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Simethicone 80 mg Tablet, Chewable, 100-count — NDC 57896-0791-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Simethicone 80 mg Tablet, Chewable, 100-count — NDC 57896-791-01 (Billing 57896-0791-01)

by Geri-Care Pharmaceuticals, Corp · 100 TABLET, CHEWABLE in 1 BOTTLE

This is a package of 100 tablets of Simethicone 80 mg Tablet, Chewable from Geri-Care Pharmaceuticals, Corp, marketed since Jan 2004 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 57896-0791-01
🏷️ FDA NDC (as labeled) 57896-791-01 billing pads the product segment with a zero
This package
Contains100-count Pack sizes2 compare ↓
Main listing for product 57896-791 · Also comes in: 80 tablets 57896-791-08
OTC 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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 57896-791-01
Product NDC 57896-791
11-digit billing NDC 57896079101
NCPDP billing unit EA — each (per item)
RxCUI 314216
UNII 92RU3N3Y1O
UPC 0357896791018, 0357896791087
Application # M002
SPL Set ID be96ce05-dd74-4915-9a8f-2a1b34e2f158
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 2004-01-01
Route ORAL
Dosage form TABLET, CHEWABLE
Substance DIMETHICONE

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

GPI-14 52200020000510
GPI class Simethicone
GCN Seq No 002821
GCN 08281
HICL code 001224
Ingredient (HICL) Simethicone
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 D4N
Therapeutic class — specific (HIC3) Antiflatulents
AHFS code 56:10.00.00
AHFS class Antiflatulents
FDB label name SIMETHICONE 80 MG TAB CHEW
FDB brand name Simethicone
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 002821
  • GCN: 08281
  • GPI-14 (Medi-Span): 52200020000510
  • HICL (First Databank): 001224
  • AHFS class code: 56:10.00.00
  • RxCUI (RxNorm): 314216
Why two NDCs? The FDA registers this code as 57896-791-01 — 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 → 57896-0791-01. 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.

Clinical

Label name SIMETHICONE 80 MG TAB CHEW Ingredient Simethicone
📖 What it is MedlinePlus · NLM

Simethicone is used to treat the symptoms of gas such as uncomfortable or painful pressure, fullness, and bloating. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It relieves the discomfort of gas. For adults, that means pressure, bloating and fullness. Infant drops are for baby gas, often caused by swallowed air or certain formulas or foods...
  • Shake the bottle well. Use only the syringe or dropper that came with it. Dispense it slowly toward the inner cheek. You can also mix it with 1 oz. of cool water, formula or anothe...
  • Doses can be repeated as needed after meals and at bedtime. Do not go over 12 doses in a day. Follow your product’s label and your doctor’s advice.
  • If you can, use your child’s weight. If not, use age. Check the chart on your product, and ask me or your doctor if you are unsure.
📖 Read our full Simethicone guide →
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: 80 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
57896-0791-01 You're viewing this Main listing 100 TABLET, CHEWABLE in 1 BOTTLE 2016-09-01 — Active
57896-0791-08 57896-791-08 80 TABLET, CHEWABLE in 1 BOTTLE 2021-08-01 — Active

