: ask a doctor before use. Heartburn in children may sometimes be caused by a serious condition.

STORAGE AND HANDLING SECTION

Other Information

  • read the directions and warnings before use
  • keep the carton. It contains important information.
  • store at 20-25°C (68-77°F)

INACTIVE INGREDIENT SECTION

Inactive Ingredients (Nexium 24HR Capsules)

corn starch, D&C red no. 28, FD&C blue no. 1, FD&C red no. 40, ferric oxide, gelatin, glyceryl monostearate, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer, pharmaceutical ink, polysorbate 80, sucrose, talc, titanium dioxide, triethyl citrate

Inactive Ingredients (Nexium 24HR ClearMinis)

carmine, corn starch, FD&C blue no. 2, FD&C blue no. 2 aluminum lake, FD&C red no. 3, FD&C red no. 40, ferric oxide, gelatin, glyceryl monostearate, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer, pharmaceutical ink, polysorbate 80, sucrose, talc, titanium dioxide, triethyl citrate

OTC - QUESTIONS SECTION

Questions or comments?

call toll-free weekdays 9 AM to 5 PM EST at 1-866-226-1600

Additional Information

SPL UNCLASSIFIED SECTION

KEEP CARTON FOR COMPLETE WARNINGS AND IMPORTANT INFORMATION.

Do Not Use if seal under bottle cap imprinted with “SEALED for YOUR PROTECTION”

or yellow band around the center of each capsule is broken or missing.

Tips for Managing Heartburn

  • Avoid foods or drinks that are more likely to cause heartburn, such as rich, spicy, fatty and fried foods, chocolate, caffeine, alcohol and even some acidic fruits and vegetables.
  • Eat slowly and do not eat big meals.
  • Do not eat late at night or just before bedtime.
  • Do not lie flat or bend over soon after eating.
  • Raise the head of your bed.
  • Wear loose-fitting clothing around your stomach.
  • If you are overweight, lose weight.
  • If you smoke, quit smoking.

Distributed by: GSK Consumer Healthcare,

Warren, NJ 07059

©2022 GSK group of companies or its licensor

Made in France

For most recent product information, visit www.Nexium24HR.com

Nexium is a registered trademark of AstraZeneca AB and is used under license.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0573-2450-14

See new warning information

Treats Frequent Heartburn

Nexium ®
24HR
esomeprazole magnesium
delayed-release capsules
20 mg/acid reducer

Capsules

May take 1 to 4 days for full effect

14
CAPSULES

One 14-day course of treatment

000078381 Front Carton

Nexium 24HR Capsules 14 ct
Nexium 24HR Capsules 14 ct

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0573-2452-14

See new warning information

Treats Frequent Heartburn

Nexium ®
24HR
esomeprazole magnesium
delayed-release capsules
20 mg/acid reducer

Clear Minis™

May take 1 to 4 days for full effect

14
CAPSULES
One 14-day course of treatment

000078392 Front Carton

Nexium 24HR Clear Minis 14 ct
Nexium 24HR Clear Minis 14 ct

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSN30
606728NexIUM 20 MG Delayed Release Oral CapsulePSN30
606728esomeprazole 20 MG Delayed Release Oral Capsule [Nexium]SBD30
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCD30
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSY30
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSY30
606728Nexium 20 MG (as esomeprazole magnesium 22.3 MG) Delayed Release Oral CapsuleSY30
606728Nexium 20 MG Delayed Release Oral CapsuleSY30
606728Nexium 24 HR 20 MG Delayed release Oral CapsuleSY30

