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Aluminum Hydroxide, Magnesium Hydroxide, and Simethicone 1200 mg/30mL; 1200 mg/30mL; 120 mg/30mL Suspension — NDC 0904-7557-73 (Billing 00904-7557-73)

by Major Pharmaceuticals · 10 TRAY in 1 CASE / 10 CUP, UNIT-DOSE in 1 TRAY / 30 mL in 1 CUP, UNIT-DOSE

This is a package of Aluminum Hydroxide, Magnesium Hydroxide, and Simethicone 1200 mg/30mL; 1200 mg/30mL; 120 mg/30mL Suspension from Major Pharmaceuticals, marketed since Jul 2025 and currently FDA-listed. It is this product's only package size.

NDC 00904-7557-73
🏷️ FDA NDC (as labeled) 0904-7557-73 billing pads the labeler segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 1, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0904-7557-73
Product NDC 0904-7557
11-digit billing NDC 00904755773
NCPDP billing unit ML — per mL (volume)
RxCUI 307746
UNII 5QB0T2IUN0, NBZ3QY004S, 92RU3N3Y1O
UPC 0309047557622
Application # M001
SPL Set ID 1bc90fa7-fcce-4a9b-862f-f30ab602ecab
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 2025-07-07
Route ORAL
Dosage form SUSPENSION
Substance ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 48991003101810
GCN Seq No 002701
GCN 63910
HICL code 001168
Ingredient (HICL) Mag Hydrox/Aluminum Hyd/Simeth
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 D4B
Therapeutic class — specific (HIC3) Antacids
AHFS code 56:04.00.00
AHFS class Antacids And Adsorbents
FDB label name ALUM-MAG HYDROXIDE-SIMETH CUP
FDB brand name Alum-Mag Hydroxide-Simethicone
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 002701
  • GCN: 63910
  • GPI-14 (Medi-Span): 48991003101810
  • HICL (First Databank): 001168
  • AHFS class code: 56:04.00.00
  • RxCUI (RxNorm): 307746
Why two NDCs? The FDA registers this code as 0904-7557-73 — 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 → 00904-7557-73. 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.

RxNorm drug class

This medicine belongs to the Aluminium compounds class.

Drug family (ATC) Aluminium compounds
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name ALUM-MAG HYDROXIDE-SIMETH CUP Ingredient Mag Hydrox/Aluminum Hyd/Simeth
🧪 What is this product?

This is an over-the-counter oral suspension containing three active ingredients commonly used to relieve heartburn and indigestion. Aluminum hydroxide and magnesium hydroxide are antacids that work to neutralize stomach acid. Simethicone (listed as dimethicone) is an anti-gas ingredient that functions to break up gas bubbles in the digestive tract. This product is marketed under FDA's OTC monograph rules for antacid and anti-gas combinations.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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.

