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Childrens Giltuss Honey Cough and Chest Congestion Dextromethorphan HBr, Guaifenesin 10 mg/5mL; 100 mg/5mL Solution — NDC 65852-003-04 (Billing 65852-0003-04)

by Dextrum Laboratories, Inc · 1 BOTTLE, PLASTIC in 1 CARTON / 118 mL in 1 BOTTLE, PLASTIC

This is a package of Childrens Giltuss Honey Cough and Chest Congestion Dextromethorphan HBr, Guaifenesin 10 mg/5mL; 100 mg/5mL Solution from Dextrum Laboratories, Inc, marketed since Jun 2020 and currently FDA-listed. It is this product's only package size.

NDC 65852-0003-04
🏷️ FDA NDC (as labeled) 65852-003-04 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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 65852-003-04
Product NDC 65852-003
11-digit billing NDC 65852000304
RxCUI 996520
UNII 9D2RTI9KYH, 495W7451VQ
Application # M012
SPL Set ID 3f909bc2-eb84-a19d-e063-6294a90ae04e
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 2020-06-22
Route ORAL
Dosage form SOLUTION
Substance DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Quick answers
  • RxCUI (RxNorm): 996520
Why two NDCs? The FDA registers this code as 65852-003-04 — 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 → 65852-0003-04. 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

📗 Our plain-language guide HelloPharmacist
  • It helps loosen mucus and makes coughs more productive. It also temporarily eases cough from minor throat and bronchial irritation, like with a cold or inhaled irritants.
  • Swallow them whole with a full glass of water. Don’t crush, chew or break them. You can take them with or without food, about every 12 hours as your label directs.
  • How do I take the extended-release tablets?
  • The extended-release tablets are not for children under 12. Some liquid products are made for children, so check that product’s label and ask me if you’re unsure.
📖 Read our full Dextromethorphan / Guaifenesin 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
65852-0003-04 You're viewing this Main listing 1 BOTTLE, PLASTIC in 1 CARTON / 118 mL in 1 BOTTLE, PLASTIC 2020-06-22 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Chest Congestion Relief DM 10 mg/5mL; 100 mg/5mL 00536-1313-85 RUGBY 473 ml $0.009 — Availability likely —
Tusnel Diabetic 10 mg/5mL; 100 mg/5mL 54859-0505-04 LLORENS 118 ml $0.011 — Availability likely —
Mucolyte DM 100 mg/5mL; 10 mg/5mL 57237-0360-12 Rising 118 ml $0.011 — Availability likely —
Tussin DM Regular 20 mg/10mL; 200 mg/10mL 82568-0014-04 AARNA 1 bottle $0.011 — Availability likely —
Tussin DM Sugar free 20 mg/10mL; 200 mg/10mL 82568-0015-04 AARNA 1 bottle $0.011 — Availability likely —
Tussin DM Cough and Chest Congestion Non Drowsy 20 mg/10mL; 200 mg/10mL 63868-0868-54 QUALITY 1 bottle $0.018 — FDA listed —
Guaifenesin and Dextromethorphan Hydrobromide 10 mg/5mL; 100 mg/5mL 58657-0504-08 Method 237 ml $0.024 — Availability likely —
Guaifenesin and Dextromethorphan Hydrobromide 10 mg/5mL; 100 mg/5mL 58657-0505-08 Method 237 ml $0.024 — Availability likely —
Dextromethorphan HBr. and Guaifenesin 10 mg/5mL; 100 mg/5mL 57237-0312-51 Rising 100 cups $0.405 — Availability likely —
Dextromethorphan HBr and Guaifenesin Oral Solution 100 mg/5mL; 10 mg/5mL 81033-0103-50 KESIN 100 cups $0.405 — Availability likely —