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ESOMEPRAZOLE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d7006a36-e68d-42e2-8cd3-d725cb2e47b1Product name620251027
d71865e8-5c35-4d76-8ecd-a7adda982240Product name920180628
d71865e8-5c35-4d76-8ecd-a7adda982240Product name820171212
094c6751-235c-4d12-acee-2baf94f676f4Product name120151116
ce67e27d-1d21-5465-4409-b0662dd99d4dProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0573-2450-02Nexium 24HR2 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE230
0573-2450-02Nexium 24HR1 in 1 CARTONCAPSULE, DELAYED RELEASE130
0573-2450-14Nexium 24HR1 in 1 CARTONCAPSULE, DELAYED RELEASE130
0573-2450-14Nexium 24HR14 in 1 BOTTLECAPSULE, DELAYED RELEASE1430
0573-2450-15Nexium 24HR14 in 1 BOTTLECAPSULE, DELAYED RELEASE1430
0573-2450-15Nexium 24HR1 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE130
0573-2450-17Nexium 24HR1 in 1 CARTONCAPSULE, DELAYED RELEASE130
0573-2450-17Nexium 24HR14 in 1 BOTTLECAPSULE, DELAYED RELEASE1430
0573-2450-28Nexium 24HR2 in 1 CARTONCAPSULE, DELAYED RELEASE230
0573-2450-28Nexium 24HR14 in 1 BOTTLECAPSULE, DELAYED RELEASE1430
0573-2450-42Nexium 24HR3 in 1 CARTONCAPSULE, DELAYED RELEASE330
0573-2450-42Nexium 24HR14 in 1 BOTTLECAPSULE, DELAYED RELEASE1430
0573-2450-43Nexium 24HR14 in 1 BOTTLECAPSULE, DELAYED RELEASE1430
0573-2450-43Nexium 24HR3 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE330
0573-2450-44Nexium 24HR3 in 1 CARTONCAPSULE, DELAYED RELEASE330
0573-2450-44Nexium 24HR14 in 1 BOTTLECAPSULE, DELAYED RELEASE1430
0573-2452-02Nexium 24HR ClearMinis1 in 1 CARTONCAPSULE, DELAYED RELEASE130
0573-2452-02Nexium 24HR ClearMinis2 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE230
0573-2452-14Nexium 24HR ClearMinis1 in 1 CARTONCAPSULE, DELAYED RELEASE130
0573-2452-14Nexium 24HR ClearMinis14 in 1 BOTTLECAPSULE, DELAYED RELEASE1430
0573-2452-42Nexium 24HR ClearMinis14 in 1 BOTTLECAPSULE, DELAYED RELEASE1430
0573-2452-42Nexium 24HR ClearMinis3 in 1 CARTONCAPSULE, DELAYED RELEASE330
0573-2452-43Nexium 24HR ClearMinis14 in 1 BOTTLECAPSULE, DELAYED RELEASE1430
0573-2452-43Nexium 24HR ClearMinis3 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE330

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0573-2450NEXIUM 24HR (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE NEXIUM 24HR CLEARMINIS (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [HALEON US HOLDINGS LLC]30Current NDC, Legacy NDC, 16 package rows20240321_4513934d-0cf0-40fc-a348-b4e75a33b094.zip
0573-2452NEXIUM 24HR (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE NEXIUM 24HR CLEARMINIS (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [HALEON US HOLDINGS LLC]30Current NDC, Legacy NDC, 8 package rows20240321_4513934d-0cf0-40fc-a348-b4e75a33b094.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0573-2450-14EA - Each0573-2450b1dd1d1e-cc3d-4bc3-a4f8-ca291490ef7412014-06-03
0573-2450-15EA - Each0573-24506b7357ba-9d45-43d2-8d27-5d06c4aa091312015-07-20
0573-2450-28EA - Each0573-24501103a115-63d5-45d7-8ebc-0b397421929a12014-06-03
0573-2450-42EA - Each0573-2450aa4a4eb6-79d1-481a-9b2d-187f0499b35812014-07-02
0573-2450-43EA - Each0573-2450834bdac9-a121-4729-81c0-bebc94327edd12014-07-02
0573-2450-56EA - Each0573-245079d2f892-8ffd-4a87-9bc5-032d0d2bc1ef12015-10-02
0573-2452-14EA - Each0573-2452bf708cba-affd-4fa4-9c7f-1a801c699cca12017-05-03
0573-2452-42EA - Each0573-2452b10b4f51-023b-4207-bd94-3dd579c6c2d612017-05-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ESOMEPRAZOLE MAGNESIUMACTIVE INGREDIENTR6DXU4WAY99
ESOMEPRAZOLEACTIVE MOIETYN3PA6559FT9
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NH9
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBD9
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOA9
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G6759
GELATININACTIVE INGREDIENT2G86QN327L9
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE49
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671P9
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WO9
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I309
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)INACTIVE INGREDIENT74G4R6TH139
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8H9
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJ9
SUCROSEINACTIVE INGREDIENTC151H8M5549
TALCINACTIVE INGREDIENT7SEV7J4R1U9
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JP9
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UM9

