NDC 50804-0689-21 — Cough and Cold HBP Chlorpheniramine maleate

🆔 Identity & classification

FDA NDC (as labeled) 50804-689-21

Product NDC 50804-689

11-digit billing NDC 50804068921

NCPDP billing unit EA — each (per item)

UNII V1Q0O9OJ9Z, 9D2RTI9KYH

UPC 0846036009767

Application # M012

SPL Set ID 1ea07a01-8779-48c2-a287-b7be866cce7b

Established class (EPC) Histamine-1 Receptor Antagonist; Sigma-1 Agonist; Uncompetitive N-methyl-D-aspartate Receptor Antagonist

Mechanism of action Histamine H1 Receptor Antagonists; Sigma-1 Receptor Agonists; Uncompetitive NMDA Receptor Antagonists

DEA schedule Non-controlled

Marketing category OTC MONOGRAPH DRUG

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2024-09-10

Route ORAL

Dosage form TABLET, FILM COATED

Substance CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE

GCN Seq No 029292

GCN 96140

HICL code 001924

Ingredient (HICL) Chlorpheniramine/Dextromethorp

HIC1 code B

Therapeutic class — broad (HIC1) Respiratory System

HIC2 code B4

Therapeutic class — intermediate (HIC2) Drugs Affecting The Trachea And Bronchi (Contin.1)

HIC3 code B4E

Therapeutic class — specific (HIC3) Non-Opioid Antitussive-1St Gen Antihistamine Comb.

AHFS code 04:04.20.00

AHFS class Propylamine Derivatives

FDB label name GS COUGH-COLD HBP TABLET

FDB brand name Cough-Cold Hbp

Legend status O — Over-the-counter (OTC) drug or device

Why two NDCs? The FDA registers this code as 50804-689-21 — 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 → 50804-0689-21. Same drug, same package — only the format differs.

Where does this data come from?

Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏭 Manufacturer & labeler

LabelerGeiss, Destin & Dunn Inc.

FDA applicationM012 (OTC MONOGRAPH DRUG)

Labeler code50804

First marketedSep 2024

Product typeHuman Otc Drug

Portfolio10 products on file

🔎 All NDCs from Geiss, Destin & Dunn Inc.

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).

Where does this data come from?

Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name GS COUGH-COLD HBP TABLET Ingredient Chlorpheniramine/Dextromethorp

📖 About the active ingredient MedlinePlus · NLM

General information about the ingredient itself — the description of this specific product follows below.

Chlorpheniramine is used to treat allergy symptoms: sneezing runny nose itchy nose or throat red, itchy, watery eyes Chlorpheniramine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.

Read the full MedlinePlus article ↗

🧪 What is this product?

This is an over-the-counter film-coated tablet taken by mouth that combines two active ingredients commonly used in cough and cold products. Chlorpheniramine maleate is an antihistamine typically used to relieve itching, sneezing, and runny nose associated with colds and allergies. Dextromethorphan hydrobromide is a cough suppressant commonly used to reduce cough. This product is marketed as an OTC monograph drug, meaning it follows FDA's established category rules for over-the-counter cough and cold medicines.

Patient education

📘 MedlinePlus patient leaflet ↗

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.

💊 What it looks like

Color red

ShapeRound

Imprint44;689

Size9 mm

ScoringNot scored

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 ZK64F7XSTX
A red synthetic colorant made by combining D&C Red No. 27 dye with aluminum salts. It's used to give tablets, capsules, or other medicines their red or pink color.
UNII GYP6Z2JR6Q
FD&C Yellow No. 6 Aluminum Lake is a yellow colorant made by combining FD&C Yellow No. 6 dye with aluminum salts. It's used to color tablets, capsules, and other medicines so they're easier to identify.
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 3WJQ0SDW1A
Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
UNII 532B59J990
Polyvinyl alcohol is a synthetic polymer made from plant-derived materials. It's used as a binder to hold ingredients together, a film-former in coatings, and a thickener in liquid formulations.
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.
UNII 7SEV7J4R1U
A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

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

The official label also statescroscarmellose sodium, D&C red #27 aluminum lake, FD&C yellow #6 aluminum lake, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, stearic acid, talc, titanium dioxide

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

Where does this data come from?

Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?

No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.

Why might an inactive ingredient be missing?

Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.

Can inactive ingredients matter?

Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price system	Per 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.

🔁 Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Cough and Cold 4 mg/1; 30 mg 00904-6634-44	Major	8 tablets	$0.111	—	Availability likely	—
Cough and Cold HBP 4 mg/1; 30 mg 46122-0705-73	Amerisource	8 tablets	$0.111	—	Availability likely	—
Cough and Cold HBP 4 mg/1; 30 mg 70000-0324-01	Cardinal	8 tablets	$0.111	—	Availability likely	—
Cough and Cold HBP 4 mg/1; 30 mg 00363-9689-21	Walgreen	8 tablets	—	—	FDA listed	—
Coricidin HBP Cough and Cold 30 mg/1; 4 mg 11523-0008-01	Bayer	16 tablets	—	—	FDA listed	—
Coricidin HBP Cough and Cold Cough Suppressant, Antihistamine 4 mg/1; 30 mg 11523-4326-01	Bayer	8 tablets	—	—	FDA listed	—
Cough and Cold HBP 4 mg/1; 30 mg 11822-0689-02	Rite	8 tablets	—	—	FDA listed	—
Cough and Cold HBP 4 mg/1; 30 mg 21130-0689-21	Better	8 tablets	—	—	FDA listed	—
Cough and Cold HBP 4 mg/1; 30 mg 36800-0689-21	Topco	8 tablets	—	—	FDA listed	—
cough and cold relief HBP 4 mg/1; 30 mg 41163-0698-21	United	8 tablets	—	—	FDA listed	—
Coricidin HBP Cough and Cold 30 mg/1; 4 mg 50090-5534-00	A-S	16 tablets	—	—	FDA listed	—
Cough and Cold HBP 4 mg/1; 30 mgthis 50804-0689-21	Geiss,	8 tablets	—	—	FDA listed	—
Cough and Cold HBP 4 mg/1; 30 mg 50844-0689-21	L.N.K.	8 tablets	—	—	FDA listed	—
Cough and Cold HBP 4 mg/1; 30 mg 53943-0689-21	Discount	8 tablets	—	—	FDA listed	—
Cough and Cold HBP 4 mg/1; 30 mg 55301-0689-21	ARMY	8 tablets	—	—	FDA listed	—
Cough and Cold HBP 4 mg/1; 30 mg 55319-0689-21	Family	8 tablets	—	—	FDA listed	—
Cough and Cold HBP 4 mg/1; 30 mg 55910-0689-21	DOLGENCORP,	8 tablets	—	—	FDA listed	—
Cough and Cold HBP 4 mg/1; 30 mg 63868-0179-01	CHAIN	8 tablets	—	—	Discontinued	—
Cough and Cold HBP 4 mg/1; 30 mg 63941-0989-21	Valu	8 tablets	—	—	FDA listed	—
Cough and Cold HBP 4 mg/1; 30 mg 69842-0689-21	CVS	8 tablets	—	—	FDA listed	—
Cough and Cold HBP 4 mg/1; 30 mg 83324-0072-16	Chain	8 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

🏛️

2024

On the market since

Sep 2024

📍

2026

Currently FDA-listed

2 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.

🔬 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 Cough and Cold HBP (this brand).

Top reported reactions

Drug Abuse3

Cardiac Arrest2

Respiratory Arrest2

Blood Pressure Increased1

Burning Sensation1

Coma1

Erythema1

Reporter sex

Male · 63%

Female · 38%

Serious outcomes

Death3

Hospitalization2

Life-threatening2

Reports over time (by year) — tap or hover for the count & year

Most recent year is provisional (FAERS lags ~3 months).

Where does this data come from?

Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDC	Description	Marketing start	Status
50804-0689-21 You're viewing this	2 BLISTER PACK in 1 CARTON (50804-689-21) / 8 TABLET, FILM COATED in 1 BLISTER PACK	2024-09-10	Active

🧭 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	✓ Available
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 FDA registers it as 50804-689-21, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 50804-0689-21, written without dashes as 50804068921. The Identity section at the top of this page lists every form of this code.

What do the three segments of this NDC mean?

In 50804-0689-21, the first segment (50804) is the labeler code FDA assigned to Geiss, Destin & Dunn Inc.; the middle segment (0689) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (21) identifies this exact package size and type. Together they name one specific package of one specific product.

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 Geiss, Destin & Dunn Inc.. Listing status can change — the directory data on this page refreshes weekly.

Who lists this product with the FDA?

Geiss, Destin & Dunn 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.

📄 FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.

🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose

🎯 Indications and Usage 28 words ▾

Uses temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold temporarily relieves runny nose and sneezing due to the common cold

⏱️ Dosage and Administration 34 words ▾

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

⚠️ Warnings 216 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 difficulty in urination due to enlargement of the prostate gland cough that occurs with excessive phlegm (mucus) glaucoma a breathing problem such as emphysema or chronic bronchitis persistent or chronic cough such as occurs with smoking, asthma, or emphysema Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

When using this product excitability may occur, especially in children marked 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 cough persists more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache. These could be signs of a serious condition. 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 36 words ▾

Other information TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) see end flap for expiration date and lot number

🧪 Active Ingredient 13 words ▾

Active ingredients (in each tablet) Chlorpheniramine maleate 4 mg Dextromethorphan HBr 30 mg

🧪 Inactive Ingredients 31 words ▾

Inactive ingredients croscarmellose sodium, D&C red #27 aluminum lake, FD&C yellow #6 aluminum lake, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, stearic acid, talc, titanium dioxide

🎯 Purpose 4 words ▾

Purpose Antihistamine Cough suppressant

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

🔗 Related NDC lookups

🧪 All Chlorpheniramine Maleate, Dextromethorphan Hbr NDCsSame ingredient 🏭 All Geiss, labeler NDCsLabeler code 50804 📚 All Histamine-1 Receptor Antagonist NDCsDrug class

💊 Related drugs in this class

Other drugs that share this product’s specific therapeutic class — Non-Opioid Antitussive-1St Gen Antihistamine Comb..

Dextromethorphan Hb/Doxylamine 00031-8718-13 Bromphenir Mal/Dextrometh Hbr 00113-6019-26 Promethazine/Dextromethorphan 00116-4024-16 Dexbrompheniramn/Chlophedianol 12830-0864-04 Pyrilamine/Chlophedianol 23359-0032-04 Pyrilamine/Dextromethorphan Hb 29978-0123-16 Dextromethorphan/Triprolidine 50991-0136-05 Dexchlorpheniramine/Dm 50991-0271-15 Dexchlorpheniram/Chlophedianol 58809-0190-16

Where does this data come from?

Other drugs sharing this product’s First Databank therapeutic class (HIC3). Each links to that NDC’s page in our directory.

Cough and Cold HBP Chlorpheniramine maleate, Dextromethorphan HBr 4 mg; 30 mg Tablet, Film Coated

🆔 Identity & classification

🏭 Manufacturer & labeler

🩺 Clinical

Patient education

Supplement & herbal interactions

💊 What it looks like

🧪 Inactive Ingredients / Excipients

Inactive ingredient FAQ

💲 Pricing

🔁 Therapeutic equivalents

⏳ Availability & generic status

🔬 Reported adverse events (FAERS)

Top reported reactions

Reporter sex

Serious outcomes

📦 Packaging — all sizes for this product

🧭 About this NDC listing & data coverage

Questions about this listing

📄 FDA label — Drug Facts FDA SPL

🔗 Related NDC lookups

💊 Related drugs in this class