FDA-filed SPL labeling · retrieved through openFDA

Dexlansoprazole

Dexlansoprazole is a proton pump inhibitor (acid-blocking medicine) used to heal erosive esophagitis, maintain healing of erosive esophagitis, and treat heartburn from GERD.

Brand name Dexilant
Drug class ⓘ Proton Pump Inhibitors
Rx Form 1 Route Oral
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 16 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

At a glance
Linked label effectiveAug 3, 2023
Clinical labels in scope ⓘ16
AvailabilityRx
Earliest approval/marketing year ⓘ2009
FDA-listed product records ⓘ63
Boxed warningNone found in compared labels
How we combine label and product data →
✓No current FDA shortage listed · checked Sep 25, 2026
⭐ Dexlansoprazole at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Dexlansoprazole is a once-daily acid-blocking capsule approved to heal erosive esophagitis, maintain that healing, and relieve heartburn from GERD in patients 12 and older. It works well when used as directed, but long-term use warrants monitoring for low magnesium, low B12, and bone health. Always take the lowest dose for the shortest time your condition requires, and keep your prescriber updated on all other medicines you take.
How we write & review this content — our editorial policy →

📖 Dexlansoprazole: Patient Information Guide

A plain-language walkthrough of Dexlansoprazole — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for▾

Dexlansoprazole delayed-release capsules are a proton pump inhibitor (PPI) approved for the following uses in patients 12 years of age and older:

  • Healing erosive esophagitis (EE): Dexilant and dexlansoprazole delayed-release capsules are approved to heal all grades of EE — acid-caused damage to the esophagus lining — for up to 8 weeks.
  • Maintaining healed EE and relieving heartburn: Dexilant and dexlansoprazole delayed-release capsules are approved to keep the esophagus healed and control heartburn — up to 6 months in adults and up to 16 weeks in adolescents 12–17 years old.
  • Symptomatic non-erosive GERD: Dexilant and dexlansoprazole delayed-release capsules are approved to treat heartburn in people with GERD who do not have visible esophageal damage, for 4 weeks.
⚙️How it works▾

Dexlansoprazole belongs to a class of medicines called proton pump inhibitors (PPIs). It works by directly blocking the H+/K+-ATPase enzyme — the "proton pump" — on the acid-secreting cells of the stomach lining. This pump is the final step in producing stomach acid, so blocking it cuts acid production at the source and allows irritated or damaged esophageal tissue to heal.

The capsule uses a dual delayed-release design, meaning it releases the medicine in two separate waves — one within the first 1–2 hours and a second wave 4–5 hours after you take it. This keeps acid suppression going longer throughout the day.

💊How it's taken▾

Dexlansoprazole delayed-release capsules are taken once daily by mouth. They can be taken with or without food. The capsule should be swallowed whole; do not chew it.

  • If swallowing is difficult, open the capsule and sprinkle the intact granules or pellets onto a tablespoon of applesauce and swallow right away — do not chew the pellets.
  • The contents can also be mixed with water and administered by oral syringe or nasogastric (NG) tube following specific preparation steps.
  • If you miss a dose, take it as soon as you remember — unless your next scheduled dose is coming up soon, in which case skip the missed dose. Never take two doses at once.

The duration of treatment differs by condition — from 4 weeks for non-erosive GERD to up to 6 months for maintaining healed EE. Follow your prescriber's instructions exactly.

🤒Side effects — in detail▾

The most common side effects reported in clinical trials include:

  • Diarrhea
  • Abdominal (stomach) pain
  • Nausea
  • Upper respiratory tract infection
  • Vomiting
  • Flatulence (gas)
  • Headache, abdominal pain, and sore throat (more common in adolescents 12–17)

More serious reactions — including severe allergic reactions, kidney inflammation, very low magnesium levels (causing muscle cramps or irregular heartbeat), severe skin reactions, and a lupus-like condition — require prompt medical attention. Call your doctor right away if you notice any of these.