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 35 matching rows.

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 4 · 224 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
GELATINGELATIN2G86QN327LCAPSULE, DELAYED RELEASE / ORAL1791 mgExact identifier — unii+route+dosage form
14 equally ranked IID candidates
TALCTALC7SEV7J4R1UCAPSULE, DELAYED RELEASE / ORAL420 mgExact identifier — unii+route+dosage form
14 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, DELAYED RELEASE / ORAL2 mgExact identifier — unii+route+dosage form
14 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HCAPSULE, DELAYED RELEASE / ORAL23 mgExact identifier — unii+route+dosage form
14 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE, DELAYED RELEASE / ORAL55 mgExact identifier — unii+route+dosage form
14 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HCAPSULE, DELAYED RELEASE / ORAL23 mgExact identifier — unii+route+dosage form
14 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30CAPSULE, DELAYED RELEASE / ORAL1060 mgExact identifier — unii+route+dosage form
14 equally ranked IID candidates
TALCTALC7SEV7J4R1UCAPSULE, DELAYED RELEASE / ORAL420 mgExact identifier — unii+route+dosage form
14 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, DELAYED RELEASE / ORAL2 mgExact identifier — unii+route+dosage form
14 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOCAPSULE, DELAYED RELEASE / ORAL105 mgExact identifier — unii+route+dosage form
14 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE, DELAYED RELEASE / ORAL55 mgExact identifier — unii+route+dosage form
14 equally ranked IID candidates
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)74G4R6TH13CAPSULE, DELAYED RELEASE / ORAL79 mgExact identifier — unii+route+dosage form
14 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE, DELAYED RELEASE / ORAL55 mgExact identifier — unii+route+dosage form
14 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, DELAYED RELEASE / ORAL2 mgExact identifier — unii+route+dosage form
14 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJCAPSULE, DELAYED RELEASE / ORAL216 mgExact identifier — unii+route+dosage form
14 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30CAPSULE, DELAYED RELEASE / ORAL1060 mgExact identifier — unii+route+dosage form
14 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE (TYPE H)HYDROXYPROPYL CELLULOSE (1600000 WAMW)RFW2ET671PCAPSULE, DELAYED RELEASE / ORAL150 mgExact identifier — unii+route+dosage form
14 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJCAPSULE, DELAYED RELEASE / ORAL216 mgExact identifier — unii+route+dosage form
14 equally ranked IID candidates
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)74G4R6TH13CAPSULE, DELAYED RELEASE / ORAL79 mgExact identifier — unii+route+dosage form
14 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4CAPSULE, DELAYED RELEASE / ORAL15 mgExact identifier — unii+route+dosage form
14 equally ranked IID candidates
SUCROSESUCROSEC151H8M554CAPSULE, DELAYED RELEASE / ORAL955 mgExact identifier — unii+route+dosage form
14 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30CAPSULE, DELAYED RELEASE / ORAL1060 mgExact identifier — unii+route+dosage form
14 equally ranked IID candidates
TALCTALC7SEV7J4R1UCAPSULE, DELAYED RELEASE / ORAL420 mgExact identifier — unii+route+dosage form
14 equally ranked IID candidates
GELATINGELATIN2G86QN327LCAPSULE, DELAYED RELEASE / ORAL1791 mgExact identifier — unii+route+dosage form
14 equally ranked IID candidates
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)74G4R6TH13CAPSULE, DELAYED RELEASE / ORAL79 mgExact identifier — unii+route+dosage form
14 equally ranked IID candidates
TALCTALC7SEV7J4R1UCAPSULE, DELAYED RELEASE / ORAL420 mgExact identifier — unii+route+dosage form
14 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACAPSULE, DELAYED RELEASE / ORAL2 mgExact identifier — unii+route+dosage form
14 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJCAPSULE, DELAYED RELEASE / ORAL216 mgExact identifier — unii+route+dosage form
14 equally ranked IID candidates
D&C RED NO. 28D&C RED NO. 28767IP0Y5NHCAPSULE, DELAYED RELEASE / ORAL1 mgExact identifier — unii+route+dosage form
14 equally ranked IID candidates
