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Gas Relief Ultra Strength Simethicone 180 mg Capsule, Liquid Filled, 60-count — NDC 00536-1306-08 package photo

Gas Relief Ultra Strength Simethicone 180 mg Capsule, Liquid Filled, 60-count

by Rugby Laboratories, Inc. · 60 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (0536-1306-08)
NDC 00536-1306-08
🏷️ FDA NDC (as labeled) 0536-1306-08 billing pads the labeler 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 →

🆔 Identity & classification

FDA NDC (as labeled) 0536-1306-08
Product NDC 0536-1306
11-digit billing NDC 00536130608
NCPDP billing unit EA — each (per item)
RxCUI 252294
UNII 92RU3N3Y1O
UPC 0305361306083
Application # M002
SPL Set ID 24731f4b-ca2b-483f-beed-dfc8104f8133
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 2020-07-24
Marketing end 2026-10-28
Route ORAL
Dosage form CAPSULE, LIQUID FILLED
Substance DIMETHICONE
GPI-14 52200020000135
GPI class Simethicone Ultra Strength
GCN Seq No 040944
GCN 94652
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 180 MG SOFTGEL
FDB brand name Simethicone
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 0536-1306-08 — a 4-4-2 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 labeler segment → 00536-1306-08. 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

LabelerRugby Laboratories, Inc.
FDA applicationM002 (OTC MONOGRAPH DRUG)
Labeler code00536
First marketedJul 2020
Product typeHuman Otc Drug
Portfolio14 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

Label name SIMETHICONE 180 MG SOFTGEL Ingredient Simethicone
📖 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?
📖 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.

💊 What it looks like

Color orange
ShapeCapsule
Imprint05A
Size12 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.

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

  • 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 H77VEI93A8
    A synthetic yellow dye used to color medications. It helps identify the drug and make it visually distinctive, with no effect on how the medicine works.
  • 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.

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

The official label also statesFD&C red #40, FD&C yellow #6, gelatin, glycerin

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 DailyMedingredient 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 systemPer eaPer package
Retail pharmacies payNADAC · weekly $0.053 $3.18 / 60 capsules
Medicaid paysCMS SDUD · 12 mo $0.1441 $8.65 / 60 capsules
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per ea) — tap or hover for the price & month
Dec 2021 Jul 2022 Dec 2025 Aug 2026 $0.066 $0.047
▼ Down 17% over the last 24 months.
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
good sense gas relief 180 mg 00113-0657-72 L. 60 capsules $0.053 Availability likely
Gas Relief Ultra Strength 180 mgthis 00536-1306-08 Rugby 60 capsules $0.053 Availability likely
Gas Relief 180 mg 00536-1421-08 Rugby 60 capsules $0.053 Availability likely
Gas Relief 180 mg 46122-0769-64 AmerisourceBergen 60 capsules $0.053 Availability likely
Gas Relief 180 mg 70677-1093-01 Strategic 60 capsules $0.053 Availability likely
Phazyme 180 mg 00132-0208-12 C.B. 12 capsules $0.228 FDA listed +330%
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 mg 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 FDA listed
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 70677-1254-01 Strategic 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

🏛️
2020
On the market since
Jul 2020
📍
2026
Currently FDA-listed
6 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.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 00536-1306-08, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
1.2K
Units reimbursed last 4 qtrs
63.9K
Gross reimbursed last 4 qtrs
$9.2K
Avg / prescription
$7.76
Avg / unit
$0.1441
Latest quarter Q4 2025
61Rx
Medicaid pays / ea
$0.1441
gross reimbursed
vs
NADAC / ea
$0.0530
acquisition cost
=
Spread
+$0.0911
+172% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care
33% FFS 67% MCO
Fee-for-service · 394 Rx Managed care · 792 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 828 units · 14.4 per 100k residents MN Wisconsin: no data reported WI Michigan: no data reported MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: 750 units · 23.5 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 1,667 units · 13.3 per 100k residents IL Indiana: 1,140 units · 16.6 per 100k residents IN Ohio: no data reported OH Pennsylvania: 584 units · 4.5 per 100k residents PA New Jersey: 666 units · 7.2 per 100k residents NJ Massachusetts: 19,024 units · 272 per 100k residents MA California: 11,556 units · 29.7 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: 648 units · 32.8 per 100k residents NE Missouri: no data reported MO Kentucky: 11,252 units · 249 per 100k residents KY West Virginia: no data reported WV Virginia: 750 units · 8.6 per 100k residents VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: 6,710 units · 90.3 per 100k residents AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 8,289 units · 27.2 per 100k residents TX Florida: no data reported FL
Units reimbursed · per 100k residents
4.5272
gray = no data reported
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Massachusetts 272 /100k
2 Kentucky 249 /100k
3 Arizona 90.3 /100k
4 Nebraska 32.8 /100k
5 California 29.7 /100k
6 Texas 27.2 /100k
7 Nevada 23.5 /100k
8 Indiana 16.6 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

🔬 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 Gas Relief Ultra Strength (this brand).

Top reported reactions

Nausea201
Diarrhoea175
Fatigue173
Vomiting155
Abdominal Pain124
Dyspnoea123
Pyrexia118

Age at onset

Neonate2
Infant2
Child19
Adolescent12
Adult122
Elderly128

Reporter sex

0 reports
Male · 46%
Female · 53%
Unknown · 0%

Serious outcomes

Death325
Disabling47
Reports over time (by year) — tap or hover for the count & year
2024 2025 2026 130 59
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
00536-1306-08 You're viewing this 60 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (0536-1306-08) 2020-07-24 Active

📄 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 11 words

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

⏱️ Dosage and Administration 26 words

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

⚠️ Warnings 26 words

Warnings Stop use and ask a doctor if condition persists. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children.

📦 Storage and Handling 11 words

Other information store between 15-30ºC (59-86ºF) protect from heat and moisture

🧪 Active Ingredient 8 words

Active ingredient (in each softgel) Simethicone 180 mg

🧪 Inactive Ingredients 10 words

Inactive ingredients FD&C red #40, FD&C yellow #6, gelatin, glycerin

🎯 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 ↗
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.