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Simethicone 125 mg Capsule, Liquid Filled, 40,000-count

by Patheon Softgels, Inc. · 40000 CAPSULE, LIQUID FILLED in 1 BOX (10888-8178-1)
NDC 10888-8178-01
🏷️ FDA NDC (as labeled) 10888-8178-1 billing pads the package segment with a zero
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 →

This page is curated, coded, and maintained by

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

🆔 Identity & classification

FDA NDC (as labeled) 10888-8178-1
Product NDC 10888-8178
11-digit billing NDC 10888817801
SPL Set ID 37d9d7db-7a13-7e38-e063-6294a90a204d
DEA schedule Non-controlled
Marketing category DRUG FOR FURTHER PROCESSING
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-11-29
Dosage form CAPSULE, LIQUID FILLED
Substance DIMETHICONE
Why two NDCs? The FDA registers this code as 10888-8178-1 — a 5-4-1 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 package segment → 10888-8178-01. 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.

🏭 Manufacturer & labeler

LabelerPatheon Softgels, Inc.
Labeler code10888
First marketedNov 2023
Product typeDrug For Further Processing
Portfolio7 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

📗 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?
📖 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.

🧪 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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Gas Relief Extra Strength 125 mg 70000-0529-01 Cardinal 1 capsule $0.069 — Availability likely —
Gas Relief Extra Strength 125 mg 62011-0419-01 Strategic 1 capsule $0.069 — FDA listed —
Gas Relief Extra Strength 125 mg 00904-6994-46 Major 1 capsule $0.074 — Availability likely —
Gas Relief 125 mg 70677-1092-01 Strategic 1 capsule $0.074 — Availability likely —
Good Sense Gas Relief Extra Strength 125 mg 00113-0428-65 L. 1 capsule $0.074 — Availability likely —
Anti-Gas 125 mg 68998-0419-85 Marc 30 capsules — — FDA listed —
Gas Relief Extra Strength 125 mg 72476-0897-30 Care 1 capsule — — FDA listed —
Simethicone 125 mg 72090-0049-01 Pioneer 18000 capsules — — FDA listed —
Simethicone 125 mg 35916-1938-01 Softgel 1000 capsules — — FDA listed —
Extra Strength Simethicone 125 mg 37835-0231-72 Bi-Mart 72 capsules — — FDA listed —
Gas Relief Extra Strength 125 mg 41163-0597-30 United 1 capsule — — FDA listed —
Gas Relief 125 mg 68391-0722-29 BJWC 240 capsules — — FDA listed —
Gas Relief 125 mg 00363-9938-07 Walgreen 18 capsules — — FDA listed —
Extra Strength Gas Relief 125 mg 83059-0056-01 Shield 15 capsules — — Discontinued —
Simethicone 125 mg 83059-0046-00 Shield 18000 capsules — — FDA listed —
Extra strength gas relief 125 mg 41226-0722-30 KROGER 30 capsules — — FDA listed —
Quality Choice Gas Relief Extra Strength Softgels 125 mg 63868-0586-30 Chain 15 capsules — — FDA listed —
Simethicone 125 mg 83059-0065-00 Shield 45500 capsules — — FDA listed —
Gas Relief Extra Strength 125 mg 37808-0797-10 H 100 capsules — — FDA listed —
Gas Relief Extra Strength 125 mg 55910-0797-72 Dolgencorp, 1 capsule — — FDA listed —
mylanta gas 125 mg 62372-0554-31 Infirst 10 capsules — — FDA listed —
Gas Relief 125 mg 49035-0583-64 Wal-Mart 150 capsules — — FDA listed —
Simethicone 125 mg 11014-0198-01 Catalent 30000 capsules — — FDA listed —
Extra Strength Gas Relief 125 mg 11673-0495-71 TARGET 24 capsules — — FDA listed —
Simethicone 125 mg 53345-0009-01 Humanwell 25000 capsules — — FDA listed —
Gas Relief Extra Strength 125 mg 63941-0897-30 Best 1 capsule — — FDA listed —
basic care gas relief 125 mg 72288-0428-65 Amazon.com 10 capsules — — FDA listed —
Gas Relief Extra Strength 125 mg 73581-0301-36 YYBA 365 capsules — — FDA listed —
Extra Strength Gas Relief 125 mg 85828-0722-30 Grocery 30 capsules — — FDA listed —
Simethicone 125 mgthis 10888-8178-01 Patheon 40000 capsules — — FDA listed —
Gas Relief Extra Strength 125 mg 36800-0197-30 TOP 1 capsule — — FDA listed —
Simethicone 125 mg 53345-0033-01 Humanwell 25000 capsules — — FDA listed —
gas relief 125 mg 69452-0542-28 BIONPHARMA 250 capsules — — FDA listed —
Simethicone 125 mg 10888-8265-01 Patheon 40000 capsules — — FDA listed —
Gas Relief 125 mg 37808-0744-20 H-E-B 200 capsules — — FDA listed —
WinCo Foods Gas Relief Extra Strength Softgels 125 mg 67091-0379-30 WinCo 15 capsules — — FDA listed —
Anti-Gas 125 mg 69168-0419-06 Allegiant 150 capsules — — FDA listed —
Gas Relief 125 mg 80513-0117-12 Advanced 120 capsules — — FDA listed —
Extra Strength Gas Relief 125 mg 57896-0292-05 Geri-Care 50 capsules — — FDA listed —
Gas Relief Extra Strength 125 mg 68391-0597-12 BJWC 1 capsule — — FDA listed —
Gas Relief Extra Strength 125 mg 00363-8970-20 Walgreens 1 capsule — — FDA listed —
Simethicone 125 mg 73581-0302-36 YYBA 365 capsules — — FDA listed —
Quality Choice Gas Relief Extra Strength Softgels 125 mg 83324-0196-30 Chain 15 capsules — — FDA listed —
Simethicone 125 mg 10888-8173-01 Patheon 40000 capsules — — FDA listed —
Discount Drugmart Gas Relief Extra Strength Softgels 125 mg 53943-0823-30 Discount 15 capsules — — FDA listed —
Gas Relief Extra Strength 125 mg 59726-0897-10 P 1 capsule — — FDA listed —
Gas Relief 125 mg 80513-0111-12 Advanced 120 capsules — — FDA listed —
Gas Relief Simethicone 125mg Softgel 125 mg 84324-0014-01 NUVICARE 100 capsules — — FDA listed —
Simethicone 125 mg 66206-1304-06 Asence 1500 capsules — — FDA listed —
Gas Relief Extra Strength 125 mg 49035-0266-20 EQUATE 20 capsules — — FDA listed —
Gas Relief 125 mg 51316-0597-12 CVS 120 capsules — — FDA listed —
Gas Relief 125 mg 55319-0555-30 Family 1 capsule — — FDA listed —
Extra Strength Gas Relief 125 mg 83059-0169-01 Shield 15 capsules — — 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