TRIETHYL CITRATETRIETHYL CITRATE8Z96QXD6UMCAPSULE, DELAYED RELEASE / ORAL70 mgExact identifier — unii+route+dosage form
14 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACAPSULE, DELAYED RELEASE / ORAL2 mgExact identifier — unii+route+dosage form
14 equally ranked IID candidates
D&C RED NO. 28D&C RED NO. 28767IP0Y5NHCAPSULE, DELAYED RELEASE / ORAL1 mgExact identifier — unii+route+dosage form
14 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675CAPSULE, DELAYED RELEASE / ORAL14 mgExact identifier — unii+route+dosage form
14 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACAPSULE, DELAYED RELEASE / ORAL2 mgExact identifier — unii+route+dosage form
14 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE, DELAYED RELEASE / ORAL55 mgExact identifier — unii+route+dosage form
14 equally ranked IID candidates
SUCROSESUCROSEC151H8M554CAPSULE, DELAYED RELEASE / ORAL955 mgExact identifier — unii+route+dosage form
14 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30CAPSULE, DELAYED RELEASE / ORAL1060 mgExact identifier — unii+route+dosage form
14 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30CAPSULE, DELAYED RELEASE / ORAL1060 mgExact identifier — unii+route+dosage form
14 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, DELAYED RELEASE / ORAL2 mgExact identifier — unii+route+dosage form
14 equally ranked IID candidates
D&C RED NO. 28D&C RED NO. 28767IP0Y5NHCAPSULE, DELAYED RELEASE / ORAL1 mgExact identifier — unii+route+dosage form
14 equally ranked IID candidates
GELATINGELATIN2G86QN327LCAPSULE, DELAYED RELEASE / ORAL1791 mgExact identifier — unii+route+dosage form
14 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30CAPSULE, DELAYED RELEASE / ORAL1060 mgExact identifier — unii+route+dosage form
14 equally ranked IID candidates
GELATINGELATIN2G86QN327LCAPSULE, DELAYED RELEASE / ORAL1791 mgExact identifier — unii+route+dosage form
14 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, DELAYED RELEASE / ORAL2 mgExact identifier — unii+route+dosage form
14 equally ranked IID candidates
TALCTALC7SEV7J4R1UCAPSULE, DELAYED RELEASE / ORAL420 mgExact identifier — unii+route+dosage form
14 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJCAPSULE, DELAYED RELEASE / ORAL216 mgExact identifier — unii+route+dosage form
14 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE, DELAYED RELEASE / ORAL55 mgExact identifier — unii+route+dosage form
14 equally ranked IID candidates
TALCTALC7SEV7J4R1UCAPSULE, DELAYED RELEASE / ORAL420 mgExact identifier — unii+route+dosage form
14 equally ranked IID candidates
GELATINGELATIN2G86QN327LCAPSULE, DELAYED RELEASE / ORAL1791 mgExact identifier — unii+route+dosage form
14 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOCAPSULE, DELAYED RELEASE / ORAL105 mgExact identifier — unii+route+dosage form
14 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJCAPSULE, DELAYED RELEASE / ORAL216 mgExact identifier — unii+route+dosage form
14 equally ranked IID candidates
SUCROSESUCROSEC151H8M554CAPSULE, DELAYED RELEASE / ORAL955 mgExact identifier — unii+route+dosage form
14 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30CAPSULE, DELAYED RELEASE / ORAL1060 mgExact identifier — unii+route+dosage form
14 equally ranked IID candidates
TALCTALC7SEV7J4R1UCAPSULE, DELAYED RELEASE / ORAL420 mgExact identifier — unii+route+dosage form
14 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOCAPSULE, DELAYED RELEASE / ORAL105 mgExact identifier — unii+route+dosage form
14 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675CAPSULE, DELAYED RELEASE / ORAL14 mgExact identifier — unii+route+dosage form
14 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, DELAYED RELEASE / ORAL2 mgExact identifier — unii+route+dosage form
14 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4CAPSULE, DELAYED RELEASE / ORAL15 mgExact identifier — unii+route+dosage form
14 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOCAPSULE, DELAYED RELEASE / ORAL105 mgExact identifier — unii+route+dosage form
14 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4CAPSULE, DELAYED RELEASE / ORAL15 mgExact identifier — unii+route+dosage form
14 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 43.

