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Simethicone 180 mg Capsule, Liquid Filled, 1,000-count — NDC 35916-1939-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Simethicone 180 mg Capsule, Liquid Filled, 1,000-count — NDC 35916-1939-1 (Billing 35916-1939-01)

by SOFTGEL HEALTHCARE PRIVATE LIMITED · 1000 CAPSULE, LIQUID FILLED in 1 BAG

This is a package of 1,000 capsules of Simethicone 180 mg Capsule, Liquid Filled from SOFTGEL HEALTHCARE PRIVATE LIMITED, no longer marketed (first marketed Oct 2025), no longer in the FDA NDC Directory. It is the main listing for this product, which comes in 2 package sizes.

NDC 35916-1939-01
🏷️ FDA NDC (as labeled) 35916-1939-1 billing pads the package segment with a zero
This package
Contains1,000-count Pack sizes2 compare ↓
Main listing for product 35916-1939 · Also comes in: 10 capsules 35916-1939-2
OTC Discontinued Non-controlled ⚠ Discontinued by firm ⇄ 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

⚠️
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 Sep 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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 35916-1939-1
Product NDC 35916-1939
11-digit billing NDC 35916193901
RxCUI 252294
UNII 92RU3N3Y1O
Application # M002
SPL Set ID 3205339a-3914-4e25-e063-6394a90a07cd
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 Sep 2026)
Marketing start 2025-10-28
Route ORAL
Dosage form CAPSULE, LIQUID FILLED
Substance DIMETHICONE
Quick answers
  • RxCUI (RxNorm): 252294
Why two NDCs? The FDA registers this code as 35916-1939-1 — 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 → 35916-1939-01. 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.

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
  • 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.
Try another pack size: 10 capsules
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
35916-1939-01 You're viewing this Main listing 1000 CAPSULE, LIQUID FILLED in 1 BAG 2025-10-28 — Discontinued by firm
35916-1939-02 35916-1939-2 5 BLISTER PACK in 1 CARTON / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 2025-10-28 — Discontinued by firm

