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ANTACID AND GASRELIEF aluminum hydroxide, magnesium hydroxide, simethicone 800 mg/10mL; 800 mg/10mL; 80 mg/10mL Liquid, 355 mL — NDC 50804-0638-12 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

ANTACID AND GASRELIEF aluminum hydroxide, magnesium hydroxide, simethicone 800 mg/10mL; 800 mg/10mL; 80 mg/10mL Liquid, 355 mL — NDC 50804-638-12 (Billing 50804-0638-12)

by GOODSENSE · 355 mL in 1 BOTTLE

This is a package of 355 mL of ANTACID AND GASRELIEF aluminum hydroxide, magnesium hydroxide, simethicone 800 mg/10mL; 800 mg/10mL; 80 mg/10mL Liquid from GOODSENSE, marketed since Jul 2020 and currently FDA-listed. It is this product's only package size.

NDC 50804-0638-12
🏷️ FDA NDC (as labeled) 50804-638-12 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 1, 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

NDC database record

One package, one record: these facts belong to NDC 50804-638-12 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
50804 labeler · 638 product · 12 package
Package marketed since
Jul 1, 2020
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
355 mL per package
Barcode (UPC-A, from the NDC)
3 5080463812 2
FDA record last changed
Oct 1, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 50804-638-12
Product NDC 50804-638
11-digit billing NDC 50804063812
NCPDP billing unit ML — per mL (volume)
RxCUI 237870
UNII 5QB0T2IUN0, NBZ3QY004S, 92RU3N3Y1O
Application # M001
SPL Set ID a9654a96-9bf9-60ea-e053-2995a90ae38d
Physiologic effect Skin Barrier Activity
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2020-07-01
Route ORAL
Dosage form LIQUID
Substance ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 48991003101835
GCN Seq No 002706
GCN 63915
HICL code 001168
Ingredient (HICL) Mag Hydrox/Aluminum Hyd/Simeth
HIC1 code D
Therapeutic class — broad (HIC1) Biliary System/Gastro-Intestinal System
HIC2 code D4
Therapeutic class — intermediate (HIC2) Drugs Acting Principally On The Alimentary Tract
HIC3 code D4B
Therapeutic class — specific (HIC3) Antacids
AHFS code 56:04.00.00
AHFS class Antacids And Adsorbents
FDB label name GS ANTACID-GAS RELIEF LIQUID
FDB brand name Antacid-Gas Relief
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 002706
  • GCN: 63915
  • GPI-14 (Medi-Span): 48991003101835
  • HICL (First Databank): 001168
  • AHFS class code: 56:04.00.00
  • RxCUI (RxNorm): 237870
Why two NDCs? The FDA registers this code as 50804-638-12 — 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 → 50804-0638-12. 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 Aluminium compounds class.

Drug family (ATC) Aluminium compounds
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

Label name GS ANTACID-GAS RELIEF LIQUID Ingredient Mag Hydrox/Aluminum Hyd/Simeth
📖 About the active ingredient MedlinePlus · NLM
General information about the ingredient itself — the description of this specific product follows below.

Aluminum Hydroxide, Magnesium Hydroxide are antacids used together to relieve heartburn, acid indigestion, and upset stomach. They may be used to treat these symptoms in patients with peptic ulcer, gastritis, esophagitis, hiatal hernia, or too much acid in the stomach (gastric hyperacidity). They combine with stomach acid and neutralize it. Aluminum Hydroxide, Magnesium Hydroxide are available without a prescription. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Read the full MedlinePlus article ↗
🧪 What is this product?

This is an over-the-counter oral liquid product marketed under FDA's standard rules for antacid and anti-gas medicines. It contains aluminum hydroxide and magnesium hydroxide, which are typically used to neutralize stomach acid and provide relief from heartburn and indigestion. The product also contains simethicone (a form of dimethicone), which is commonly used to help break up gas bubbles in the digestive tract and reduce bloating and discomfort.

