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Extra Strength Gas Relief Simethicone 125 mg Capsule, Liquid Filled, 15-count

by Shield Pharmaceuticals Corp · 1 BOTTLE in 1 CARTON (83059-0056-1) / 15 CAPSULE, LIQUID FILLED in 1 BOTTLE
NDC 83059-0056-01
🏷️ FDA NDC (as labeled) 83059-0056-1 billing pads the package segment with a zero
OTC Discontinued Non-controlled ⚠ Discontinued by firm
🗂️ 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

⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Aug 2026. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 83059-0056-1
Product NDC 83059-0056
11-digit billing NDC 83059005601
RxCUI 198852
UNII 92RU3N3Y1O
Application # M001
SPL Set ID 5f1dbf5e-a28a-4941-9bef-6584ecb78709
Physiologic effect Skin Barrier Activity
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through Aug 2026)
Marketing start 2024-04-07
Route ORAL
Dosage form CAPSULE, LIQUID FILLED
Substance DIMETHICONE
Why two NDCs? The FDA registers this code as 83059-0056-1 — 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 → 83059-0056-01. 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

LabelerShield Pharmaceuticals Corp
FDA applicationM001 (OTC MONOGRAPH DRUG)
Labeler code83059
First marketedApr 2024
Product typeHuman Otc Drug
Portfolio103 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 —
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 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 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 mgthis 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

🏛️
2024
On the market since
Apr 2024
📍
2026
Currently FDA-listed
2 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 Extra Strength Gas Relief (this brand).

Top reported reactions

Nausea107
Fatigue83
Diarrhoea80
Vomiting70
Abdominal Pain67
Dyspnoea67
Pain58

Age at onset

Neonate2
Infant1
Child9
Adolescent6
Adult28
Elderly12

Reporter sex

1,067 reports
Male · 49%
Female · 51%
Unknown · 0%

Serious outcomes

Hospitalization566
Death151
Life-threatening68
Disabling29
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 10 0
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
83059-0056-01 You're viewing this 1 BOTTLE in 1 CARTON (83059-0056-1) / 15 CAPSULE, LIQUID FILLED in 1 BOTTLE 2024-10-27 Discontinued by firm

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product No longer marketed (per FDA listing data)
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 "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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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 83059-0056-1, 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: 83059-0056-01, written without dashes as 83059005601. 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 83059-0056-01, the first segment (83059) is the labeler code FDA assigned to Shield Pharmaceuticals Corp; the middle segment (0056) 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.
Who lists this product with the FDA?
Shield 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.

📄 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 🧪 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.

🧪 Active Ingredient 8 words ▾

Active ingredient (in each softgel) Simethicone 125 mg

🧪 Inactive Ingredients 16 words ▾

Inactive ingredients FD & C Blue #01, D&C Yellow #10, gelatin, glycerin, sorbitol 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 ↗
83059-0057-01 · Shield →
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.