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Gas Relief Extra Strength Simethicone 125 mg Capsule, Liquid Filled — NDC 36800-0197-50 package photo

Gas Relief Extra Strength Simethicone 125 mg Capsule, Liquid Filled

by TOP CARE (Topco Associates LLC) · 50 BLISTER PACK in 1 CARTON (36800-197-50) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
NDC 36800-0197-50
🏷️ FDA NDC (as labeled) 36800-197-50 billing pads the product segment with a zero
This package
Contains1 capsule, liquid filled in 1 blister pack Pack sizes2 compare ↓
Also comes in: 1 capsule 36800-0197-30
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 →

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) 36800-197-50
Product NDC 36800-197
11-digit billing NDC 36800019750
RxCUI 198852
UNII 92RU3N3Y1O
UPC 0036800054417
Application # M002
SPL Set ID ed8a723a-7dac-4670-8f02-f4154e0a36c9
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 2019-11-29
Route ORAL
Dosage form CAPSULE, LIQUID FILLED
Substance DIMETHICONE
Why two NDCs? The FDA registers this code as 36800-197-50 — 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 → 36800-0197-50. 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

LabelerTOP CARE (Topco Associates LLC)
FDA applicationM002 (OTC MONOGRAPH DRUG)
Labeler code36800
First marketedNov 2019
Product typeHuman Otc Drug
Portfolio35 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

📖 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?
📖 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.

💊 What it looks like

Color green
ShapeOval
ImprintPO
Size9 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 35SW5USQ3G
    A synthetic yellow dye used to color medicines. It helps make tablets, capsules, and liquids visually distinct so patients can easily identify their medication.
  • UNII H3R47K3TBD
    FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
  • UNII WZB9127XOA
    A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
  • UNII 2G86QN327L
    Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII 3OWL53L36A
    A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
  • UNII AV092KU4JH
    A natural oil extracted from peppermint plants. It's used as a flavoring agent to mask bitter tastes and add a refreshing mint flavor to medicines, making them easier to take.
  • UNII 6O92ICV9RU
    A waxy substance derived from sorbitol that helps mix oil and water together in medicines. It's used as an emulsifier to keep ingredients evenly blended and stable.
  • UNII 506T60A25R
    Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
  • 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 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.

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

The official label also statesD&C yellow #10, edible ink, FD&C blue #1, FD&C red #40, gelatin, glycerin, mannitol,  peppermint oil, purified water, sorbitan, sorbitol, titanium dioxide

