Home › NDC Lookup › Ingredients › Chlorpheniramine Maleate, Dextromethorph... › 58552-0139-04
Giltuss Childrens Allergy Plus Cough and Congestion CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE 2 mg/5mL; 10 mg/5mL; 5 mg/5mL Solution — NDC 58552-0139-04 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Giltuss Childrens Allergy Plus Cough and Congestion CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE 2 mg/5mL; 10 mg/5mL; 5 mg/5mL Solution — NDC 58552-139-04 (Billing 58552-0139-04)

by Gil Pharmaceutical Corp · 1 BOTTLE in 1 CARTON / 118 mL in 1 BOTTLE

This is a package of Giltuss Childrens Allergy Plus Cough and Congestion CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE 2 mg/5mL; 10 mg/5mL; 5 mg/5mL Solution from Gil Pharmaceutical Corp, marketed since Nov 2018 and currently FDA-listed. It is this product's only package size.

NDC 58552-0139-04
🏷️ FDA NDC (as labeled) 58552-139-04 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 Oct 1, 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 58552-139-04 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
58552 labeler · 139 product · 04 package
Package marketed since
Nov 7, 2018
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 5855213904 5
FDA record last changed
Oct 1, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 58552-139-04
Product NDC 58552-139
11-digit billing NDC 58552013904
NCPDP billing unit ML — per mL (volume)
RxCUI 1363752
UNII V1Q0O9OJ9Z, 9D2RTI9KYH, 04JA59TNSJ
Application # M012
SPL Set ID 852c5a57-7ee4-3c5c-e053-2a91aa0a1433
Established class (EPC) Histamine-1 Receptor Antagonist; Sigma-1 Agonist; Uncompetitive N-methyl-D-aspartate Receptor Antagonist; Uncompetitive NMDA Rece
Mechanism of action Adrenergic alpha1-Agonists; Histamine H1 Receptor Antagonists; Sigma-1 Receptor Agonists
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2018-11-07
Route ORAL
Dosage form SOLUTION
Substance CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE

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

GPI-14 43995803120905
GPI class Giltuss Allergy Cgh&Cong Child
GCN Seq No 047004
GCN 85914
HICL code 000375
Ingredient (HICL) Chlorpheniramine/Phenyleph/Dm
HIC1 code B
Therapeutic class — broad (HIC1) Respiratory System
HIC2 code B3
Therapeutic class — intermediate (HIC2) Drugs Affecting Primarily The Trachea And Bronchi
HIC3 code B3R
Therapeutic class — specific (HIC3) Non-Opioid Antitus-1St Gen.antihistamine-Decongest
AHFS code 04:04.00.00
AHFS class First Generation Antihistamines
FDB label name CHILD GILTUSS ALLERGY PLUS LIQ
FDB brand name Child Giltuss Allergy Plus
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 047004
  • GCN: 85914
  • GPI-14 (Medi-Span): 43995803120905
  • HICL (First Databank): 000375
  • AHFS class code: 04:04.00.00
  • RxCUI (RxNorm): 1363752
Why two NDCs? The FDA registers this code as 58552-139-04 — 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 → 58552-0139-04. 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

Label name CHILD GILTUSS ALLERGY PLUS LIQ Ingredient Chlorpheniramine/Phenyleph/Dm
📖 About the active ingredient MedlinePlus · NLM
General information about the ingredient itself — the description of this specific product follows below.

Chlorpheniramine is used to treat allergy symptoms: sneezing runny nose itchy nose or throat red, itchy, watery eyes Chlorpheniramine 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.

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

This is an over-the-counter oral liquid solution containing three active ingredients commonly combined in children's allergy and cold products. Chlorpheniramine maleate is an antihistamine typically used to reduce allergy symptoms such as sneezing and itching. Dextromethorphan hydrobromide is a cough suppressant, while phenylephrine hydrochloride is a nasal decongestant commonly used to help relieve stuffiness. As an OTC monograph drug, this product is marketed under established FDA guidelines for its category rather than through individual product approval.

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 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
58552-0139-04 You're viewing this Main listing 1 BOTTLE in 1 CARTON / 118 mL in 1 BOTTLE 2018-11-07 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Bio-Rytuss 2 mg/5mL; 10 mg/5mL; 5 mg/5mL 45737-0250-16 Advanced 473 ml — — FDA listed —
Gencontuss 2 mg/5mL; 10 mg/5mL; 5 mg/5mL 52083-0650-16 KRAMER 473 ml — — FDA listed —
Dometuss 2 mg/5mL; 10 mg/5mL; 5 mg/5mL 53809-0222-04 Domel 118 ml — — FDA listed —
Giltuss Allergy Plus Cough and Congestion 4 mg/10mL; 20 mg/10mL; 10 mg/10mL 58552-0138-04 Gil 1 bottle — — FDA listed —
Giltuss Childrens Allergy Plus Cough and Congestion 2 mg/5mL; 10 mg/5mL; 5 mg/5mLthis 58552-0139-04 Gil 1 bottle — — FDA listed —
Dometuss 2 mg/5mL; 5 mg/5mL; 10 mg/5mL 65852-0002-04 Dextrum 118 ml — — FDA listed —
Giltuss Allergy Plus 20 mg/10mL; 10 mg/10mL; 4 mg/10mL 65852-0017-04 Dextrum 1 bottle — — FDA listed —
Giltuss Childrens Allergy Plus 5 mg/5mL; 2 mg/5mL; 10 mg/5mL 65852-0018-04 Dextrum 1 bottle — — FDA listed —
Rycontuss 5 mg/5mL; 2 mg/5mL; 10 mg/5mL 65852-0021-16 Dextrum 473 ml — — FDA listed —
Rycontuss Cherry Flavor 2 mg/5mL; 10 mg/5mL; 5 mg/5mL 76117-0001-16 Okendpharma, 473 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

