Polytussin DM Dextromethorphan HBr, Phenylephrine HCl, Pyrilamine Maleate 7.5 mg/5mL; 12.5 mg/5mL; 5 mg/5mL Syrup, 480 mL
by Poly Pharmaceuticals, Inc. · 480 mL in 1 BOTTLE (50991-132-16)
NDC 50991-0132-16
🏷️ FDA NDC (as labeled)
50991-132-16
billing pads the product segment with a zero
This package
Also priced by: Medicaid pays $0.0663/unit — full pricing hub ↓
OTC
On market
Non-controlled
🗂️ Data synced Sep 3, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
🆔 Identity & classification
FDA NDC (as labeled)
50991-132-16
Product NDC
50991-132
11-digit billing NDC
50991013216
NCPDP billing unit
ML — per mL (volume)
RxCUI
2639753
UNII
9D2RTI9KYH, R35D29L3ZA, 04JA59TNSJ
UPC
0350991132168
Application #
M012
SPL Set ID
fda8f594-82bf-1781-e053-6294a90ad344
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
SYRUP
Substance
DEXTROMETHORPHAN HYDROBROMIDE; PYRILAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE
GCN Seq No
085040
GCN
54479
HICL code
035673
Ingredient (HICL)
Pyrilamine/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
04:04.08.00
AHFS class
Ethylenediamine Derivatives
FDB label name
POLYTUSSIN DM 7.5-5-12.5MG/5ML
FDB brand name
Polytussin Dm
Legend status
O — Over-the-counter (OTC) drug or device
Why two NDCs?
The FDA registers this code as 50991-132-16 — 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 → 50991-0132-16. 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
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 POLYTUSSIN DM 7.5-5-12.5MG/5ML Ingredient Pyrilamine/Phenylephrine/Dm
🧪 What is this product?
Polytussin DM is an over-the-counter cough and cold syrup taken by mouth. It contains dextromethorphan, a cough suppressant typically used to reduce cough, along with phenylephrine, a decongestant commonly used to relieve nasal congestion. The product also includes pyrilamine, an antihistamine typically used to help reduce sneezing and runny nose symptoms associated with colds and allergies.
Patient education
Supplement & herbal interactions
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.
💬 Questions about Dextromethorphan HBr, Phenylephrine HCl, Pyrilamine Maleate?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
💊 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 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 statesInactive ingredients Citric 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 | $0.062 | $29.90 / 480 ml |
| Medicaid paysCMS SDUD · 12 mo | $0.0663 | $31.82 / 480 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 10% over the last 5 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 |
|---|---|---|---|---|---|---|
| Polytussin DM 7.5 mg/5mL; 12.5 mg/5mL; 5 mg/5mLthis 50991-0132-16 | Poly | 480 ml | $0.062 | — | 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
🏛️
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 50991-0132-16, 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
206
Units reimbursed last 4 qtrs
33.7K
Gross reimbursed last 4 qtrs
$2.2K
Avg / prescription
$10.83
Avg / unit
$0.0663
Latest quarter Q4 2025
75Rx
Medicaid pays / mL
$0.0663
gross reimbursed
vs
NADAC / mL
$0.0623
acquisition cost
=
Spread
+$0.0040
+6% 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 ⓘ
Fee-for-service · 0 Rx Managed care · 206 Rx
State Medicaid map
Units reimbursed · per 100k residents
110110
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
Prescriptions—
Units—
Reimbursed—
🏆 Top states by units · per 100k residents
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.
Drug total (last 4 qtrs): 244 Rx · 38,015 units · $2,535 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 Polytussin DM (this brand).
Top reported reactions
Age at onset
Reporter sex
Male · 29%
Female · 71%
Serious outcomes
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 |
|---|---|---|---|---|---|
| 50991-0132-15 | 15 mL in 1 BOTTLE (50991-132-15) | — | — | 2023-06-08 | Active |
| 50991-0132-16 You're viewing this | 480 mL in 1 BOTTLE (50991-132-16) | $0.0623 / mL | $29.90 | 2023-06-08 | Active |
| 50991-0132-05 | 5 mL in 1 CUP, UNIT-DOSE (50991-132-05) | — | — | 2026-08-18 | Active |
You're viewing the largest of 3 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 50991-0132-16?
NDC 50991-0132-16 contains 480 mL — 480 ml in 1 bottle.
What is the difference between NDC 50991-0132-16 and NDC 50991-0132-05?
Both are Polytussin DM Dextromethorphan HBr, Phenylephrine HCl, Pyrilamine Maleate 7.5 mg/5mL; 12.5 mg/5mL; 5 mg/5mL Syrup — the drug itself is identical. NDC 50991-0132-16 is the 480 mL package, while NDC 50991-0132-05 is the 5 ml package.
What NDC number is used to bill for this package of Polytussin DM Dextromethorphan HBr, Phenylephrine HCl, Pyrilamine Maleate 7.5 mg/5mL; 12.5 mg/5mL; 5 mg/5mL Syrup?
Bill NDC 50991-0132-16 — the 11-digit billing format is 50991013216. 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 ▾
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 ▾
Directions Do not exceed recommended dosage. Adults and children 12 years of age and over: 2 teaspoonfuls (10 mL) every 4 to 6 hours, not to exceed 12 teaspoonfuls in 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 ▾
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.
🧪 Active Ingredient ▾
Active ingredients (in each 5 mL teaspoonful) Dextromethorphan HBr............... 7.5 mg Phenylephrine HCl....................... 5 mg Pyrilamine Maleate................. 12.5 mg
🧪 Inactive Ingredients ▾
Inactive ingredients Citric Acid, Flavor, Methylparaben, Potassium Citrate, Propylene Glycol, Propylparaben, Purified water, Sucralose, Sorbitol
🎯 Purpose ▾
Antihistamine Cough Suppressant Nasal Decongestant
No label section mentions that — try another word, or open the full label on DailyMed below.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
Prefer the government’s original formatting? View this label on DailyMed ↗
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.