⚠️Warnings & precautions▾
  • Serious allergic reactions and kidney inflammation: Dexlansoprazole can, rarely, cause acute tubulointerstitial nephritis (sudden kidney inflammation) or severe allergic reactions including anaphylaxis. Stop taking it and seek care immediately if you have trouble breathing, facial swelling, or signs of kidney trouble.
  • Severe skin reactions: Rare but life-threatening skin conditions like Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported. Stop the medicine at the first sign of blistering, peeling, or a widespread rash.
  • Low magnesium (hypomagnesemia): Long-term use can deplete magnesium, potentially causing muscle cramps, irregular heartbeat, or seizures. Monitoring may be needed, especially if you also take digoxin or diuretics.
  • Lupus-like reactions: Both skin-only and systemic lupus erythematosus have been reported with PPI use. If you develop a new rash or joint pain, tell your doctor.
  • Bone fractures: Long-term or high-dose PPI use is linked to a higher risk of hip, wrist, and spine fractures. Use the lowest dose for the shortest time needed.
  • C. difficile infection: PPI use may increase the risk of a serious gut infection called Clostridioides (formerly Clostridium) difficile, especially in hospitalized patients. Persistent diarrhea should be evaluated.
  • Vitamin B12 deficiency: Using acid-suppressing medicines for more than 3 years may reduce absorption of vitamin B12.
  • Gastric malignancy: In adults, feeling better on this medicine does not rule out stomach cancer. If symptoms return quickly or don't respond well, further evaluation may be needed.
  • Not for children under 2 years old: Animal studies showed heart valve thickening; dexlansoprazole is not recommended in pediatric patients under age 2.
🔀What it interacts with▾

Dexlansoprazole can interact with several medications — always tell your prescriber and pharmacist everything you take:

  • Rilpivirine-containing HIV products — absolutely contraindicated; combining these reduces HIV treatment effectiveness and is not safe.
  • Nelfinavir (HIV medicine) — avoid combining; dexlansoprazole reduces its absorption and effectiveness.
  • Warfarin (blood thinner) — can increase warfarin's effect, raising bleeding risk; INR needs to be monitored.
  • Methotrexate — dexlansoprazole may raise methotrexate levels in the blood, increasing the risk of toxicity, particularly at high doses used for cancer.
  • Digoxin (heart medicine) — dexlansoprazole may increase digoxin blood levels; monitoring and possible dose adjustment needed.
  • Tacrolimus (transplant anti-rejection drug) — blood levels may rise, especially in poor metabolizers of CYP2C19; close monitoring required.
  • St. John's Wort and rifampin — these can lower dexlansoprazole levels significantly; avoid combining.
  • Iron salts, antifungals (ketoconazole, itraconazole), and some cancer drugs — lower stomach acid from dexlansoprazole can reduce absorption of these medications.
  • Neuroendocrine tumor tests and secretin stimulation tests — dexlansoprazole can cause false positive results; stop the medicine at least 14–30 days before these tests as directed.

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it▾
  • Do not take dexlansoprazole if you are allergic to any of its ingredients or if you take rilpivirine-containing HIV medications.
  • Tell your doctor if you have moderate or severe liver disease — a dose adjustment may be needed, and the medicine is not recommended in severe liver impairment.
  • Tell your doctor if you are pregnant. Animal studies suggest possible effects on fetal bone development; discuss the risks and benefits with your healthcare provider.
  • If you are breastfeeding, talk to your doctor — it is not known whether dexlansoprazole passes into human breast milk.
  • This medicine is approved for ages 12 and older only. It should not be used in children under 2 years of age.
  • Older adults (65+) can take dexlansoprazole; no overall differences in safety or effectiveness were observed compared to younger adults, but report any new symptoms to your doctor.
  • Tell your doctor if you take digoxin, diuretics, tacrolimus, methotrexate, or any HIV medications before starting dexlansoprazole.
  • If you have a history of low magnesium, low calcium, or osteoporosis, make sure your doctor knows before starting long-term therapy.
🚑If you take too much▾

There are no reports of significant harm from dexlansoprazole overdose. High doses used in studies did not cause death, though serious high blood pressure has been reported with above-recommended doses. If you think you or someone else has taken too much, call Poison Control at 1-800-222-1222 right away. Treatment is supportive, and dexlansoprazole is not removed by dialysis.

