NDC 50991-0444-16 — ALAHIST DM Dextromethorphan HBr, Pheniramine

🆔 Identity & classification

FDA NDC (as labeled) 50991-444-16

Product NDC 50991-444

11-digit billing NDC 50991044416

NCPDP billing unit ML — per mL (volume)

RxCUI 2639752

UNII 9D2RTI9KYH, 04JA59TNSJ, NYW905655B

Application # M012

SPL Set ID fdaa062d-110e-798d-e053-6394a90a755c

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 2023-06-08

Route ORAL

Dosage form LIQUID

Substance DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; PHENIRAMINE MALEATE

GPI-14 43995803150920

GCN Seq No 085034

GCN 54425

HICL code 005273

Ingredient (HICL) Pheniramine/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 ALAHIST DM 10-12.5-5 MG/5ML LQ

FDB brand name Alahist Dm

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

Why two NDCs? The FDA registers this code as 50991-444-16 — 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 → 50991-0444-16. 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

LabelerPoly Pharmaceuticals, Inc.

FDA applicationM012 (OTC MONOGRAPH DRUG)

Labeler code50991

First marketedJun 2023

Product typeHuman Otc Drug

Portfolio18 products on file

🔎 All NDCs from Poly Pharmaceuticals, 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 ALAHIST DM 10-12.5-5 MG/5ML LQ Ingredient Pheniramine/Phenylephrine/Dm

🧪 What is this product?

Alahist DM is an over-the-counter oral liquid cough and cold product containing three active ingredients. Dextromethorphan is a cough suppressant typically used to reduce cough. Pheniramine is an antihistamine commonly used to relieve allergy and cold symptoms such as sneezing and runny nose. Phenylephrine is a decongestant typically used to help clear nasal congestion. This product is marketed under the FDA's over-the-counter monograph rules for cough and cold 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

FlavorStrawberry

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 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 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.

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

The official label also statesCitric Acid, Flavor, Methylparaben, Potassium Citrate, Propylene Glycol, Propylparaben, Purified water, Sucralose,Sorbitol

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	Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo	$0.0611	$28.90 / 473 ml
Medicare drug plans payPart D · quarterly	No Part D plan price is available for this NDC in our data.

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
Alahist Dm 10 mg/5mL; 5 mg/5mL; 12.5 mg/5mLthis 50991-0444-16	Poly	473 ml	—	—	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

🏛️

2023

On the market since

Jun 2023

📍

2026

Currently FDA-listed

3 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 50991-0444-16, 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 – Q4 2025 · 4 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

5.4K

Units reimbursed last 4 qtrs

836.2K

Gross reimbursed last 4 qtrs

$51.1K

Avg / prescription

$9.54

Avg / unit

$0.0611

Latest quarter Q4 2025

1.6KRx

Fee-for-service vs managed care ⓘ

100% MCO

Fee-for-service · 13 Rx Managed care · 5,343 Rx

State Medicaid map

Units reimbursed · per 100k residents

2,7412,741

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 Texas 2,741 /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.

473 ml this page50991-0444-16 5,356 Rx · $51,105

15 ml50991-0444-15 No Medicaid data

Drug total (last 4 qtrs): 5,356 Rx · 836,187 units · $51,105 gross reimbursed

Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📦 Packaging — all sizes for this product

Package NDC	Description	Marketing start	Status
50991-0444-15	15 mL in 1 BOTTLE (50991-444-15)	2023-06-08	Active
50991-0444-16 You're viewing this	473 mL in 1 BOTTLE (50991-444-16)	2023-06-08	Active

You're viewing the largest of 2 pack sizes for this product.

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 50991-0444-16?

NDC 50991-0444-16 contains 473 mL — 473 ml in 1 bottle.

What is the difference between NDC 50991-0444-16 and NDC 50991-0444-15?

Both are ALAHIST DM Dextromethorphan HBr, Pheniramine Maleate, Phenylephrine HCl 10 mg/5mL; 5 mg/5mL; 12.5 mg/5mL Liquid — the drug itself is identical. NDC 50991-0444-16 is the 473 mL package, while NDC 50991-0444-15 is the 15 ml package.

