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SIMETHICONE INFANT Gas Relief Drops 20 mg/.3mL Suspension, 120 syringes — NDC 17856-1017-02 package photo

SIMETHICONE INFANT Gas Relief Drops 20 mg/.3mL Suspension, 120 syringes

by Atlantic Biologicals Corp. · 120 SYRINGE in 1 CASE (17856-1017-2) / .3 mL in 1 SYRINGE
NDC 17856-1017-02
🏷️ FDA NDC (as labeled) 17856-1017-2 billing pads the package segment with a zero
This package
Contains120 syringes Pack sizes9 compare ↓
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) 17856-1017-2
Product NDC 17856-1017
11-digit billing NDC 17856101702
NCPDP billing unit EA — each (per item)
RxCUI 198857
UNII 92RU3N3Y1O
Application # M002
SPL Set ID 410d80fc-e55b-08d0-e063-6294a90aba73
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 2025-02-20
Route ORAL
Dosage form SUSPENSION
Substance DIMETHICONE
GCN Seq No 082810
GCN 51467
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 INF GAS RLF 20 MG/0.3 ML SYRNG
FDB brand name Infants' Gas Relief
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 17856-1017-2 — a 5-4-1 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 package segment → 17856-1017-02. 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

LabelerAtlantic Biologicals Corp.
FDA applicationM002 (OTC MONOGRAPH DRUG)
Labeler code17856
First marketedFeb 2025
Product typeHuman Otc Drug
Portfolio108 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 INF GAS RLF 20 MG/0.3 ML SYRNG 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

FlavorStrawberry
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 XF417D3PSL
    Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
  • UNII K679OBS311
    Carboxymethylcellulose sodium is a plant-derived thickening agent made from cellulose. In medicines, it acts as a binder to hold ingredients together, a disintegrant to help the tablet break apart, or a thickener in liquids.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII CAL22UVI4M
    A synthetic emulsifier derived from sorbitol and fatty acids. It helps mix oil and water-based ingredients together and improves the texture and stability of the medicine.
  • UNII 1VPU26JZZ4
    Potassium sorbate is a salt derived from sorbic acid, a naturally occurring preservative. It prevents growth of mold, yeast, and some bacteria, extending the medicine's shelf life.
  • UNII OJ245FE5EU
    Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
  • UNII NVZ4I0H58X
    A waxy substance made from sorbitol and stearic acid. It acts as an emulsifier and stabilizer, helping keep oil and water mixed together and preventing separation in the medicine.
  • 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.
  • UNII TTV12P4NEE
    Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.

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

The official label also statesCarboxymethylcellulose sodium, Citric acid, Flavor strawberry, Microcrystalline cellulose, Polysorbate 60, Potassium sorbate, Purified water, Sodium benzoate, Sorbitan monostearate, Sorbitol solution, Xanthan gum.

