NDC 29978-0127-16 — Capron DM Dextromethorphan HBr and Pyrilamine

🆔 Identity & classification

FDA NDC (as labeled) 29978-127-16

Product NDC 29978-127

11-digit billing NDC 29978012716

NCPDP billing unit ML — per mL (volume)

RxCUI 1423307

UNII 9D2RTI9KYH, R35D29L3ZA

UPC 0329978127152

Application # M012

SPL Set ID cf778c5f-475e-4a86-a87c-2be1e665f5a5

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

Mechanism of action 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 2013-06-20

Route ORAL

Dosage form LIQUID

Substance DEXTROMETHORPHAN HYDROBROMIDE; PYRILAMINE MALEATE

GPI-14 43995702700920

GPI class Capron DM

GCN Seq No 070898

GCN 34563

HICL code 040243

Ingredient (HICL) Pyrilamine/Dextromethorphan Hb

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 04:04.08.00

AHFS class Ethylenediamine Derivatives

FDB label name CAPRON DM LIQUID

FDB brand name Capron Dm

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

Why two NDCs? The FDA registers this code as 29978-127-16 — 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 → 29978-0127-16. 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 Uncompetitive N-methyl-D-aspartate Receptor Antagonist class.

Pharmacologic class Uncompetitive N-methyl-D-aspartate Receptor Antagonist, Sigma-1 Agonist

Drug family (ATC) Other antidepressants, Opium alkaloids and derivatives

How it works Uncompetitive NMDA Receptor Antagonists, Sigma-1 Receptor Agonists

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

LabelerCapital Pharmaceutical, LLC

FDA applicationM012 (OTC MONOGRAPH DRUG)

Labeler code29978

First marketedJun 2013

Product typeHuman Otc Drug

Portfolio6 products on file

🔎 All NDCs from Capital Pharmaceutical, LLC

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 CAPRON DM LIQUID Ingredient Pyrilamine/Dextromethorphan Hb

🧪 What is this product?

Capron DM is an over-the-counter oral liquid containing dextromethorphan and pyrilamine maleate. Dextromethorphan is a cough suppressant typically used to reduce coughing, while pyrilamine maleate is an antihistamine commonly used to help relieve allergy symptoms such as sneezing and runny nose. This combination product is marketed as an OTC monograph drug, meaning it follows FDA's established rules for this class of over-the-counter medications.

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

FlavorApple

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 3VRD35U26C
A natural extract from licorice root, ammonium glycyrrhizate is used as a flavoring agent and sweetener in medicines. It may also help soothe irritated tissues in the mouth or throat.
UNII 2968PHW8QP
A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
UNII A2I8C7HI9T
Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
UNII EE90ONI6FF
Potassium citrate is a salt derived from citric acid and potassium. In medicines, it acts as a buffer to adjust and maintain the pH balance of the product, helping keep it stable and palatable.
UNII 1VPU26JZZ4
Potassium sorbate is a salt derived from sorbic acid, a naturally occurring preservative. It prevents growth of mold, yeast, and some bacteria, extending the medicine's shelf life.
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 Z8IX2SC1OH
Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
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.

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

The official label also statesCitric Acid, Flavor, Magnasweet, Methyl Paraben, Potassium Citrate, Potassium Sorbate, Propyl Paraben, Propylene Glycol, Purified Water, Sorbitol, 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.

💲 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 mL	Per package
Retail pharmacies payNADAC · weekly	$0.070	$32.92 / 473 ml
Medicaid paysCMS SDUD · 12 mo	$0.1092	$51.65 / 473 ml
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

▲ Up 1% over the last 4 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

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Pyrilamine Maleate and Dextromethorphan Hydrobromide 7.5 mg/5mL; 7.5 mg/5mL 69367-0398-16	Westminster	473 ml	$0.065	—	FDA listed	save 7%
Capron DM 7.5 mg/5mL; 7.5 mg/5mLthis 29978-0127-16	Capital	1 bottle	$0.070	—	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

🏛️

2013

On the market since

Jun 2013

📍

2026

Currently FDA-listed

13 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 29978-0127-16, 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

4.1K

Units reimbursed last 4 qtrs

888.3K

Gross reimbursed last 4 qtrs

$97K

Avg / prescription

$23.57

Avg / unit

$0.1092

Latest quarter Q1 2026

888Rx

Medicaid pays / mL

$0.1092

gross reimbursed

vs

NADAC / mL

$0.0696

acquisition cost

=

Spread

+$0.0396

+57% vs cost

What Medicaid paid per mL (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 ⓘ

25% FFS 75% MCO

Fee-for-service · 1,035 Rx Managed care · 3,079 Rx

State Medicaid map

Units reimbursed · per 100k residents

6,2998,249

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 West Virginia 8,249 /100k

2 Ohio 6,299 /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.

💊 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.

