Poly Hist Forte Doxylamine Succinate and Phenylephrine Hydrochloride 10.5 mg; 10 mg Tablet, 100-count
by Poly Pharmaceuticals, Inc. · 100 TABLET in 1 BOTTLE (50991-626-01)
NDC 50991-0626-01
🏷️ FDA NDC (as labeled)
50991-626-01
billing pads the product segment with a zero
This package
Also priced by: Medicaid pays $0.7035/unit — full pricing hub ↓
Also comes in:
12 tablets 50991-0626-02
OTC
On market
Non-controlled
🗂️ Data synced Jul 24, 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)
50991-626-01
Product NDC
50991-626
11-digit billing NDC
50991062601
NCPDP billing unit
EA — each (per item)
RxCUI
2172491
UNII
V9BI9B5YI2, 04JA59TNSJ
Application #
M012
SPL Set ID
8aa0015b-8fc1-7951-e053-2a95a90a8e72
Established class (EPC)
Antihistamine; alpha-1 Adrenergic Agonist
Mechanism of action
Adrenergic alpha1-Agonists; Histamine Receptor Antagonists
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2019-06-01
Route
ORAL
Dosage form
TABLET
Substance
DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE
GPI-14
43993002930325
GPI class
Poly Hist Forte
GCN Seq No
079894
GCN
46499
HICL code
040737
Ingredient (HICL)
Doxylamine/Phenylephrine Hcl
HIC1 code
Z
Therapeutic class — broad (HIC1)
Body As A Whole
HIC2 code
Z2
Therapeutic class — intermediate (HIC2)
Antihistamines, Antiserotonins, Immunosuppressants
HIC3 code
Z2N
Therapeutic class — specific (HIC3)
1St Gen Antihistamine And Decongestant Combination
AHFS code
04:04.04.00
AHFS class
Ethanolamine Derivatives
FDB label name
POLY HIST FORTE 10.5-10 MG TAB
FDB brand name
Poly Hist Forte
Legend status
O — Over-the-counter (OTC) drug or device
Why two NDCs?
The FDA registers this code as 50991-626-01 — 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 → 50991-0626-01. 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 Antihistamine class.
Pharmacologic class
Antihistamine
Drug family (ATC)
Aminoalkyl ethers
How it works
Histamine Receptor Antagonists
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 2019
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 POLY HIST FORTE 10.5-10 MG TAB Ingredient Doxylamine/Phenylephrine Hcl
📖 About the active ingredient MedlinePlus · NLM
General information about the ingredient itself — the description of this specific product follows below.
Doxylamine is used to treat insomnia (difficulty falling asleep or staying asleep). Doxylamine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms. Doxylamine is also used in combination with acetaminophen, dextromethorphan, decongestants and other medications to manage cold and flu symptoms. This monograph only includes information about the use of doxylamine alone. If you are taking the doxylamine combination products, read the information on the package label or ask your doctor or pharmacis...
Read the full MedlinePlus article ↗🧪 What is this product?
Poly Hist Forte is an over-the-counter oral tablet marketed under FDA's OTC monograph rules. It contains doxylamine succinate, a sedating antihistamine typically used to relieve allergy symptoms and sneezing, and phenylephrine hydrochloride, a decongestant commonly used to reduce nasal congestion. This combination is intended for people seeking temporary relief from cold and allergy symptoms.
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 Doxylamine Succinate and Phenylephrine Hydrochloride?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
Color
blue
ShapeCapsule
ImprintPoly;216
Size14 mm
ScoringScored — splits in 2
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 OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
-
UNII L06K8R7DQK
A synthetic blue dye approved by the FDA for use in medications and foods. It serves as a colorant to make pills and liquids visually distinct and easier to identify.
-
UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
-
UNII 5856J3G2A2
A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.
4 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesFD&C Blue # 2, magnesium stearate, microcrystalline cellulose, sodium starch glycolate.
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 ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.664 | $66.37 / 100 tablets |
| Medicaid paysCMS SDUD · 12 mo | $0.7035 | $70.35 / 100 tablets |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
NADAC price history (per ea) — tap or hover for the price & month
Flat over the last 9 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 |
|---|---|---|---|---|---|---|
| Poly Hist Forte 10.5 mg/1; 10 mgthis 50991-0626-01 | Poly | 100 tablets | $0.664 | — | 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
🏛️
2019
On the market since
Jun 2019
📍
2026
Currently FDA-listed
7 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 50991-0626-01, 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
262
Units reimbursed last 4 qtrs
7.9K
Gross reimbursed last 4 qtrs
$5.6K
Avg / prescription
$21.24
Avg / unit
$0.7035
Latest quarter Q4 2025
60Rx
Medicaid pays / ea
$0.7035
gross reimbursed
vs
NADAC / ea
$0.6637
acquisition cost
=
Spread
+$0.0398
+6% vs cost
What Medicaid paid per ea (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 · 262 Rx
State Medicaid map
Units reimbursed · per 100k residents
25.925.9
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): 262 Rx · 7,912 units · $5,566 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 Poly Hist Forte (this brand).
Top reported reactions
Age at onset
Reporter sex
Male · 6%
Female · 94%
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 |
|---|---|---|---|---|---|
| 50991-0626-01 You're viewing this | 100 TABLET in 1 BOTTLE (50991-626-01) | $0.6637 / ea | $66.37 | 2019-06-01 | Active |
| 50991-0626-02 | 12 BLISTER PACK in 1 CARTON (50991-626-02) / 1 TABLET in 1 BLISTER PACK | — | — | 2019-06-01 | Active |
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 50991-0626-01?
NDC 50991-0626-01 is a 100-count package — 100 tablet in 1 bottle.
What is the difference between NDC 50991-0626-01 and NDC 50991-0626-02?
Both are Poly Hist Forte Doxylamine Succinate and Phenylephrine Hydrochloride 10.5 mg; 10 mg Tablet — the drug itself is identical. NDC 50991-0626-01 is the 100-count package, while NDC 50991-0626-02 is the 12 tablets package.
What NDC number is used to bill for this package of Poly Hist Forte Doxylamine Succinate and Phenylephrine Hydrochloride 10.5 mg; 10 mg Tablet?
Bill NDC 50991-0626-01 — the 11-digit billing format is 50991062601. 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: nasal congestion reduces swelling of nasal passages runny nose sneezing itching of nose or throat itchy, watery eyes
⏱️ Dosage and Administration ▾
Directions Do not exceed recommended dosage. Adults and children 12 years of age and over 1 tablet every 4 hours, not to exceed 6 tablets in 24 hours. Children 6 to 12 years of age: 1/2 tablet every 4 hours, not to exceed 3 tablets in 24 hours. Children 6 years of age and younger: Consult a physician.
⚠️ Warnings ▾
Warnings
🧪 Active Ingredient ▾
Active ingredients (in each tablet) Doxylamine Succinate 10.5mg
Active ingredients (in each tablet) Phenylephrine HCl 10 mg
🧪 Inactive Ingredients ▾
Inactive ingredients FD&C Blue # 2, magnesium stearate, microcrystalline cellulose, sodium starch glycolate.
🎯 Purpose ▾
Purpose Antihistamine
Purpose 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.