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Omeprazole Delayed-Release 20 mg Tablet, Delayed Release — NDC 37808-569-41 (Billing 37808-0569-41)

by H-E-B · 3 BOTTLE in 1 CARTON / 14 TABLET, DELAYED RELEASE in 1 BOTTLE

This is a package of Omeprazole Delayed-Release 20 mg Tablet, Delayed Release from H-E-B, marketed since Jul 2026 and currently FDA-listed. It is the main listing for this product, which comes in 3 package sizes.

NDC 37808-0569-41
🏷️ FDA NDC (as labeled) 37808-569-41 billing pads the product segment with a zero
This package
Contains14 tablet, delayed release in 1 bottle Pack sizes3 compare ↓
Main listing for product 37808-569 · Also comes in: 14 tablets 37808-569-45 14 tablets 37808-569-82
OTC Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
Other active recalls for Omeprazole (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Jun 30, 2025 — Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules. (Dr. Reddy's Laboratories, Inc.) · FDA recall D-0525-2025
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 37808-569-41
Product NDC 37808-569
11-digit billing NDC 37808056941
RxCUI 402014
UNII 426QFE7XLK
Application # ANDA218829
SPL Set ID 448ba584-6a6e-3d85-e063-6294a90a5579
Established class (EPC) Proton Pump Inhibitor
Mechanism of action Cytochrome P450 2C19 Inhibitors; Proton Pump Inhibitors
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-07-01
Route ORAL
Dosage form TABLET, DELAYED RELEASE
Substance OMEPRAZOLE MAGNESIUM
Quick answers
  • RxCUI (RxNorm): 402014
Why two NDCs? The FDA registers this code as 37808-569-41 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 37808-0569-41. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Proton Pump Inhibitor class.

Pharmacologic class Proton Pump Inhibitor
Drug family (ATC) Proton pump inhibitors
How it works Proton Pump Inhibitors, Cytochrome P450 2C19 Inhibitors
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

📗 Our plain-language guide HelloPharmacist
  • It lowers stomach acid. Prescription versions treat ulcers, GERD, erosive esophagitis and H. pylori infection. Over-the-counter versions treat frequent heartburn, which is heartbur...
  • Take it by mouth once a day, before eating. For over-the-counter use, that means the morning, with water, for a 14-day course. Swallow capsules and regular tablets whole. Dissolvin...
  • It is not for immediate relief. The over-the-counter label says full effect can take 1 to 4 days. Some people feel complete relief within 24 hours.
  • The most common are headache, stomach pain, nausea, diarrhea, vomiting and gas. Call your doctor for diarrhea that does not go away, new rash or joint pain, or signs of an allergic...
📖 Read our full Omeprazole guide →
9
Nutrient depletion considerations