You're viewing the largest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This is a 100-count package — 100 tablet, chewable in 1 bottle.
How does this package differ from NDC 57896-0791-08?
Both are Simethicone 80 mg Tablet, Chewable — the drug itself is identical. This page's package is the 100-count one, while NDC 57896-0791-08 is the 80 tablets package.
What NDC number is used to bill for this package of Simethicone 80 mg Tablet, Chewable?
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
Antiflatulent 80 mg 00904-7206-60 Major 100 tablets $0.032 — Availability likely —
GNP Regular Strength Gas Relief 80 mg 24385-0118-78 Amerisource 100 tablets $0.032 — Availability likely —
Leader Gas relief 80 mg 70000-0434-01 CARDINAL 100 tablets $0.032 — Availability likely —
Gas Relief 80 mg 70677-1067-01 STRATEGIC 36 tablets $0.032 — Availability likely —
Gas Relief 80 mg 17714-0019-01 Advance 100 tablets — — FDA listed —
GNP Regular Strength Gas Relief 80 mg 17856-1118-01 ATLANTIC 1 tablet — — FDA listed —
CVS PHARMACY Gas relief 80 mg 51316-0111-00 CVS 100 tablets — — FDA listed —
Gas relief Anti-gas 80 mg 51316-0904-16 CVS 100 tablets — — FDA listed —
Gas relief 80 mg 53041-0103-16 Guardian 100 tablets — — FDA listed —
Gas relief 80 mg 53943-0301-16 Discount 100 tablets — — FDA listed —
Simethicone 80 mg 54738-0518-01 Richmond 100 tablets — — FDA listed —
Simethicone 80Mg 80 mg 55154-2606-00 Cardinal 1 tablet — — FDA listed —
Simethicone 80 mgthis 57896-0791-01 Geri-Care 100 tablets — — FDA listed —
QC Gas Relief Mint Flavor 80 mg 63868-0108-01 QUALITY 100 tablets — — FDA listed —
Simethicone 80 mg 68071-2746-03 NuCare 30 tablets — — FDA listed —
Gas Relief Mint Flavor 80 mg 68163-0111-36 Raritan 36 tablets — — FDA listed —
Simethicone 80 mg 69618-0033-01 Reliable 100 tablets — — FDA listed —
Simethicone 80 mg 71610-0607-04 Aphena 4 tablets — — FDA listed —
Simethicone 80 mg 71610-0649-04 Aphena 4 tablets — — FDA listed —
Antiflatulent 80 mg 71610-0650-04 Aphena 4 tablets — — FDA listed —
Simethicone 80Mg 80 mg 77333-0812-10 Gendose 1 tablet — — FDA listed —
Simethicone 80 mg 82804-0043-30 Proficient 30 tablets — — 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

🏛️
2004
On the market since
Jan 2004
📍
2026
Currently FDA-listed
22 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

Color white
ShapeRound
Imprint44;137
Size13 mm
ScoringNot scored
FlavorPeppermint
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 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 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 G263MI44RU
    Dextrates are a carbohydrate mixture made from corn or potato starch. They work as fillers and binders in tablets and capsules to add bulk and help hold the medicine together.
  • 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 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 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 96K6UQ3ZD4
    Sucralose is a synthetic sweetener made from sugar. It's added to medicines to improve taste without adding calories, helping make bitter or unpleasant-tasting drugs easier to take.
  • UNII K4C08XP666
    A mineral salt made from calcium and phosphate. It acts as a filler to add bulk and texture to tablets and powders, and also helps stabilize and bind ingredients together.

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

The official label also statescellulose, corn starch, crospovidone, dextrates hydrated, flavor, magnesium stearate, silica, sucralose, tricalcium phosphate.

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

LabelerGeri-Care Pharmaceuticals, Corp
FDA applicationM002 (OTC MONOGRAPH DRUG)
Labeler code57896
First marketedJan 2004
Product typeHuman Otc Drug
Portfolio47 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 📦 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 11 words ▾

Uses relieves pressure, bloating, and fullness commonly referred to as gas

⏱️ Dosage and Administration 49 words ▾

Directions chew or crush tablet completely before swallowing adults and children 12 years and over: take 1-2 tablets as needed after meals and at bedtime. Do not exceed 6 tablets in 24 hours except under the advice and supervision of a doctor. children under 12 years: ask a doctor

⚠️ Warnings 18 words ▾

Warnings If pregnant or breast feeding, ask a health professional before use. Keep out of reach of children.

📦 Storage and Handling 34 words ▾

Other information each tablet contains: calcium 65 mg Tamper Evident: Do not use if imprinted seal under cap is missing or broken store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) protect from moisture

🧪 Active Ingredient 8 words ▾

Active ingredient (in each tablet) Simethicone 80 mg

🧪 Inactive Ingredients 15 words ▾

Inactive ingredients cellulose, corn starch, crospovidone, dextrates hydrated, flavor, magnesium stearate, silica, sucralose, tricalcium phosphate.

🎯 Purpose 2 words ▾

Purpose 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 4 words ▾

package Label 1 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 Geri-Care Pharmaceuticals, Corp. 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 1 other package presentation of this same product, including 80 tablets (57896-0791-08). 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?
Geri-Care Pharmaceuticals, Corp 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.
← 57896-0785-72 · Geri-Care 57896-0794-01 · Geri-Care →
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.