SIMETHICONE 80 mg Tablet, Chewable, 4-count
by Aphena Pharma Solutions - Tennessee, LLC · 4 TABLET, CHEWABLE in 1 BOTTLE (71610-649-04)
NDC 71610-0649-04
🏷️ FDA NDC (as labeled)
71610-649-04
billing pads the product segment with a zero
OTC
On market
Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
🆔 Identity & classification
FDA NDC (as labeled)
71610-649-04
Product NDC
71610-649
11-digit billing NDC
71610064904
NCPDP billing unit
EA — each (per item)
RxCUI
314216
UNII
92RU3N3Y1O
Application #
M002
SPL Set ID
5df94be7-0bc9-4be1-9982-8193e3a3c8ef
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
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
Why two NDCs?
The FDA registers this code as 71610-649-04 — 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 → 71610-0649-04. 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.
🏭 Manufacturer & labeler
LabelerAphena Pharma Solutions - Tennessee, LLC
FDA applicationM002 (OTC MONOGRAPH DRUG)
Labeler code71610
First marketedJan 2004
Product typeHuman Otc Drug
Portfolio795 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.
🩺 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
- Simethicone works to relieve the uncomfortable pressure, bloating, and full or stuffed feeling that comes from trapped gas in your stomach or intestines. It's used when gas builds...
- What exactly does simethicone do for gas?
- Yes — there are infant-specific simethicone products, like Mylicon Infants Gas Relief and similar infant drops, designed just for babies. They're used to relieve gas discomfort tha...
- Can I give simethicone drops to my baby?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Simethicone — tap one for details:
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.
💬 Questions about Simethicone?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
💊 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, calcium 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.
💲 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 system | Per each | Per 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.
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price 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 mg 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 mgthis 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.
🔬 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 Simethicone — the ingredient across all brands.
Top reported reactions
Reporter sex
Serious outcomes
Reports over time (by year) — tap or hover for the count & year
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.
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 71610-0649-04 You're viewing this | 4 TABLET, CHEWABLE in 1 BOTTLE (71610-649-04) | 2022-05-19 | Active |
🧭 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 FDA registers it as 71610-649-04, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 71610-0649-04, written without dashes as 71610064904. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 71610-0649-04, the first segment (71610) is the labeler code FDA assigned to Aphena Pharma Solutions - Tennessee, LLC; the middle segment (0649) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (04) identifies this exact package size and type. Together they name one specific package of one specific product.
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 Aphena Pharma Solutions - Tennessee, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Aphena Pharma Solutions - Tennessee, LLC 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.
📄 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
📦 How Supplied / Storage and Handling
📦 Storage and Handling
🧪 Active Ingredient
🧪 Inactive Ingredients
🎯 Purpose
🎯 Indications and Usage ▾
Uses relieves pressure, bloating, and fullness commonly referred to as gas
⏱️ Dosage and Administration ▾
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 ▾
Warnings If pregnant or breast feeding, ask a health professional before use. Keep out of reach of children.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Simethicone Chewable Tablets, 80 mg are white, round, tablets, debossed with "44 & 137" on one side and are supplied as: NDC 57896-791-01 in bottle of 100 chewable tablets NDC 57896-791-08 in bottle of 80 chewable tablets Distributed by: GERI-CARE Pharmaceuticals Corp. 1650 63rd Street, Brooklyn, NY 11204
📦 Storage and Handling ▾
Other information each tablet contains: calcium 65 mg Tamper Evident: Do not use if imprinted seal under cap is missing or broken store at room temperature, 15°C - 30°C (59˚F - 86˚F) protect from moisture
🧪 Active Ingredient ▾
Active ingredient (in each tablet) Simethicone 80 mg
🧪 Inactive Ingredients ▾
Inactive ingredients cellulose, corn starch, crospovidone, dextrates hydrated, flavor, magnesium stearate, silica, sucralose, calcium phosphate.
🎯 Purpose ▾
Purpose Anti-Gas
No label section mentions that — try another word, or open the full label on DailyMed below.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
Prefer the government’s original formatting? View this label on DailyMed ↗
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.