📡Pharmacodynamics — effects in the body▾

Dexlansoprazole significantly raises the pH (reduces the acidity) inside the stomach. In a clinical study, a once-daily dose kept stomach acid suppressed for about 17 hours out of every 24 — longer than comparator lansoprazole at 14 hours. With long-term use, the body responds to reduced acid by producing more of a hormone called gastrin; this returns to normal levels within about a month of stopping the medicine. At doses up to five times the maximum recommended amount, dexlansoprazole does not cause any clinically meaningful changes to heart rhythm.

🔬Pharmacokinetics — how your body processes it▾

Dexlansoprazole uses a dual delayed-release design that produces two absorption peaks — one within 1–2 hours after taking it, and a second 4–5 hours later — providing prolonged acid suppression from a single daily dose. The medicine is extensively broken down in the liver, mainly by enzymes CYP2C19 and CYP3A4, into inactive metabolites; none of the original drug is excreted unchanged in urine. Its half-life (the time for half the drug to leave the body) is approximately 1–2 hours. About half the absorbed drug is excreted in urine and half in feces, and food intake can modestly affect how much is absorbed, though the capsule can be taken with or without food.

📦How to store it▾

Store at 20 to 25°C (68 to 77°F); excursions permitted to 15 to 30°C (59 to 86°F) .

📄 Written from Dexlansoprazole’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

153

Supplements & herbs that interact with Dexlansoprazole

153 supplements and herbal products have documented interactions with Dexlansoprazole in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 3
  • Moderate · 101
  • Minor · 49
ACTIVATED CHARCOAL Major GRAPEFRUIT Major ST. JOHN'S WORT Major ACACIA RIGIDULA Moderate ADRAFINIL Moderate AFRICAN WILD POTATO Moderate AMERICAN ELDER Moderate ARTICHOKE Moderate +145 more
Every supplement checked against Dexlansoprazole — ranked by severity The full interaction hub: 3 major · 101 moderate · 49 minor · every one linked to its full report. Check Dexlansoprazole against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

9

Nutrient depletion considerations

Dexlansoprazole has been associated with lower levels of 9 nutrients in the clinical literature. This does not mean a deficiency will occur — it means these may be worth discussing with your pharmacist or healthcare provider, especially with long-term use.

Evidence & significance mix
  • Higher significance · 5
  • Moderate · 1
  • Unrated · 3
CALCIUM Insignificant Depletion FOLIC ACID Insignificant Depletion IRON Insignificant Depletion MAGNESIUM Major Depletion ZINC Insignificant Depletion VITAMIN B12 Moderate Depletion BETA-CAROTENE Insufficient Evidence CHROMIUM Insufficient Evidence +1 more
See the full Dexlansoprazole nutrient depletion report

Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.

🩺 Pharmacist Counseling Corner

Quick, plain-English answers to the questions patients ask most about Dexlansoprazole — the kind of thing our pharmacy team would talk through with you at the counter.

