Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.
Mylanta Gas Minis Assorted Fruit Flavor Simethicone 125 mg Tablet, Chewable, 50-count — NDC 62372-801-50 (Billing 62372-0801-50)
by Infirst Healthcare Inc. · 50 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC
This is a package of 50 tablets of Mylanta Gas Minis Assorted Fruit Flavor Simethicone 125 mg Tablet, Chewable from Infirst Healthcare Inc., no longer marketed (first marketed Mar 2016), no longer in the FDA NDC Directory.
NDC 62372-0801-50
🏷️ FDA NDC (as labeled)
62372-801-50
billing pads the product segment with a zero
This package
Contains50-count
Pack sizes3 compare ↓
🗂️ FDA directory synced Oct 1, 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 62372-801-50 alone.
- Record
- FDA NDC Directory package listing · Human OTC drug
- Code segments
- 62372 labeler · 801 product · 50 package
- Listing certified through
- Dec 31, 2026
- Billing quantity
- 50 EA per package
- Barcode (UPC)
- 0819903010371
- FDA record last changed
- Jul 24, 2026
⚠️
Excluded from the active FDA NDC Directory.
The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory.
Search the FDA NDC Directory ↗
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
FDA NDC (as labeled)
62372-801-50
Product NDC
62372-801
11-digit billing NDC
62372080150
NCPDP billing unit
EA — each (per item)
RxCUI
314221
UNII
92RU3N3Y1O
UPC
0819903010371
Application #
M002
SPL Set ID
c6db9af2-d457-477d-baa9-470ddbba5905
Physiologic effect
Skin Barrier Activity
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
Discontinued
FDA listing status
Discontinued by firm
Marketing start
2016-03-21
Route
ORAL
Dosage form
TABLET, CHEWABLE
Substance
DIMETHICONE
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
GCN Seq No
002819
GCN
08282
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
MYLANTA GAS 125 MG CHEW TABLET
FDB brand name
Mylanta Gas Minis
Legend status
O — Over-the-counter (OTC) drug or device
Quick answers
- GSN (GCN sequence number): 002819
- GCN: 08282
- HICL (First Databank): 001224
- AHFS class code: 56:10.00.00
- RxCUI (RxNorm): 314221
Why two NDCs?
The FDA registers this code as 62372-801-50 — 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 → 62372-0801-50. 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 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
Clinical
Label name MYLANTA GAS 125 MG CHEW TABLET Ingredient Simethicone
📗 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 5, 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 each | 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 5, 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 |
|---|---|---|---|---|
| 62372-0801-03 62372-801-03 Main listing | 3 TABLET, CHEWABLE in 1 POUCH | 2019-10-04 | — | Discontinued by firm |
| 62372-0801-50 You're viewing this | 50 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC | 2016-03-21 | — | Discontinued by firm |
| 62372-0801-60 62372-801-60 | 60 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC | 2016-03-21 | — | Active |
You're viewing one of 3 pack sizes for this product.
Pack size FAQ
What quantity is in this package?
This is a 50-count package — 50 tablet, chewable in 1 bottle, plastic.
How does this package differ from NDC 62372-0801-03?
Both are Mylanta Gas Minis Assorted Fruit Flavor Simethicone 125 mg Tablet, Chewable — the drug itself is identical. This page's package is the 50-count one, while NDC 62372-0801-03 is the 3 tablets package.
What NDC number is used to bill for this package of Mylanta Gas Minis Assorted Fruit Flavor Simethicone 125 mg Tablet, Chewable?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| gas relief 125 mg 62011-0189-01 | Strategic | 9 tablets | $0.097 | — | FDA listed | — |
| Rugby Gas relief 125 mg 00536-1223-08 | Rugby | 60 tablets | $0.103 | — | Availability likely | — |
| extra strength Gas Relief cherry creme 125 mg 46122-0811-08 | Amerisource | 9 tablets | $0.103 | — | Availability likely | — |
| Foster and Thrive Extra Strength Gas Relief Cherry 125 mg 70677-1077-01 | Strategic | 9 tablets | $0.103 | — | Availability likely | — |
| Gas-X Extra Strength 125 mg 00067-0117-01 | Haleon | 12 tablets | — | — | FDA listed | — |
| Gas-X Extra Strength 125 mg 00067-0129-18 | Haleon | 9 tablets | — | — | FDA listed | — |
| Walgreens Extra Strength 125 mg 00363-0118-18 | WALGREENS | 9 tablets | — | — | FDA listed | — |
| Extra Strength Gas Relief 125 mg 00363-0119-18 | WALGREENS | 9 tablets | — | — | FDA listed | — |
| Gas Relief - Cherry Flavor 125 mg 11673-0066-48 | TARGET | 12 tablets | — | — | FDA listed | — |
| up and up extra strength gas relief chewables Extra Strength 125 mg 11673-0610-48 | Target | 12 tablets | — | — | FDA listed | — |
| Gas Relief 125 mg 11822-6080-02 | Rite | 12 tablets | — | — | FDA listed | — |
| Simethicone 125 mg 17714-0040-60 | Advance | 60 tablets | — | — | FDA listed | — |
