INFANT GAS RELIEF Simethicone 20 mg/.3mL Suspension/ Drops
by AMERISOURCEBERGEN DRUG CORPORATION · 1 BOTTLE, DROPPER in 1 CARTON (46122-547-03) / 30 mL in 1 BOTTLE, DROPPER
NDC 46122-0547-03
🏷️ FDA NDC (as labeled)
46122-547-03
billing pads the product segment with a zero
OTC
On market
Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
🆔 Identity & classification
FDA NDC (as labeled)
46122-547-03
Product NDC
46122-547
11-digit billing NDC
46122054703
NCPDP billing unit
ML — per mL (volume)
RxCUI
198857
UNII
92RU3N3Y1O
Application #
M002
SPL Set ID
7d3c3cc6-b0a2-620d-e053-2a91aa0a159b
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
2018-06-01
Route
ORAL
Dosage form
SUSPENSION/ DROPS
Substance
DIMETHICONE
GPI-14
52200020001810
GPI class
GNP Infant Gas Relief
GCN Seq No
002815
GCN
08260
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
INFANT GAS RLF 20 MG/0.3 ML
FDB brand name
Infant Gas Relief
Legend status
O — Over-the-counter (OTC) drug or device
Why two NDCs?
The FDA registers this code as 46122-547-03 — a 5-3-2 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 product segment → 46122-0547-03. 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
LabelerAMERISOURCEBERGEN DRUG CORPORATION
FDA applicationM002 (OTC MONOGRAPH DRUG)
Labeler code46122
First marketedJun 2018
Product typeHuman Otc Drug
Portfolio37 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 INFANT GAS RLF 20 MG/0.3 ML 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.
💊 What it looks like
Color
white
FlavorCherry
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 D65DG142WK
Maltitol is a sugar alcohol made by hydrogenating maltose. It's used as a sweetener and filler in medicines to improve taste and add bulk to tablets and capsules.
-
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 1Q73Q2JULR
Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.
-
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.
8 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statescarboxymethylcellulose sodium, citric acid, flavor, maltitol, microcrystalline cellulose, purified water, sodium benzoate, sodium citrate, 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 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 mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.102 | $3.07 / 30 ml |
| Medicaid paysCMS SDUD · 12 mo | $0.2508 | $7.52 / 30 ml |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
NADAC price history (per mL) — tap or hover for the price & month
▲ Up 11% over the last 13 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Infants 20 mg/.3mL 00536-1303-75 | RUGBY | 1 bottle | $0.102 | — | Availability likely | — |
| Infant Gas Relief 20 mg/.3mLthis 46122-0547-03 | AMERISOURCEBERGEN | 1 bottle | $0.102 | — | Availability likely | — |
| Cardinal Health Infants Gas Relief 20 mg/.3mL 70000-0051-01 | CARDINAL | 1 bottle | $0.102 | — | Availability likely | — |
| Foster and Thrive infants Gas relief 20 mg/.3mL 70677-1078-01 | Strategic | 1 bottle | $0.102 | — | Availability likely | — |
| SIMETHICONE INFANT Gas Relief Drops 20 mg/.3mL 82568-0017-03 | AARNA | 1 bottle | $0.102 | — | Availability likely | — |
| Quality Choice Infants Non-staining Gas relief 20 mg/.3mL 83324-0133-01 | Chain | 1 bottle | $0.102 | — | 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/.3mL 17856-1017-01 | 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
🏛️
2018
On the market since
Jun 2018
📍
2026
Currently FDA-listed
8 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found
We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.
🗺️ Medicaid utilization & spend
📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 46122-0547-03, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
1.4K
Units reimbursed last 4 qtrs
63.2K
Gross reimbursed last 4 qtrs
$15.9K
Avg / prescription
$10.94
Avg / unit
$0.2508
Latest quarter Q1 2026
322Rx
Medicaid pays / mL
$0.2508
gross reimbursed
vs
NADAC / mL
$0.1023
acquisition cost
=
Spread
+$0.1485
+145% vs cost
What Medicaid paid per mL (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
Fee-for-service · 483 Rx Managed care · 966 Rx
State Medicaid map
Units reimbursed · per 100k residents
8.4150
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
Prescriptions—
Units—
Reimbursed—
🏆 Top states by units · per 100k residents
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.
🔬 Reported adverse events (FAERS)
Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for INFANT GAS RELIEF (this brand).
Top reported reactions
Age at onset
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 | Marketing start | Status |
|---|---|---|---|
| 46122-0547-03 You're viewing this | 1 BOTTLE, DROPPER in 1 CARTON (46122-547-03) / 30 mL in 1 BOTTLE, DROPPER | 2018-11-16 | Active |
📄 FDA label — Drug Facts FDA SPL
The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage
⏱️ Dosage and Administration
⚠️ Warnings
📦 Storage and Handling
🧪 Active Ingredient
🧪 Inactive Ingredients
🎯 Purpose
🎯 Indications and Usage ▾
Use relieves the symptoms referred to as gas
⏱️ Dosage and Administration ▾
Directions shake well before using all dosages may be repeated as needed, after 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 inner cheek dosage can also be mixed with 1 oz. of cool water, infan formula or other suitable liquids clean dropper well after each use and replace original cap on bottle Age (years) Weight (lbs) Dose infants (under 2) under 24 0.3 mL children (over 2) 24 and over 0.6 mL
⚠️ Warnings ▾
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 ▾
Other information store at room temperature do not freeze see bottom panel for lot number and expiration date
🧪 Active Ingredient ▾
Active ingredient (in each 0.3 mL) Simethicone 20 mg
🧪 Inactive Ingredients ▾
Inactive ingredients carboxymethylcellulose sodium, citric acid, flavor, maltitol, microcrystalline cellulose, purified water, sodium benzoate, sodium citrate, xanthan gum. Questions or comments? 1-800-540-3765
🎯 Purpose ▾
Purpose Antigas
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.