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HISTEX-DM New Formulation DEXTROMETHORPHAN HBr, PSEUDOEPHEDRINE HCI, and TRIPROLIDINE HCI 20 mg/5mL; 30 mg/5mL; 2.5 mg/5mL Syrup, 473 mL — NDC 28595-0310-16 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

HISTEX-DM New Formulation DEXTROMETHORPHAN HBr, PSEUDOEPHEDRINE HCI, and TRIPROLIDINE HCI 20 mg/5mL; 30 mg/5mL; 2.5 mg/5mL Syrup, 473 mL — NDC 28595-310-16 (Billing 28595-0310-16)

by Allegis Pharmaceuticals, LLC · 473 mL in 1 BOTTLE

This is a package of 473 mL of HISTEX-DM New Formulation DEXTROMETHORPHAN HBr, PSEUDOEPHEDRINE HCI, and TRIPROLIDINE HCI 20 mg/5mL; 30 mg/5mL; 2.5 mg/5mL Syrup from Allegis Pharmaceuticals, LLC, marketed since Mar 2025 and currently FDA-listed. It is this product's only package size.

NDC 28595-0310-16
🏷️ FDA NDC (as labeled) 28595-310-16 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 28595-310-16 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
28595 labeler · 310 product · 16 package
Package marketed since
Mar 10, 2025
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
473 mL per package
Barcode (UPC-A, from the NDC)
3 2859531016 9
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 28595-310-16
Product NDC 28595-310
11-digit billing NDC 28595031016
NCPDP billing unit ML — per mL (volume)
RxCUI 2707699
UNII 9D2RTI9KYH, 6V9V2RYJ8N, YAN7R5L890
Application # M012
SPL Set ID 30010401-e5b4-2bd9-e063-6394a90a0b0b
Established class (EPC) Sigma-1 Agonist; Uncompetitive N-methyl-D-aspartate Receptor Antagonist; alpha-Adrenergic Agonist
Mechanism of action Adrenergic alpha-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 2025-03-10
Route ORAL
Dosage form SYRUP
Substance DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE

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

GCN Seq No 087418
GCN 57325
HICL code 037294
Ingredient (HICL) Triprolidine/Pseudoephedrin/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 HISTEX-DM 20-30-2.5MG/5ML SYRP
FDB brand name Histex-Dm
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 087418
  • GCN: 57325
  • HICL (First Databank): 037294
  • AHFS class code: 04:04.20.00
  • RxCUI (RxNorm): 2707699
Why two NDCs? The FDA registers this code as 28595-310-16 — 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 → 28595-0310-16. 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 Other antihistamines for systemic use class.

Drug family (ATC) Other antihistamines for systemic use
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 HISTEX-DM 20-30-2.5MG/5ML SYRP Ingredient Triprolidine/Pseudoephedrin/Dm
🧪 What is this product?

Histex-DM New Formulation is an over-the-counter syrup taken by mouth that combines three active ingredients commonly used to treat cold and allergy symptoms. Dextromethorphan is typically used as a cough suppressant, while pseudoephedrine functions as a nasal decongestant to help relieve nasal congestion. Triprolidine is an antihistamine commonly used to reduce sneezing, itching, and runny nose. This product is marketed as an OTC monograph drug, meaning it follows established FDA guidelines for combination cold and allergy remedies.

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 Not in the retail survey — common for institutional, discontinued, or low-volume packs.
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.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
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
28595-0310-16 You're viewing this Main listing 473 mL in 1 BOTTLE 2025-03-10 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
HISTEX-DM New Formulation 20 mg/5mL; 30 mg/5mL; 2.5 mg/5mLthis 28595-0310-16 Allegis 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

🏛️
2025
On the market since
Mar 2025
📍
2026
Currently FDA-listed
1 year 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

FlavorGrape
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 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 6X543N684K
    A natural flavoring derived from grapes that enhances taste appeal. It's used in medicines to improve flavor and make medications more palatable, especially for children or patients who need better taste acceptance.
  • 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 SB8ZUX40TY
    Saccharin sodium is an artificial sweetener made from saccharin salt. It's added to medicines to improve taste, especially in liquid formulations for children or bitter drugs.
  • 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 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.

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

The official label also statesCitric Acid, Glycerin, Grape Flavor, Propylene Glycol, Purified Water, Sodium Bensoate, Soduim Citrate, Sodium Saccharin, Sorbitol Solution.