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 systemPer mLPer 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
00904-7557-73 You're viewing this Main listing 10 TRAY in 1 CASE / 10 CUP, UNIT-DOSE in 1 TRAY / 30 mL in 1 CUP, UNIT-DOSE 2025-07-07 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
QCH Regular Strength Antacid 509 400 mg/10mL; 400 mg/10mL; 40 mg/10mL 83324-0121-12 Chain 355 ml $0.010 — Availability likely —
Antacid 400 mg/10mL; 400 mg/10mL; 40 mg/10mL 00536-1293-83 Rugby 355 ml $0.011 — Availability likely —
Regular Strength Antacid/Antigas 400 mg/10mL; 400 mg/10mL; 40 mg/10mL 00536-1317-83 RUGBY 355 ml $0.011 — Availability likely —
Regular Strength Antacid 400 mg/10mL; 400 mg/10mL; 40 mg/10mL 46122-0433-40 AMERISOURCEBERGEN 355 ml $0.011 — Availability likely —
Regular Strength Antacid 400 mg/10mL; 400 mg/10mL; 40 mg/10mL 46122-0434-40 AMERISOURCEBERGEN 355 ml $0.011 — Availability likely —
Antacid Mint 400 mg/10mL; 400 mg/10mL; 40 mg/10mL 70000-0063-01 CARDINAL 355 ml $0.011 — Availability likely —
Regular Strength Antacid And Antigas 200 mg/5mL; 200 mg/5mL; 20 mg/5mL 70677-1063-01 STRATEGIC 355 ml $0.011 — Availability likely —
Regular Strength Antacid And Antigas 200 mg/5mL; 200 mg/5mL; 20 mg/5mL 70677-1066-01 STRATEGIC 355 ml $0.011 — Availability likely —
Antacid Mint 200 mg/5mL; 200 mg/5mL; 20 mg/5mL 63868-0694-57 Chain 355 ml $0.011 — FDA listed —
Regular Strength Antacid 200 mg/5mL; 200 mg/5mL; 20 mg/5mL 63868-0712-57 Chain 355 ml $0.011 — FDA listed —
Mag-AL Plus 1200 mg/30mL; 1200 mg/30mL; 120 mg/30mL 00121-1761-30 PAI 10 cups — — FDA listed —
Advanced Regular Strength Antacid 200 mg/5mL; 200 mg/5mL; 20 mg/5mL 00363-1639-12 WALGREEN 355 ml — — FDA listed —
Regular Strength Antacid Antigas 200 mg/5mL; 200 mg/5mL; 20 mg/5mL 00363-2628-12 WALGREEN 355 ml — — FDA listed —
Aluminum Hydroxide, Magnesium Hydroxide, and Simethicone 1200 mg/30mL; 1200 mg/30mL; 120 mg/30mLthis 00904-7557-73 Major 10 cups — — FDA listed —
Regular Strength Antacid And Gas Relief 200 mg/5mL; 20 mg/5mL; 200 mg/5mL 11822-3324-07 RITE 355 ml — — Discontinued —
Geri-Lanta Antacid Antigas 200 mg/5mL; 200 mg/5mL; 20 mg/5mL 17856-0630-01 ATLANTIC 50 cups — — FDA listed —
Antacid Plus 400 mg/10mL; 400 mg/10mL; 40 mg/10mL 21130-0629-12 BETTER 355 ml — — FDA listed —
Melox 200 mg/5mL; 200 mg/5mL; 20 mg/5mL 27854-0115-01 Belmora 355 ml — — FDA listed —
Melox 400 mg/10mL; 400 mg/10mL; 40 mg/10mL 27854-0117-01 Belmora 355 ml — — FDA listed —
Regular Strength Antacid 400 mg/10mL; 400 mg/10mL; 40 mg/10mL 30142-0637-12 KROGER 355 ml — — FDA listed —
Regular Strength Antacid Mint 400 mg/10mL; 400 mg/10mL; 40 mg/10mL 30142-0639-12 KROGER 355 ml — — FDA listed —
Regular Strength Antacid Mint 400 mg/10mL; 400 mg/10mL; 40 mg/10mL 36800-0582-40 Topco 355 ml — — FDA listed —
