Walgreens Infants Dye Free Gas Relief Simethicone 20 mg/.3mL Emulsion — NDC 0363-0790-30 (Billing 00363-0790-30)
by WALGREEN CO. · 1 BOTTLE in 1 CARTON / 30 mL in 1 BOTTLE
This is a package of Walgreens Infants Dye Free Gas Relief Simethicone 20 mg/.3mL Emulsion from WALGREEN CO., marketed since Aug 2017 and currently FDA-listed. It is this product's only package size.
NDC 00363-0790-30
🏷️ FDA NDC (as labeled)
0363-0790-30
billing pads the labeler segment with a zero
🗂️ 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 0363-0790-30 alone.
- Record
- FDA NDC Directory package listing · Human OTC drug
- Code segments
- 0363 labeler · 0790 product · 30 package
- Package marketed since
- Aug 30, 2017
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC-A, from the NDC)
- 3 0363079030 4
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
FDA NDC (as labeled)
0363-0790-30
Product NDC
0363-0790
11-digit billing NDC
00363079030
RxCUI
198857
UNII
92RU3N3Y1O
Application #
M002
SPL Set ID
05d2a37f-f47d-40e6-a799-120d846bf5d6
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
2017-08-30
Route
ORAL
Dosage form
EMULSION
Substance
DIMETHICONE, UNSPECIFIED
Quick answers
- RxCUI (RxNorm): 198857
Why two NDCs?
The FDA registers this code as 0363-0790-30 — 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 → 00363-0790-30. 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 6, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 8, 2026
Clinical
📖 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
- 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 1, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 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 8, 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 |
|---|---|---|---|---|
| 00363-0790-30 You're viewing this Main listing | 1 BOTTLE in 1 CARTON / 30 mL in 1 BOTTLE | 2017-08-30 | — | Active |
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/.3mL 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/.3mLthis 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.
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
Availability & generic status
🏛️
2017
On the market since
Aug 2017
📍
2026
Currently FDA-listed
9 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
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.
- FDA label on DailyMed · label index refreshed Oct 6, 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 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, microcrystalline cellulose, natural flavors, 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.- FDA label on DailyMed · label index refreshed Oct 6, 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
LabelerWALGREEN CO.
FDA applicationM002 (OTC MONOGRAPH DRUG)
Labeler code00363
First marketedAug 2017
Product typeHuman Otc Drug
Portfolio132 products on file
More NDCs from WALGREEN CO. labeler code 00363
- Esomeprazole Magnesium 20 mg Capsule, Delayed Release NDC 0363-0772-14
- Daytime and Nighttime Cold and Flu Maximum Strength ACETAMINOPHEN, DEXTROMETHORPHAN HBr,GUAIFENESIN, PHENYLEPHRINE HCl / ACETAMINOPHEN, DEXTROMETHORPHAN HBr, DOXYLAMINE SUCCINATE, Kit NDC 0363-0775-24
- First Aid Antiseptic POVIDONE-IODINE 10 mg/mL Solution NDC 0363-0777-34
- Mucus Relief Maximum StrengthCold Flu and Sore Throat Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl 650 mg/20mL; 20 mg/20mL; 400 mg/20mL; 10 mg/20mL Liquid NDC 0363-0782-06
- Fexofenadine hydrochloride 60 mg Tablet NDC 0363-0783-24
- Wal-Fex Fexofenadine hydrochloride 180 mg Tablet NDC 0363-0784-07
- Pain Reliever Acetaminophen 500 mg Tablet NDC 0363-0792-29
- Pamabrom 50 mg Capsule, Liquid Filled NDC 0363-0795-84
- Walgreens Soothing Eye Relief Lubricant Eye Drops Polyvinyl alcohol, Povidone .5 g/100mL; .6 g/100mL Solution/ Drops NDC 0363-0796-01
- Well at Walgreens SODIUM BICARBONATE, SODIUM CHLORIDE 700 mg/3000mg; 2300 mg/3000mg Powder, For Solution NDC 0363-0801-10
- Well at Walgreens SODIUM BICARBONATE, SODIUM CHLORIDE 700 mg/3000mg; 2300 mg/3000mg Powder, For Solution NDC 0363-0802-00
- Witch Hazel 860 mg/mL Liquid NDC 0363-0803-43
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 ▾
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, if you pass the prescribed level, simply push syringe back until you have reached the desired level, Slowly dispense the liquid into your child’s mouth (towards inner cheek) all dosages may be repeated 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, microcrystalline cellulose, natural flavors, polysorbate 60, potassium sorbate, purified water, sodium benzoate, sorbitan monostearate, sorbitol, xanthan gum. Questions? 1-866-467-2748
🎯 Purpose ▾
Purpose Antigas
📄 Keep Out of Reach of Children ▾
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
📄 Questions or Comments ▾
Questions? 1-866-467-2748
📄 Package Label / Principal Display Panel ▾
Principal Display Panel Walgreens Compare to infant’s Mylicon Gas Relief active ingredient†† Infants' Dye- Free Gas Relief Simethicone 20 mg PER DOSE /ANTI-GAS DYE FREE NONSTAINING FORMULA ALCOHOL FREE No saccharin No artificial flavor Includes dosing syringe 100 DOSES DYE FREE 1 FL OZ (30 mL) 200 WILMOT RD., DEERFIELD, IL 60015 100% SATISFACTION GUARANTEED Walgreens.com ©2017 Walgreen Co, WALGREENS PHARMACIST RECOMMENDED‡ ‡Walgreens Pharmacist Survey ‡‡ This product is not manufactured or distributed by infirst Healthcare Inc., the distributor of Infants’ Mylicon ® Gas Relief.
IMPORTANT: KEEP THIS CARTON FOR FUTURE REFERENCE ON FULL LABELING infants' Dye-Free Gas Relief Simethicone 20 mg PER DOSE /ANTI GAS 100 Doses 1 FL OZ (30 mL)
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 Simethicone — the ingredient across all brands.
Top reported reactions
Age at onset
Reporter sex
Male · 35%
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 | — Not published for this NDC No photo available yet for this listing. |
| 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 WALGREEN CO.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
WALGREEN CO. 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.