| Simethicone 125 mg 17856-0137-01 | ATLANTIC | 1 tablet | — | — | FDA listed | — |
| Extra Strength Gas Relief 125 mg 21130-0110-18 | SAFEWAY | 6 tablets | — | — | FDA listed | — |
| Gas Relief 125 mg 21130-0135-73 | Safeway | 9 tablets | — | — | FDA listed | — |
| Extra Strength Gas Relief 125 mg 21130-0441-18 | SAFEWAY | 9 tablets | — | — | FDA listed | — |
| Kroger Extra Strength Gas Relief 125 mg 30142-0481-48 | KROGER | 4 tablets | — | — | FDA listed | — |
| Gas Relief 125 mg 36800-0122-73 | Topco | 6 tablets | — | — | FDA listed | — |
| TopCare Extra Strength Gas Relief Cherry Creme 125 mg 36800-0488-48 | TOPCO | 48 tablets | — | — | FDA listed | — |
| HEB Gas Relief Extra Strength Peppermint 125 mg 37808-0155-73 | H | 9 tablets | — | — | FDA listed | — |
| Extra Strength Gas Relief Cherry 125 mg 37808-0692-13 | H | 12 tablets | — | — | FDA listed | — |
| Extra Strength Simethicone 125 mg 37835-0233-18 | Bi-Mart | 9 tablets | — | — | FDA listed | — |
| gas relief 125 mg 41163-0408-44 | United | 9 tablets | — | — | FDA listed | — |
| Extra Strength gas relief 125 mg 41415-0110-18 | PUBLIX | 6 tablets | — | — | FDA listed | — |
| Extra Strength Gas Relief 125 mg 42507-0701-34 | Hyvee | 9 tablets | — | — | FDA listed | — |
| Extra Strength Gas Relief 125 mg 49035-0910-48 | Wal-Mart | 48 tablets | — | — | FDA listed | — |
| Extra Strength Gas Relief Cherry 125 mg 50804-0134-73 | Good | 9 tablets | — | — | FDA listed | — |
| CVS PHARMACY Extra Strength Gas Relief 125 mg 51316-0011-18 | CVS | 9 tablets | — | — | FDA listed | — |
| CVS PHARMACY Extra Strength 125 mg 51316-0110-18 | CVS | 9 tablets | — | — | FDA listed | — |
| Extra Strength Gas Relief Cherry Creme 125 mg 51316-0134-13 | CVS | 9 tablets | — | — | FDA listed | — |
| Extra Strength Gas Relief Cherry Flavor 125 mg 53943-0134-39 | Discount | 9 tablets | — | — | FDA listed | — |
| Gas Relief Extra Strength 125 mg 55301-0680-44 | ARMY | 9 tablets | — | — | FDA listed | — |
| Family Wellness Extra Strength Gas Relief Cherry 125 mg 55319-0134-34 | Family | 12 tablets | — | — | FDA listed | — |
| Extra Strength Gas Relief 125 mg 57896-0694-03 | Geri-Care | 30 tablets | — | — | FDA listed | — |
| Mylanta Gas Minis Mint Flavor 125 mg 62372-0800-50 | Infirst | 50 tablets | — | — | FDA listed | — |
| Mylanta Gas Minis Assorted Fruit Flavor 125 mgthis 62372-0801-50 | Infirst | 50 tablets | — | — | Discontinued | — |
| Best Choice Extra Strength 125 mg 63941-0110-18 | BEST | 9 tablets | — | — | FDA listed | — |
| WinCo FOODS Extra Strength Gas Relief 125 mg 67091-0361-18 | WINCO | 6 tablets | — | — | FDA listed | — |
| Premier Value Extra Strength 125 mg 68016-0811-18 | PHARMACY | 9 tablets | — | — | FDA listed | — |
| Extra Strength Gas Relief Cherry 125 mg 69256-0134-73 | Harris | 9 tablets | — | — | FDA listed | — |
| Extra Strength Gas Relief 125 mg 69256-0135-73 | Harris | 9 tablets | — | — | FDA listed | — |
| Simethicone 125 mg 69618-0032-06 | Reliable | 60 tablets | — | — | FDA listed | — |
| Gas-Aid 125 mg 69626-7197-03 | Leosons | 9 tablets | — | — | FDA listed | — |
| Firstcare Gas Relief Simethicone 125 mg Anti-gas 71594-0709-10 | USpharma | 100 tablets | — | — | FDA listed | — |
| Extra Strength Gas Relief Cherry 125 mg 72476-0134-73 | Retail | 9 tablets | — | — | FDA listed | — |
| Gas Relief 125 mg 79481-0608-04 | Meijer | 9 tablets | — | — | FDA listed | — |
| Gas Relief 125 mg 80136-0859-68 | Heartland | 100 tablets | — | — | FDA listed | — |
| Wonderbelly Extra Strength Anti-Gas 125 mg 82431-0201-02 | Ginger | 2 tablets | — | — | Discontinued | — |
| Wonderbelly Extra Strength Anti-Gas 125 mg 82431-0202-02 | Ginger | 2 tablets | — | — | Discontinued | — |
| Wonderbelly Extra Strength Anti-Gas 125 mg 82431-0203-02 | Ginger | 2 tablets | — | — | Discontinued | — |
| Wonderbelly Extra Strength Anti-Gas 82431-0291-10 | Ginger | 10 tablets | — | — | Discontinued | — |
| Simethicone 125 mg 82804-0152-09 | Proficient | 9 tablets | — | — | FDA listed | — |
| QCH Extra Strength Gas Relief Cherry Flavor 134CHR 125 mg 83324-0132-18 | Chain | 9 tablets | — | — | FDA listed | — |
| Gas Relief 125 mg 83324-0325-18 | Chain | 9 tablets | — | — | FDA listed | — |
| Pepto Gas plus Bloating 125 mg 84126-0378-16 | The | 16 tablets | — | — | FDA listed | — |
| Maximum Strength Antacid Mint 125 mg 53041-0100-23 | Guardian | 60 tablets | — | — | 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 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
Availability & generic status
🏛️
2016
On the market since
Mar 2016
📍
2026
Currently FDA-listed
10 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
pink / orange / purple
ShapeOval
ImprintMYLG
Size12 mm
ScoringNot scored
FlavorFruit
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 5, 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.
