Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.
PHAZYME Simethicone 250 mg Capsule, Gelatin Coated — NDC 0132-0211-24 (Billing 00132-0211-24)
by C.B. Fleet Company, Inc. · 2 BLISTER PACK in 1 BOX / 12 CAPSULE, GELATIN COATED in 1 BLISTER PACK
This is a package of PHAZYME Simethicone 250 mg Capsule, Gelatin Coated from C.B. Fleet Company, Inc., marketed since Apr 2014 and currently FDA-listed.
NDC 00132-0211-24
🏷️ FDA NDC (as labeled)
0132-0211-24
billing pads the labeler segment with a zero
This package
Contains12 capsule, gelatin coated in 1 blister pack
Pack sizes3 compare ↓
🗂️ 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 →
NDC database record
One package, one record: these facts belong to NDC 0132-0211-24 alone.
- Record
- FDA NDC Directory package listing · Human OTC drug
- Code segments
- 0132 labeler · 0211 product · 24 package
- Package marketed since
- Apr 1, 2014
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC-A, from the NDC)
- 3 0132021124 5
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
FDA NDC (as labeled)
0132-0211-24
Product NDC
0132-0211
11-digit billing NDC
00132021124
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
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
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
Quick answers
- GSN (GCN sequence number): 024814
- GCN: 09274
- GPI-14 (Medi-Span): 52200020000145
- HICL (First Databank): 001224
- AHFS class code: 56:10.00.00
- RxCUI (RxNorm): 412111
Why two NDCs?
The FDA registers this code as 0132-0211-24 — 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 → 00132-0211-24. 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.
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 8, 2026
Clinical
Label name PHAZYME 250 MG SOFTGEL 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.
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.
- MedlinePlus (NLM) · refreshed Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
💬 Questions about Simethicone?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
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 each | Per 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.
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 8, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Marketing end | Status |
|---|---|---|---|---|---|---|
| 00132-0211-12 0132-0211-12 Main listing | 1 BLISTER PACK in 1 BOX / 12 CAPSULE, GELATIN COATED in 1 BLISTER PACK | $0.2581 / ea | $3.10 | 2014-04-01 | — | Active |
| 00132-0211-24 You're viewing this | 2 BLISTER PACK in 1 BOX / 12 CAPSULE, GELATIN COATED in 1 BLISTER PACK | — | — | 2014-04-01 | — | Active |
| 00132-0211-36 0132-0211-36 | 3 BLISTER PACK in 1 BOX / 12 CAPSULE, GELATIN COATED in 1 BLISTER PACK | — | — | 2014-04-01 | — | Active |
Pack size FAQ
What quantity is in this package?
This package is listed by the FDA — 2 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?
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.
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.
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Gas-X Maximum Strength Softgels 250 mg 00067-6283-01 | Haleon | 10 capsules | — | — | FDA listed | — |
| Phazyme 250 mgthis 00132-0211-24 | C.B. | 12 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.
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
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.
- FDA Orange Book · refreshed Oct 3, 2026
What it looks like
Color
purple
ShapeCapsule
ImprintPZ;250
Size11 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.
- FDA label on DailyMed · label index refreshed Oct 8, 2026
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 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.- FDA label on DailyMed · label index refreshed Oct 8, 2026
- FDA openFDA NDC Directory · synced Oct 8, 2026
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
LabelerC.B. Fleet Company, Inc.
FDA applicationM002 (OTC MONOGRAPH DRUG)
Labeler code00132
First marketedApr 2014
Product typeHuman Otc Drug
Portfolio23 products on file
More NDCs from C.B. Fleet Company, Inc. labeler code 00132
- Fleet glycerin 5.4 g Liquid NDC 0132-0185-01
- Pedia-Lax Glycerin 2.8 g/2.7mL Liquid NDC 0132-0190-12
- Pedia-Lax Glycerin 2.8 g/4mL Liquid NDC 0132-0195-12
- Fleet sodium phosphate, dibasic and sodium phosphate, monobasic 7 g/118mL; 19 g/118mL Enema NDC 0132-0201-10
- Pedia-Lax sodium phosphate, dibasic and sodium phosphate, monobasic 3.5 g/66mL; 9.5 g/66mL Enema NDC 0132-0202-20
- PHAZYME Simethicone 180 mg Capsule, Gelatin Coated NDC 0132-0208-12
- Phazyme Ultimate SIMETHICONE 500 mg Capsule, Liquid Filled NDC 0132-0222-20
- FLEET Mineral Oil 100 g/100mL Enema NDC 0132-0301-40
- Boudreauxs Zinc Oxide 40 g/113g Cream NDC 0132-0323-14
- Boudreauxs Zinc Oxide 16 g/113g Ointment NDC 0132-0324-02
- Boudreauxs Butt Barrier Dimethicone 1 g/113g Ointment NDC 0132-0326-04
- Boudreauxs Baby Shower Bundle Zinc oxide Kit NDC 0132-0327-01
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 openFDA NDC Directory · synced Oct 8, 2026
- Drugs@FDA
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
📄 Stop Use and Ask a Doctor If
📄 Keep Out of Reach of Children
📄 Other Information
📄 Questions or Comments
📄 Package Label / Principal Display Panel
🎯 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
📄 Stop Use and Ask a Doctor If ▾
Stop use and ask a doctor if condition persists.
📄 Keep Out of Reach of Children ▾
Keep out of reach of children .
📄 Other Information ▾
Other information Store at room temperature 59º-86ºF (15º-30ºC).
📄 Questions or Comments ▾
Questions? Call toll-free 1-855-727-4277
📄 Package Label / Principal Display Panel ▾
Principal Display Panel PHAZYME® ANTI-GAS SIMETHICONE 250 mg MAXIMUM STRENGTH 250 MG 12 FAST GELS PHAZYME® ANTI-GAS SIMETHICONE 250 mg MAXIMUM STRENGTH 250 MG 12 FAST GELS
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 ↗
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
Age at onset
Reporter sex
Male · 44%
Female · 56%
Unknown · 0%
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.
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 C.B. Fleet Company, Inc.. 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 2 other package presentations of this same product, including 12 capsules (00132-0211-12), 12 capsules (00132-0211-36). 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?
C.B. Fleet Company, Inc. 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.
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.