Infants Simethicone 20 mg/.3mL Suspension/ Drops
by RUGBY LABORATORIES · 1 BOTTLE, DROPPER in 1 CARTON (0536-1303-75) / 30 mL in 1 BOTTLE, DROPPER
NDC 00536-1303-75
🏷️ FDA NDC (as labeled)
0536-1303-75
billing pads the labeler 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)
0536-1303-75
Product NDC
0536-1303
11-digit billing NDC
00536130375
NCPDP billing unit
ML — per mL (volume)
RxCUI
198857
UNII
92RU3N3Y1O
UPC
0305361303754
Application #
M002
SPL Set ID
c6fa71bc-de48-47f4-80c4-7d92643d2664
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
2020-09-01
Route
ORAL
Dosage form
SUSPENSION/ DROPS
Substance
DIMETHICONE, UNSPECIFIED
GPI-14
52200020001810
GPI class
Simethicone Drops Infants
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
INFANTS' SIMETHICONE DROPS
FDB brand name
Infants' Simethicone
Legend status
O — Over-the-counter (OTC) drug or device
Why two NDCs?
The FDA registers this code as 0536-1303-75 — 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 → 00536-1303-75. 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
LabelerRUGBY LABORATORIES
FDA applicationM002 (OTC MONOGRAPH DRUG)
Labeler code00536
First marketedSep 2020
Product typeHuman Otc Drug
Portfolio149 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 INFANTS' SIMETHICONE DROPS 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
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, flavors, microcrystalline cellulose, polysorbate 60, potassium sorbate, purified water, sodium benzoate, sorbitan monostearate, sorbitol, 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 | $0.100 | $3.00 / 30 ml |
| Medicaid paysCMS SDUD · 12 mo | $0.9077 | $27.23 / 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 8% over the last 24 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/.3mLthis 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/.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
🏛️
2020
On the market since
Sep 2020
📍
2026
Currently FDA-listed
6 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 00536-1303-75, 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 – Q4 2025 · 4 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
49.9K
Units reimbursed last 4 qtrs
2.1M
Gross reimbursed last 4 qtrs
$1.89M
Avg / prescription
$37.92
Avg / unit
$0.9077
Latest quarter Q4 2025
11.6KRx
Medicaid pays / mL
$0.9077
gross reimbursed
vs
NADAC / mL
$0.1001
acquisition cost
=
Spread
+$0.8076
+807% 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 · 11,882 Rx Managed care · 38,060 Rx
State Medicaid map
Units reimbursed · per 100k residents
0.53,362
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 Infants (this brand).
Top reported reactions
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 |
|---|---|---|---|
| 00536-1303-75 You're viewing this | 1 BOTTLE, DROPPER in 1 CARTON (0536-1303-75) / 30 mL in 1 BOTTLE, DROPPER | 2020-09-01 | 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 ▾
Uses relieves the discomfort of infant gas frequently caused by air swallowing or certain formulas or foods
⏱️ Dosage and Administration ▾
Directions shake well before using find right dose on chart below. If possible, use weight to dose; otherwise, use age. only use the enclosed syringe. Do not use other syringe, dropper, spoon or dosing device when giving this medicine to your child. remove cap and insert syringe into the bottle. pull syringe up until filled to the prescribed level, simply push syringe back until you have reached the described level.
Slowly dispense the liquid into your child’s mouth (towards inner cheek). 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. dosage can also be mixed with 1 oz. cool water, infant formula or other suitable liquids. Replace cap tightly to maintain child resistance mL = milliliter Age (yr) Weight (lb) Dose (mL) infants under 2 under 24 0.3 children over 2 over 24 0.6
⚠️ Warnings ▾
Warnings Keep out of reach of children. Overdose warning: In case of overdose get medical help or contact a Poison Control Center right away at 1-800-222-1222. Quick medical attention is critical even if you do not notice any signs or symptoms.
📦 Storage and Handling ▾
Other information tamper evident: do not use if printed seal under cap is broken or missing 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, flavors, microcrystalline cellulose, polysorbate 60, potassium sorbate, purified water, sodium benzoate, sorbitan monostearate, sorbitol, xanthan gum Questions or comments? 1-800-645-2158
🎯 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.