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Simethicone 80 mg 80 mg Tablet, Chewable, 100-count — NDC 69618-033-01 (Billing 69618-0033-01)

by Reliable 1 Laboratories LLC · 100 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC

This is a package of 100 tablets of Simethicone 80 mg 80 mg Tablet, Chewable from Reliable 1 Laboratories LLC, marketed since Apr 2018 and currently FDA-listed. It is this product's only package size.

NDC 69618-0033-01
🏷️ FDA NDC (as labeled) 69618-033-01 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

NDC database record

One package, one record: these facts belong to NDC 69618-033-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
69618 labeler · 033 product · 01 package
Package marketed since
Apr 24, 2018
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
100 EA per package
Barcode (UPC)
0369618033016
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 69618-033-01
Product NDC 69618-033
11-digit billing NDC 69618003301
NCPDP billing unit EA — each (per item)
RxCUI 314216
UNII 92RU3N3Y1O
UPC 0369618033016
Application # M002
SPL Set ID 32fb242b-7051-072c-e054-00144ff88e88
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 2018-04-24
Route ORAL
Dosage form TABLET, CHEWABLE
Substance DIMETHICONE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 52200020000510
GPI class Simethicone
GCN Seq No 002821
GCN 08281
HICL code 001224
Ingredient (HICL) Simethicone
HIC1 code D
Therapeutic class — broad (HIC1) Biliary System/Gastro-Intestinal System
HIC2 code D4
Therapeutic class — intermediate (HIC2) Drugs Acting Principally On The Alimentary Tract
HIC3 code D4N
Therapeutic class — specific (HIC3) Antiflatulents
AHFS code 56:10.00.00
AHFS class Antiflatulents
FDB label name SIMETHICONE 80 MG TAB CHEW
FDB brand name Simethicone
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 002821
  • GCN: 08281
  • GPI-14 (Medi-Span): 52200020000510
  • HICL (First Databank): 001224
  • AHFS class code: 56:10.00.00
  • RxCUI (RxNorm): 314216
Why two NDCs? The FDA registers this code as 69618-033-01 — 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 → 69618-0033-01. 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

Label name SIMETHICONE 80 MG TAB CHEW Ingredient Simethicone
📗 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 eachPer 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
69618-0033-01 You're viewing this Main listing 100 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC 2018-04-24 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Antiflatulent 80 mg 00904-7206-60 Major 100 tablets $0.032 — Availability likely —
GNP Regular Strength Gas Relief 80 mg 24385-0118-78 Amerisource 100 tablets $0.032 — Availability likely —
Leader Gas relief 80 mg 70000-0434-01 CARDINAL 100 tablets $0.032 — Availability likely —
Gas Relief 80 mg 70677-1067-01 STRATEGIC 36 tablets $0.032 — Availability likely —
Gas Relief 80 mg 17714-0019-01 Advance 100 tablets — — FDA listed —
GNP Regular Strength Gas Relief 80 mg 17856-1118-01 ATLANTIC 1 tablet — — FDA listed —
CVS PHARMACY Gas relief 80 mg 51316-0111-00 CVS 100 tablets — — FDA listed —
Gas relief Anti-gas 80 mg 51316-0904-16 CVS 100 tablets — — FDA listed —
Gas relief 80 mg 53041-0103-16 Guardian 100 tablets — — FDA listed —
Gas relief 80 mg 53943-0301-16 Discount 100 tablets — — FDA listed —
Simethicone 80 mg 54738-0518-01 Richmond 100 tablets — — FDA listed —
Simethicone 80Mg 80 mg 55154-2606-00 Cardinal 1 tablet — — FDA listed —
Simethicone 80 mg 57896-0791-01 Geri-Care 100 tablets — — FDA listed —
QC Gas Relief Mint Flavor 80 mg 63868-0108-01 QUALITY 100 tablets — — FDA listed —
Simethicone 80 mg 68071-2746-03 NuCare 30 tablets — — FDA listed —
Gas Relief Mint Flavor 80 mg 68163-0111-36 Raritan 36 tablets — — FDA listed —
Simethicone 80 mgthis 69618-0033-01 Reliable 100 tablets — — FDA listed —
Simethicone 80 mg 71610-0607-04 Aphena 4 tablets — — FDA listed —
Simethicone 80 mg 71610-0649-04 Aphena 4 tablets — — FDA listed —
Antiflatulent 80 mg 71610-0650-04 Aphena 4 tablets — — FDA listed —
Simethicone 80Mg 80 mg 77333-0812-10 Gendose 1 tablet — — FDA listed —
Simethicone 80 mg 82804-0043-30 Proficient 30 tablets — — 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

🏛️
2018
On the market since
Apr 2018
📍
2026
Currently FDA-listed
8 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.

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.

Manufacturer & labeler

LabelerReliable 1 Laboratories LLC
FDA applicationM002 (OTC MONOGRAPH DRUG)
Labeler code69618
First marketedApr 2018
Product typeHuman Otc Drug
Portfolio26 products on file

More NDCs from Reliable 1 Laboratories LLC labeler code 69618

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 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 11 words ▾

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

⏱️ Dosage and Administration 21 words ▾

Directions thoroughly chew 1-2 tablets as needed after meals and at bedtime do not take more then 6 tablets per day

⚠️ Warnings 7 words ▾

Warnings Keep out of reach of children

📦 Storage and Handling 8 words ▾

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

🧪 Active Ingredient 9 words ▾

Active ingredient (in each chewable tablet) Simethicone 80 mg

🧪 Inactive Ingredients 15 words ▾

Inactive ingredients compressible sugar, dextrose, maltodextrin, micdocrystalline cellulose, peppermint flavor, Silicon dioxide, sorbitol, stearic acid

🎯 Purpose 2 words ▾

Purpose Antiflatulent

📄 Keep Out of Reach of Children 6 words ▾

Keep out of reach of children

📄 Questions or Comments 15 words ▾

Questions or comments? call 516-341-0666 , 8:30 am to 4:30 pm ET, Monday - Friday

📄 Package Label / Principal Display Panel 11 words ▾

NDC 69618-033-01 Simethicone 80 mg ANTIFLATULENT 100 CHEWABLE TABLETS Simethicone 80mg

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 — 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.
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 Reliable 1 Laboratories LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Reliable 1 Laboratories 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.
← 69618-0032-06 · Reliable 69618-0034-10 · Reliable →
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.