Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.
Gas-X Extra Strength Softgels Simethicone 125 mg Capsule, Liquid Filled — NDC 0067-6275-20 (Billing 00067-6275-20)
by Haleon US Holdings LLC · 2 BLISTER PACK in 1 CARTON / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
This is a package of Gas-X Extra Strength Softgels Simethicone 125 mg Capsule, Liquid Filled from Haleon US Holdings LLC, marketed since Sep 2011 and currently FDA-listed.
NDC 00067-6275-20
🏷️ FDA NDC (as labeled)
0067-6275-20
billing pads the labeler segment with a zero
This package
Contains10 capsule, liquid filled in 1 blister pack
Pack sizes6 compare ↓
Product page 00067-6275-01
Also comes in:
10 capsules 0067-6275-10
10 capsules 0067-6275-30
10 capsules 0067-6275-50
12 capsules 0067-6275-72
120 capsules 0067-6275-01
🗂️ 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 0067-6275-20 alone.
- Record
- FDA NDC Directory package listing · Human OTC drug
- Code segments
- 0067 labeler · 6275 product · 20 package
- Package marketed since
- Sep 12, 2011
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC-A, from the NDC)
- 3 0067627520 8
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
FDA NDC (as labeled)
0067-6275-20
Product NDC
0067-6275
11-digit billing NDC
00067627520
NCPDP billing unit
EA — each (per item)
UNII
92RU3N3Y1O
Application #
M001
SPL Set ID
fa4a3b07-591b-4445-aa67-b17ba1e67d5c
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
2011-09-12
Route
ORAL
Dosage form
CAPSULE, LIQUID FILLED
Substance
DIMETHICONE, UNSPECIFIED
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
GPI-14
52200020000120
GPI class
Gas-X Extra Strength
GCN Seq No
002814
GCN
09270
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
GAS-X EXTRA STRENGTH SOFTGEL
FDB brand name
Gas-X
Legend status
O — Over-the-counter (OTC) drug or device
Quick answers
- GSN (GCN sequence number): 002814
- GCN: 09270
- GPI-14 (Medi-Span): 52200020000120
- HICL (First Databank): 001224
- AHFS class code: 56:10.00.00
- RxCUI (RxNorm): 198852
Why two NDCs?
The FDA registers this code as 0067-6275-20 — 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 → 00067-6275-20. 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 8, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 8, 2026
Clinical
Label name GAS-X EXTRA STRENGTH 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 mL | 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 9, 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 | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 00067-6275-01 0067-6275-01 Main listing | 120 CAPSULE, LIQUID FILLED in 1 CARTON | 2017-08-01 | — | Active |
| 00067-6275-10 0067-6275-10 | 1 BLISTER PACK in 1 CARTON / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | 2011-09-12 | — | Active |
| 00067-6275-20 You're viewing this | 2 BLISTER PACK in 1 CARTON / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | 2011-09-12 | — | Active |
| 00067-6275-30 0067-6275-30 | 3 BLISTER PACK in 1 CARTON / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | 2011-09-12 | — | Active |
| 00067-6275-50 0067-6275-50 | 5 BLISTER PACK in 1 CARTON / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | 2011-09-12 | — | Active |
| 00067-6275-72 0067-6275-72 | 6 BLISTER PACK in 1 CARTON / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | 2011-09-12 | — | Active |
Pack size FAQ
What quantity is in this package?
This package is listed by the FDA — 2 blister pack in 1 carton / 10 capsule, liquid filled in 1 blister pack.
