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Giltuss Honey DM Cough Dextromethorphan HBr 30 mg/10mL Solution — NDC 58552-0143-04 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Giltuss Honey DM Cough Dextromethorphan HBr 30 mg/10mL Solution — NDC 58552-143-04 (Billing 58552-0143-04)

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

This is a package of Giltuss Honey DM Cough Dextromethorphan HBr 30 mg/10mL Solution from Gil Pharmaceutical Corp, marketed since Jun 2020 and currently FDA-listed. It is this product's only package size.

NDC 58552-0143-04
🏷️ FDA NDC (as labeled) 58552-143-04 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 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 58552-143-04 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
58552 labeler · 143 product · 04 package
Package marketed since
Jun 22, 2020
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 5855214304 2
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 58552-143-04
Product NDC 58552-143
11-digit billing NDC 58552014304
NCPDP billing unit ML — per mL (volume)
RxCUI 1090496
UNII 9D2RTI9KYH
Application # M012
SPL Set ID a8c08532-1169-6603-e053-2a95a90a3484
Established class (EPC) Sigma-1 Agonist; Uncompetitive N-methyl-D-aspartate Receptor Antagonist
Mechanism of action Sigma-1 Receptor Agonists; Uncompetitive NMDA Receptor Antagonists
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2020-06-22
Route ORAL
Dosage form SOLUTION
Substance DEXTROMETHORPHAN HYDROBROMIDE

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

GPI-14 43102030500940
GPI class Giltuss Honey DM
GCN Seq No 016524
GCN 17748
HICL code 001925
Ingredient (HICL) Dextromethorphan Hbr
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H6
Therapeutic class — intermediate (HIC2) Drugs Acting Principally On The Midbrain
HIC3 code H6C
Therapeutic class — specific (HIC3) Antitussives, Non-Opioid
AHFS code 48:08.00.00
AHFS class Antitussives
FDB label name GILTUSS HONEY DM 30 MG/10 ML
FDB brand name Giltuss Honey Dm Cough
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 016524
  • GCN: 17748
  • GPI-14 (Medi-Span): 43102030500940
  • HICL (First Databank): 001925
  • AHFS class code: 48:08.00.00
  • RxCUI (RxNorm): 1090496
Why two NDCs? The FDA registers this code as 58552-143-04 — 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 → 58552-0143-04. 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 Uncompetitive N-methyl-D-aspartate Receptor Antagonist class.

Pharmacologic class Uncompetitive N-methyl-D-aspartate Receptor Antagonist, Sigma-1 Agonist
Drug family (ATC) Other antidepressants, Opium alkaloids and derivatives
How it works Uncompetitive NMDA Receptor Antagonists, Sigma-1 Receptor Agonists
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 GILTUSS HONEY DM 30 MG/10 ML Ingredient Dextromethorphan Hbr
📖 What it is MedlinePlus · NLM

Dextromethorphan is used to temporarily relieve cough caused by the common cold, the flu, or other conditions. Dextromethorphan will relieve a cough but will not treat the cause of the cough or speed recovery. Dextromethorphan is in a class of medications called antitussives. It works by decreasing activity in the part of the brain that causes coughing.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It's a cough suppressant. It temporarily relieves cough from minor throat and bronchial irritation, like with a cold or inhaled irritants. Some products also help you sleep by calm...
  • It depends on the product. Extended-release suspensions like Delsym are labeled for every 12 hours, while Giltuss Honey DM Cough is every 6 to 8 hours with a 4-dose daily limit. Ch...
  • Be careful. Don't use it if you take a prescription MAOI, or within 2 weeks of stopping one. If you're not sure whether your medicine is an MAOI, ask me or your doctor before takin...
  • Nighttime products can cause marked drowsiness, and children may become excitable. Avoid alcohol and be careful driving.
📖 Read our full Dextromethorphan guide →
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
58552-0143-04 You're viewing this Main listing 1 BOTTLE in 1 CARTON / 118 mL in 1 BOTTLE 2020-06-22 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Good Neighbor Long Acting Cough Adult Tussin 30 mg/10mL 46122-0784-29 AMERISOURCE 1 bottle $0.023 — Availability likely —
Adult Cough Relief 15 mg/5mL 83324-0134-04 QUALITY 1 bottle $0.023 — Availability likely —
Cough Relief Adult 15 mg/5mL 36800-0509-04 TOP 1 bottle — — FDA listed —
Tussin Long Acting Cough READYINCASE 30 mg/10mL 49580-0383-04 P 1 bottle — — Discontinued —
Cough Relief Adult 15 mg/5mL 55910-0309-04 Dolgencorp, 1 bottle — — FDA listed —
Giltuss Honey DM Cough 30 mg/10mLthis 58552-0143-04 Gil 1 bottle — — FDA listed —
Childrens Giltuss Honey DM Cough 15 mg/5mL 58552-0144-04 Gil 1 bottle — — FDA listed —
Giltuss Diabetic Dm 30 mg/10mL 58552-0149-04 Gil 1 bottle — — FDA listed —
Giltuss DM 30 mg/10mL 58552-0150-04 Gil 1 bottle — — FDA listed —
Mielim y mas 15 mg/5mL 58593-0295-04 Efficient 118 ml — — Discontinued —
Cough Relief Cough Suppressant 15 mg/5mL 63868-0957-04 QUALITY 1 bottle — — FDA listed —
Cough Relief 15 mg/5mL 63941-0309-04 Best 1 bottle — — FDA listed —
Cough Relief 15 mg/5mL 63941-0455-04 Best 1 bottle — — FDA listed —
Giltuss Honey DM Cough 30 mg/10mL 65852-0004-04 Dextrum 1 bottle — — FDA listed —
Childrens Giltuss Honey DM Cough 15 mg/5mL 65852-0007-04 Dextrum 1 bottle — — FDA listed —
Premier Value Tussin Cough Long Acting 30 mg/10mL 68016-0742-04 Chain 1 bottle — — FDA listed —
DRx Choice Long Acting Cough 30 mg/10mL 68163-0742-04 RARITAN 1 bottle — — FDA listed —
CVS Long Acting Cough 30 mg/10mL 69842-0634-04 CVS 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