Regular Strength Antacid Mint 400 mg/10mL; 400 mg/10mL; 40 mg/10mL 37808-0099-12 H 355 ml — — FDA listed —
Antacid 400 mg/10mL; 400 mg/10mL; 40 mg/10mL 37808-0554-05 H 355 ml — — FDA listed —
Geri-Lanta Antacid 200 mg/5mL; 200 mg/5mL; 20 mg/5mL 50090-4259-00 A-S 355 ml — — FDA listed —
Antacid And Gasrelief 400 mg/10mL; 400 mg/10mL; 40 mg/10mL 50804-0629-12 GOODSENSE 355 ml — — FDA listed —
Advanced Antacid Mint 400 mg/10mL; 400 mg/10mL; 40 mg/10mL 50804-0639-12 GOODSENSE 355 ml — — FDA listed —
Mag-Al Plus 200 mg/5mL; 200 mg/5mL; 20 mg/5mL 55154-9429-05 Cardinal 5 cups — — FDA listed —
Aluminum Hydroxide, Magnesium Hydroxide and Simethicone 1200 mg/30mL; 1200 mg/30mL; 120 mg/30mL 57237-0316-31 Rising 100 cups — — FDA listed —
Ko-Lanta 200 mg/5mL; 200 mg/5mL; 20 mg/5mL 57896-0004-12 Geri-Care 355 ml — — FDA listed —
Geri-Lanta Antacid Antigas 200 mg/5mL; 200 mg/5mL; 20 mg/5mL 57896-0629-06 Geri-Care 177 ml — — Discontinued —
Geri-Mox Antacid Antigas 200 mg/5mL; 200 mg/5mL; 20 mg/5mL 57896-0639-12 Geri-Care 355 ml — — FDA listed —
Aluminum Hydroxide, Magnesium Hydroxide, and Simethicone 200 mg/5mL; 200 mg/5mL; 20 mg/5mL 60687-0877-76 American 10 cups — — FDA listed —
Regular Strength Antacid 200 mg/5mL; 200 mg/5mL; 20 mg/5mL 63941-0629-12 VALU 355 ml — — FDA listed —
Regular Strength Antacid Antigas 200 mg/5mL; 200 mg/5mL; 20 mg/5mL 63941-0639-12 VALU 355 ml — — FDA listed —
Regular Strength Antacid/Antigas 400 mg/10mL; 400 mg/10mL; 40 mg/10mL 68071-5289-01 NuCare 355 ml — — FDA listed —
Regular Strength Antacid 200 mg/5mL; 200 mg/5mL; 20 mg/5mL 68788-7841-03 Preferred 355 ml — — FDA listed —
Geri-Lanta Antacid Antigas 200 mg/5mL; 200 mg/5mL; 20 mg/5mL 68788-8169-03 Preferred 355 ml — — FDA listed —
Antacid 400 mg/10mL; 400 mg/10mL; 40 mg/10mL 68788-8506-03 Preferred 355 ml — — FDA listed —
Regular Strength Antacid Antigas 400 mg/10mL; 400 mg/10mL; 40 mg/10mL 69256-0503-05 Harris 355 ml — — FDA listed —
Regular Strength Antacid 400 mg/10mL; 400 mg/10mL; 40 mg/10mL 69842-0286-12 CVS 355 ml — — FDA listed —
Regular Strength Antacid Mint 400 mg/10mL; 400 mg/10mL; 40 mg/10mL 69842-0355-26 CVS 769 ml — — FDA listed —
Antacid Antigas 400 mg/10mL; 400 mg/10mL; 40 mg/10mL 72476-0503-05 Retail 355 ml — — FDA listed —
Antacid 400 mg/10mL; 400 mg/10mL; 40 mg/10mL 72476-0509-05 Retail 355 ml — — FDA listed —
Kesin MAG-AL Plus 200 mg/5mL; 200 mg/5mL; 20 mg/5mL 81033-0006-01 Kesin 100 cups — — FDA listed —
Regular Strength Antacid Antigas 400 mg/10mL; 400 mg/10mL; 40 mg/10mL 83324-0125-12 Chain 355 ml — — FDA listed —
Aluminum Hydroxide, Magnesium Hydroxide and Simethicone 1200 mg/30mL; 1200 mg/30mL; 120 mg/30mL 84415-0017-01 Everpharm 100 cups — — 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
Jul 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.