Guaifenesin Dm 100 mg/5mL; 10 mg/5mL 00121-0638-00 PAI 10 cups — — FDA listed —
Guaifenesin Dm 200 mg/10mL; 20 mg/10mL 00121-1276-00 PAI 10 cups — — FDA listed —
Guaifenesin and Dextromethorphan 100 mg/5mL; 10 mg/5mL 00904-7512-70 Major 10 cups — — FDA listed —
Guaifenesin and Dextromethorphan 200 mg/10mL; 20 mg/10mL 00904-7513-72 Major 10 cups — — FDA listed —
Carolina Crud Crusher 200 mg/10mL; 20 mg/10mL 11383-0311-08 Weeks 236 ml — — FDA listed —
Target Cough plus Chest Congestion DM Max with Honey 20 mg/20mL; 400 mg/20mL 11673-0775-08 TARGET 1 bottle — — FDA listed —
MAX Tussin Cough and Chest Congestion DM Sugar Free 20 mg/10mL; 200 mg/10mL 17856-1126-01 ATLANTIC 72 cups — — FDA listed —
Adult Cough and Chest Congestion Relief DM Non Drowsy 20 mg/10mL; 200 mg/10mL 21130-0385-04 Safeway, 1 bottle — — FDA listed —
Tussin DM Cough and Chest Congestion 20 mg/10mL; 200 mg/10mL 21130-0583-04 Safeway, 1 bottle — — FDA listed —
Tussin Cough Sugar Free 20 mg/10mL; 200 mg/10mL 49580-0834-04 P 1 bottle — — FDA listed —
Tukol Sugar Free Cough and Cold 2 mg/mL; 20 mg/mL 50066-0505-04 Genomma 1 bottle — — FDA listed —
Sorbugen 15 mg/7.5mL; 150 mg/7.5mL 52083-0660-16 Kramer 480 ml — — FDA listed —
Defensol Adult Syrup 200 mg/10mL; 20 mg/10mL 53145-0039-04 Menper 1 bottle — — FDA listed —
Cosedal Drops 10 mg/5mL; 100 mg/5mL 53145-0059-02 Menper 1 bottle — — FDA listed —
Adult Bisolvine Adult 20 mg/10mL; 200 mg/10mL 53145-0323-04 MENPER 120 ml — — FDA listed —
Altituss 15 mg/7.5mL; 150 mg/7.5mL 53163-0113-16 Alternative 473 ml — — FDA listed —
Tussin DM Cough and Chest Congestion 10 mg/5mL; 100 mg/5mL 53942-0503-26 DeMoulas 237 ml — — FDA listed —
Tussin DM 10 mg/5mL; 100 mg/5mL 53943-0503-26 Discount 237 ml — — FDA listed —
Limpia Pecho 10 mg/5mL; 100 mg/5mL 54859-0011-04 Llorens 118 ml — — FDA listed —
Tusnel SF 10 mg/5mL; 100 mg/5mL 54859-0506-04 Llorens 118 ml — — FDA listed —
Tusnel Cough Suppressant Expectorant 10 mg/5mL; 100 mg/5mL 54859-0509-16 Llorens 473 ml — — FDA listed —
Llorens Care Tussin DM 10 mg/5mL; 100 mg/5mL 54859-0833-04 Llorens 118 ml — — FDA listed —
Guaifenesin Dm 100 mg/5mL; 10 mg/5mL 55154-5783-05 Cardinal 5 cups — — FDA listed —
Guaifenesin Dm 100 mg/5mL; 10 mg/5mL 55154-5785-05 Cardinal 5 cups — — FDA listed —
Dextromethorphan HBr. and Guaifenesin 20 mg/10mL; 200 mg/10mL 57237-0313-18 Rising 80 cups — — FDA listed —
Tussin Cough Expectorant Cough Supressant Dm 10 mg/5mL; 100 mg/5mL 57243-0503-24 Salado 118 ml — — FDA listed —
Geri-Tussin DM 20 mg/10mL; 200 mg/10mL 57896-0291-16 Geri-Care 473 ml — — FDA listed —
Geri-Tussin DM 10 mg/5mL; 100 mg/5mL 57896-0661-08 Geri-Care 237 ml — — FDA listed —
Guaiasorb DM 10 mg/5mL; 100 mg/5mL 57896-0736-04 Geri-Care 118 ml — — FDA listed —
Guaiasorb Dm 20 mg/10mL; 200 mg/10mL 57896-0739-04 Geri-Care 118 ml — — FDA listed —
Giltuss HBP Cough and Chest Congestion 20 mg/10mL; 200 mg/10mL 58552-0132-04 Gil 1 bottle — — FDA listed —
Giltuss Childrens Cough and Chest Congestion 10 mg/5mL; 100 mg/5mL 58552-0133-04 Gil 1 bottle — — FDA listed —
Giltuss Diabetic Cough and Cold 200 mg/10mL; 20 mg/10mL 58552-0134-04 Gil 1 bottle — — FDA listed —
Giltuss Honey Cough and Chest Congestion 200 mg/10mL; 20 mg/10mL 58552-0140-04 Gil 1 bottle — — FDA listed —
Childrens Giltuss Honey Cough and Chest Congestion 100 mg/5mL; 10 mg/5mL 58552-0141-04 Gil 1 bottle — — FDA listed —