Omeprazole may be associated with lower levels of 9 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Omeprazole nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 14 tablets 14 tablets
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
37808-0569-41 You're viewing this Main listing 3 BOTTLE in 1 CARTON / 14 TABLET, DELAYED RELEASE in 1 BOTTLE 2026-07-01 — Active
37808-0569-45 37808-569-45 1 BOTTLE in 1 CARTON / 14 TABLET, DELAYED RELEASE in 1 BOTTLE 2026-07-01 — Active
37808-0569-82 37808-569-82 2 BOTTLE in 1 CARTON / 14 TABLET, DELAYED RELEASE in 1 BOTTLE 2026-07-01 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 3 bottle in 1 carton / 14 tablet, delayed release in 1 bottle.
What NDC number is used to bill for this package of Omeprazole Delayed-Release 20 mg Tablet, Delayed Release?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Acid Reducer 20 mg 70000-0521-01 Cardinal 14 tablets $0.383 — FDA listed —
Acid Reducer 20 mg 00536-1322-13 Rugby 14 tablets $0.473 — Availability likely —
Acid Reducer 20 mg 10202-0722-05 7-Eleven 14 tablets — — FDA listed —
Acid Reducer 20 mg 53943-0016-05 DISCOUNT 14 tablets — — FDA listed —
Acid Reducer 20 mg 63941-0006-05 Best 14 tablets — — FDA listed —
Acid Reducer 20 mg 69618-0054-42 RELIABLE 14 tablets — — FDA listed —
Acid Reducer 20 mg 49035-0983-62 Wal-Mart 14 tablets — — FDA listed —
Acid Reducer 20 mg 57483-0120-42 INNOVUS 14 tablets — — FDA listed —
Acid Reducer 20 mg 80136-0852-03 NORTHEAST 14 tablets — — FDA listed —
Acid Reducer 20 mg 30142-0077-01 KROGER 14 tablets — — FDA listed —
Acid Reducer 20 mg 58602-0729-01 Aurohealth 14 tablets — — FDA listed —
Acid Reducer 20 mg 67091-0316-14 Winco 14 tablets — — FDA listed —
Omeprazole 20 mg 59726-0740-42 P 14 tablets — — FDA listed —
Acid Reducer 20 mg 69842-0941-01 CVS 14 tablets — — FDA listed —
Amazon Basic Care Omeprazole 20 mg 72288-0409-01 Amazon.com 14 tablets — — FDA listed —
Acid Reducer 20 mg 00363-1008-05 WALGREEN 14 tablets — — FDA listed —
Acid Reducer 20 mg 58602-0826-05 Aurohealth 14 tablets — — FDA listed —
Acid Reducer 20 mg 37835-0189-14 Bi-Mart 14 tablets — — FDA listed —
Acid Reducer 20 mg 58602-0850-05 Aurohealth 14 tablets — — FDA listed —
Acid Reducer 20 mg 55315-0996-04 Fred's, 14 tablets — — FDA listed —
Acid Reducer 20 mg 55319-0037-05 Family 14 tablets — — FDA listed —
Omeprazole 20 mg 59726-0744-42 P 14 tablets — — FDA listed —
Omeprazole Delayed-Release 20 mgthis 37808-0569-41 H-E-B 14 tablets — — FDA listed —
Omeprazole Delayed release 20 mg 61269-0720-14 H2-Pharma, 14 tablets — — FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2026
On the market since
Jul 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

Color pink
ShapeOval
Imprint91
Size14 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 2S7830E561
    Crospovidone is a synthetic polymer derived from povidone. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the active ingredient can be absorbed.
  • UNII 92RU3N3Y1O
    Dimethicone is a silicone-based oil that acts as an anti-foaming agent and lubricant in medicines. It reduces gas bubbles in liquid formulations and helps coat and protect the stomach lining when ingested.
  • UNII 1K09F3G675
    Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
  • UNII 230OU9XXE4
    A waxy substance made from glycerin and stearic acid that acts as an emulsifier to blend oily and watery ingredients together. It also helps thicken and stabilize the medicine's texture.
  • UNII 9XZ8H6N6OH
    A plant-based cellulose derivative used as a binder to hold tablet ingredients together, a thickener in liquids, and a coating agent to control how fast the medicine dissolves.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII NX76LV5T8J
    A synthetic plastic polymer made from methacrylic acid and ethyl acrylate. It's used as a coating or binder to control how and where the medicine dissolves in your digestive system.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII B697894SGQ
    Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • UNII 30IQX730WE
    Polyethylene glycol 6000 is a synthetic polymer made from ethylene glycol units. It acts as a binder, filler, and solubilizer in medicines to help hold ingredients together, add bulk, and improve how well active drugs dissolve and absorb.
  • UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 7CV7WJK4UI
    Sodium stearyl fumarate is a synthetic compound made from stearyl alcohol and fumaric acid. It acts as a lubricant and glidant in tablets and capsules, helping ingredients flow smoothly during manufacturing and preventing sticking.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
  • UNII C151H8M554
    A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
  • UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
  • UNII 8Z96QXD6UM
    Triethyl citrate is a clear liquid derived from citric acid. It acts as a plasticizer and solvent in tablet coatings and film formulations, helping the coating remain flexible and adhere properly to the medicine.

19 inactive ingredients listed in the exact product block matched to this NDC.

