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Cough and Cold HBP Chlorpheniramine maleate, Dextromethorphan HBr 4 mg; 30 mg Tablet, Film Coated — NDC 70000-0324-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Cough and Cold HBP Chlorpheniramine maleate, Dextromethorphan HBr 4 mg; 30 mg Tablet, Film Coated — NDC 70000-0324-1 (Billing 70000-0324-01)

by Cardinal Health 110, LLC. DBA Leader · 2 BLISTER PACK in 1 CARTON / 8 TABLET, FILM COATED in 1 BLISTER PACK

This is a package of Cough and Cold HBP Chlorpheniramine maleate, Dextromethorphan HBr 4 mg; 30 mg Tablet, Film Coated from Cardinal Health 110, LLC. DBA Leader, marketed since May 2017 and currently FDA-listed; retail pharmacies pay about $0.1112 per unit (NADAC). It is this product's only package size.

NDC 70000-0324-01
🏷️ FDA NDC (as labeled) 70000-0324-1 billing pads the package segment with a zero
OTC On market Non-controlled ⇄ 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 70000-0324-1 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
70000 labeler · 0324 product · 1 package
Package marketed since
May 15, 2017
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC)
0096295132779
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 70000-0324-1
Product NDC 70000-0324
11-digit billing NDC 70000032401
NCPDP billing unit EA — each (per item)
RxCUI 1421985
UNII V1Q0O9OJ9Z, 9D2RTI9KYH
UPC 0096295132779
Application # M012
SPL Set ID 0fad61d8-4393-47ec-9ff6-7df5be761f5b
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 2017-05-15
Route ORAL
Dosage form TABLET, FILM COATED
Substance CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE

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

GPI-14 43995702100320
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 HBP TABLET
FDB brand name Cough-Cold Hbp
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 029292
  • GCN: 96140
  • GPI-14 (Medi-Span): 43995702100320
  • HICL (First Databank): 001924
  • AHFS class code: 04:04.20.00
  • RxCUI (RxNorm): 1421985
Why two NDCs? The FDA registers this code as 70000-0324-1 — a 5-4-1 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 package segment → 70000-0324-01. 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 COUGH-COLD HBP TABLET Ingredient Chlorpheniramine/Dextromethorp
🧪 What is this product?

This is an over-the-counter film-coated tablet taken by mouth, marketed under FDA's monograph rules for cough and cold products. It contains chlorpheniramine maleate, an antihistamine typically used to reduce sneezing, itching, and runny nose, and dextromethorphan hydrobromide, a cough suppressant commonly used to help reduce coughing. This combination is typically used for temporary relief of multiple cold and allergy symptoms in people who do not have high blood pressure concerns.

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 $0.111 $1.78 / 16 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
Jan 2022 Aug 2022 Jan 2026 Sep 2026 $0.129 $0.082
▼ Down 4% 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
70000-0324-01 You're viewing this Main listing 2 BLISTER PACK in 1 CARTON / 8 TABLET, FILM COATED in 1 BLISTER PACK 2017-05-15 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice 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 mgthis 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
May 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.

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.

Manufacturer & labeler

LabelerCardinal Health 110, LLC. DBA Leader
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code70000
First marketedMay 2017
Product typeHuman Otc Drug
Portfolio163 products on file

More NDCs from Cardinal Health 110, LLC. DBA Leader labeler code 70000

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 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

📄 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 47 words ▾

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 14 words ▾

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

📄 When Using This Product 34 words ▾

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 34 words ▾

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 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 55 words ▾

Principal display panel LEADER™ NDC 70000-0324-1 Cough & Cold HBP Chlorpheniramine Maleate, 4 mg Dextromethorphan HBr, 30 mg Antihistamine | Cough Suppressant Relieves: Cough, Runny Nose, Sneezing For People with High Blood Pressure Decongestant-Free 16 TABLETS Actual Size COMPARE TO CORICIDIN® HBP COUGH & COLD active ingredients* 100% Money Back Guarantee Leader 44-689 Leader 44-689

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 70000-0323-01 · LEADER/ 70000-0329-01 · LEADER/ →
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.