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WesTussin DM dexchlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl 1 mg/5mL; 10 mg/5mL; 5 mg/5mL Syrup, 480 mL — NDC 69367-334-16 (Billing 69367-0334-16)

by Westminster Pharmaceuticals, LLC · 480 mL in 1 BOTTLE, PLASTIC

This is a package of 480 mL of WesTussin DM dexchlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl 1 mg/5mL; 10 mg/5mL; 5 mg/5mL Syrup from Westminster Pharmaceuticals, LLC, marketed since Jul 2021 and currently FDA-listed; retail pharmacies pay about $0.0410 per mL (NADAC). It is this product's only package size.

NDC 69367-0334-16
🏷️ FDA NDC (as labeled) 69367-334-16 billing pads the product 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 69367-334-16 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
69367 labeler · 334 product · 16 package
Package marketed since
Jul 29, 2021
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
480 mL per package
Barcode (UPC-A, from the NDC)
3 6936733416 7
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 69367-334-16
Product NDC 69367-334
11-digit billing NDC 69367033416
NCPDP billing unit ML — per mL (volume)
RxCUI 1990881
UNII B10YD955QW, 9D2RTI9KYH, 04JA59TNSJ
Application # M012
SPL Set ID 68a0cd44-3fdd-430e-af1a-498d4415ab78
Established class (EPC) Sigma-1 Agonist; Uncompetitive N-methyl-D-aspartate Receptor Antagonist; alpha-1 Adrenergic Agonist
Mechanism of action Adrenergic alpha1-Agonists; 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 2021-07-29
Route ORAL
Dosage form SYRUP
Substance DEXCHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE

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

GPI-14 43995803781220
GPI class WesTussin DM
GCN Seq No 078018
GCN 44218
HICL code 044697
Ingredient (HICL) Dexchlorphen/Phenylephrine/Dm
HIC1 code B
Therapeutic class — broad (HIC1) Respiratory System
HIC2 code B3
Therapeutic class — intermediate (HIC2) Drugs Affecting Primarily The Trachea And Bronchi
HIC3 code B3R
Therapeutic class — specific (HIC3) Non-Opioid Antitus-1St Gen.antihistamine-Decongest
AHFS code 04:04.20.00
AHFS class Propylamine Derivatives
FDB label name WESTUSSIN DM 1-5-10 MG/5ML SYR
FDB brand name Westussin Dm
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 078018
  • GCN: 44218
  • GPI-14 (Medi-Span): 43995803781220
  • HICL (First Databank): 044697
  • AHFS class code: 04:04.20.00
  • RxCUI (RxNorm): 1990881
Why two NDCs? The FDA registers this code as 69367-334-16 — 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 → 69367-0334-16. 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 Substituted alkylamines class.

Drug family (ATC) Substituted alkylamines
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 WESTUSSIN DM 1-5-10 MG/5ML SYR Ingredient Dexchlorphen/Phenylephrine/Dm
📖 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?

WesTussin DM is an over-the-counter cough and cold syrup taken by mouth. It contains three active ingredients: dextromethorphan, which is typically used to suppress coughs; dexchlorpheniramine, an antihistamine commonly used to relieve allergy and cold symptoms like sneezing and runny nose; and phenylephrine, a nasal decongestant typically used to reduce nasal congestion. This is an OTC monograph product, meaning it is marketed under established FDA guidelines for over-the-counter cold and cough medicines.

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 $0.041 $19.68 / 480 ml
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 mL) — tap or hover for the price & month
Dec 2021 Dec 2023 Apr 2026 Sep 2026 $0.051 $0.041
▼ Down 20% over the last 15 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
69367-0334-16 You're viewing this Main listing 480 mL in 1 BOTTLE, PLASTIC 2021-07-29 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
WesTussin DM 1 mg/5mL; 10 mg/5mL; 5 mg/5mLthis 69367-0334-16 Westminster 480 ml $0.041 — Availability likely —
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

🏛️
2021
On the market since
Jul 2021
📍
2026
Currently FDA-listed
5 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

FlavorCotton Candy
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 XF417D3PSL
    Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • 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 OJ245FE5EU
    Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
  • UNII 1Q73Q2JULR
    Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.
  • 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 96K6UQ3ZD4
    Sucralose is a synthetic sweetener made from sugar. It's added to medicines to improve taste without adding calories, helping make bitter or unpleasant-tasting drugs easier to take.
  • 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 statesCitric acid anhydrous, cotton candy flavoring, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sorbitol solution, sucralose.