The official label also statesInactive ingredients colloidal silicone dioxide, crospovidone, glyceryl monostearate, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, microcrystalline cellulose, polyethylene glycol 400, polyethylene glycol 6000, polysorbate 80, red iron oxide, simethicone, sodium stearyl fumarate, starch, sucrose, talc, titanium dioxide, triethyl citrate

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerH-E-B
Application holderMARKSANS PHARMA LTD
FDA applicationANDA218829 (ANDA)
Labeler code37808
First marketedJul 2026
Product typeHuman Otc Drug
Portfolio15 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 Ask a Doctor Before Use If 📄 Ask a Doctor or Pharmacist Before Use If 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Other Information 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 29 words ▾

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

⏱️ Dosage and Administration 160 words ▾

Directions for adults 18 years of age and older this product is to be used once a day (every 24 hours), every day for 14 days it may take 1 to 4 days for full effect; some people get complete relief of symptoms within 24 hours 14-Day Course of Treatment - swallow 1 tablet with a glass of water before eating in the morning - take every day for 14 days - do not take more than 1 tablet a day - do not use for more than 14 days unless directed by your doctor - swallow whole. Do not chew or crush tablets. Repeated 14-Day Courses (if needed) - 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.

Heartburn in children may sometimes be caused by a serious condition.

⚠️ Warnings ~1 min read ▾

Warnings Allergy alert: Do not use if you are allergic to omeprazole. Omeprazole may cause severe skin reactions. Symptoms may include: - skin reddening - blisters - rash If an allergic reaction occurs, stop use and seek medical attention right away.

Do not use if you have: 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: 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 Ask a doctor or pharmacist before use if you are taking a prescription drug. Acid reducers may interact with certain prescription drugs. Stop use and ask a doctor if 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 If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

🧪 Active Ingredient 15 words ▾

Active ingredient (in each tablet) Omeprazole, USP 20 mg (equivalent to 20.6 mg omeprazole magnesium)

🧪 Inactive Ingredients 43 words ▾

Inactive ingredients colloidal silicone dioxide, crospovidone, glyceryl monostearate, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, microcrystalline cellulose, polyethylene glycol 400, polyethylene glycol 6000, polysorbate 80, red iron oxide, simethicone, sodium stearyl fumarate, starch, sucrose, talc, titanium dioxide, triethyl citrate

🎯 Purpose 3 words ▾

Purpose Acid reducer

📄 Do Not Use 58 words ▾

Do not use if you have: 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 36 words ▾

Ask a doctor before use if you have: 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

📄 Ask a Doctor or Pharmacist Before Use If 22 words ▾

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

📄 Stop Use and Ask a Doctor If 46 words ▾

Stop use and ask a doctor if 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

🤰 If Pregnant or Breast-Feeding 10 words ▾

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

📄 Keep Out of Reach of Children 22 words ▾

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

📄 Other Information 24 words ▾

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

📄 Questions or Comments 5 words ▾

Questions or comments? Call 1-877-290-4008

📄 Package Label / Principal Display Panel 32 words ▾

731R HEB 14ct label 731R HEB 14ct carton 731R HEB 28ct carton 731R HEB 42ct carton 731R HEB 14ct label 731R HEB 14ct carton 731R HEB 28ct carton 731R HEB 42ct carton

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Omeprazole (matched by generic name) — the program that covers self-administered drugs. 14 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Omeprazole. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$75.01M
Claims incl. refills
7.1M
Beneficiaries
5.3M
Spend / beneficiary
$14.18
Spend / claim
$10.59
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Omeprazole Delayed-Release (this brand).

Top reported reactions

Fatigue20,600
Nausea20,530
Diarrhoea20,329
Dyspnoea16,907
Headache15,219
Pain14,226
Vomiting13,731

Reporter sex

341,711 reports

Serious outcomes

Hospitalization125,668
Death31,099
Life-threatening17,249
Disabling12,103
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 31,574 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Over-the-counter (OTC) product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by H-E-B. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 14 tablets (37808-0569-45), 14 tablets (37808-0569-82). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
H-E-B is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 37808-0564-25 · H 37808-0574-02 · HEB →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.