Can I take this medicine with food, or do I need to take it on an empty stomach? ▾
Good news — you can take dexlansoprazole with or without food, whichever is easier for you. Unlike some older acid-suppressing medicines, there's no requirement to time it before meals. Just try to take it around the same time each day to keep things consistent.
I have trouble swallowing capsules. Is there another way to take this? ▾
Yes, absolutely. You can open the capsule and sprinkle the small pellets or granules onto one tablespoon of applesauce, then swallow the mixture right away — just don't chew the pellets. You can also mix the contents with water and use an oral syringe to take it, or it can be given through a feeding tube. The key is to never chew the pellets, since that would ruin the delayed-release design.
How long will I need to take this? ▾
That depends on why you're taking it. For healing an irritated or damaged esophagus, treatment typically runs up to 8 weeks. For keeping it healed and controlling heartburn, it can be continued up to 6 months in adults. For non-erosive acid reflux, it's usually about 4 weeks. Your doctor will guide you on the right duration for your situation — the general principle is to use the lowest dose for the shortest time that works for you.
Are there any medicines I really should not take alongside this? ▾
Yes — if you take any HIV medicine that contains rilpivirine (like Complera, Odefsey, or Juluca), you absolutely cannot take dexlansoprazole at the same time; that combination is contraindicated. You should also avoid nelfinavir, another HIV drug. If you take warfarin, digoxin, tacrolimus, or methotrexate, let your doctor know, as dexlansoprazole can affect how those medicines work. St. John's Wort and the antibiotic rifampin can also reduce how well dexlansoprazole works, so those should be avoided too.
What side effects should I actually worry about versus just put up with? ▾
The most common ones — diarrhea, stomach pain, nausea, gas — are usually mild and often settle down. Those you can generally ride out and mention at your next visit. But call your doctor right away if you have severe or ongoing diarrhea (possible gut infection), trouble breathing or facial swelling (allergic reaction), blistering or peeling skin, new joint pain with a rash (could be a lupus-like reaction), or muscle cramps with an irregular heartbeat (low magnesium). These are rarer but need attention quickly.
Is it safe to take this for a long time? ▾
Dexlansoprazole is effective long-term when needed, but longer use does come with some things to watch. After several months to years, some people develop low magnesium or vitamin B12 levels, and there's a small increased risk of hip, wrist, or spine fractures. Your doctor may periodically check your magnesium and bone health if you're on it long-term. The goal is always to use the lowest dose that keeps your condition under control — so check in with your prescriber regularly about whether you still need it.
Is Dexlansoprazole available over the counter? ▾
Dexlansoprazole is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
When was Dexlansoprazole first available? ▾
Dexlansoprazole has been available in the United States since at least 2009, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Dexlansoprazole? ▾
Dexlansoprazole is supplied by 27 manufacturers listed in the FDA NDC Directory, including A-S Medication Solutions, Twi Pharmaceuticals, Inc., Takeda Pharmaceuticals America, Inc..

💬 Answers drafted from Dexlansoprazole’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

📊Dexlansoprazole supplement interactions153 checked — ranked by severity 🌿Drug & Supplement CheckerDexlansoprazole vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Dexlansoprazole NDCs & costs 🅰️Browse Drugs A–ZLook up any medication

💊 How Dexlansoprazole comes

Dexlansoprazole is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Delayed-release capsule

By mouth
Brands Dexilant
How this form is used
What it may be used for
  • Dexilant is approved to heal all grades of erosive esophagitis (EE) in patients 12 and older
  • Dexilant is approved to maintain healed EE and relieve heartburn in patients 12 and older
  • Dexilant is approved to treat heartburn from symptomatic non-erosive GERD in patients 12 and older
  • Dexlansoprazole delayed-release capsules carry the same three approvals: healing EE, maintaining healed EE with heartburn relief, and treating symptomatic non-erosive GERD in patients 12 and older
Important instructions
  • Take once daily by mouth, with or without food; swallow the capsule whole and do not chew
  • If you have trouble swallowing, open the capsule and sprinkle the intact pellets or granules onto one tablespoon of applesauce — swallow immediately and do not chew
  • The capsule contents can also be mixed with water and given by oral syringe or nasogastric (NG) tube — follow the detailed steps in the prescribing information
  • If you miss a dose, take it as soon as you remember unless your next dose is due soon — never take two doses at once
Available strengths 2 strengths
30 mg 60 mg
47 FDA-listed product records ⓘ

📊 Dexlansoprazole across the U.S. market

How Dexlansoprazole appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

1
Dose forms ⓘ
27
Manufacturers
3
Brand names
63
FDA-listed product records ⓘ
2009
First marketed ⓘ

Also listed with the FDA, not a patient dose form: Powder (16) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

A-S Medication Solutions10%
Twi Pharmaceuticals, Inc.10%
Takeda Pharmaceuticals America, Inc.10%
Golden State Medical Supply, Inc.10%
Bryant Ranch Prepack6%
Par Pharmaceutical, Inc.5%
Other makers51%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

📈 How widely Dexlansoprazole is used

A general measure of how commonly Dexlansoprazole is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Dexlansoprazole is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

141,938
Medicaid prescriptions filled (Q1–Q4 2025)
$34.2M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Dexlansoprazole prescribed? Of the 1,597 medications we measure, Dexlansoprazole ranks #448 by Medicaid prescriptions — more than 72% of them.