What NDC number is used to bill for this package of Gas-X Extra Strength Softgels Simethicone 125 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
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Gas Relief Extra Strength 125 mg 70000-0529-01 | Cardinal | 1 capsule | $0.069 | — | FDA listed | — |
| Gas Relief Extra Strength 125 mg 62011-0419-01 | Strategic | 1 capsule | $0.069 | — | Discontinued | — |
| Good Sense Gas Relief Extra Strength 125 mg 00113-0428-65 | L. | 1 capsule | $0.071 | — | Availability likely | — |
| Gas Relief Extra Strength 125 mg 00904-6994-46 | Major | 1 capsule | $0.071 | — | Availability likely | — |
| Gas Relief 125 mg 70677-1092-01 | Strategic | 1 capsule | $0.071 | — | Availability likely | — |
| Gas-X Extra Strength Softgels 125 mgthis 00067-6275-20 | Haleon | 10 capsules | — | — | FDA listed | — |
| Gas Relief Extra Strength 125 mg 00363-8970-20 | Walgreens | 1 capsule | — | — | FDA listed | — |
| Gas Relief 125 mg 00363-9938-07 | Walgreen | 18 capsules | — | — | FDA listed | — |
| Extra Strength Gas Relief 125 mg 11673-0495-71 | TARGET | 24 capsules | — | — | FDA listed | — |
| Gas Relief Extra Strength 125 mg 11673-0550-50 | Target | 10 capsules | — | — | Discontinued | — |
| Kroger Extra Strength 125 mg 30142-0330-30 | KROGER | 15 capsules | — | — | FDA listed | — |
| Simethicone 125 mg 35916-1938-01 | Softgel | 1000 capsules | — | — | FDA listed | — |
| Gas Relief Extra Strength 125 mg 36800-0197-30 | TOP | 1 capsule | — | — | FDA listed | — |
| Gas Relief Extra Strength 125 mg 36800-0785-05 | TOPCO | 25 capsules | — | — | FDA listed | — |
| HEB Anti Gas Extra Strength 125 mg 37808-0231-20 | HEB | 30 capsules | — | — | FDA listed | — |
| Gas Relief 125 mg 37808-0744-20 | H-E-B | 200 capsules | — | — | FDA listed | — |
| Gas Relief Extra Strength 125 mg 37808-0797-10 | H | 100 capsules | — | — | FDA listed | — |
| Extra Strength Simethicone 125 mg 37835-0231-72 | Bi-Mart | 72 capsules | — | — | FDA listed | — |
| Gas Relief Extra Strength 125 mg 41163-0597-30 | United | 1 capsule | — | — | FDA listed | — |
| Extra strength gas relief 125 mg 41226-0722-30 | KROGER | 30 capsules | — | — | FDA listed | — |
| Meijer Extra Strength Gas Relief 125 mg 41250-0257-50 | MEIJER | 10 capsules | — | — | FDA listed | — |
| PUBLIX Extra Strength 125 mg 41415-0113-30 | PUBLIX | 15 capsules | — | — | FDA listed | — |
| Gas Relief Extra Strength 125 mg 49035-0266-20 | EQUATE | 20 capsules | — | — | FDA listed | — |
| Gas Relief 125 mg 49035-0583-64 | Wal-Mart | 150 capsules | — | — | FDA listed | — |
| Gas Relief 125 mg 51316-0597-12 | CVS | 120 capsules | — | — | FDA listed | — |
| Simethicone 125 mg 53345-0009-01 | Humanwell | 25000 capsules | — | — | FDA listed | — |
| Simethicone 125 mg 53345-0033-01 | Humanwell | 25000 capsules | — | — | FDA listed | — |
| Discount Drugmart Gas Relief Extra Strength Softgels 125 mg 53943-0823-30 | Discount | 15 capsules | — | — | FDA listed | — |
| Gas Relief 125 mg 55319-0555-30 | Family | 1 capsule | — | — | FDA listed | — |
| Gas Relief Extra Strength 125 mg 55910-0797-72 | Dolgencorp, | 1 capsule | — | — | FDA listed | — |
| Extra Strength Gas Relief 125 mg 57896-0292-05 | Geri-Care | 50 capsules | — | — | FDA listed | — |
| Gas Relief Extra Strength 125 mg 59726-0897-10 | P | 1 capsule | — | — | FDA listed | — |
| mylanta gas 125 mg 62372-0554-31 | Infirst | 10 capsules | — | — | FDA listed | — |
| Quality Choice Gas Relief Extra Strength Softgels 125 mg 63868-0586-30 | Chain | 15 capsules | — | — | FDA listed | — |
| Gas Relief Extra Strength 125 mg 63941-0897-30 | Best | 1 capsule | — | — | FDA listed | — |
| WinCo Foods Gas Relief Extra Strength Softgels 125 mg 67091-0379-30 | WinCo | 15 capsules | — | — | FDA listed | — |