🏛️
2023
On the market since
Nov 2023
📍
2026
Currently FDA-listed
3 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

Chronic Kidney Disease1,159
Nausea723
Diarrhoea673
Fatigue644
Acute Kidney Injury633
Renal Failure583
Pain416

Reporter sex

8,245 reports

Serious outcomes

Death769
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 961 236
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 NDCDescription Marketing startStatus
10888-8178-01 You're viewing this 40000 CAPSULE, LIQUID FILLED in 1 BOX (10888-8178-1) — Active

🧭 About this NDC listing & data coverage

Listed for further processing / repackaging

What "drug for further processing" means

FDA lists this package under the "drug for further processing" marketing category: Patheon Softgels, Inc. supplies it to other companies for further processing or repackaging (blister cards that are later repackaged or co-packaged are a common example). The units themselves are a finished dosage form — which is why pricing or Medicaid data can still appear — but this exact package code may not be the presentation a retail pharmacy dispenses.

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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 "Drug For Further Processing". 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 10888-8178-1, 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: 10888-8178-01, written without dashes as 10888817801. 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 10888-8178-01, the first segment (10888) is the labeler code FDA assigned to Patheon Softgels, Inc.; the middle segment (8178) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) 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 Patheon Softgels, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Patheon Softgels, Inc. 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.
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.

📄 Full FDA label FDA SPL

The complete FDA label for this product, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
📄 FDA label
📄 FDA label 19 words ▾

No FDA label is on file for this product yet. Labels load from openFDA / DailyMed and refresh weekly.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 10888-8177-01 · Patheon 10888-8180-01 · Patheon →
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.