Where Dexlansoprazole ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #448 of 1,597
#443 Scopolamine Transderma... 143,028 Rx #444 Somatropin 142,879 Rx #445 Indomethacin 142,731 Rx #446 Lovastatin 141,955 Rx #447 Regadenoson 141,955 Rx #448 Dexlansoprazole 141,938 Rx #449 Levocarnitine 141,917 Rx #450 Acetazolamide 141,794 Rx #451 Letrozole 140,810 Rx #452 Cenobamate 139,992 Rx #453 Empagliflozin / Metfor... 139,145 Rx

Utilization by Dexlansoprazole product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 60 mg delayed release oral capsule is the most-dispensed Dexlansoprazole product — about 82% of these Medicaid prescriptions.

dexlansoprazole 60 MG Delayed Release Oral Capsule Most dispensed

116,439 Medicaid prescriptions (Q1–Q4 2025) 82% of Dexlansoprazole prescriptions shown $28M gross reimbursement (before rebates) ≈ $240 per prescription (gross)

Summed across the 8 of 34 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 833213

dexlansoprazole 30 MG Delayed Release Oral Capsule

25,499 Medicaid prescriptions (Q1–Q4 2025) 18% of Dexlansoprazole prescriptions shown $6.2M gross reimbursement (before rebates) ≈ $242 per prescription (gross)

Summed across the 4 of 22 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 833204

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Dexlansoprazole, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 12 of 56 listed Dexlansoprazole NDCs with Medicaid activity.

🔍 Compare Dexlansoprazole products

A representative set of FDA-listed product records for Dexlansoprazole — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 63 of 63 products — FDA National Drug Code Directory. See every product, package size and price: browse all 63 Dexlansoprazole NDCs →

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Dexlansoprazole RxCUI 816346 1 dose form · 2 strengths
  1. Dose form (SCDF) Delayed Release Oral Capsule RxCUI 833203 In current FDA listings
    Clinical drug / strength (SCD) 30 MG RxCUI 833204 60 MG RxCUI 833213

Look up RxCUI 816346 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

🏷️ Sold under these brand names

Dexilant

🏭 Manufacturers & labelers

A-S Medication Solutions 6 Twi Pharmaceuticals, Inc. 6 Takeda Pharmaceuticals America, Inc. 6 Golden State Medical Supply, Inc. 6 Bryant Ranch Prepack 4 Par Pharmaceutical, Inc. 3 Metrochem API Private Limited 3 Alembic Pharmaceuticals Inc. 2 Upsher-Smith Laboratories, LLC 2 Takeda GmbH, Oranienburg 2 Par Health USA, LLC 2 Mylan Pharmaceuticals Inc. 2 MSN Laboratories Private Limited 2 Hetero Drugs Limited 2 Dr.Reddy's laboratories Limited 2 Alembic Pharmaceuticals Limited 2 Matrix Pharmacorp Private Limited 1 Jubilant Biosys limited 1 MSN Life Sciences Private Limited 1 Optimus Drugs Private Limited 1 Chromo Laboratories India Private Limited 1 Cardinal Health 107, LLC 1 Piramal Pharma Limited 1 Remedyrepack Inc. 1

…and 3 more on the FDA NDC directory.

RxNorm drug class

Dexlansoprazole belongs to the Proton Pump Inhibitor class.

Pharmacologic class Proton Pump Inhibitor
Drug family (ATC) Proton pump inhibitors
How it works Proton Pump Inhibitors

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

🔬 Where this comes from

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Aug 3, 2023
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Dexlansoprazole.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Dexlansoprazole after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
16
NDC products indexed
63
Distinct labelers/manufacturers represented
27
Linked representative label ⓘ
Twi Pharmaceuticals, Inc.
Linked label effective
Aug 3, 2023
Composite sections available
24
Linked SPL Set ID
9abcfb1e-c894-44bb-807a-e4bdd755f28f
Linked SPL Document ID
cceebcc4-476b-4e95-a711-9a58936a16bf
Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 16 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Twi Pharmaceuticals, Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.