| Gas Relief Extra Strength 125 mg 68391-0597-12 | BJWC | 1 capsule | — | — | FDA listed | — |
| Gas Relief 125 mg 68391-0722-29 | BJWC | 240 capsules | — | — | FDA listed | — |
| Anti-Gas 125 mg 68998-0419-85 | Marc | 30 capsules | — | — | FDA listed | — |
| Anti-Gas 125 mg 69168-0419-06 | Allegiant | 150 capsules | — | — | FDA listed | — |
| gas relief 125 mg 69452-0542-28 | BIONPHARMA | 250 capsules | — | — | FDA listed | — |
| RIGHT REMEDIES Extra Strength Gas Relief 125 mg 70692-0835-65 | Strive | 365 capsules | — | — | FDA listed | — |
| Gas Relief 125 mg 72090-0014-01 | Pioneer | 180 capsules | — | — | FDA listed | — |
| Gas Relief 125 mg 72090-0045-01 | Pioneer | 180 capsules | — | — | FDA listed | — |
| Gas Relief 125 mg 72090-0060-01 | Pioneer | 180 capsules | — | — | FDA listed | — |
| basic care gas relief 125 mg 72288-0428-65 | Amazon.com | 10 capsules | — | — | FDA listed | — |
| Gas Relief Extra Strength 125 mg 72476-0897-30 | Care | 1 capsule | — | — | FDA listed | — |
| Gas Relief Extra Strength 125 mg 73581-0301-36 | YYBA | 365 capsules | — | — | FDA listed | — |
| Simethicone 125 mg 73581-0302-36 | YYBA | 365 capsules | — | — | FDA listed | — |
| Gas Relief 125 mg 75907-0365-01 | Dr. | 150 capsules | — | — | FDA listed | — |
| TopCare health EXTRA STRENGTH Gas Relief SOFTGEL 125 mg 76162-0538-05 | Topco | 25 capsules | — | — | FDA listed | — |
| meijer EXTRA STRENGTH Gas Relief SOFTGEL 125 mg 79481-0791-05 | Meijer, | 25 capsules | — | — | FDA listed | — |
| meijer EXTRA STRENGTH Gas Relief 125 mg 79481-0835-05 | Meijer, | 25 capsules | — | — | FDA listed | — |
| Gas Relief 125 mg 80513-0111-12 | Advanced | 120 capsules | — | — | FDA listed | — |
| Gas Relief 125 mg 80513-0117-12 | Advanced | 120 capsules | — | — | FDA listed | — |
| Extra Strength Gas Relief 125 mg 83059-0056-01 | Shield | 15 capsules | — | — | Discontinued | — |
| Quality Choice Gas Relief Extra Strength Softgels 125 mg 83324-0196-30 | Chain | 15 capsules | — | — | FDA listed | — |
| Gas Relief Simethicone 125mg Softgel 125 mg 84324-0014-01 | NUVICARE | 100 capsules | — | — | FDA listed | — |
| Gas Relief 125 mg 84324-0022-01 | NUVICARE | 100 capsules | — | — | FDA listed | — |
| Extra Strength Gas Relief 125 mg 85828-0722-30 | Grocery | 30 capsules | — | — | FDA listed | — |
| HyVee Extra Strength Gas Relief SOFTGEL 125 mg 42507-0835-05 | HyVee | 25 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
🏛️
2011
On the market since
Sep 2011
📍
2026
Currently FDA-listed
15 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
Green
ShapeOval
ImprintG;X
Size1 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 35SW5USQ3G
A synthetic yellow dye used to color medicines. It helps make tablets, capsules, and liquids visually distinct so patients can easily identify their medication.
-
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 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 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 3NXW29V3WO
Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
-
UNII 3OWL53L36A
A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
-
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 AV092KU4JH
A natural oil extracted from peppermint plants. It's used as a flavoring agent to mask bitter tastes and add a refreshing mint flavor to medicines, making them easier to take.
-
UNII 6DC9Q167V3
Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
-
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 1DI56QDM62
A natural fatty substance from soybeans that helps mix oil and water-based ingredients together. It acts as an emulsifier and lubricant in medicines to improve texture and help the product break down properly in your body.
-
UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
-
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.
