PHAZYME Simethicone 250 mg Capsule, Gelatin Coated, 12-count
by C.B. Fleet Company, Inc. · 1 BLISTER PACK in 1 BOX (0132-0211-12) / 12 CAPSULE, GELATIN COATED in 1 BLISTER PACK
NDC 00132-0211-12
🏷️ FDA NDC (as labeled)
0132-0211-12
billing pads the labeler segment with a zero
This package
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)
0132-0211-12
Product NDC
0132-0211
11-digit billing NDC
00132021112
NCPDP billing unit
EA — each (per item)
UNII
92RU3N3Y1O
Application #
M002
SPL Set ID
ea04f5a5-cf56-4176-a234-5a73e01ff218
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
2014-04-01
Route
ORAL
Dosage form
CAPSULE, GELATIN COATED
Substance
DIMETHICONE
GPI-14
52200020000145
GPI class
Phazyme Maximum Strength
GCN Seq No
024814
GCN
09274
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
PHAZYME 250 MG SOFTGEL
FDB brand name
Phazyme
Legend status
O — Over-the-counter (OTC) drug or device
Why two NDCs?
The FDA registers this code as 0132-0211-12 — 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 → 00132-0211-12. 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
LabelerC.B. Fleet Company, Inc.
FDA applicationM002 (OTC MONOGRAPH DRUG)
Labeler code00132
First marketedApr 2014
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.
🩺 Clinical
Label name PHAZYME 250 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?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Simethicone — 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 Simethicone?
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 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 C9H2L21V7U
A fat derived from coconut or palm oil containing shorter fatty acid chains. It serves as a solvent and carrier to help dissolve or suspend active ingredients, improving absorption and stability in liquid formulations.
-
UNII ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
-
UNII 506T60A25R
Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
-
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.
8 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesDC Red #33, FD&C Blue #1, gelatin, glycerin, medium-chain triglycerides, silicon dioxide, sorbitol, purified water
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 ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.258 | $3.10 / 12 capsules |
| 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. | |
NADAC price history (per ea) — tap or hover for the price & month
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 |
|---|---|---|---|---|---|---|
| Phazyme 250 mgthis 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 mg 53345-0032-02 | Humanwell | 12 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
🏛️
2014
On the market since
Apr 2014
📍
2026
Currently FDA-listed
12 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.
🔬 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 PHAZYME (this brand).
Top reported reactions
Reporter sex
Serious outcomes
Reports over time (by year) — tap or hover for the count & year
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 NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 00132-0211-12 You're viewing this | 1 BLISTER PACK in 1 BOX (0132-0211-12) / 12 CAPSULE, GELATIN COATED in 1 BLISTER PACK | $0.2581 / ea | $3.10 | 2014-04-01 | Active |
| 00132-0211-24 | 2 BLISTER PACK in 1 BOX (0132-0211-24) / 12 CAPSULE, GELATIN COATED in 1 BLISTER PACK | — | — | 2014-04-01 | Active |
| 00132-0211-36 | 3 BLISTER PACK in 1 BOX (0132-0211-36) / 12 CAPSULE, GELATIN COATED in 1 BLISTER PACK | — | — | 2014-04-01 | Active |
Pack size FAQ
What quantity is in NDC 00132-0211-12?
NDC 00132-0211-12 is a 12-count package — 1 blister pack in 1 box / 12 capsule, gelatin coated in 1 blister pack.
What NDC number is used to bill for this package of PHAZYME Simethicone 250 mg Capsule, Gelatin Coated?
Bill NDC 00132-0211-12 — the 11-digit billing format is 00132021112. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
📄 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
🎯 Indications and Usage ▾
Use Relieves bloating, pressure or fullness commonly referred to as gas
⏱️ Dosage and Administration ▾
Directions Swallow one or two fast gels as symptoms occur. Do not exceed two fast gels per 24 hours except under the advice and supervision of a physician.
⚠️ Warnings ▾
Warnings Stop use and ask a doctor if condition persists. Keep out of reach of children .
🧪 Active Ingredient ▾
Active Ingredient (in each fast gel) Simethicone 250 mg
🧪 Inactive Ingredients ▾
Inactive In g redients DC Red #33, FD&C Blue #1, gelatin, glycerin, medium-chain triglycerides, silicon dioxide, sorbitol, purified water
🎯 Purpose ▾
Purpose Anti-gas
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.