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.- FDA label on DailyMed · label index refreshed Oct 5, 2026
- FDA openFDA NDC Directory · synced Oct 1, 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
LabelerInfirst Healthcare Inc.
FDA applicationM002 (OTC MONOGRAPH DRUG)
Labeler code62372
First marketedMar 2016
Product typeHuman Otc Drug
Portfolio17 products on file
More NDCs from Infirst Healthcare Inc. labeler code 62372
- Mylanta One Antacid/Anti-Gas Calcium carbonate, Magnesium hydroxide, Dimethicone 1000 mg; 270 mg; 80 mg Tablet, Chewable NDC 62372-552-50
- mylanta gas Simethicone 125 mg Capsule, Liquid Filled NDC 62372-554-31
- Mylicon Infants Gas Relief Original Simethicone 20 mg/.3mL Emulsion NDC 62372-630-15
- Mylicon Infants Gas Relief Dye Free Simethicone 20 mg/.3mL Emulsion NDC 62372-650-15
- Mylanta Coat and Cool Calcium Carbonate, Magnesium hydroxide, Simethicone 1200 mg/10mL; 270 mg/10mL; 80 mg/10mL Liquid NDC 62372-796-12
- Mylanta Gas Minis Mint Flavor Simethicone 125 mg Tablet, Chewable NDC 62372-800-50
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 1, 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 pressure and bloating commonly referred to as gas
⏱️ Dosage and Administration ▾
Directions Adults and children 12 years and older : thoroughly chew 3-6 mini-tablets as needed. • do not exceed 12 mini-tablets in 24 hours except under the advice and supervision of a physician.
⚠️ Warnings ▾
Warnings Keep out of the reach of children. Keep out of reach of children
📦 Storage and Handling ▾
Other information each dose contains: calcium 75 mg • protect from heat and moisture • store at 20-25° C (68-77° F)
🧪 Active Ingredient ▾
Active ingredient (in each 3 tablet dose) Simethicone 125 mg
🧪 Inactive Ingredients ▾
Inactive ingredients adipic acid , carboxymethylcellulose sodium ,D&C red 27 lake, FD&C blue 1 lake, FD &C yellow 6 lake, flavors, hydroxypropyl cellulose, isomalt, magnesium stearate, maltodextrin, silica, sucralose, sucrose, tricalcium phosphate,
🎯 Purpose ▾
Purpose Anti-gas
📄 Keep Out of Reach of Children ▾
Keep out of reach of children
📄 Questions or Comments ▾
Questions or comments? call 1-844-695-6624 toll free (English & Spanish)
📄 Package Label / Principal Display Panel ▾
Principal Display Panel FREE 20% MORE CONVENIENT POCKET PACK Mylanta ® GAS Minis Fast relief of the bloating , pressure, and discomfort of gas Extra Strength, with the #1 selling medicine for gas relief Great tasting ,chewable mini-tablets in an on-the-go pack Also available in great tasting Arctic Mint & Cherry TAMPER EVIDENT: DO NOT USE MYLANTA GAS MINI-TABLETS IF THE BREAKAWAY BAND ON TOP OF CONTAINER IS BROKEN OR MISSING. Mylanta is a registered trademark of McNeil Consumer Pharmaceuticals Co. Patent pending infirst + HEALTHCARE Manufactured for: Infirst Healthcare Inc.
Westport, CT 06880 © 2016 Infirst Healthcare Inc. Mylanta.com KEEP OUTER PACKAGING FOR COMPLETE LABELING Mylanta GAS Minis 50 tablets Assorted Flavor Package level for 60 chewable tablets MYLGAF60FC MYLANTA GAS RELIEF Mylanta Pouch Pack Label Mylanta Mini Pouch Pack 3 Mini Tablets
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
No longer marketed (per FDA listing data)
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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 3 tablets (62372-0801-03), 60 tablets (62372-0801-60). 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?
Infirst Healthcare 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.
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.