Pack size FAQ

What quantity is in this package?
This is a 1,000-count package — 1000 capsule, liquid filled in 1 bag.
What NDC number is used to bill for this package of Simethicone 180 mg Capsule, Liquid Filled?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
good sense gas relief 180 mg 00113-0657-72 L. 60 capsules $0.054 — Availability likely —
Gas Relief Ultra Strength 180 mg 00536-1306-08 Rugby 60 capsules $0.054 — Availability likely —
Gas Relief 180 mg 00536-1421-08 Rugby 60 capsules $0.054 — Availability likely —
Gas Relief 180 mg 46122-0769-64 AmerisourceBergen 60 capsules $0.054 — Availability likely —
Gas Relief 180 mg 70677-1093-01 Strategic 60 capsules $0.054 — Availability likely —
Gas Relief 180 mg 70677-1254-01 Strategic 60 capsules $0.054 — Availability likely —
Phazyme 180 mg 00132-0208-12 C.B. 12 capsules $0.228 — FDA listed —
Gas-X Ultra Strength AntiGas Softgels 180 mg 00067-6274-18 Haleon 9 capsules — — FDA listed —
Gas Relief Ultra Strength 180 mg 00363-0833-50 Walgreens 1 capsule — — FDA listed —
Gas Relief Ultra Strength 180 mg 00363-0932-20 Walgreens 1 capsule — — FDA listed —
Gas Relief 180 mg 00363-1510-20 Walgreens 1 capsule — — FDA listed —
Gas Relief Ultra Strength 180 mg 00363-8730-20 Walgreens 1 capsule — — FDA listed —
Gas Relief Ultra Strength 180 mg 00363-8740-20 Walgreens 1 capsule — — FDA listed —
Ultra Strength Gas Relief 180 mg 00363-9941-09 Walgreen 10 capsules — — FDA listed —
Ultra Strength Gas Relief 180 mg 00363-9942-22 Walgreen 60 capsules — — FDA listed —
Gas Relief Ultra Strength 180 mg 21130-0073-60 Safeway, 1 capsule — — FDA listed —
Gas Relief 180 mg 21130-0446-60 Safeway, 60 capsules — — FDA listed —
Ultra Strength Gas Relief 180 mg 21130-0717-06 BETTER 60 capsules — — FDA listed —
Simethicone 180 mgthis 35916-1939-01 SOFTGEL 1000 capsules — — Discontinued —
Gas Relief Ultra Strength 180 mg 36800-0324-05 TOPCO 25 capsules — — FDA listed —
Gas Relief Ultra Strength 180 mg 37808-0874-60 H 60 capsules — — FDA listed —
Gas Relief 180 mg 41163-0773-60 United 60 capsules — — FDA listed —
Gas Relief Ultra Strength 180 mg 41163-0832-60 United 60 capsules — — FDA listed —
Ultra Strength Gas Relief 180 mg 41226-0717-30 KROGER 60 capsules — — FDA listed —
Care One Gas Relief 180 mg 41520-0657-72 American 60 capsules — — FDA listed —
Ultra Strength Gas Relief 180 mg 49035-0585-21 Wal-Mart 50 capsules — — FDA listed —
Gas Relief Ultra Strength 180 mg 50090-6088-00 A-S 1440 capsules — — FDA listed —
Gas Relief 180 mg 51316-0152-20 CVS 1 capsule — — FDA listed —
Ultrastrength Gas Relief 180 mg 51316-0621-76 CVS 50 capsules — — FDA listed —
Gas Relief Ultra Strength 410 180 mg 53345-0003-03 Humanwell 25000 capsules — — FDA listed —
Simethicone 180 mg 53345-0036-01 Humanwell 25000 capsules — — FDA listed —
Gas Relief 180 mg 56062-0657-72 Publix 60 capsules — — FDA listed —
Gas Relief 180 mg 59726-0152-60 P 60 capsules — — FDA listed —
Gas Relief Ultra Strength 180 mg 59726-0773-20 P 1 capsule — — FDA listed —
Gas Relief 180 mg 63941-0152-60 Best 60 capsules — — FDA listed —
Anti-Gas Ultra Strength 180 mg 63941-0773-60 Best 60 capsules — — FDA listed —
good sense gas relief 180 mg 68788-4101-03 Preferred 30 capsules — — FDA listed —
Gas Relief Ultra Strength 180 mg 68788-7890-03 Preferred 30 capsules — — Discontinued —
Gas Relief 180 mg 69168-0433-06 Allegiant 120 capsules — — FDA listed —
ultra strength gas relief 180 mg 69452-0543-83 BIONPHARMA 300 capsules — — FDA listed —
Gas Relief Ultra Strength 180 mg 69842-0832-20 CVS 20 capsules — — FDA listed —
Gas Relief 180 mg 70000-0668-01 CARDINAL 60 capsules — — FDA listed —
Gas Relief 180 mg 72090-0015-01 Pioneer 180 capsules — — FDA listed —
basic care gas relief 180 mg 72288-0657-72 Amazon.com 60 capsules — — FDA listed —
Curist Gas Relief 180 mg/180mg 72559-0041-48 Little 365 mg — — FDA listed —
Simethicone 180 mg 73629-0002-18 AMZ789 180 capsules — — FDA listed —
ULTRA STRENGTH Gas Relief Softgels 180 mg 76162-0840-05 Topco 25 capsules — — FDA listed —
meijer ULTRA STRENGTH Gas Relief SOFTGEL 180 mg 79481-0814-05 Meijer, 25 capsules — — FDA listed —
Gas Relief 180 mg 83455-0152-60 United 60 capsules — — FDA listed —
Gas Relief Simethicone 180mg Softgel 180 mg 84324-0015-01 NUVICARE 100 capsules — — FDA listed —
Simethicone 180 MG 85786-0401-24 Farmacias 24 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
Oct 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.

What it looks like

Color blue
ShapeOval
Size14 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.

From the label’s inactive-ingredient sectionInactive ingredients FD&C blue no.1, gelatin, glycerin, purified water, sorbitol 70%

This is label-wide narrative text, not a normalized exact-product ingredient list. A label can cover multiple strengths or packages.

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.

Manufacturer & labeler

LabelerSOFTGEL HEALTHCARE PRIVATE LIMITED
FDA applicationM002 (OTC MONOGRAPH DRUG)
Labeler code35916
First marketedOct 2025
Product typeHuman Otc Drug
Portfolio23 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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Keep Out of Reach of Children 📄 Other Information 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 14 words ▾

Use for the relief of pressure, bloating, and fullness commonly referred to as gas

⏱️ Dosage and Administration 33 words ▾

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

⚠️ Warnings 1 words ▾

Warnings

🧪 Active Ingredient 9 words ▾

Active ingredient (in each softgel) Simethicone USP 500 mg

🧪 Inactive Ingredients 11 words ▾

Inactive ingredients FD&C blue no.1, gelatin, glycerin, purified water, sorbitol 70%

🎯 Purpose 2 words ▾

Purpose Antigas

📄 Keep Out of Reach of Children 6 words ▾

Keep out of reach of children.

📄 Other Information 9 words ▾

Other information store at controlled room temperature 15ºC-30ºC (59-86ºF)

📄 Package Label / Principal Display Panel 22 words ▾

Principal Display Panel NDC 35916-1942-1 Simethicone Capsules USP, 500 mg Simethicone 500 mg/ Antigas RELIEVES GAS FAST: Pressure Bloating Discomfort Bulk Label

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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 ✓ 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.
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 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.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 10 capsules (35916-1939-02). 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?
SOFTGEL HEALTHCARE PRIVATE LIMITED 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.
← 35916-1938-01 · Softgel 35916-1940-01 · SOFTGEL →
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.