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Gilphex Guaifenesin, Phenylephrine HCl 390 mg; 10 mg Tablet, 100-count — NDC 58552-336-01 (Billing 58552-0336-01)

by Gil Pharmaceutical Corp. · 100 TABLET in 1 BOTTLE

This is a package of 100 tablets of Gilphex Guaifenesin, Phenylephrine HCl 390 mg; 10 mg Tablet from Gil Pharmaceutical Corp., marketed since May 2022 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 58552-0336-01
🏷️ FDA NDC (as labeled) 58552-336-01 billing pads the product segment with a zero
This package
Contains100-count Pack sizes2 compare ↓
Main listing for product 58552-336 · Also comes in: 2 tablets 58552-336-02
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 58552-336-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
58552 labeler · 336 product · 01 package
Package marketed since
May 5, 2022
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
100 EA per package
Barcode (UPC-A, from the NDC)
3 5855233601 7
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 58552-336-01
Product NDC 58552-336
11-digit billing NDC 58552033601
NCPDP billing unit EA — each (per item)
RxCUI 2603663
UNII 495W7451VQ, 04JA59TNSJ
Application # M012
SPL Set ID e7c8fb97-02cf-4df6-b477-9ff69d6b675d
Established class (EPC) Expectorant
Physiologic effect Decreased Respiratory Secretion Viscosity; Increased Respiratory Secretions
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-05-05
Route ORAL
Dosage form TABLET
Substance GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE

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

GCN Seq No 083887
GCN 52957
HICL code 000250
Ingredient (HICL) Guaifenesin/Phenylephrine Hcl
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 B4W
Therapeutic class — specific (HIC3) Decongestant-Expectorant Combinations
AHFS code 12:12.04.00
AHFS class Alpha-Adrenergic Agonists (12:12)
FDB label name GILPHEX TR 390 MG-10 MG TABLET
FDB brand name Gilphex Tr
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 083887
  • GCN: 52957
  • HICL (First Databank): 000250
  • AHFS class code: 12:12.04.00
  • RxCUI (RxNorm): 2603663
Why two NDCs? The FDA registers this code as 58552-336-01 — 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 → 58552-0336-01. 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 Expectorant class.

Pharmacologic class Expectorant
Drug family (ATC) Expectorants
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 GILPHEX TR 390 MG-10 MG TABLET Ingredient Guaifenesin/Phenylephrine Hcl
📖 About the active ingredient: Guaifenesin; Phenylephrine Hydrochloride MedlinePlus · NLM
General information about the ingredient itself — the description of this specific product follows below.

Guaifenesin is used to relieve chest congestion. Guaifenesin may help control symptoms but does not treat the cause of symptoms or speed recovery. Guaifenesin is in a class of medications called expectorants. It works by thinning the mucus in the air passages to make it easier to cough up the mucus and clear the airways.

Read the full MedlinePlus article ↗
🧪 What is this product?

Gilphex is an over-the-counter tablet taken by mouth. It contains guaifenesin, an expectorant typically used to help thin mucus and make coughs more productive, and phenylephrine hydrochloride, a decongestant commonly used to help relieve nasal and sinus congestion. This product is marketed under the FDA's over-the-counter monograph rules for cough and cold medicines.

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.
Try another pack size: 2 tablets
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
58552-0336-01 You're viewing this Main listing 100 TABLET in 1 BOTTLE 2022-05-05 — Active
58552-0336-02 58552-336-02 2 TABLET in 1 BLISTER PACK Sample 2022-05-05 — Active

You're viewing the largest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This is a 100-count package — 100 tablet in 1 bottle.
How does this package differ from NDC 58552-0336-02?
Both are Gilphex Guaifenesin, Phenylephrine HCl 390 mg; 10 mg Tablet — the drug itself is identical. This page's package is the 100-count one, while NDC 58552-0336-02 is the 2 tablets package.
What NDC number is used to bill for this package of Gilphex Guaifenesin, Phenylephrine HCl 390 mg; 10 mg Tablet?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Gilphex 390 mg/1; 10 mgthis 58552-0336-01 Gil 100 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

🏛️
2022
On the market since
May 2022
📍
2026
Currently FDA-listed
4 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

Color white
ShapeCapsule
Imprint304;Gil
Size8 mm
ScoringNot scored
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

LabelerGil Pharmaceutical Corp.
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code58552
First marketedMay 2022
Product typeHuman Otc Drug
Portfolio2 products on file

More NDCs from Gil Pharmaceutical Corp. labeler code 58552

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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Ask a Doctor Before Use If 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Other Information 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 43 words ▾

Uses Temporarily relieves the symptoms associated with a cough, the common cold, hay fever, or other upper respiratory allergies. Helps loosen phlegm (mucus), loosens nasal congestion, thin bronchial secretions, drain bronchial tubes, make coughs more productive,clear stuffy nose,clear nasal passageways, shrinks swollen membranes.

⏱️ Dosage and Administration 58 words ▾

Directions Do not exceed recommended doses in a 24 hour period Adults and Children 12 years and over: 1 tablet every 4 hours. Do not exceed 6 tablets in 24 hours. Children 6 to 12 years: 1/2 tablet every 4 hours. Do not exceed 3 tablets in 24 hours. Children under 6 years of age: ask a doctor.

⚠️ Warnings 58 words ▾

Warnings Do not use this product more than the recommended dosage, or 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 are uncertain whether your prescription drug contains an MAOI, ask a health professional.

🧪 Active Ingredient 14 words ▾

Drug Facts Active Ingredients (in each tablet) Guaifenesin 390 mg Phenylephrine HCl 10 mg

🧪 Inactive Ingredients 16 words ▾

Inactive Ingredients Hydroxypropyl Methylcellulose, Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, Polyethylene Glycol, Povidone, Silicone Dioxide, Stearic Acid.

🎯 Purpose 4 words ▾

Purposes Expectorant Nasal Decongestant

📄 Ask a Doctor Before Use If 43 words ▾

Ask a doctor before use if you have heart disease. excessive phlegm (mucus). high blood pressure. diabetes. thyroid disease. difficulty in urination due to enlargement of the prostate gland. persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema.

📄 Stop Use and Ask a Doctor If 45 words ▾

Stop use and ask a doctor If nervousness, dizziness, or sleeplessness occurs. symptoms are accompanied by fever, rash, persistent headache, or excessive phlegm (mucus). cough and congestion do not improve within 7 days or tend to recur. These could be signs of a serious condition.

📄 Keep Out of Reach of Children 32 words ▾

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

📄 Other Information 20 words ▾

Other Information store at room temperature, USP. do not use if imprinted safety seal under cap is broken or missing.

📄 Questions or Comments 15 words ▾

Questions? Call 787-848-9114 Manufactured for: GIL PHARMACEUTICAL CORP. Ponce, Puerto Rico 00716 Revised Label: 03/22

📄 Package Label / Principal Display Panel 16 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Gilphex ® Total Release - NDC-58552-336-01 - 100's Bottle Label 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 — Not published for this NDC No photo available yet for this listing.
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) — 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.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 2 tablets (58552-0336-02). 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?
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.
← 58552-0335-01 · Gil 58552-0337-01 · 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.