🏛️
2018
On the market since
Nov 2018
📍
2026
Currently FDA-listed
8 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 yellow
FlavorTutti Frutti
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 XF417D3PSL
    Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
  • 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 A2I8C7HI9T
    Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
  • UNII Z8IX2SC1OH
    Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
  • UNII 96K6UQ3ZD4
    Sucralose is a synthetic sweetener made from sugar. It's added to medicines to improve taste without adding calories, helping make bitter or unpleasant-tasting drugs easier to take.
  • 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.

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

The official label also statesInactive ingredients citric acid, flavor, glycerin, methylparaben, propylparaben, purified water and sucralose

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 marketedNov 2018
Product typeHuman Otc Drug
Portfolio31 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 📦 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 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 61 words ▾

Uses temporarily relieves cough due to minor throat and bronchial irritation associated with a cold or inhaled irritants nasal congestion due to the common cold, hay fever or other upper respiratory allergies temporarily relieves these symptoms due to hay fever (allergic rhinitis): runny nose sneezing itchy, watery eyes itching of the nose or throat temporarily restores freer breathing through the nose

⏱️ Dosage and Administration 58 words ▾

Directions not take more than 6 doses in any 24-hour period use enclosed dosing cup keep dosage cup for use with this product mL=milliter children under 6 years Consult a Doctor children 6 to under 12 years 5 mL every 4 to 6 hours adults and children 12 years and over 10 mL every 4 to 6 hours

⚠️ Warnings ~1 min read ▾

Warnings Do not use to sedate a child or to make a child sleepy in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if the child has heart disease high blood pressure thyroid disease diabetes glaucoma cough that occurs with too much phlegm (mucus) a breathing problem or persistent or chronic cough that lasts such as occurs with asthma Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers taking any other oral nasal decongestant or stimulant When using this product do not use more than directed may cause marked drowsiness excitability may occur, especially in children Stop use and ask a doctor if nervousness, dizzyness, or sleepless occurs symptoms do not get better within 7 days or are accompanied by a fever cough lasts more than 7 days, comes back, or is accompanied by fever, rash or persistent headache.

These could be signs of a serious condition. If pregnant or breastfeeding, ask a health professional before use. Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

📦 Storage and Handling 21 words ▾

Other information store at room temperature 15° - 30°C (59° - 86°F) close cap tightly SAVE CARTON FOR COMPLETE DRUG FACTS

🧪 Active Ingredient 21 words ▾

Active ingredients (in each 5 mL) Chlorpheniramine maleate USP, 2 mg Dextromethorphan HBr USP, 10 mg Phenylephrine HCl USP, 5 mg

🧪 Inactive Ingredients 12 words ▾

Inactive ingredients citric acid, flavor, glycerin, methylparaben, propylparaben, purified water and sucralose

🎯 Purpose 6 words ▾

Purposes Antihistamine Cough Suppressant Nasal decongestant

📄 Do Not Use 67 words ▾

Do not use to sedate a child or to make a child sleepy in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

📄 Ask a Doctor Before Use If 41 words ▾

Ask a doctor before use if the child has heart disease high blood pressure thyroid disease diabetes glaucoma cough that occurs with too much phlegm (mucus) a breathing problem or persistent or chronic cough that lasts such as occurs with asthma

📄 Ask a Doctor or Pharmacist Before Use If 23 words ▾

Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers taking any other oral nasal decongestant or stimulant

📄 When Using This Product 20 words ▾

When using this product do not use more than directed may cause marked drowsiness excitability may occur, especially in children

📄 Stop Use and Ask a Doctor If 51 words ▾

Stop use and ask a doctor if nervousness, dizzyness, or sleepless occurs symptoms do not get better within 7 days or are accompanied by a fever cough lasts more than 7 days, comes back, or is accompanied by fever, rash or persistent headache. These could be signs of a serious condition.

🤰 If Pregnant or Breast-Feeding 10 words ▾

If pregnant or breastfeeding, ask a health professional before use.

📄 Keep Out of Reach of Children 21 words ▾

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

📄 Questions or Comments 21 words ▾

Questions or comments? Call 1-787-848-9114 , Monday-Friday 9AM-5PM EST. Call your doctor for medical advice in the event of side effects.

📄 Package Label / Principal Display Panel 45 words ▾

Children's Giltuss® ALLERGY PLUS COUGH & CONGESTION ANTIHISTAMINIC, ANTITUSSIVE, & NASAL DECONGESTANT Alcohol Free. Sodium Free. Sugar Free. Dye Free. SNEEZING RUNNY NOSE COUGH ITCHY & WATERY EYES STUFFY NOSE SINUS PRESSURE TUTTI FRUTTI FLAVOR 4 FL OZ (118 mL) 58552-139 Child Allergy Cough Congestion

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

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 CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE — the ingredient across all brands.

Top reported reactions

Hypoxia2
Organising Pneumonia2
Pneumonia Influenzal2

Reporter sex

0 reports

Serious outcomes

Hospitalization2
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.

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.
← 58552-0138-04 · Gil 58552-0140-04 · 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.