Gas Relief Extra Strength DIMETHICONE 125 mg Capsule, Liquid Filled
by TOPCO ASSOCIATES LLC · 2 BLISTER PACK in 1 CARTON (36800-785-05) / 25 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
NDC 36800-0785-05
🏷️ FDA NDC (as labeled)
36800-785-05
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 →
⚠️
Other active recalls for Dimethicone (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Jun 11, 2026 — Failed Impurities/Degradation Specifications; Formaldehyde levels exceeded specification. (BioMed Laboratories, LLC.) · FDA recall D-0663-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗
🆔 Identity & classification
FDA NDC (as labeled)
36800-785-05
Product NDC
36800-785
11-digit billing NDC
36800078505
RxCUI
198852
UNII
92RU3N3Y1O
UPC
0036800339606
Application #
M002
SPL Set ID
bb1c54d4-3a36-4b77-8659-2e92845d2f0e
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
2021-05-01
Route
ORAL
Dosage form
CAPSULE, LIQUID FILLED
Substance
DIMETHICONE, UNSPECIFIED
Why two NDCs?
The FDA registers this code as 36800-785-05 — 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 → 36800-0785-05. 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.
🏭 Manufacturer & labeler
LabelerTOPCO ASSOCIATES LLC
FDA applicationM002 (OTC MONOGRAPH DRUG)
Labeler code36800
First marketedMay 2021
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.
🩺 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?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Dimethicone — 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 DIMETHICONE?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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 N6K5787QVP
Light mineral oil is a clear, odorless liquid derived from petroleum. In medicines, it acts as a lubricant and emollient to help the product spread smoothly and improve texture.
-
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 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.
9 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesD&C yellow #10, edible white ink, FD&C blue #1, FD&C red #40, gelatin. glycerin, light mineral oil, peppermint oil, purified water, 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 system | Per mL | 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 |
|---|---|---|---|---|---|---|
| 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 mgthis 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 | — |
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
🏛️
2021
On the market since
May 2021
📍
2026
Currently FDA-listed
5 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 NDC | Description | Marketing start | Status |
|---|---|---|---|
| 36800-0785-05 You're viewing this | 2 BLISTER PACK in 1 CARTON (36800-785-05) / 25 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | 2021-05-01 | 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 36800-785-05, 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: 36800-0785-05, written without dashes as 36800078505. 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 36800-0785-05, the first segment (36800) is the labeler code FDA assigned to TOPCO ASSOCIATES LLC; the middle segment (0785) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (05) 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 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.
📄 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 ▾
Uses for the relief of • Pressure, bloating, and fullness commonly referred to as gas
⏱️ Dosage and Administration ▾
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 ▾
Warnings Keep out of reach of children.
📦 Storage and Handling ▾
Other information store between 20-25°C (68-77°F) protect from heat and moisture
🧪 Active Ingredient ▾
Active ingredient (in each softgel) Simethicone 125 mg
🧪 Inactive Ingredients ▾
Inactive ingredients D&C yellow #10, edible white ink, FD&C blue #1, FD&C red #40, gelatin. glycerin, light mineral oil, peppermint oil, purified water, titanium dioxide
🎯 Purpose ▾
Purpose Antigas
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.