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 3QPI1U3FV8
    A preservative derived from benzoic acid that prevents bacterial and fungal growth in medicines. It helps extend shelf life and maintain product safety during storage and use.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII AV092KU4JH
    A natural oil extracted from peppermint plants. It's used as a flavoring agent to mask bitter tastes and add a refreshing mint flavor to medicines, making them easier to take.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII Z8IX2SC1OH
    Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
  • UNII SB8ZUX40TY
    Saccharin sodium is an artificial sweetener made from saccharin salt. It's added to medicines to improve taste, especially in liquid formulations for children or bitter drugs.
  • 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.

8 inactive ingredients listed in the exact product block matched to this NDC.

The official label also statesInactive ingredients butylparaben, hydroxypropyl methylcellulose, flavoring, propylene glycol, propylparaben, purified water, saccharin sodium, and sorbitol solution.

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.

Manufacturer & labeler

LabelerMajor Pharmaceuticals
FDA applicationM001 (OTC MONOGRAPH DRUG)
Labeler code00904
First marketedJul 2025
Product typeHuman Otc Drug
Portfolio630 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.

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 📄 Ask a Doctor Before Use If 📄 Ask a Doctor or Pharmacist Before Use If 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 24 words ▾

Uses for the relief of: acid indigestion heartburn sour stomach upset stomach due to these symptoms pressure and bloating commonly referred to as gas

⏱️ Dosage and Administration 54 words ▾

Directions shake well before using do not take more than 16 teaspoonfuls in 24 hours or use the maximum dosage for more than 2 weeks adults and children 12 years and older take 2 to 4 teaspoonfuls four times a day or as directed by a physician children under 12 years consult a physician

⚠️ Warnings 86 words ▾

Warnings Do not take more than 16 teaspoonfuls in a 24-hour period or use the maximum dosage for more than 2 weeks except under the advice and supervision of a physician. Ask a doctor before use if you have kidney disease a magnesium-restricted diet Ask a doctor or pharmacist b efore use if you are presently taking a prescription drug. Antacids may interact with certain prescription drugs.

Stop use and ask a doctor if symptoms last more than 2 weeks. Keep out of reach of children.

📦 Storage and Handling 56 words ▾

Other information each 5 mL contains: magnesium 83 mg, sodium 1.34 mg store at controlled room temperature 20° - 25°C (68° - 77°F) {See USP Controlled Room Temperature]. protect from freezing White colored, peppermint flavored liquid supplied in the following oral dosage form: NDC 0904-7557-62: 30 mL unit dose cup, in a tray of ten cups.

🧪 Active Ingredient 34 words ▾

Drug Facts Active ingredients Purpose (in each 5 mL = 1 teaspoonful) Aluminum hydroxide (equiv. to dried gel, USP) 200 mg .......................... Antacid Magnesium hydroxide 200 mg .............................................................. Antacid Simethicone 20 mg ............................................................................... Antigas

🧪 Inactive Ingredients 16 words ▾

Inactive ingredients butylparaben, hydroxypropyl methylcellulose, flavoring, propylene glycol, propylparaben, purified water, saccharin sodium, and sorbitol solution.

📄 Ask a Doctor Before Use If 13 words ▾

Ask a doctor before use if you have kidney disease a magnesium-restricted diet

📄 Ask a Doctor or Pharmacist Before Use If 23 words ▾

Ask a doctor or pharmacist b efore use if you are presently taking a prescription drug. Antacids may interact with certain prescription drugs.

📄 Stop Use and Ask a Doctor If 13 words ▾

Stop use and ask a doctor if symptoms last more than 2 weeks.

📄 Keep Out of Reach of Children 6 words ▾

Keep out of reach of children.

📄 Questions or Comments 5 words ▾

Questions or comments? Call 1-800-845-8210

📄 Package Label / Principal Display Panel 51 words ▾

PRINCIPAL DISPLAY PANEL - 30 mL Unit-Dose Cup Lidding Label MAJOR ® NDC 0904-7557-62 Each 30 mL Contains: Magnesium Hydroxide 1200 mg Aluminum Hydroxide 1200 mg Simethicone 120 mg SHAKE WELL Delivers 30 mL • See insert For Institutional Use Only MAJOR ® PHARMACEUTICALS Indianapolis, IN 46268 30 mL lidding label

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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 Major Pharmaceuticals. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Major Pharmaceuticals 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.
← 00904-7553-61 · Major 00904-7558-06 · Major →
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.