5
Nutrient depletion considerations

Aluminum Hydroxide, Magnesium Hydroxide, Simethicone (OTC drug) may be associated with lower levels of 5 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Aluminum Hydroxide, Magnesium Hydroxide, Simethicone (OTC drug) 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 mLPer 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.
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
50804-0638-12 You're viewing this Main listing 355 mL in 1 BOTTLE 2020-07-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Maximum Strength Antacid 400 mg/5mL; 400 mg/5mL; 40 mg/5mL 63868-0715-57 Chain 355 ml $0.010 — FDA listed —
Almacone Double Strength 400 mg/5mL; 400 mg/5mL; 40 mg/5mL 00536-0015-83 RUGBY 355 ml $0.012 — Availability likely —
Mintox Maximum Strength 400 mg/5mL; 400 mg/5mL; 40 mg/5mL 00904-5725-14 MAJOR 355 ml $0.012 — Availability likely —
Antacid Antigas Nta 800 mg/10mL; 800 mg/10mL; 80 mg/10mL 46122-0431-40 AMERISOURCEBERGEN 355 ml $0.012 — Availability likely —
Antacid Antigas Nta 800 mg/10mL; 800 mg/10mL; 80 mg/10mL 46122-0432-40 AMERISOURCEBERGEN 355 ml $0.012 — Availability likely —
Maximum Strength Antacid 800 mg/10mL; 800 mg/10mL; 80 mg/10mL 70000-0062-01 CARDINAL 355 ml $0.012 — Availability likely —
Maximum Strength Antacid 400 mg/5mL; 400 mg/5mL; 40 mg/5mL 70000-0422-01 CARDINAL 355 ml $0.012 — Availability likely —
Maximum Strength Antacid Antigas 400 mg/5mL; 400 mg/5mL; 40 mg/5mL 70677-1064-01 STRATEGIC 355 ml $0.012 — Availability likely —
Maximum Strength Antacid And Antigas 400 mg/5mL; 400 mg/5mL; 40 mg/5mL 70677-1065-01 STRATEGIC 355 ml $0.012 — Availability likely —
QCH Maximum Strength Antacid 516 800 mg/10mL; 800 mg/10mL; 80 mg/10mL 83324-0122-12 Chain 355 ml $0.012 — Availability likely —
Mag-AL Plus XS 400 mg/5mL; 400 mg/5mL; 40 mg/5mL 00121-1762-30 PAI 10 cups — — FDA listed —
Maximum Strength Antacid Antigas 400 mg/5mL; 400 mg/5mL; 40 mg/5mL 00363-1691-12 WALGREEN 355 ml — — FDA listed —
Maximum Strength Antacid And Gas Relief 400 mg/5mL; 400 mg/5mL; 40 mg/5mL 11822-3727-06 RITE 355 ml — — Discontinued —
Maximum Strength Antacid And Antigas 400 mg/5mL; 400 mg/5mL; 40 mg/5mL 11822-5742-00 RITE 355 ml — — Discontinued —
Mintox Maximum Strength 400 mg/5mL; 400 mg/5mL; 40 mg/5mL 17856-5725-03 ATLANTIC 30 ml — — FDA listed —
Antacid 400 mg/5mL; 400 mg/5mL; 40 mg/5mL 21130-0508-05 Safeway 177 ml — — FDA listed —
Antacid Plus 800 mg/10mL; 800 mg/10mL; 80 mg/10mL 21130-0691-12 BETTER 355 ml — — FDA listed —
Maximum Strength Antacid 400 mg/5mL; 400 mg/5mL; 40 mg/5mL 30142-0638-12 KROGER 355 ml — — FDA listed —
Maximum Strength Antacid Mint 800 mg/10mL; 800 mg/10mL; 80 mg/10mL 36800-0342-40 Topco 355 ml — — FDA listed —
Maximum Strength Antacid Cherry liquid 800 mg/10mL; 800 mg/10mL; 80 mg/10mL 36800-0587-40 Topco 355 ml — — FDA listed —
maximum strength antacid cherry 800 mg/10mL; 800 mg/10mL; 80 mg/10mL 41163-0065-05 UNITED 355 ml — — FDA listed —
Maximum Strength Antacid Cherry 800 mg/10mL; 800 mg/10mL; 80 mg/10mL 49035-0638-12 WAL-MART 355 ml — — FDA listed —
Maximum Strength Antacid 800 mg/10mL; 800 mg/10mL; 80 mg/10mL 49035-0681-12 WAL-MART 355 ml — — FDA listed —