🏛️
2020
On the market since
Jun 2020
📍
2026
Currently FDA-listed
6 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
FlavorLemon
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 Y9H1V576FH
    Honey is a natural sweetener made by bees from flower nectar. In medicines, it adds sweetness to improve taste and may help soothe throat irritation in lozenges or syrups.
  • 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 1VPU26JZZ4
    Potassium sorbate is a salt derived from sorbic acid, a naturally occurring preservative. It prevents growth of mold, yeast, and some bacteria, extending the medicine's shelf life.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • 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.

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

The official label also statesInactive ingredients natural and artificial flavor, natural grade A honey, methylparaben, potassium sorbate, propylene glycol, propylparaben, purified water, 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 marketedJun 2020
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 📄 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 34 words ▾

Uses temporarily relieves: cough due to minor throat and bronchial irritation associated with the common cold or inhaled irritants the intensity of coughing the impulse to cough to help your child get to sleep

⏱️ Dosage and Administration 74 words ▾

Directions do not take more than 4 doses in any 24-hour period use enclosed dosing cup keep dosage cup for use with this product ml = milliliters adults and children 12 years and over 10 mL every 6-8 hours children 6 to under 12 years of age 5 mL every 6-8 hours children 4 to under 6 years of age 2.5 mL every 6-8 hours children under 4 years of age Consult a doctor

⚠️ Warnings 150 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 a cough with too much phlegm (mucus) a persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema Stop use and ask a doctor if cough lasts for 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 , 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 17 words ▾

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

🧪 Active Ingredient 10 words ▾

Active ingredient (in each 10 mL) Dextromethorphan HBr, 30 mg

🧪 Inactive Ingredients 19 words ▾

Inactive ingredients natural and artificial flavor, natural grade A honey, methylparaben, potassium sorbate, propylene glycol, propylparaben, purified water, sucralose.

🎯 Purpose 3 words ▾

Purposes Cough Suppresant

📄 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 29 words ▾

Ask a doctor before use if you have a cough with too much phlegm (mucus) a persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema

📄 Stop Use and Ask a Doctor If 33 words ▾

Stop use and ask a doctor if cough lasts for 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 11 words ▾

If pregnant or breast-feeding , 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 23 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 32 words ▾

MAXIMUM STRENGTH Giltuss® Honey DM Cough Made with real honey ALCOHOL FREE. DYE FREE. NON-DROWSY RELIEVES PERSISTENT COUGH UP TO 8 HOURS HONEY LEMON FLAVOR. 4FL OZ (118 mL) 58552-143 Honey DM

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 Giltuss Honey DM Cough (this brand).

Top reported reactions

Drug Abuse109
Cardiac Arrest21
Completed Suicide21
Respiratory Arrest21
Death16
Toxicity To Various Agents12
Drug Hypersensitivity10

Age at onset

Adult3
Elderly1

Reporter sex

213 reports
Male · 57%
Female · 43%
Unknown · 0%

Serious outcomes

Death144
Hospitalization28
Life-threatening3
Disabling3
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.
← 58552-0142-15 · Gil 58552-0144-04 · 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.