SIMETHICONE INFANT Gas Relief Drops 20 mg/.3mL Suspension, 118 mL
by AARNA USA Inc. · 118 mL in 1 BOTTLE (82568-0017-4)
NDC 82568-0017-04
🏷️ FDA NDC (as labeled)
82568-0017-4
billing pads the package segment with a zero
This package
Contains118 mL
Pack sizes2 compare ↓
Also comes in:
30 mL 82568-0017-03
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)
82568-0017-4
Product NDC
82568-0017
11-digit billing NDC
82568001704
NCPDP billing unit
ML — per mL (volume)
RxCUI
198857
UNII
92RU3N3Y1O
UPC
0382568001737
Application #
M002
SPL Set ID
9b0fde90-35ae-498e-99cc-d120f1a87182
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
GPI-14
52200020001810
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'S GAS RLF 20 MG/0.3 ML
FDB brand name
Infant's Gas Relief
Legend status
O — Over-the-counter (OTC) drug or device
Why two NDCs?
The FDA registers this code as 82568-0017-4 — 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 → 82568-0017-04. 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
LabelerAARNA USA Inc.
FDA applicationM002 (OTC MONOGRAPH DRUG)
Labeler code82568
First marketedFeb 2025
Product typeHuman Otc Drug
Portfolio19 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'S GAS RLF 20 MG/0.3 ML Ingredient Simethicone
📗 Our plain-language guide HelloPharmacist
- Simethicone works to relieve the uncomfortable pressure, bloating, and full or stuffed feeling that comes from trapped gas in your stomach or intestines. It's used when gas builds...
- What exactly does simethicone do for gas?
- Yes — there are infant-specific simethicone products, like Mylicon Infants Gas Relief and similar infant drops, designed just for babies. They're used to relieve gas discomfort tha...
- Can I give simethicone drops to my baby?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Simethicone — tap one for details:
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.
💬 Questions about Simethicone?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.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 | 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.
Try another pack size:
30 mL
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 | $0.100 | — | 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 | — |
| 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/.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 | — |
| SIMETHICONE INFANT Gas Relief Drops 20 mg/.3mLthis 82568-0017-04 | AARNA | 118 ml | — | — | 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.
💊 Medicaid utilization by pack size
Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
Drug total (last 4 qtrs): 33 Rx · 1,170 units · $392 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.
🔬 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
Age at onset
Reporter sex
Male · 49%
Female · 51%
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.
📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 82568-0017-03 | 1 BOTTLE in 1 PACKAGE (82568-0017-3) / 30 mL in 1 BOTTLE | $0.1001 / mL | $3.00 | 2025-02-20 | Active |
| 82568-0017-04 You're viewing this | 118 mL in 1 BOTTLE (82568-0017-4) | — | — | 2025-02-20 | Active |
Pack size FAQ
What quantity is in NDC 82568-0017-04?
NDC 82568-0017-04 contains 118 mL — 118 ml in 1 bottle.
What NDC number is used to bill for this package of SIMETHICONE INFANT Gas Relief Drops 20 mg/.3mL Suspension?
Bill NDC 82568-0017-04 — the 11-digit billing format is 82568001704. 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.
🧭 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) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 82568-0017-4, 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: 82568-0017-04, written without dashes as 82568001704. 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 82568-0017-04, the first segment (82568) is the labeler code FDA assigned to AARNA USA Inc.; the middle segment (0017) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (04) 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 AARNA USA 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 1 other package presentation of this same product, including 1 bottle (82568-0017-03). 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?
AARNA USA 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.
📄 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 ▾
Uses relieves the symptoms referred to as gas
⏱️ Dosage and Administration ▾
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 ▾
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 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 ▾
Active ingredient (in each 0.3 mL) Simethicone 20 mg
🧪 Inactive Ingredients ▾
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 ? Call toll-free 1-877-225-6999. Manufactured for: AARNA USA Inc. Leland, NC-28451
🎯 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.