Maximum Strength Antacid And Gasrelief 800 mg/10mL; 800 mg/10mL; 80 mg/10mL 50804-0619-12 GOODSENSE 355 ml — — FDA listed —
Antacid And Gasrelief 800 mg/10mL; 800 mg/10mL; 80 mg/10mLthis 50804-0638-12 GOODSENSE 355 ml — — FDA listed —
Maximum Strength Antacid 800 mg/10mL; 800 mg/10mL; 80 mg/10mL 51316-0142-12 CVS 355 ml — — FDA listed —
Mag-Al Plus XS 2400 mg/30mL; 2400 mg/30mL; 240 mg/30mL 55154-9422-05 Cardinal 5 cups — — FDA listed —
Maximum Strength Advanced Antacid 800 mg/10mL; 800 mg/10mL; 80 mg/10mL 55910-0638-12 DOLGENCORP, 355 ml — — FDA listed —
Aluminum Hydroxide, Magnesium Hydroxide and Simethicone 2400 mg/30mL; 2400 mg/30mL; 240 mg/30mL 57237-0324-31 Rising 100 cups — — FDA listed —
Geri-Lanta Maximum Strength 400 mg/5mL; 400 mg/5mL; 40 mg/5mL 57896-0619-12 Geri-Care 355 ml — — FDA listed —
Geri-Mox Max Cherry 400 mg/5mL; 400 mg/5mL; 40 mg/5mL 57896-0638-10 Geri-Care 100 cups — — FDA listed —
MAXIMUM STRENGTH Antacid 400 mg/5mL; 400 mg/5mL; 40 mg/5mL 57896-0664-12 Geri-Care 355 ml — — FDA listed —
Aluminum Hydroxide, Magnesium Hydroxide, and Dimethicone 400 mg/5mL; 400 mg/5mL; 40 mg/5mL 60687-0888-76 American 10 cups — — FDA listed —
Mylanta Maximum Strength Classic Flavor 800 mg/10mL; 800 mg/10mL; 80 mg/10mL 62372-0500-12 Infirst 355 ml — — FDA listed —
Mylanta Maximum Strength Vanilla Caramel Flavor 800 mg/10mL; 800 mg/10mL; 80 mg/10mL 62372-0504-12 Infirst 355 ml — — FDA listed —
Maximum Strength Antacid And Antigas 400 mg/5mL; 400 mg/5mL; 40 mg/5mL 63941-0619-12 VALU 355 ml — — FDA listed —
Maximum Strength Antacid And Antigas Cherry 400 mg/5mL; 400 mg/5mL; 40 mg/5mL 63941-0638-12 VALU 355 ml — — FDA listed —
Geri-Lanta Maximum Strength 400 mg/5mL; 400 mg/5mL; 40 mg/5mL 68071-3423-01 NuCare 355 ml — — FDA listed —
Mintox Maximum Strength 400 mg/5mL; 400 mg/5mL; 40 mg/5mL 68071-4114-01 NuCare 355 ml — — FDA listed —
Maximum Strength Antacid Cherry 800 mg/10mL; 800 mg/10mL; 80 mg/10mL 69256-0508-40 Harris 355 ml — — FDA listed —
Maximum Strength Antacid 800 mg/10mL; 800 mg/10mL; 80 mg/10mL 69256-0517-05 Harris 355 ml — — FDA listed —
Maximum Strength Antacid Mint 800 mg/10mL; 800 mg/10mL; 80 mg/10mL 69842-0296-73 CVS 355 ml — — FDA listed —
Antacid 400 mg/5mL; 400 mg/5mL; 40 mg/5mL 69842-0508-05 CVS 355 ml — — FDA listed —
Maximum Strength Antacid 800 mg/10mL; 800 mg/10mL; 80 mg/10mL 69842-0619-12 CVS 355 ml — — FDA listed —
Maximum Strength Antacid Cherry 400 mg/5mL; 400 mg/5mL; 40 mg/5mL 69842-0683-12 CVS 355 ml — — Discontinued —
Mintox Maximum Strength 400 mg/5mL; 400 mg/5mL; 40 mg/5mL 71205-0515-35 Proficient 355 ml — — FDA listed —
Antacid 800 mg/10mL; 800 mg/10mL; 80 mg/10mL 72476-0516-05 Retail 355 ml — — FDA listed —
Maximum Strength Antacid and Antigas 800 mg/10mL; 800 mg/10mL; 80 mg/10mL 79481-0638-01 Meijer, 355 ml — — FDA listed —
Kesin MAG-AL Plus XS 40 mg/5mL; 400 mg/5mL; 400 mg/5mL 81033-0007-01 Kesin 100 cups — — FDA listed —
Aluminum Hydroxide, Magnesium Hydroxide and Simethicone 2400 mg/30mL; 2400 mg/30mL; 240 mg/30mL 84415-0010-01 Everpharm 100 cups — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
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

