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TopCare health EXTRA STRENGTH Gas Relief SOFTGEL Simethicone 125 mg Capsule, Liquid Filled — NDC 76162-538-05 (Billing 76162-0538-05)

by Topco Associates LLC · 2 BLISTER PACK in 1 CARTON / 25 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

This is a package of TopCare health EXTRA STRENGTH Gas Relief SOFTGEL Simethicone 125 mg Capsule, Liquid Filled from Topco Associates LLC, marketed since Aug 2025 and currently FDA-listed. It is this product's only package size.

NDC 76162-0538-05
🏷️ FDA NDC (as labeled) 76162-538-05 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 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) 76162-538-05
Product NDC 76162-538
11-digit billing NDC 76162053805
RxCUI 198852
UNII 92RU3N3Y1O
Application # M002
SPL Set ID 2ea0eb22-f679-d136-e063-6294a90a1dfe
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 2025-08-01
Route ORAL
Dosage form CAPSULE, LIQUID FILLED
Substance DIMETHICONE, UNSPECIFIED
Quick answers
  • RxCUI (RxNorm): 198852
Why two NDCs? The FDA registers this code as 76162-538-05 — 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 → 76162-0538-05. 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

📗 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 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
76162-0538-05 You're viewing this Main listing 2 BLISTER PACK in 1 CARTON / 25 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 2025-08-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Gas Relief Extra Strength 125 mg 70000-0529-01 Cardinal 1 capsule $0.069 — FDA listed —
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 $0.071 — Availability likely —
Gas Relief Extra Strength 125 mg 00904-6994-46 Major 1 capsule $0.071 — Availability likely —
Gas Relief 125 mg 70677-1092-01 Strategic 1 capsule $0.071 — 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 mg 36800-0197-30 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 mgthis 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 —
HyVee Extra Strength Gas Relief SOFTGEL 125 mg 42507-0835-05 HyVee 25 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

🏛️
2025
On the market since
Aug 2025
📍
2026
Currently FDA-listed
1 year 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.

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 5138Q19F1X
    Ammonia is a colorless gas made from nitrogen and hydrogen. It's used in medicines as a pH buffer to maintain the correct acidity level and help keep the product stable.
  • UNII 8PJ61P6TS3
    Butyl alcohol is a clear liquid organic solvent derived from petroleum or natural sources. In medicines, it helps dissolve active ingredients and serves as a solvent in liquid formulations and some topical products.
  • 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 XM0M87F357
    A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
  • 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 ND2M416302
    Isopropyl alcohol is a clear liquid solvent derived from petroleum. In medicines, it dissolves active ingredients and other components, helps the product flow smoothly, and aids in sterilization during manufacturing.
  • 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 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII 46N107B71O
    Shellac is a natural resin secreted by the lac beetle. It's used as a coating on tablets and capsules to control how quickly the medicine dissolves and to improve appearance and stability.
  • 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.

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

The official label also statesammonium hydroxide, black iron oxide, D&C Yellow No.10, FD&C Blue No.1, gelatin, glycerin, isopropyl alcohol, N-butyl alcohol, peppermint oil, propylene glycol, shellac glaze, sorbitol sorbitan solution, 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.

Manufacturer & labeler

LabelerTopco Associates LLC
FDA applicationM002 (OTC MONOGRAPH DRUG)
Labeler code76162
First marketedAug 2025
Product typeHuman Otc Drug
Portfolio408 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
🎯 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 physician

⚠️ Warnings 7 words ▾

Warnings Keep out of reach of children.

📦 Storage and Handling 15 words ▾

Other information store at controlled room temperature 20-25°C (68-77°F) protect from light, heat and moisture

🧪 Active Ingredient 8 words ▾

Active ingredient (in each softgel) Simethicone 125 mg

🧪 Inactive Ingredients 30 words ▾

Inactive ingredients ammonium hydroxide, black iron oxide, D&C Yellow No.10, FD&C Blue No.1, gelatin, glycerin, isopropyl alcohol, N-butyl alcohol, peppermint oil, propylene glycol, shellac glaze, sorbitol sorbitan solution, 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 ↗

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 TopCare health EXTRA STRENGTH Gas Relief SOFTGEL (this brand).

Top reported reactions

Nausea106
Fatigue83
Diarrhoea79
Vomiting70
Abdominal Pain67
Dyspnoea66
Pain58

Age at onset

Neonate2
Infant1
Child9
Adolescent6
Adult27
Elderly11

Reporter sex

1,061 reports
Male · 49%
Female · 51%
Unknown · 0%

Serious outcomes

Death150
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.

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 — Not published for this NDC No photo available yet for this listing.
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 Topco Associates LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
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.
← 76162-0523-01 · Topco 76162-0559-12 · 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.