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 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.
Try another pack size: 1 capsule
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 — Discontinued —
Good Sense Gas Relief Extra Strength 125 mg 00113-0428-65 L. 1 capsule $0.074 — Availability likely —
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 —
Gas-X Extra Strength Softgels 125 mg 00067-6275-01 Haleon 120 capsules — — FDA listed —
Gas Relief Extra Strength 125 mg 00363-8970-20 Walgreens 1 capsule — — FDA listed —
Gas Relief 125 mg 00363-9938-07 Walgreen 18 capsules — — FDA listed —
Extra Strength Gas Relief 125 mg 11673-0495-71 TARGET 24 capsules — — FDA listed —
Gas Relief Extra Strength 125 mg 11673-0550-50 Target 10 capsules — — Discontinued —
Kroger Extra Strength 125 mg 30142-0330-30 KROGER 15 capsules — — FDA listed —
Simethicone 125 mg 35916-1938-01 Softgel 1000 capsules — — FDA listed —
Gas Relief Extra Strength 125 mgthis 36800-0197-50 TOP 1 capsule — — FDA listed —
Gas Relief Extra Strength 125 mg 36800-0785-05 TOPCO 25 capsules — — FDA listed —
HEB Anti Gas Extra Strength 125 mg 37808-0231-20 HEB 30 capsules — — FDA listed —
Gas Relief 125 mg 37808-0744-20 H-E-B 200 capsules — — FDA listed —
Gas Relief Extra Strength 125 mg 37808-0797-10 H 100 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 —
Extra strength gas relief 125 mg 41226-0722-30 KROGER 30 capsules — — FDA listed —
Meijer Extra Strength Gas Relief 125 mg 41250-0257-50 MEIJER 10 capsules — — FDA listed —
PUBLIX Extra Strength 125 mg 41415-0113-30 PUBLIX 15 capsules — — FDA listed —
Gas Relief Extra Strength 125 mg 49035-0266-20 EQUATE 20 capsules — — FDA listed —
Gas Relief 125 mg 49035-0583-64 Wal-Mart 150 capsules — — FDA listed —
Gas Relief 125 mg 51316-0597-12 CVS 120 capsules — — FDA listed —
Simethicone 125 mg 53345-0009-01 Humanwell 25000 capsules — — FDA listed —
Simethicone 125 mg 53345-0033-01 Humanwell 25000 capsules — — FDA listed —
Discount Drugmart Gas Relief Extra Strength Softgels 125 mg 53943-0823-30 Discount 15 capsules — — FDA listed —
Gas Relief 125 mg 55319-0555-30 Family 1 capsule — — FDA listed —
Gas Relief Extra Strength 125 mg 55910-0797-72 Dolgencorp, 1 capsule — — FDA listed —
Extra Strength Gas Relief 125 mg 57896-0292-05 Geri-Care 50 capsules — — FDA listed —
Gas Relief Extra Strength 125 mg 59726-0897-10 P 1 capsule — — FDA listed —
mylanta gas 125 mg 62372-0554-31 Infirst 10 capsules — — FDA listed —
Quality Choice Gas Relief Extra Strength Softgels 125 mg 63868-0586-30 Chain 15 capsules — — FDA listed —
Gas Relief Extra Strength 125 mg 63941-0897-30 Best 1 capsule — — FDA listed —
WinCo Foods Gas Relief Extra Strength Softgels 125 mg 67091-0379-30 WinCo 15 capsules — — FDA listed —
Gas Relief Extra Strength 125 mg 68391-0597-12 BJWC 1 capsule — — FDA listed —
Gas Relief 125 mg 68391-0722-29 BJWC 240 capsules — — FDA listed —
Anti-Gas 125 mg 68998-0419-85 Marc 30 capsules — — FDA listed —
Anti-Gas 125 mg 69168-0419-06 Allegiant 150 capsules — — FDA listed —
gas relief 125 mg 69452-0542-28 BIONPHARMA 250 capsules — — FDA listed —
RIGHT REMEDIES Extra Strength Gas Relief 125 mg 70692-0835-65 Strive 365 capsules — — FDA listed —
Gas Relief 125 mg 72090-0014-01 Pioneer 180 capsules — — FDA listed —
Gas Relief 125 mg 72090-0045-01 Pioneer 180 capsules — — FDA listed —
Gas Relief 125 mg 72090-0060-01 Pioneer 180 capsules — — FDA listed —
basic care gas relief 125 mg 72288-0428-65 Amazon.com 10 capsules — — FDA listed —
Gas Relief Extra Strength 125 mg 72476-0897-30 Care 1 capsule — — FDA listed —
Gas Relief Extra Strength 125 mg 73581-0301-36 YYBA 365 capsules — — FDA listed —
Simethicone 125 mg 73581-0302-36 YYBA 365 capsules — — FDA listed —
Gas Relief 125 mg 75907-0365-01 Dr. 150 capsules — — FDA listed —
TopCare health EXTRA STRENGTH Gas Relief SOFTGEL 125 mg 76162-0538-05 Topco 25 capsules — — FDA listed —
meijer EXTRA STRENGTH Gas Relief SOFTGEL 125 mg 79481-0791-05 Meijer, 25 capsules — — FDA listed —
meijer EXTRA STRENGTH Gas Relief 125 mg 79481-0835-05 Meijer, 25 capsules — — FDA listed —
Gas Relief 125 mg 80513-0111-12 Advanced 120 capsules — — FDA listed —
Gas Relief 125 mg 80513-0117-12 Advanced 120 capsules — — FDA listed —
Extra Strength Gas Relief 125 mg 83059-0056-01 Shield 15 capsules — — Discontinued —
Quality Choice Gas Relief Extra Strength Softgels 125 mg 83324-0196-30 Chain 15 capsules — — FDA listed —
Gas Relief Simethicone 125mg Softgel 125 mg 84324-0014-01 NUVICARE 100 capsules — — FDA listed —
Gas Relief 125 mg 84324-0022-01 NUVICARE 100 capsules — — FDA listed —
Extra Strength Gas Relief 125 mg 85828-0722-30 Grocery 30 capsules — — 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

🏛️
2019
On the market since
Nov 2019
📍
2026
Currently FDA-listed
7 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
36800-0197-30 30 BLISTER PACK in 1 CARTON (36800-197-30) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 2019-11-29 Active
36800-0197-50 You're viewing this 50 BLISTER PACK in 1 CARTON (36800-197-50) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 2019-11-29 Active

Pack size FAQ

What quantity is in NDC 36800-0197-50?
NDC 36800-0197-50 is listed by the FDA — 50 blister pack in 1 carton / 1 capsule, liquid filled in 1 blister pack.
What NDC number is used to bill for this package of Gas Relief Extra Strength Simethicone 125 mg Capsule, Liquid Filled?
Bill NDC 36800-0197-50 — the 11-digit billing format is 36800019750. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 36800-197-50, 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: 36800-0197-50, written without dashes as 36800019750. 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 36800-0197-50, the first segment (36800) is the labeler code FDA assigned to TOP CARE (Topco Associates LLC); the middle segment (0197) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (50) 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 TOP CARE (Topco Associates LLC). 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 1 capsule (36800-0197-30). 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?
TOP CARE (Topco Associates 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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 14 words ▾

Uses For the relief of pressure, bloating, and fullness commonly referred to as gas.

⏱️ Dosage and Administration 39 words ▾

Directions adults and children 12 years and older: swallow with water 1 or 2 softgels as needed after meals and at bedtime do not exceed 4 softgels in 24 hours except under the advice and supervision of a physican

⚠️ Warnings 17 words ▾

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

📦 Storage and Handling 15 words ▾

Other information store between 20-25°C (68-77°F) do not refrigerate protect from light, heat, and moisture

🧪 Active Ingredient 8 words ▾

Active ingredient (in each softgel) Simethicone 125 mg

🧪 Inactive Ingredients 24 words ▾

Inactive ingredients D&C yellow #10, edible ink, FD&C blue #1, FD&C red #40, gelatin, glycerin, mannitol, peppermint oil, purified water, sorbitan, sorbitol, titanium dioxide

🎯 Purpose 2 words ▾

Purpose Antigas

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 36800-0194-02 · Topco 36800-0199-00 · Topco →
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.