What NDC number is used to bill for this package of ALAHIST DM Dextromethorphan HBr, Pheniramine Maleate, Phenylephrine HCl 10 mg/5mL; 5 mg/5mL; 12.5 mg/5mL Liquid?

Bill NDC 50991-0444-16 — the 11-digit billing format is 50991044416. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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)	✓ Available

“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 50991-444-16, 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: 50991-0444-16, written without dashes as 50991044416. 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 50991-0444-16, the first segment (50991) is the labeler code FDA assigned to Poly Pharmaceuticals, Inc.; the middle segment (0444) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (16) 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 Poly Pharmaceuticals, Inc.. Listing status can change — the directory data on this page refreshes weekly.

Does this product come in other package sizes?

Yes — the FDA directory lists 1 other package presentation of this same product, including 15 ml (50991-0444-15). Each has its own NDC and its own page — see the package list near the top of this page.

Who lists this product with the FDA?

Poly Pharmaceuticals, 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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose

🎯 Indications and Usage 45 words ▾

Uses temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies: runny nose sneezing itching of nose or throat itchy, watery eyes cough due to minor throat and bronchial irritation nasal congestion reduces swelling of nasal passages

⏱️ Dosage and Administration 67 words ▾

Directions Do not exceed recommended dosage. Adults and children 12 years of age and over: 2 teaspoonful (10 mL) every 4 to 6 hours, not to exceed 12 teaspoonfuls in a 24 hours Children 6 to under 12 years of age: 1 teaspoonful (5 mL) every 4 to 6 hours, not to exceed 6 teaspoonfuls in 24 hours Children under 6 years of age: Consult a doctor.

⚠️ Warnings 209 words ▾

Warnings Do not exceed recommended dosage. 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.

Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis glaucoma trouble urinating due to an enlarged prostate gland a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema a cough that occurs with too much phlegm (mucus) heart disease high blood pressure thyroid disease diabetes Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. When using this product excitability may occur, especially in children may cause marked drowsiness avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase the drowsiness effect be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if 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.

🧪 Active Ingredient 20 words ▾

Active ing redients (in each 5 mL teaspoonful) Dextromethorphan HBr............... 10 mg Pheniramine Maleate.............. 12.5 mg Phenylephrine HCl...................... 5 mg

🧪 Inactive Ingredients 14 words ▾

Inactive ingredients Citric Acid, Flavor, Methylparaben, Potassium Citrate, Propylene Glycol, Propylparaben, Purified water, Sucralose,Sorbitol

🎯 Purpose 5 words ▾

Purpose Antitussive Antihistamine Nasal Decongestant

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, Pheniramine Maleate, Phenylephrine Hcl NDCsSame ingredient 🏭 All Poly labeler NDCsLabeler code 50991 📚 All Sigma-1 Agonist NDCsDrug class

💊 Related drugs in this class

Other drugs that share this product’s specific therapeutic class — Non-Opioid Antitus-1St Gen.antihistamine-Decongest.

Brompheniramine/Pseudoephed/Dm 00121-0933-04 Chlorpheniramine/Phenyleph/Dm 00485-0171-16 Chlorpheniramin/Pseudoephed/Dm 64543-0105-04

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.

ALAHIST DM Dextromethorphan HBr, Pheniramine Maleate, Phenylephrine HCl 10 mg/5mL; 5 mg/5mL; 12.5 mg/5mL Liquid, 473 mL

🆔 Identity & classification

🏷️ RxNorm drug class

🏭 Manufacturer & labeler

🩺 Clinical

Patient education

Supplement & herbal interactions

💊 What it looks like

🧪 Inactive Ingredients / Excipients

Inactive ingredient FAQ

💲 Pricing

🔁 Therapeutic equivalents

⏳ Availability & generic status

🗺️ Medicaid utilization & spend

💊 Medicaid utilization by pack size

📦 Packaging — all sizes for this product

Pack size FAQ

🧭 About this NDC listing & data coverage

Questions about this listing

📄 FDA label — Drug Facts FDA SPL

🔗 Related NDC lookups

💊 Related drugs in this class