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 mLPer 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Infants 20 mg/.3mL 00536-1303-75 RUGBY 1 bottle $0.100 Availability likely
Infant Gas Relief 20 mg/.3mL 46122-0547-03 AMERISOURCEBERGEN 1 bottle $0.100 Availability likely
Cardinal Health Infants Gas Relief 20 mg/.3mL 70000-0051-01 CARDINAL 1 bottle $0.100 Availability likely
Foster and Thrive infants Gas relief 20 mg/.3mL 70677-1078-01 Strategic 1 bottle $0.100 Availability likely
SIMETHICONE INFANT Gas Relief Drops 20 mg/.3mL 82568-0017-03 AARNA 1 bottle $0.100 Availability likely
Quality Choice Infants Non-staining Gas relief 20 mg/.3mL 83324-0133-01 Chain 1 bottle $0.100 Availability likely
Infants Simethicone Drops 20 mg/.3mL 00121-1094-03 PAI 25 syringes FDA listed
Childrens Simethicone Drops 40 mg/.6mL 00121-1095-03 PAI 25 syringes FDA listed
Walgreens Infants Dye Free Gas Relief 20 mg/.3mL 00363-0790-30 WALGREEN 1 bottle FDA listed
SIMETHICONE INFANT Gas Relief Drops 20 mg/.3mLthis 17856-1017-02 Atlantic 120 syringes FDA listed
SIMETHICONE INFANT Gas Relief Drops 20 mg/.3mL 17856-1018-01 Atlantic 60 syringes FDA listed
TEENY TUMMY Gas Relief Drops 20 mg/.3mL 17856-1141-01 ATLANTIC 120 syringes FDA listed
TEENY TUMMY Gas Relief Drops 20 mg/.3mL 17856-1142-01 ALTANTIC 60 syringes FDA listed
Infants 20 mg/.3mL 17856-1303-01 ATLANTIC 120 syringes FDA listed
QUITA COLICOS Gas RELIEF Drops 20 mg/.3mL 24286-1533-08 DLC 1 bottle FDA listed
Infants Gas Relief Dye Free 20 mg/.3mL 30142-0171-01 THE 1 bottle FDA listed
Infants Gas relief 20 mg/.3mL 41163-0096-09 UNITED 1 bottle FDA listed
Meijer Infants Gas Relief Drops 20 mg/.3mL 41250-0470-01 MEIJER 1 bottle FDA listed
Publix Infants Dye Free Gas Relief 20 mg/.3mL 41415-0709-01 PUBLIX 1 bottle FDA listed
Infants Gas Relief Drops 20 mg/.3mL 49035-0709-01 Wal-Mart 1 bottle FDA listed
Infants Gas Relief Drops 20 mg/.3mL 55910-0790-01 DOLGENCORP 1 bottle FDA listed
Infants Gas Relief 20 mg/.3mL 57896-0798-01 Geri-Care 1 bottle FDA listed
Mylicon Infants Gas Relief Original 20 mg/.3mL 62372-0630-15 Infirst 1 bottle FDA listed
Mylicon Infants Gas Relief Dye Free 20 mg/.3mL 62372-0650-15 Infirst 1 bottle FDA listed
Little Remedies Gas Relief Drops 20 mg/.3mL 63029-0103-01 Medtech 1 bottle Discontinued
Quality Choice Infants Dye Free Gas Relief 20 mg/.3mL 63868-0696-30 CHAIN 1 bottle FDA listed
Best Choice 20 mg/.3mL 63941-0709-01 BEST 1 bottle FDA listed
premier value infants gas relief 20 mg/.3mL 68016-0670-00 Chain 1 bottle FDA listed
Infants Gas Relief Drops 20 mg/.3mL 69618-0059-51 RELIABLE 1 bottle FDA listed
Gas-Aid Drops for infants 20 mg/.3mL 69626-5200-09 Leosons 1 bottle FDA listed
CVS Health Anti gas 20 mg/.3mL 69842-0977-01 CVS 1 bottle FDA listed
CVS Health Infant Gas Relief 20 mg/.3mL 69842-0979-15 CVS 1 bottle FDA listed
TEENY TUMMY Gas Relief Drops 20 mg/.3mL 71399-0041-01 Akron 30 ml FDA listed
simethicone gas relief 20 mg/.3mL 71444-0788-01 MOM 1 bottle FDA listed
Infants Gas Relief 20 mg/.3mL 82179-0007-01 Mollec 1 bottle FDA listed
Quality Choice Infants Gas Relief Dye Free 20 mg/.3mL 83324-0335-01 QUALITY 1 bottle 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

🏛️
2025
On the market since
Feb 2025
📍
2026
Currently FDA-listed
1 year 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 SIMETHICONE INFANT Gas Relief Drops (this brand).

