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SudoGest Chlorpheniramine maleate, pseudoephedrine HCl 4 mg; 60 mg Tablet, 48-count — NDC 0904-5351-96 (Billing 00904-5351-96)

by Major Pharmaceuticals · 2 BLISTER PACK in 1 CARTON / 24 TABLET in 1 BLISTER PACK

This is a package of 48 tablets of SudoGest Chlorpheniramine maleate, pseudoephedrine HCl 4 mg; 60 mg Tablet from Major Pharmaceuticals, no longer marketed (first marketed Dec 1992), no longer in the FDA NDC Directory; retail pharmacies pay about $0.0436 per tablet (NADAC).

NDC 00904-5351-96
🏷️ FDA NDC (as labeled) 0904-5351-96 billing pads the labeler segment with a zero
This package
Contains48-count Cost per ea$0.0436 NADAC Per package$2.09 / 48 tablets Pack sizes2 compare ↓
Product page 00904-5351-24 Also comes in: 24 tablets 0904-5351-24
OTC Discontinued Non-controlled ⚠ Discontinued by firm ⇄ Compare with another NDC
🗂️ 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 →

This page is curated, coded, and maintained by

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

NDC database record

One package, one record: these facts belong to NDC 0904-5351-96 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
0904 labeler · 5351 product · 96 package
Listing certified through
Dec 31, 2027
Billing quantity
48 EA per package
Barcode (UPC)
0309045351246
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) 0904-5351-96
Product NDC 0904-5351
11-digit billing NDC 00904535196
NCPDP billing unit EA — each (per item)
RxCUI 998254
UNII V1Q0O9OJ9Z, 6V9V2RYJ8N
UPC 0309045351246
Application # M012
SPL Set ID 7cd8f7f3-c262-4f7c-bcaf-068be2c952f9
Established class (EPC) Histamine-1 Receptor Antagonist; alpha-Adrenergic Agonist
Mechanism of action Adrenergic alpha-Agonists; Histamine H1 Receptor Antagonists
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status Discontinued
FDA listing status Discontinued by firm
Marketing start 1992-12-16
Route ORAL
Dosage form TABLET
Substance CHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE

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

GPI-14 43993002340310
GPI class SudoGest Sinus/Allergy
GCN Seq No 026792
GCN 44023
HICL code 000503
Ingredient (HICL) Chlorpheniramine/Pseudoephed
HIC1 code Z
Therapeutic class — broad (HIC1) Body As A Whole
HIC2 code Z2
Therapeutic class — intermediate (HIC2) Antihistamines, Antiserotonins, Immunosuppressants
HIC3 code Z2N
Therapeutic class — specific (HIC3) 1St Gen Antihistamine And Decongestant Combination
AHFS code 04:04.00.00
AHFS class First Generation Antihistamines
FDB label name SUDOGEST SINUS AND ALLERGY TAB
FDB brand name Sudogest Sinus And Allergy
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 026792
  • GCN: 44023
  • GPI-14 (Medi-Span): 43993002340310
  • HICL (First Databank): 000503
  • AHFS class code: 04:04.00.00
  • RxCUI (RxNorm): 998254
Why two NDCs? The FDA registers this code as 0904-5351-96 — 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 → 00904-5351-96. 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 Histamine-1 Receptor Antagonist class.

Pharmacologic class Histamine-1 Receptor Antagonist
Drug family (ATC) Substituted alkylamines
How it works Histamine H1 Receptor Antagonists
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 SUDOGEST SINUS AND ALLERGY TAB Ingredient Chlorpheniramine/Pseudoephed
🧪 What is this product?

SudoGest Chlorpheniramine maleate and pseudoephedrine HCl is an oral tablet sold over-the-counter under FDA monograph rules for cold and allergy symptom relief. Chlorpheniramine maleate is an antihistamine typically used to reduce sneezing, itching, and runny nose. Pseudoephedrine hydrochloride is a decongestant commonly used to relieve nasal congestion. This combination product is designed to address multiple cold and allergy symptoms at once.

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 eaPer package
Retail pharmacies payNADAC · weekly $0.044 $2.09 / 48 tablets
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.
NADAC price history (per ea) — tap or hover for the price & month
Oct 2021 Jul 2022 Nov 2022 $0.053 $0.044
▼ Down 18% over the last 3 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.

Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startMarketing endStatus
00904-5351-24 0904-5351-24 Main listing 1 BLISTER PACK in 1 CARTON / 24 TABLET in 1 BLISTER PACK $0.0787 / ea $1.89 1992-12-16 — Active
00904-5351-96 You're viewing this 2 BLISTER PACK in 1 CARTON / 24 TABLET in 1 BLISTER PACK $0.0436 / ea $2.09 1992-12-16 — Discontinued by firm

This pack has the lowest per-ea cost of the 2 priced pack sizes ($0.0436 NADAC).

This pack shows little to no recent Medicaid volume — a different pack size carries most fills. See all packs ↓

Pack size FAQ

What quantity is in this package?
This is a 48-count package — 2 blister pack in 1 carton / 24 tablet in 1 blister pack.
How does this package differ from NDC 00904-5351-24?
Both are SudoGest Chlorpheniramine maleate, pseudoephedrine HCl 4 mg; 60 mg Tablet — the drug itself is identical. This page's package is the 48-count one, while NDC 00904-5351-24 is the 24 tablets package. Per-ea NADAC also differs: $0.0436 here vs $0.0787 for the 24 tablets pack.
What NDC number is used to bill for this package of SudoGest Chlorpheniramine maleate, pseudoephedrine HCl 4 mg; 60 mg Tablet?
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.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
SudoGest 4 mg/1; 60 mgthis 00904-5351-96 Major 48 tablets $0.044 — Discontinued —
Allergy Relief D 4 mg/1; 60 mg 00363-1110-22 Walgreen 48 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.