🏛️
2020
On the market since
Jul 2020
📍
2026
Currently FDA-listed
6 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

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

FlavorCherry
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 LKG8494WBH
    Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid formulations.
  • UNII 3QPI1U3FV8
    A preservative derived from benzoic acid that prevents bacterial and fungal growth in medicines. It helps extend shelf life and maintain product safety during storage and use.
  • UNII K679OBS311
    Carboxymethylcellulose sodium is a plant-derived thickening agent made from cellulose. In medicines, it acts as a binder to hold ingredients together, a disintegrant to help the tablet break apart, or a thickener in liquids.
  • 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 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 Z8IX2SC1OH
    Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
  • UNII SB8ZUX40TY
    Saccharin sodium is an artificial sweetener made from saccharin salt. It's added to medicines to improve taste, especially in liquid formulations for children or bitter drugs.
  • UNII 8KW3E207O2
    A liquid sweetener made from sorbitol, a sugar alcohol derived from glucose. It sweetens the medicine and also acts as a humectant to help retain moisture and improve texture in liquid formulations.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

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

The official label also statesbenzyl alcohol, butylparaben, carboxymethylcellulose sodium, flavor, hypromellose, microcrystalline cellulose, propylparaben, purified water, saccharin sodium, sorbitol solution

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

LabelerGOODSENSE
FDA applicationM001 (OTC MONOGRAPH DRUG)
Labeler code50804
First marketedJul 2020
Product typeHuman Otc Drug
Portfolio31 products on file

More NDCs from GOODSENSE labeler code 50804

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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 13 words ▾

Uses relieves heartburn sour stomach acid indigestion the symptoms referred to as gas

⏱️ Dosage and Administration 65 words ▾

Directions shake well before use adults and children 12 years of age and older: take 10 mL to 20 mL (1 to 2 doses) two times a day, or as directed by a doctor do not exceed 40 mL (4 doses) in a 24 hour period or use the maximum dosage for more than 2 weeks children under 12 years of age: ask a doctor

⚠️ Warnings 66 words ▾

Warnings Ask a doctor before use if you have • kidney disease • a magnesium-restricted diet Ask a doctor or pharmacist before use if you are taking a prescription drug. Antacids may interact with certain prescription drugs. Stop use and ask a doctor if symptoms last more than 2 weeks If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children.

📦 Storage and Handling 22 words ▾

Other information each 10 mL dose contains: magnesium 340 mg, sodium 10 mg do not freeze store at room temperature tightly closed

🧪 Active Ingredient 23 words ▾

Active ingredients (in each 10 mL dose) Aluminum hydroxide (equivalent to dried gel, USP) 800 mg Magnesium hydroxide 800 mg Simethicone 80 mg

🧪 Inactive Ingredients 22 words ▾

Inactive ingredients benzyl alcohol, butylparaben, carboxymethylcellulose sodium, flavor, hypromellose, microcrystalline cellulose, propylparaben, purified water, saccharin sodium, sorbitol solution Questions or Comments? 1-800-540-3765

🎯 Purpose 3 words ▾

Purposes Antacid Antigas

📄 Keep Out of Reach of Children 6 words ▾

Keep out of reach of children.

📄 Questions or Comments 4 words ▾

Questions or Comments? 1-800-540-3765

📄 Package Label / Principal Display Panel 3 words ▾

package label 1

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

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 ✓ Available
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

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.
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 GOODSENSE. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
GOODSENSE 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.
← 50804-0629-12 · GOODSENSE 50804-0639-12 · GOODSENSE →
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.