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

LabelerWestminster Pharmaceuticals, LLC
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code69367
First marketedJul 2021
Product typeHuman Otc Drug
Portfolio186 products on file

More NDCs from Westminster Pharmaceuticals, LLC labeler code 69367

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 62 words ▾

Uses temporarily relieves cough due to minor throat and bronchial irritation occurring with a cold or inhaled irritants temporarily relieves nasal congestion due to the common cold, hay fever or other respiratory allergies temporarily relieves these symptoms due to hay fever (allergic rhinitis): runny nose sneezing itching of the nose of throat itchy, watery eyes temporarily restores freer breathing through the nose

⏱️ Dosage and Administration 36 words ▾

Directions Adults 12 and over: 10 mL every 4 hours Not to exceed 60 mL in 24hrs Children 6-12: 5 mL every 4 hours Not to exceed 30 mL in 24hrs Children 2-6: Consult a doctor

⚠️ Warnings ~1 min read ▾

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 heart disease high blood pressure thyroid disease diabetes a breathing problem such as emphysema or chronic bronchitis glaucoma difficulty in urination due to enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma or emphysema cough accompanied by excessive phlegm (mucus) Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

When using this product do not exceed recommended dosage marked drowsiness may occur alcohol, sedatives, and tranquilizers may increase the drowsiness effect avoid alcoholic beverages use caution when driving a motor vehicle or operating machinery excitability may occur especially in children Stop use and ask a doctor if cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash or persistent headache. A persistent cough may be a sign of a serious condition. symptoms do not improve within 7 days or are accompanied by fever nervousness, dizziness, or sleeplessness occur If pregnant or breastfeeding 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 8 words ▾

Other information Store at room temperature 15°C-30°C (59°F-86°F)

🧪 Active Ingredient 25 words ▾

Active ingredients (in each 5 mL teaspoonful) Purpose Dexchlorpheniramine Maleate 1 mg Antihistamine Dextromethorphan HBr 10 mg Cough Suppressant Phenylephrine HCl 5 mg Nasal Decongestant

🧪 Inactive Ingredients 21 words ▾

Inactive ingredients Citric acid anhydrous, cotton candy flavoring, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sorbitol solution, sucralose.

🎯 Purpose 25 words ▾

Active ingredients (in each 5 mL teaspoonful) Purpose Dexchlorpheniramine Maleate 1 mg Antihistamine Dextromethorphan HBr 10 mg Cough Suppressant Phenylephrine HCl 5 mg 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 52 words ▾

Ask a doctor before use if you have heart disease high blood pressure thyroid disease diabetes a breathing problem such as emphysema or chronic bronchitis glaucoma difficulty in urination due to enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma or emphysema cough accompanied by excessive phlegm (mucus)

📄 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 41 words ▾

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

📄 Stop Use and Ask a Doctor If 54 words ▾

Stop use and ask a doctor if cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash or persistent headache. A persistent cough may be a sign of a serious condition. symptoms do not improve within 7 days or are accompanied by fever nervousness, dizziness, or sleeplessness occur

🤰 If Pregnant or Breast-Feeding 10 words ▾

If pregnant or breastfeeding ask a health professional before use

📄 Keep Out of Reach of Children 22 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 23 words ▾

Questions? Call weekdays from 9 AM to 5 PM EST at 1-844-221-7294. You may also report serious side effects to this phone number.

📄 Package Label / Principal Display Panel 84 words ▾

PRINCIPAL DISPLAY PANEL - 480 mL Bottle Label NDC 69367-334-16 WesTussin DM Antihistamine • Cough Suppressant Nasal Decongestant • Alcohol Free • Dye Free • Sugar Free • Gluten Free Each 5 mL (1 teaspoonful) contains: Dexchlorpheniramine Maleate 1 mg Dextromethorphan HBr 10 mg Phenylephrine HCl 5 mg Cotton Candy Flavor TAMPER EVIDENT: Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing. 16 oz (480 mL) Westminster Pharmaceuticals PRINCIPAL DISPLAY PANEL - 480 mL Bottle Label

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 69367-0333-60 · Westminster 69367-0335-30 · Westminster →
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.