Availability & generic status

🏛️
1992
On the market since
Dec 1992
📍
2026
Currently FDA-listed
34 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.

What it looks like

Color white
ShapeRound
Imprint44;111
Size7 mm
ScoringScored — splits in 2
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 3SY5LH9PMK
    Anhydrous lactose is a milk sugar with no water content. It acts as a filler and binder in tablets and capsules, adding bulk and helping ingredients stick together.
  • UNII M28OL1HH48
    Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • 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 ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 4ELV7Z65AP
    Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.

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

The official label also statescolloidal silicon dioxide, croscarmellose sodium, lactose anhydrous, magnesium stearate, microcrystalline cellulose, stearic acid

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 applicationM012 (OTC MONOGRAPH DRUG)
Labeler code00904
First marketedDec 1992
Product typeHuman Otc Drug
Portfolio630 products on file

More NDCs from Major Pharmaceuticals labeler code 00904

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 🎯 Purpose 📄 Do Not Use 📄 Ask a Doctor Before Use If 📄 Ask a Doctor or Pharmacist Before Use If 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 46 words ▾

Uses temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies: runny nose sneezing itchy, watery eyes nasal congestion itching of the nose or throat temporarily relieves these symptoms due to the common cold: runny nose sneezing sinus congestion and pressure

⏱️ Dosage and Administration 39 words ▾

Directions do not take more than directed adults and children 12 years and over: take 1 tablet every 4 to 6 hours. Do not take more than 4 tablets in 24 hours. children under 12 years: do not use

⚠️ Warnings 199 words ▾

Warnings Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have diabetes heart disease high blood pressure thyroid disease glaucoma difficulty in urination due to enlargement of the prostate gland a breathing problem such as emphysema or chronic bronchitis Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

When using this product do not exceed recommended dosage excitability may occur, especially in children drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness avoid alcoholic beverages use caution when driving a motor vehicle or operating machinery Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur symptoms do not improve within 7 days or occur with a fever If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

📦 Storage and Handling 45 words ▾

Other information TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN store in a dry place and protect from light store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) see end flap for expiration date and lot number

🧪 Active Ingredient 13 words ▾

Active ingredients (in each tablet) Chlorpheniramine maleate 4 mg Pseudoephedrine HCl 60 mg

🧪 Inactive Ingredients 15 words ▾

Inactive ingredients colloidal silicon dioxide, croscarmellose sodium, lactose anhydrous, magnesium stearate, microcrystalline cellulose, stearic acid

🎯 Purpose 4 words ▾

Purpose Antihistamine Nasal decongestant

📄 Do Not Use 55 words ▾

Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

📄 Ask a Doctor Before Use If 36 words ▾

Ask a doctor before use if you have diabetes heart disease high blood pressure thyroid disease glaucoma difficulty in urination due to enlargement of the prostate gland a breathing problem such as emphysema or chronic bronchitis

📄 Ask a Doctor or Pharmacist Before Use If 14 words ▾

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

📄 When Using This Product 38 words ▾

When using this product do not exceed recommended dosage excitability may occur, especially in children drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness avoid alcoholic beverages use caution when driving a motor vehicle or operating machinery

📄 Stop Use and Ask a Doctor If 24 words ▾

Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur symptoms do not improve within 7 days or occur with a fever

🤰 If Pregnant or Breast-Feeding 10 words ▾

If pregnant or breast-feeding, ask a health professional before use.

📄 Keep Out of Reach of Children 21 words ▾

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

📄 Questions or Comments 4 words ▾

Questions or comments? 1-800-426-9391

📄 Package Label / Principal Display Panel 82 words ▾

Principal Display Panel MAJOR ® NDC 0904-5351-24 maximum strength SudoGest™ sinus & allergy chlorpheniramine maleate 4 mg antihistamine pseudoephedrine HCl 60 mg nasal decongestant relieves: • runny nose • sneezing • itchy, watery eyes • sinus congestion and pressure 24 Tablets actual size TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING 50844 REV1025N11108 Distributed by: MAJOR ® PHARMACEUTICALS Indianapolis, IN 46268 (800) 616-2471 www.major-rugby.com Major 44-111 Major 44-111

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

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
24 tablets00904-5351-24 3,162 Rx · $43,830
48 tablets this page00904-5351-96 No Medicaid data
Drug total (last 4 qtrs): 3,162 Rx · 122,809 units · $43,830 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for SudoGest (this brand).

Top reported reactions

Systemic Lupus Erythematosus5,337
Pain5,307
Pemphigus5,214
Rheumatoid Arthritis5,213
Abdominal Discomfort5,117
Alopecia5,011
Glossodynia4,787

Reporter sex

10,900 reports
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 1,961 308
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 — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) ✓ Available
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.
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 1 other package presentation of this same product, including 24 tablets (00904-5351-24). 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?
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.
← 00904-5309-09 · Major 00904-5354-31 · 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.