Top reported reactions

Nausea106
Fatigue83
Diarrhoea79
Vomiting70
Abdominal Pain67
Dyspnoea66
Pain58

Age at onset

Neonate2
Infant1
Child9
Adolescent6
Adult27
Elderly11

Reporter sex

1,061 reports
Male · 49%
Female · 51%
Unknown · 0%

Serious outcomes

Hospitalization565
Reports over time (by year) — tap or hover for the count & year
2022 2023 2024 2026 5 0
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
17856-1017-01 120 SYRINGE in 1 CASE (17856-1017-1) / .3 mL in 1 SYRINGE 2025-10-13 Active
17856-1017-02 You're viewing this 120 SYRINGE in 1 CASE (17856-1017-2) / .3 mL in 1 SYRINGE 2025-10-13 Active
17856-1017-03 120 SYRINGE in 1 CASE (17856-1017-3) / .6 mL in 1 SYRINGE 2025-10-13 Active
17856-1017-04 120 SYRINGE in 1 CASE (17856-1017-4) / .6 mL in 1 SYRINGE 2025-10-13 Active
17856-1017-05 60 SYRINGE in 1 CASE (17856-1017-5) / 1.2 mL in 1 SYRINGE 2025-10-13 Active
17856-1017-06 48 SYRINGE in 1 CASE (17856-1017-6) / 5 mL in 1 SYRINGE 2025-10-13 Active
17856-1017-07 60 SYRINGE in 1 CASE (17856-1017-7) / .6 mL in 1 SYRINGE 2025-12-18 Active
17856-1017-08 120 SYRINGE in 1 CASE (17856-1017-8) / 2 mL in 1 SYRINGE 2025-12-18 Active
17856-1017-09 120 SYRINGE in 1 CASE (17856-1017-9) / .6 mL in 1 SYRINGE 2026-03-18 Active

Pack size FAQ

What quantity is in NDC 17856-1017-02?
NDC 17856-1017-02 contains 120 syringes — 120 syringe in 1 case / .3 ml in 1 syringe.
What is the difference between NDC 17856-1017-02 and NDC 17856-1017-05?
Both are SIMETHICONE INFANT Gas Relief Drops 20 mg/.3mL Suspension — the drug itself is identical. NDC 17856-1017-02 is the 120 syringes package, while NDC 17856-1017-05 is the 60 syringes package.
What NDC number is used to bill for this package of SIMETHICONE INFANT Gas Relief Drops 20 mg/.3mL Suspension?
Bill NDC 17856-1017-02 — the 11-digit billing format is 17856101702. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 FDA registers it as 17856-1017-2, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 17856-1017-02, written without dashes as 17856101702. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 17856-1017-02, the first segment (17856) is the labeler code FDA assigned to Atlantic Biologicals Corp.; the middle segment (1017) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (02) identifies this exact package size and type. Together they name one specific package of one specific product.
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 Atlantic Biologicals Corp.. 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 8 other package presentations of this same product, including 48 syringes (17856-1017-06), 60 syringes (17856-1017-05), 60 syringes (17856-1017-07). 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?
Atlantic Biologicals Corp. 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.

📄 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 8 words

Uses relieves the symptoms referred to as gas

⏱️ Dosage and Administration 86 words

Directions shake well before using all dosages may be repeated as needed, alter meals and at bedtime, or as directed by a physician do not exceed 12 doses per day fill enclosed dropper to recommended dosage level and dispense liquid slowly into baby's mouth, toward the inner cheek dosage can also be mixed with 1 oz. of cool water, infant formula or other suitable liquids Age (years) Weight (lbs) Dose infants (under 2) under 24 0.3 mL children (2 and over) 24 and over 0.6 mL

⚠️ Warnings 22 words

Warnings Keep out of reach of children. In case of overdose get medical help or contact a Poison Control Center right away.

📦 Storage and Handling 32 words

Other information TAMPER-EVIDENT : Do not use if printed seal under cap is broken or punctured store at room temperature do not freeze see bottom panel for lot number and expiration date

🧪 Active Ingredient 9 words

Active ingredient (in each 0.3 mL) Simethicone 20 mg

🧪 Inactive Ingredients 36 words

Inactive ingredients Carboxymethylcellulose sodium, Citric acid, Flavor strawberry, Microcrystalline cellulose, Polysorbate 60, Potassium sorbate, Purified water, Sodium benzoate, Sorbitan monostearate, Sorbitol solution, Xanthan gum. Questions or comments ? Distributed by: Atlantic Biologicals Corp. Miami, FL 33179

🎯 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.