Home › NDC Lookup › Ingredients › Chlorpheniramine Maleate, Dextromethorph... › 00904-6634-44
Cough and Cold Chlorpheniramine maleate, Dextromethorphan HBr 4 mg; 30 mg Tablet, Film Coated — NDC 00904-6634-44 package photo

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

by Major Pharmaceuticals · 2 BLISTER PACK in 1 CARTON (0904-6634-44) / 8 TABLET, COATED in 1 BLISTER PACK
NDC 00904-6634-44
🏷️ FDA NDC (as labeled) 0904-6634-44 billing pads the labeler segment with a zero
OTC On market Non-controlled
🗂️ Data synced 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

🆔 Identity & classification

FDA NDC (as labeled) 0904-6634-44
Product NDC 0904-6634
11-digit billing NDC 00904663444
NCPDP billing unit EA — each (per item)
RxCUI 1421985
UNII V1Q0O9OJ9Z, 9D2RTI9KYH
UPC 0309046634447
Application # M012
SPL Set ID 3adc412b-c65f-4860-aa66-0cc1687e84b2
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 2017-03-31
Route ORAL
Dosage form TABLET, FILM COATED
Substance CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE
GPI-14 43995702100320
GPI class Cough & Cold
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 COUGH-COLD TABLET
FDB brand name Cough-Cold
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 0904-6634-44 — 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 → 00904-6634-44. 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.

🏭 Manufacturer & labeler

LabelerMajor Pharmaceuticals
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code00904
First marketedMar 2017
Product typeHuman Otc Drug
Portfolio629 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.

🩺 Clinical

Label name COUGH-COLD 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 oral film-coated tablet containing chlorpheniramine maleate and dextromethorphan hydrobromide, marketed as an over-the-counter cough and cold product under FDA's OTC monograph rules. Chlorpheniramine maleate is a first-generation antihistamine typically used to relieve allergy and cold-related symptoms such as sneezing, runny nose, and itching. Dextromethorphan hydrobromide is a cough suppressant commonly used to reduce coughing. The combination is intended for oral use to address multiple cold and cough 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.

🧪 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.

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 systemPer eaPer package
Retail pharmacies payNADAC · weekly $0.111 $1.78 / 16 tablets
Medicaid paysCMS SDUD · 12 mo $0.4970 $7.95 / 16 tablets
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
Dec 2021 Jul 2022 Dec 2025 Aug 2026 $0.129 $0.082
▲ Up 20% over the last 24 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Cough and Cold 4 mg/1; 30 mgthis 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 mg 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

🏛️
2017
On the market since
Mar 2017
📍
2026
Currently FDA-listed
9 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 00904-6634-44, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
602
Units reimbursed last 4 qtrs
4K
Gross reimbursed last 4 qtrs
$2K
Avg / prescription
$3.30
Avg / unit
$0.4970
Latest quarter Q1 2026
95Rx
Medicaid pays / ea
$0.4970
gross reimbursed
vs
NADAC / ea
$0.1114
acquisition cost
=
Spread
+$0.3856
+346% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
90% MCO
Fee-for-service · 63 Rx Managed care · 539 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: 3,992 units · 33.9 per 100k residents OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: no data reported CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
33.933.9
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Ohio 33.9 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
00904-6634-44 You're viewing this 2 BLISTER PACK in 1 CARTON (0904-6634-44) / 8 TABLET, COATED in 1 BLISTER PACK 2017-03-31 Active

📄 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 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 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 ↗
← 00904-6627-35 · Major 00904-6635-61 · 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.