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HISTEX PD Drops New Formulation TRIPROLIDINE HYDROCHLORIDE 1.25 mg/mL Syrup — NDC 28595-0809-30 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

HISTEX PD Drops New Formulation TRIPROLIDINE HYDROCHLORIDE 1.25 mg/mL Syrup — NDC 28595-809-30 (Billing 28595-0809-30)

by Allegis Pharmaceuticals, LLC · 1 BOTTLE in 1 CARTON / 30 mL in 1 BOTTLE

This is a package of HISTEX PD Drops New Formulation TRIPROLIDINE HYDROCHLORIDE 1.25 mg/mL Syrup from Allegis Pharmaceuticals, LLC, marketed since Dec 2023 and currently FDA-listed. It is this product's only package size.

NDC 28595-0809-30
🏷️ FDA NDC (as labeled) 28595-809-30 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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 28595-809-30
Product NDC 28595-809
11-digit billing NDC 28595080930
NCPDP billing unit ML — per mL (volume)
RxCUI 1926926
UNII YAN7R5L890
Application # M012
SPL Set ID 0c693f15-5d76-3dbf-e063-6294a90af9ac
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-12-13
Route ORAL
Dosage form SYRUP
Substance TRIPROLIDINE HYDROCHLORIDE

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

GPI-14 41100040100950
GCN Seq No 077542
GCN 43586
HICL code 004508
Ingredient (HICL) Triprolidine Hcl
HIC1 code Z
Therapeutic class — broad (HIC1) Body As A Whole
HIC2 code Z2
Therapeutic class — intermediate (HIC2) Antihistamines, Antiserotonins, Immunosuppressants
HIC3 code Z2P
Therapeutic class — specific (HIC3) Antihistamines - 1St Generation
AHFS code 04:04.00.00
AHFS class First Generation Antihistamines
FDB label name HISTEX PD 1.25 MG/ML DROP
FDB brand name Histex Pd
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 077542
  • GCN: 43586
  • GPI-14 (Medi-Span): 41100040100950
  • HICL (First Databank): 004508
  • AHFS class code: 04:04.00.00
  • RxCUI (RxNorm): 1926926
Why two NDCs? The FDA registers this code as 28595-809-30 — 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 → 28595-0809-30. 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 PD 1.25 MG/ML DROP Ingredient Triprolidine Hcl
📗 Our plain-language guide HelloPharmacist
  • Triprolidine helps relieve the common, uncomfortable symptoms of hay fever and other upper respiratory allergies — things like a runny nose, sneezing, itchy or watery eyes, and itc...
  • Yes, drowsiness is a real possibility with triprolidine, and it's something to take seriously. Avoid driving, operating machinery, or doing anything that needs sharp focus until yo...
  • For children under 6 years old, you should check with a doctor before giving any triprolidine product. The labels for these products don't include dosing for that age group without...
  • Yes — if you have emphysema, chronic bronchitis, glaucoma, or trouble urinating due to an enlarged prostate, you should not take triprolidine without talking to a doctor first. The...
📖 Read our full Triprolidine guide →

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 $0.5199 $15.60 / 30 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
28595-0809-30 You're viewing this Main listing 1 BOTTLE in 1 CARTON / 30 mL in 1 BOTTLE 2023-12-13 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
HISTEX PD Drops New Formulation 1.25 mg/mLthis 28595-0809-30 Allegis 1 bottle — — FDA listed —
Triprolidine Hydrochloride 1.25 mg/mL 69367-0450-30 Westminster 1 bottle — — 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
Dec 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.

What it looks like

FlavorBubble Gum
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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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 marketedDec 2023
Product typeHuman Otc Drug
Portfolio10 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.

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 📄 Ask a Doctor or Pharmacist Before Use If 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 28 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

⏱️ Dosage and Administration 98 words ▾

Directions Do not exceed recommended dosage. use only the enclosed dropper. do not use enclosed dropper for any other drug products. AGE DOSE Adutls & Children 12 years of age or older: 2 mL (2.5 mg) every 4 to 6 hours, not to exceed 8 mL (10 mg) in 24 hours or as directed by a doctor. Children 6 to under12 years of age: 1 mL (1.25 mg) every 4 to 6 hours, not to exceed 4 mL (5 mg) in 24 hours or as directed by a doctor.

Children under 6 years of age: Consult a docotor.

⚠️ Warnings 91 words ▾

Warnings Do not exceed recommended dosage. Ask a doctor before use if the child has a breathing problem such as emphysema or chronic bronchitis glaucoma Ask a doctor before use if the child is taking sedatives or tranquilizers When using this product excitability may occur, especially in children may cause drowsiness sedatives and tranquilizers may increase the drowsiness effect Stop use and ask a doctor if new symptoms occur 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 11 words ▾

Active ingredient (in each 1 mL dropperful) Triprolidine HCl 1.25 mg

🧪 Inactive Ingredients 19 words ▾

Inactive ingredients bubble gum flavor, citric acid, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose.

🎯 Purpose 2 words ▾

Purpose Antihistamine

📄 Do Not Use 5 words ▾

Do not exceed recommended dosage.

📄 Ask a Doctor Before Use If 19 words ▾

Ask a doctor before use if the child has a breathing problem such as emphysema or chronic bronchitis glaucoma

📄 Ask a Doctor or Pharmacist Before Use If 13 words ▾

Ask a doctor before use if the child is taking sedatives or tranquilizers

📄 When Using This Product 21 words ▾

When using this product excitability may occur, especially in children may cause drowsiness sedatives and tranquilizers may increase the drowsiness effect

📄 Stop Use and Ask a Doctor If 10 words ▾

Stop use and ask a doctor if new symptoms occur

📄 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 4 words ▾

Questions? Comments? Call 1-866-633-9033.

📄 Package Label / Principal Display Panel 41 words ▾

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton NDC 28595-809-30 HISTEX™ PD New Formulation Drops Antihistamine Each dropperful (1 mL) contains: Triprolidine HCl 1.25 mg Sugar-Free • Dye Free Alcohol Free Bubble Gum Flavor 1 fl oz (30 mL) Bottle Label

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

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 this package alone, 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
170.1K
Units reimbursed last 4 qtrs
5.4M
Gross reimbursed last 4 qtrs
$2.79M
Avg / prescription
$16.40
Avg / unit
$0.5199
Latest quarter Q1 2026
45.8KRx
Fee-for-service vs managed care ⓘ
99% MCO
Fee-for-service · 1,036 Rx Managed care · 169,041 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: no data reported CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 5,364,328 units · 17,586 per 100k residents TX Florida: no data reported FL
Units reimbursed · per 100k residents
17,58617,586
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 17,586 /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.

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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 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.
← 28595-0804-16 · Allegis 28663-0009-10 · McNeil →
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.