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

LabelerAllegis Pharmaceuticals, LLC
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code28595
First marketedMar 2025
Product typeHuman Otc Drug
Portfolio10 products on file

More NDCs from Allegis Pharmaceuticals, LLC labeler code 28595

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 📄 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 45 words ▾

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

⏱️ Dosage and Administration 80 words ▾

Directions Do not exceed recommended dosage. AGE DOSE Adults and Children 12 years of age and older: 1 teaspoonful (5 mL) every 4 hours, not to exceed 4 teaspoonfuls (20 mL) in 24 hours, or as directed by a doctor Children 6 to under 12 years of age ½ teaspoonful (2.5 mL) every 4 hours, not to exceed 2 teaspoonfuls (10 mL) in 24 hours, or as directed by a doctor. Children under 6 years of age Consult a doctor

⚠️ Warnings ~1 min read ▾

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 giving this product.

Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis heart disease high blood pressure thyroid disease diabetes glaucoma a persistent or chronic cough such occurs with smoking, asthma, chronic bronchitits, or emphysema a cough that occurs with too much phlegm (mucus) trouble urinating due to an enlarged 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 drowsiness alcohol, sedatives and tranquilizers may increase the drowsiness effect avoid alcoholic beverages use caution when driving a motor vehicle or operating machinery Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur cough or nasal congestion persists for more than 1 week, tends to recur or is accompanied by a fever, rash or persistent headache. new symptoms occur These could be signs of a serious condition.

If pregnant or breast-feeding, ask a health professional before use. Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

📦 Storage and Handling 25 words ▾

Other Information Store at 15°-30° C (59°-86° F). Tamper evident by foil seal under cap. Do not use if foil seal is missing or broken.

🧪 Active Ingredient 25 words ▾

Active ingredients (in each 5 mL teaspoonful) Purpose Dextromethorphan HBr 20 mg Cough Suppressant Pseudoephedrine HCI 30 mg Nasal Decongestant Triprolidine HCl 2.5 mg Antihistamine

🧪 Inactive Ingredients 19 words ▾

Inactive ingredients Citric Acid, Glycerin, Grape Flavor, Propylene Glycol, Purified Water, Sodium Bensoate, Soduim Citrate, Sodium Saccharin, Sorbitol Solution.

🎯 Purpose 25 words ▾

Active ingredients (in each 5 mL teaspoonful) Purpose Dextromethorphan HBr 20 mg Cough Suppressant Pseudoephedrine HCI 30 mg Nasal Decongestant Triprolidine HCl 2.5 mg Antihistamine

📄 Do Not Use 57 words ▾

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 giving this product.

📄 Ask a Doctor Before Use If 69 words ▾

Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis heart disease high blood pressure thyroid disease diabetes glaucoma a persistent or chronic cough such occurs with smoking, asthma, chronic bronchitits, or emphysema a cough that occurs with too much phlegm (mucus) trouble urinating due to an enlarged prostate gland Ask a doctor before use if you are taking sedatives or tranquilizers

📄 When Using This Product 35 words ▾

When using this product excitability may occur, especially in children may cause drowsiness alcohol, sedatives and tranquilizers may increase the drowsiness effect avoid alcoholic beverages use caution when driving a motor vehicle or operating machinery

📄 Stop Use and Ask a Doctor If 46 words ▾

Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur cough or nasal congestion persists for more than 1 week, tends to recur or is accompanied by a fever, rash or persistent headache. new symptoms occur 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 22 words ▾

Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

📄 Questions or Comments 15 words ▾

Questions? Comments? Call 1-866-633-9033. Manufactured for: Allegis Pharmaceuticals, Inc. Canton MS 39046 www.allegispharma.com Rev. 01/2025

📄 Package Label / Principal Display Panel 52 words ▾

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label NDC 28595-310-16 Antihistamine - Nasal Decongestant - Cough Suppressant HISTEX™-DM New Formulation Syrup Each teaspoonful (5 mL) contains: Dextromethorphan HBr 20 mg Pseudoephedrine HCI 30mg Triprolidine HCl 2.5 mg Sugar-Free - Dye Free - Alcohol Free Grape Flavor 16 fl oz (473 mL) Label

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

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) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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 Allegis Pharmaceuticals, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Allegis Pharmaceuticals, LLC 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.
← 28595-0299-60 · Allegis 28595-0501-08 · Allegis →
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.