Endal Triprolidine HCl, Dextromethorphan HBr 1.25 mg/5mL; 10 mg/5mL Liquid, 5 mL
by Poly Pharmaceuticals, Inc. · 5 mL in 1 BOTTLE (50991-136-05)
NDC 50991-0136-05
🏷️ FDA NDC (as labeled)
50991-136-05
billing pads the product segment with a zero
This package
Contains5 mL
Pack sizes3 compare ↓
OTC
On market
Non-controlled
🗂️ Data synced Aug 27, 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)
50991-136-05
Product NDC
50991-136
11-digit billing NDC
50991013605
RxCUI
2637485
UNII
YAN7R5L890, 9D2RTI9KYH
UPC
0350991136166
Application #
M012
SPL Set ID
fc5401e2-ed65-72e7-e053-6294a90a81f3
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
2023-05-22
Route
ORAL
Dosage form
LIQUID
Substance
TRIPROLIDINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
GPI-14
43995702600925
GCN Seq No
042840
GCN
92562
HICL code
007899
Ingredient (HICL)
Dextromethorphan/Triprolidine
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
04:04.20.00
AHFS class
Propylamine Derivatives
FDB label name
ENDAL 1.25-10 MG/5 ML LIQUID
FDB brand name
Endal
Legend status
O — Over-the-counter (OTC) drug or device
Why two NDCs?
The FDA registers this code as 50991-136-05 — 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 → 50991-0136-05. 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.
🏭 Manufacturer & labeler
LabelerPoly Pharmaceuticals, Inc.
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code50991
First marketedMay 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 ENDAL 1.25-10 MG/5 ML LIQUID Ingredient Dextromethorphan/Triprolidine
🧪 What is this product?
Endal is an over-the-counter liquid medicine taken by mouth that combines two active ingredients. Dextromethorphan is commonly used to help suppress cough, while triprolidine is an antihistamine typically used to relieve allergy and cold symptoms such as sneezing, itching, and runny nose. This product is marketed under FDA's over-the-counter monograph rules for cough and cold medicines.
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 Triprolidine HCl, Dextromethorphan HBr?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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 DSO12WL7AU
A salt derived from citric acid, this ingredient acts as a buffer and pH regulator in medicines. It helps maintain stable acidity levels and may improve taste or aid preservation.
-
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 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.
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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 8KW3E207O2
A liquid sweetener made from sorbitol, a sugar alcohol derived from glucose. It sweetens the medicine and also acts as a humectant to help retain moisture and improve texture in liquid formulations.
-
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, glycerin, grape flavor, propylene glycol, purified water, sodium benzoate, sodium 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.
💲 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 | 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
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 |
|---|---|---|---|---|---|---|
| Endal 1.25 mg/5mL; 10 mg/5mLthis 50991-0136-05 | Poly | 5 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
May 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 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): 27 Rx · 3,481 units · $223 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 Endal (this brand).
Top reported reactions
Age at onset
Reporter sex
Male · 17%
Female · 83%
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 | Marketing start | Status |
|---|---|---|---|
| 50991-0136-15 | 15 mL in 1 BOTTLE (50991-136-15) | 2023-05-22 | Active |
| 50991-0136-16 | 473 mL in 1 BOTTLE (50991-136-16) | 2023-05-22 | Active |
| 50991-0136-05 You're viewing this | 5 mL in 1 BOTTLE (50991-136-05) | 2025-10-29 | Active |
You're viewing the smallest of 3 pack sizes for this product.
Pack size FAQ
What quantity is in NDC 50991-0136-05?
NDC 50991-0136-05 contains 5 mL — 5 ml in 1 bottle.
What is the difference between NDC 50991-0136-05 and NDC 50991-0136-15?
Both are Endal Triprolidine HCl, Dextromethorphan HBr 1.25 mg/5mL; 10 mg/5mL Liquid — the drug itself is identical. NDC 50991-0136-05 is the 5 mL package, while NDC 50991-0136-15 is the 15 ml package.
What NDC number is used to bill for this package of Endal Triprolidine HCl, Dextromethorphan HBr 1.25 mg/5mL; 10 mg/5mL Liquid?
Bill NDC 50991-0136-05 — the 11-digit billing format is 50991013605. 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) | — 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 FDA registers it as 50991-136-05, 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: 50991-0136-05, written without dashes as 50991013605. 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 50991-0136-05, the first segment (50991) is the labeler code FDA assigned to Poly Pharmaceuticals, Inc.; the middle segment (0136) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (05) 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 2 other package presentations of this same product, including 15 ml (50991-0136-15), 473 ml (50991-0136-16). 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
📦 Storage and Handling
🧪 Active Ingredient
🧪 Inactive Ingredients
🎯 Purpose
🎯 Indications and Usage ▾
Uses Uses temporarily relieves these symptoms due to the common cold, 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
⏱️ Dosage and Administration ▾
Directions AGE DOSE Adults and children over 12 years of age 2 teaspoonfuls (10 mL) every 4 to 6 hours, over 12 years not to exceed 8 teaspoonfuls in of age: 24 hours, or as directed by a doctor. Children 6 to under 12 years of age 1 teaspoonful (5 mL) every 4 to 6 hours, 12 years of age: not to exceed 4 teaspoonfuls in 24 hours, or as directed by a doctor. 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.
Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis glaucoma difficulty in urination due to the enlargement of the 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 a chronic pulmonary disease or shortness of breath, or children who are taking other drugs 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 may cause or aggravate constipation alcohol, sedatives, and tranquilizers may increase drowsiness effect 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. These could be signs of a serious new symptoms occur 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 ▾
Other Information Store at 59° - 86°F (15° - 30°C)
🧪 Active Ingredient ▾
Active Ingredient Triprolidine HCl, Dextromethorphan HBr
🧪 Inactive Ingredients ▾
Inactive Ingredients Citric acid, glycerin, grape flavor, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin, sorbitol solution.
🎯 Purpose ▾
Purpose Antihistimine, Antitussive
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.