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Simethicone 250 mg Capsule, Liquid Filled, 20,000-count — NDC 53345-0032-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Simethicone 250 mg Capsule, Liquid Filled, 20,000-count — NDC 53345-032-01 (Billing 53345-0032-01)

by Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd · 1 BAG in 1 BOX / 20000 CAPSULE, LIQUID FILLED in 1 BAG

This is a package of 20,000 capsules of Simethicone 250 mg Capsule, Liquid Filled from Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd, marketed since Jun 2016 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 53345-0032-01
🏷️ FDA NDC (as labeled) 53345-032-01 billing pads the product segment with a zero
This package
Contains20,000-count Pack sizes2 compare ↓
Main listing for product 53345-032 · Also comes in: 12 capsules 53345-032-02
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 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

NDC database record

One package, one record: these facts belong to NDC 53345-032-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
53345 labeler · 032 product · 01 package
Package marketed since
Jan 28, 2015
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 5334503201 5
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 53345-032-01
Product NDC 53345-032
11-digit billing NDC 53345003201
RxCUI 412111
UNII 92RU3N3Y1O
Application # M002
SPL Set ID 0c9c5fec-ddd4-41a5-8ff9-6b55c376dd36
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 2016-06-30
Route ORAL
Dosage form CAPSULE, LIQUID FILLED
Substance DIMETHICONE
Quick answers
  • RxCUI (RxNorm): 412111
Why two NDCs? The FDA registers this code as 53345-032-01 — 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 → 53345-0032-01. 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

📗 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: 12 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
53345-0032-02 53345-032-02 124 BLISTER PACK in 1 BOX / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 2016-06-30 — Active
53345-0032-01 You're viewing this Main listing 1 BAG in 1 BOX / 20000 CAPSULE, LIQUID FILLED in 1 BAG 2015-01-28 — Active

Pack size FAQ

What quantity is in this package?
This is a 20,000-count package — 1 bag in 1 box / 20000 capsule, liquid filled in 1 bag.
What NDC number is used to bill for this package of Simethicone 250 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
Phazyme 250 mg 00132-0211-12 C.B. 12 capsules $0.258 — Availability likely —
Gas-X Maximum Strength Softgels 250 mg 00067-6283-01 Haleon 10 capsules — — FDA listed —
Maximum Strength Gas Relief 250 mg 00363-9888-30 WALGREENS 10 capsules — — FDA listed —
Simethicone 250 mg 00363-9945-02 WALGREEN 12 capsules — — FDA listed —
Maximum Strength Gas Relief 250 mg 11673-0827-30 TARGET 10 capsules — — FDA listed —
Simethicone 250 mg 35916-1940-01 SOFTGEL 1000 capsules — — FDA listed —
Maximum Strength Gas Relief Softgel-60ct 250 mg 37808-0813-06 HEB 60 capsules — — FDA listed —
Maximum Strength Gas Relief 250 mg 41520-0983-02 FOODHOLD 12 capsules — — FDA listed —
CVS Health Gas Relief SOFTGEL 250 mg 51316-0311-05 CVS 25 capsules — — FDA listed —
Maximum Strength Gas Relief Softgel 250 mg 51316-0813-06 CVS 60 capsules — — FDA listed —
Simethicone 250 mgthis 53345-0032-01 Humanwell 20000 capsules — — FDA listed —
Maximum Strength Gas Relief 250 mg 63868-0975-06 Chain 60 capsules — — FDA listed —
Gas Relief 250 mg 69168-0434-01 Allegiant 100 capsules — — FDA listed —
Maximum Strength Gas Relief Softgel 250 mg 70000-0632-01 Cardinal 60 capsules — — FDA listed —
Right Remedies Maximum Strength Gas Relief Softgel 250 mg 70692-0813-12 Strive 120 capsules — — FDA listed —
Curist Gas Relief Maximum Strength 250 mg 72559-0019-23 Little 300 capsules — — FDA listed —
Simethicone 250mg 250 mg 73629-0006-12 AMZ789 120 capsules — — FDA listed —
Simethicone 250 mg 79903-0020-22 WALMART 60 capsules — — FDA listed —
Gas Relief 250 mg 80513-0112-01 Advanced 100 capsules — — FDA listed —
FEVIA Gas Control 250 mg 82706-0031-02 VIVUNT 20 capsules — — FDA listed —
QUALITY CHOICE Maximum Strength Gas Relief Softgel 250 mg 83324-0304-60 Chain 60 capsules — — FDA listed —
Pepto Gas plus Bloating 250 mg 84126-0368-24 The 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

🏛️
2016
On the market since
Jun 2016
📍
2026
Currently FDA-listed
10 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.

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.

🧪 Avoiding an ingredient? See Simethicone inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 9DBA0SBB0L
    A synthetic red dye derived from coal tar used as a colorant in medicines and cosmetics. It gives tablets, capsules, and liquids their red or pink appearance for identification and visual appeal.
  • 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 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 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.

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

The official label also statesD&C red # 33, FD&C blue # 1, gelatin, glycerin, purified water and white edible ink

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

LabelerHumanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd
FDA applicationM002 (OTC MONOGRAPH DRUG)
Labeler code53345
First marketedJun 2016
Product typeHuman Otc Drug
Portfolio7 products on file

More NDCs from Humanwell PuraCap Pharmaceutical (Wuhan) Co., Lt... labeler code 53345

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 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 11 words ▾

Use relieves bloating, pressure or fullness commonly referred to as gas

⏱️ Dosage and Administration 26 words ▾

Directions swallow one or two softgels after a meal do not exceed two softgels per 24 hours except under the advice and supervision of a physician

⚠️ Warnings 16 words ▾

Warnings Stop use and ask a doctor if condition persists Keep out of reach of children.

📦 Storage and Handling 8 words ▾

Other information store at room temperature 59°-86°F (15°-30°C)

🧪 Active Ingredient 8 words ▾

Active ingredient (in each softgel) Simethicone 250 mg

🧪 Inactive Ingredients 18 words ▾

Inactive ingredients D&C red # 33, FD&C blue # 1, gelatin, glycerin, purified water and white edible ink

🎯 Purpose 2 words ▾

Purpose Anti-gas

📄 Stop Use and Ask a Doctor If 9 words ▾

Stop use and ask a doctor if condition persists

📄 Keep Out of Reach of Children 6 words ▾

Keep out of reach of children.

📄 Package Label / Principal Display Panel 59 words ▾

PRINCIPAL DISPLAY PANEL - Shipping Label Simethicone Capsules 250 mg NDC 53345-032-02 Quantity: 12 Capsules per blister 124 Blisters per box IMPORTANT: Inspect immediately upon receipt. This is a bulk shipment, intended for further processing only. Protect from heat, humidity, and light. Do not refrigerate. Store at 15-30°C (59-86°F) CAUTION : FOR FURTHER MANUFACTURING, PROCESSING OR REPACKAGING Shipping 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
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 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 Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd. 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 12 capsules (53345-0032-02). 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?
Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd 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.
← 53345-0031-01 · Humanwell 53345-0033-01 · Humanwell →
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.