14 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesD&C yellow no. 10, FD&C blue no. 1, FD&C red no. 40, gelatin, glycerin, hypromellose, mannitol, medium-chain triglycerides, peppermint oil, propylene glycol, purified water, sorbitol, soy lecithin, titanium dioxide
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
LabelerHaleon US Holdings LLC
FDA applicationM001 (OTC MONOGRAPH DRUG)
Labeler code00067
First marketedSep 2011
Product typeHuman Otc Drug
Portfolio405 products on file
More NDCs from Haleon US Holdings LLC labeler code 00067
- 4 Way Fast Acting Phenylephrine hydrochloride 10 mg/mL Spray NDC 0067-2086-01
- Excedrin Rapid Relief acetaminophen 500 mg Tablet NDC 0067-2200-20
- Acetaminophen, aspirin, caffeine 250 mg; 250 mg; 65 mg Tablet, Film Coated NDC 0067-4202-99
- Theraflu PowerPods Daytime Severe Cold ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE 650 mg; 20 mg; 10 mg Powder, For Solution NDC 0067-6094-01
- Theraflu Powerpods Nighttime Severe Cold Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl 650 mg; 25 mg; 10 mg Powder, For Solution NDC 0067-6095-01
- Gas-X Ultra Strength AntiGas Softgels Simethicone 180 mg Capsule, Liquid Filled NDC 0067-6274-18
- Gas-X Maximum Strength Softgels Simethicone 250 mg Capsule, Liquid Filled NDC 0067-6283-01
- THERAFLU MULTI-SYMPTOM SEVERE COLD ACETAMINOPHEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCl 500 mg/237mL; 20 mg/237mL; 10 mg/237mL Powder, For Solution NDC 0067-6426-06
- Theraflu Severe Cold Relief Daytime Berry Burst Acetaminophen, Dextromethorphan HBr, Phenylephrine Hydrochloride 650 mg; 20 mg; 10 mg Powder NDC 0067-6800-02
- Theraflu Severe Cold relief Nighttime Acetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride 500 mg; 25 mg; 10 mg Powder NDC 0067-6801-02
- THERAFLU Severe Cold Relief Daytime ACETAMINOPHEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCl 500 mg/237mL; 20 mg/237mL; 10 mg/237mL Powder, For Solution NDC 0067-6802-02
- Theraflu Severe Cold Relief Nighttime ACETAMINOPHEN, DIPHENHYDRAMINE HCl, PHENYLEPHRINE HCl 650 mg/237mL; 25 mg/237mL; 10 mg/237mL Powder, For Solution NDC 0067-6803-02
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
📦 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 ▾
Use for the relief of • pressure, bloating, and fullness commonly referred to as gas
⏱️ Dosage and Administration ▾
Directions • adults and children 12 years and older: swallow with water 1 or 2 softgels as needed after meals and at bedtime • do not exceed 4 softgels in 24 hours except under the advice and supervision of a physician
⚠️ Warnings ▾
Warning Keep out of reach of children.
📦 Storage and Handling ▾
Other information • store at controlled room temperature 20-25ºC (68-77ºF) • protect from light, heat and moisture
🧪 Active Ingredient ▾
Active ingredient (in each softgel) Simethicone 125 mg
🧪 Inactive Ingredients ▾
Inactive ingredients D&C yellow no. 10, FD&C blue no. 1, FD&C red no. 40, gelatin, glycerin, hypromellose, mannitol, medium-chain triglycerides, peppermint oil, propylene glycol, purified water, sorbitol, soy lecithin, titanium dioxide
🎯 Purpose ▾
Purpose Antigas
📄 Keep Out of Reach of Children ▾
Keep out of reach of children.
📄 Questions or Comments ▾
Questions or comments? 1-800-452-0051
📄 Package Label / Principal Display Panel ▾
Principal Display Panel #1 DOCTOR RECOMMENDED BRAND Gas-X SIMETHICONE 125 mg / ANTIGAS RELIEVES GAS FAST PRESSURE – BLOATING – DISCOMFORT EXTRA STRENGTH 120 SoftGels GasX ES Softgels 120ct
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 Gas-X Extra Strength Softgels (this brand).
Top reported reactions
Age at onset
Reporter sex
Male · 34%
Female · 65%
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 Haleon US Holdings LLC. 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 5 other package presentations of this same product, including 10 capsules (00067-6275-10), 10 capsules (00067-6275-30), 10 capsules (00067-6275-50). 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?
Haleon US Holdings 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.
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.