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
N204655-001NEXIUM 24HRESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRLD, RS2014-03-28

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N204655-001NEXIUM 24HREQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRLD, RS2014-03-2884e616aacf4f…
2026-08-18 06:07:402026-07N204655-001NEXIUM 24HREQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRLD, RS2014-03-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N204655-001NEXIUM 24HREQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRLD, RS2014-03-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204655-001NEXIUM 24HREQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRLD, RS2014-03-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08N204655-001NEXIUM 24HREQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRLD, RS2014-03-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N204655-001NEXIUM 24HREQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRLD, RS2014-03-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N204655-001NEXIUM 24HREQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRLD, RS2014-03-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N204655-001NEXIUM 24HREQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRLD, RS2014-03-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N204655-001NEXIUM 24HREQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRLD, RS2014-03-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N204655-001NEXIUM 24HREQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRLD, RS2014-03-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N204655-001NEXIUM 24HREQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRLD, RS2014-03-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N204655-001NEXIUM 24HREQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRLD, RS2014-03-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N204655-001NEXIUM 24HREQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRLD, RS2014-03-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N204655-001NEXIUM 24HREQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRLD, RS2014-03-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N204655-001NEXIUM 24HREQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRLD, RS2014-03-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05N204655-001NEXIUM 24HREQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRLD, RS2014-03-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N204655-001NEXIUM 24HREQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRLD, RS2014-03-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N204655-001NEXIUM 24HREQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRLD, RS2014-03-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N204655-001NEXIUM 24HREQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRLD, RS2014-03-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N204655-001NEXIUM 24HREQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRLD, RS2014-03-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03N204655-001NEXIUM 24HREQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRLD, RS2014-03-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N204655-001NEXIUM 24HREQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRLD, RS2014-03-28782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N204655-001NEXIUM 24HREQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRLD, RS2014-03-2887673890dc5c…
2021-03-12 10:30 UTC2021-03N204655-001NEXIUM 24HREQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRLD, RS2014-03-285aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N204655-001NEXIUM 24HREQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRLD, RS2014-03-288869cabd3fbd…
2020-11-12 02:37 UTC2020-11N204655-001NEXIUM 24HREQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRLD, RS2014-03-28c0c555d07b60…
2019-12-14 00:12 UTC2019-12N204655-001NEXIUM 24HREQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRLD, RS2014-03-283f01610625f2…
2019-09-15 20:21 UTC2019-09N204655-001NEXIUM 24HREQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRLD, RS2014-03-28b00525d2431f…
2019-07-19 19:46 UTC2019-07N204655-001NEXIUM 24HREQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRLD, RS2014-03-28ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N204655-001NEXIUM 24HREQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRLD, RS2014-03-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N204655-001NEXIUM 24HREQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRLD, RS2014-03-281c564ffb4f44…
2023-12-20 04:57 UTC2023-12N204655-001NEXIUM 24HREQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRLD, RS2014-03-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N204655-001NEXIUM 24HREQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRLD, RS2014-03-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N204655-001NEXIUM 24HREQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRLD, RS2014-03-289b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N204655-001NEXIUM 24HREQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRLD, RS2014-03-28a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N204655-001NEXIUM 24HREQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRLD, RS2014-03-283f0d92c62455…
2023-05-13 08:27 UTC2023-05N204655-001NEXIUM 24HREQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRLD, RS2014-03-28053a50430f4f…
2023-01-26 05:58 UTC2023-01N204655-001NEXIUM 24HREQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRLD, RS2014-03-283bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N204655-001NEXIUM 24HREQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRLD, RS2014-03-283a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N204655-001NEXIUM 24HREQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRLD, RS2014-03-28f41ea6bd6efb…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2019-12-13 00:20 UTC2019-12N204655-00164288102019-11-03U-1874Drug product2014-04-2474a2ff9319b5…
2019-12-13 00:20 UTC2019-12N204655-00164288102019-11-03U-1509Drug product2014-04-2474a2ff9319b5…
2019-12-13 00:20 UTC2019-12N204655-0016428810*PED2020-05-03Pediatric extension74a2ff9319b5…
2020-12-22 03:56 UTC2020-12N204655-0016428810*PED2020-05-03Pediatric extension8869cabd3fbd…
2020-11-12 02:37 UTC2020-11N204655-0016428810*PED2020-05-03Pediatric extensionc0c555d07b60…
2019-12-14 00:12 UTC2019-12N204655-00164288102019-11-03U-1874Drug product2014-04-243f01610625f2…
2019-12-14 00:12 UTC2019-12N204655-00164288102019-11-03U-1509Drug product2014-04-243f01610625f2…
2019-12-14 00:12 UTC2019-12N204655-0016428810*PED2020-05-03Pediatric extension3f01610625f2…
2019-09-15 20:21 UTC2019-09N204655-00164288102019-11-03U-1874Drug product2014-04-24b00525d2431f…
2019-09-15 20:21 UTC2019-09N204655-00164288102019-11-03U-1509Drug product2014-04-24b00525d2431f…
2019-09-15 20:21 UTC2019-09N204655-0016428810*PED2020-05-03Pediatric extensionb00525d2431f…
2019-07-19 19:46 UTC2019-07N204655-00164288102019-11-03U-1874Drug product2014-04-24ea99ee380514…
2019-07-19 19:46 UTC2019-07N204655-00164288102019-11-03U-1509Drug product2014-04-24ea99ee380514…
2019-07-19 19:46 UTC2019-07N204655-0016428810*PED2020-05-03Pediatric extensionea99ee380514…