1 bottle this page29978-0127-16 4,114 Rx · $96,976

6 bottles29978-0127-15 No Medicaid data

Drug total (last 4 qtrs): 4,114 Rx · 888,287 units · $96,976 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 Capron DM (this brand).

Top reported reactions

Pyrexia3

Asthenia2

Bacterial Vaginosis2

Bronchitis2

Covid-192

Dyspnoea2

Fatigue2

Age at onset

Adult1

Elderly2

Reporter sex

Male · 57%

Female · 43%

Serious outcomes

Hospitalization6

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	Per unit	Per pack	Marketing start	Status
29978-0127-15	6 BOTTLE in 1 BOX (29978-127-15) / 15 mL in 1 BOTTLE	—	—	2013-06-20	Active
29978-0127-16 You're viewing this	1 BOTTLE in 1 BOX (29978-127-16) / 473 mL in 1 BOTTLE	$0.0696 / mL	$32.91	2013-06-20	Active

In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 29978-0127-16?

NDC 29978-0127-16 is listed by the FDA — 1 bottle in 1 box / 473 ml in 1 bottle.

What NDC number is used to bill for this package of Capron DM Dextromethorphan HBr and Pyrilamine Maleate 7.5 mg/5mL; 7.5 mg/5mL Liquid?

Bill NDC 29978-0127-16 — the 11-digit billing format is 29978012716. 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.

📄 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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose

🎯 Indications and Usage 54 words ▾

Uses temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies: runny nose sneezing itching of the nose or throat itchy, watery eyes cough due to minor throat and bronchial irritation associated with a cold alleviates cough to help you sleep nonnarcotic cough suppressant for the relief of cough

⏱️ Dosage and Administration 101 words ▾

Directions Do not exceed recommended dosage. Adults and children 12 years of age and over: 4 teaspoonfuls every 6-8 hours, not to exceed 16 teaspoonfuls in 24 hours, or as directed by a doctor Children 6 to under 12 years of age: 2 teaspoonfuls every 6-8 hours, not to exceed 8 teaspoonfuls in 24 hours, or as directed by a doctor Children 2 to under 6 years of age (For Professional Use Only) 1 teaspoonful every 6-8 hours, not to exceed 4 teaspoonfuls in 24 hours, or as directed by a doctor Children under 2 years of age: Consult a doctor

⚠️ Warnings ~1 min read ▾

Warnings Do not exceed recommended dosage. a persistent cough may be a sign of a serious condition. If cough persist for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache, consult a doctor. Do not use this product 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 for persistent or chronic cough such as occurs with smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis glaucoma difficulty in urination due to enlargement of the prostate gland Ask a doctor before use if you are taking sedatives or tranquilizers .

When using this product excitability may occur, especially in children may cause marked drowsiness sedatives and tranquilizers may increase drowsiness effect avoid alcoholic beverages use caution when driving a motor vehicle or operating machinery If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of accidental overdose, seek professional help or contact a Poison Control Center immediately.

🧪 Active Ingredient 22 words ▾

Active Ingredients (in each 5 mL teaspoonful) Dextromethorphan HBr 7.5 mg

Active Ingredients (in each 5 mL teaspoonful) Pyrilamine Maleate 7.5 mg

🧪 Inactive Ingredients 20 words ▾

Inactive ingredients Citric Acid, Flavor, Magnasweet, Methyl Paraben, Potassium Citrate, Potassium Sorbate, Propyl Paraben, Propylene Glycol, Purified Water, Sorbitol, Sucralose

🎯 Purpose 4 words ▾

Purpose Antitussive

Purpose Antihistamine

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

🔗 Related NDC lookups

🧪 All Dextromethorphan Hbr And Pyrilamine Maleate NDCsSame ingredient 🏭 All Capital labeler NDCsLabeler code 29978 📚 All Sigma-1 Agonist NDCsDrug class

💊 Related drugs in this class

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

Chlorpheniramine/Dextromethorp 00031-8693-12 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 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.