Home › NDC Lookup › Ingredients › Phenylephrine Hcl And Chlorpheniramine M... › 58552-0351-02
Phenagil Phenylephrine HCl and Chlorpheniramine Maleate 10 mg; 3.5 mg Tablet, 2-count — NDC 58552-0351-02 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Phenagil Phenylephrine HCl and Chlorpheniramine Maleate 10 mg; 3.5 mg Tablet, 2-count — NDC 58552-351-02 (Billing 58552-0351-02)

by Gil Pharmaceutical Corp · 2 TABLET in 1 BLISTER PACK

This is a package of 2 tablets of Phenagil Phenylephrine HCl and Chlorpheniramine Maleate 10 mg; 3.5 mg Tablet from Gil Pharmaceutical Corp, marketed since Sep 2026 and currently FDA-listed. It is this product's only package size.

NDC 58552-0351-02
🏷️ FDA NDC (as labeled) 58552-351-02 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 Sep 17, 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) 58552-351-02
Product NDC 58552-351
11-digit billing NDC 58552035102
RxCUI 1367227
UNII 04JA59TNSJ, V1Q0O9OJ9Z
Application # M012
SPL Set ID fa8510d8-d50a-4743-ba87-a12e9ab43125
Established class (EPC) Histamine-1 Receptor Antagonist; alpha-1 Adrenergic Agonist
Mechanism of action Adrenergic alpha1-Agonists; Histamine H1 Receptor Antagonists
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-09-01
Route ORAL
Dosage form TABLET
Substance PHENYLEPHRINE HYDROCHLORIDE; CHLORPHENIRAMINE MALEATE
Quick answers
  • RxCUI (RxNorm): 1367227
Why two NDCs? The FDA registers this code as 58552-351-02 — 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 → 58552-0351-02. 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 Histamine-1 Receptor Antagonist class.

Pharmacologic class Histamine-1 Receptor Antagonist
Drug family (ATC) Substituted alkylamines
How it works Histamine H1 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.

Clinical

🧪 What is this product?

Phenagil is an over-the-counter oral tablet containing phenylephrine hydrochloride and chlorpheniramine maleate. Phenylephrine is a decongestant typically used to relieve nasal congestion, while chlorpheniramine is an antihistamine commonly used to reduce allergy symptoms such as sneezing, itching, and runny nose. This combination product is marketed as an OTC monograph drug, meaning it follows FDA's established guidelines for this category rather than undergoing individual FDA review.

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 eachPer 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
58552-0351-02 You're viewing this Main listing 2 TABLET in 1 BLISTER PACK 2026-09-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Phenagil 10 mg/1; 3.5 mg 58552-0322-01 Gil 100 tablets — — FDA listed —
Phenagil 10 mg/1; 3.5 mgthis 58552-0351-02 Gil 2 tablets — — 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

🏛️
2026
On the market since
Sep 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
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

Color white
ShapeRound
ImprintGIL;322
Size8 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 EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • 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 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.

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

The official label also statesMagnesium Stearate, Microcrystalline Cellulose and Lactose Monohydrate.

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

LabelerGil Pharmaceutical Corp
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code58552
First marketedSep 2026
Product typeHuman Otc Drug
Portfolio31 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 🆘 Overdosage 🧪 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 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Other Information 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 39 words ▾

Uses Temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper-respiratory allergies: • runny nose • sneezing • itchy, watery eyes • nasal congestion • itching of the nose or throat • sinus congestion and pressure

⏱️ Dosage and Administration 62 words ▾

Directions Adults and children 12 years and over: take one tablet every 4 hours. Do not take more than 6 tablets in a 24 hour period. Children 6 to 12 years of age: Take 1/2 tablet every 4 hours. Do not take more than 3 tablets in a 24 hour period. Children under 6 years of age: Do not use this product.

⚠️ Warnings 201 words ▾

Warnings Do not use 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 heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis glaucoma Ask a doctor or pharmacist before you use if you are taking sedatives or tranquilizers When using this product do not exceed recommended dose excitability may occur, especially in children drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occurs symptoms do not improve within 7 days or occur with a fever.

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 (1-800-222-1222).

🆘 Overdosage 16 words ▾

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

🧪 Active Ingredient 15 words ▾

Drug Facts Active Ingredients (in each tablet) Chlorpheniramine Maleate 3.5 mg Phenylephrine HCl 10 mg

🧪 Inactive Ingredients 7 words ▾

Magnesium Stearate, Microcrystalline Cellulose and Lactose Monohydrate.

🎯 Purpose 4 words ▾

Purposes Antihistamine Nasal Decongestant

📄 Do Not Use 55 words ▾

Do not use 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 34 words ▾

Ask a doctor before use if you have heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis glaucoma

📄 Ask a Doctor or Pharmacist Before Use If 15 words ▾

Ask a doctor or pharmacist before you use if you are taking sedatives or tranquilizers

📄 When Using This Product 38 words ▾

When using this product do not exceed recommended dose excitability may occur, especially in children drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery

📄 Stop Use and Ask a Doctor If 24 words ▾

Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occurs symptoms do not improve within 7 days or occur with a fever.

🤰 If Pregnant or Breast-Feeding 11 words ▾

If pregnant or breast-feeding , ask a health professional before use.

📄 Keep Out of Reach of Children 7 words ▾

Keep out of the reach of children.

📄 Other Information 17 words ▾

Other Informaton store at room temperature, USP do not use if safety seal is broken or missing.

📄 Questions or Comments 12 words ▾

Questions? Call 787-848-9114 Manufactured for: GIL PHARMACEUTICAL CORP. Ponce, Puerto Rico 00716

📄 Package Label / Principal Display Panel 42 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 58552-351-01 PHENAGIL ANTIHISTAMINE AND NASAL DECONGESTANT SUGAR FREE AND DYE FREE Each tablet contains: Chlorpheniramine Maleate 3.5 mg Phenylephrine HCI 10 mg 100 Tablets MANUFACTURED FOR GIL PHARMACEUTICAL CORP. PONCE, PUERTO RICO 00716 image description image description

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 Gil Pharmaceutical Corp. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Gil Pharmaceutical Corp 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.
← 58552-0341-07 · Gil 58552-0352-02 · Gil →
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.