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
Nexium 24HRESOMEPRAZOLE MAGNESIUMHaleon US Holdings LLC4513934d-0cf0-40fc-a348-b4e75a33b0942024-03-19WarningsExact identifier
ndc (package): 0573-2450-14
ndc (package): 0573-2450-15
ndc (package): 0573-2450-28
ndc (package): 0573-2450-02
ndc (package): 0573-2450-43
ndc (package): 0573-2452-42
ndc (package): 0573-2450-17
ndc (package): 0573-2452-14
ndc (package): 0573-2452-43
ndc (package): 0573-2452-02
ndc (package): 0573-2450-42
ndc (package): 0573-2450-44
ndc (product): 0573-2452
ndc (product): 0573-2450
ndc11 (package): 00573245015
ndc11 (package): 00573245042
ndc11 (package): 00573245202
ndc11 (package): 00573245242
ndc11 (package): 00573245002
ndc11 (package): 00573245044
ndc11 (package): 00573245243
ndc11 (package): 00573245214
ndc11 (package): 00573245017
ndc11 (package): 00573245014
ndc11 (package): 00573245028
ndc11 (package): 00573245043
spl id: 140967ff-7019-a38f-e063-6394a90ab708
spl set id: 4513934d-0cf0-40fc-a348-b4e75a33b094

Reported adverse events (FAERS/openFDA)#

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