Rompe Pecho DM 10 mg/5mL; 100 mg/5mL 58593-0275-04 Efficient 118 ml — — Discontinued —
Rompe Pechito DM for Kids 5 mg/2.5mL; 50 mg/2.5mL 58593-0276-04 Efficient 118 ml — — FDA listed —
Guaifenesin DM 100 mg/5mL; 10 mg/5mL 60687-0817-17 American 10 cups — — FDA listed —
Guaifenesin DM 200 mg/10mL; 20 mg/10mL 60687-0828-56 American 10 cups — — FDA listed —
ACTINEL Diabetic 10 mg/5mL; 100 mg/5mL 63102-0140-16 ACTIPHARMA, 473 ml — — FDA listed —
Tussin Cough DM Sugar Free 20 mg/10mL; 200 mg/10mL 63868-0869-04 QUALITY 1 bottle — — FDA listed —
Cough and Congestion DM Sugar Free 20 mg/10mL; 200 mg/10mL 63941-0817-04 Best 1 bottle — — FDA listed —
Childrens Giltuss Honey Cough and Chest Congestion 10 mg/5mL; 100 mg/5mLthis 65852-0003-04 Dextrum 1 bottle — — FDA listed —
Giltuss Honey Cough and Chest Congestion 200 mg/10mL; 20 mg/10mL 65852-0005-04 Dextrum 1 bottle — — FDA listed —
Giltuss HBP Cough and Chest Congestion 200 mg/10mL; 20 mg/10mL 65852-0006-04 Dextrum 1 bottle — — FDA listed —
Giltuss Diabetic 20 mg/10mL; 200 mg/10mL 65852-0009-04 Dextrum 1 bottle — — FDA listed —
Giltuss Childrens Cough and Chest Congestion 100 mg/5mL; 10 mg/5mL 65852-0019-04 Dextrum 1 bottle — — FDA listed —
SDA Laboratories Tussin DM 10 mg/5mL; 100 mg/5mL 66424-0565-16 SDA 473 ml — — FDA listed —
Adult Tussin DM Lil Drug Store Products 10 mg/5mL; 100 mg/5mL 66715-6858-04 Lil' 1 bottle — — FDA listed —
Tussin DM Cough and Chest Non Drowsy 20 mg/10mL; 200 mg/10mL 67091-0265-18 WinCo 1 bottle — — FDA listed —
Tussin DM Cough and Chest 20 mg/10mL; 200 mg/10mL 67091-0469-04 WinCo 1 bottle — — FDA listed —
Guaiasorb DM 10 mg/5mL; 100 mg/5mL 68071-3938-04 NuCare 118 ml — — FDA listed —
Sorbutuss NR 10 mg/5mL; 100 mg/5mL 68436-0120-16 Dextrum 474 ml — — FDA listed —
Tussin DM 10 mg/5mL; 100 mg/5mL 69168-0477-66 Allegiant 1 bottle — — FDA listed —
Tussin Cough and Chest Congestion DM adult 20 mg/10mL; 200 mg/10mL 69256-0385-08 Harris 1 bottle — — FDA listed —
Guaifenesin Syrup and Dextromethorphan 100 mg/5mL; 10 mg/5mL 69339-0149-19 Natco 10 cups — — FDA listed —
Guaifenesin Syrup and Dextromethorphan 100 mg/5mL; 10 mg/5mL 69339-0150-19 Natco 10 cups — — FDA listed —
DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN 10 mg/5mL; 100 mg/5mL 69729-0035-04 OPMX 118 ml — — FDA listed —
DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN 10 mg/5mL; 100 mg/5mL 69729-0036-04 OPMX 118 ml — — FDA listed —
DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN 10 mg/5mL; 100 mg/5mL 69729-0069-04 OPMX 118 ml — — FDA listed —
DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN 10 mg/5mL; 100 mg/5mL 69729-0812-04 OPMX 118 ml — — FDA listed —
Akin Cough Formula DM 10 mg/5mL; 100 mg/5mL 69822-0202-04 Southern 118 ml — — FDA listed —
MAX Tussin Cough and Chest Congestion DM 20 mg/10mL; 200 mg/10mL 71399-0025-04 Akron 1 bottle — — FDA listed —
MAX Tussin Cough and Chest Congestion DM Sugar Free 20 mg/10mL; 200 mg/10mL 71399-0026-04 Akron 1 bottle — — FDA listed —
Guaifenesin DM 10 mg/5mL; 100 mg/5mL 71800-0057-05 Innovida 119 ml — — FDA listed —
Guaifenesin and Dextromethorphan Hydrobromide 10 mg/5mL; 100 mg/5mL 72162-2277-02 Bryant 237 ml — — FDA listed —
Guaifed DM 200 mg/10mL; 20 mg/10mL 73564-0802-04 Aldama 118 ml — — FDA listed —
Tussin Cough Expectorant Cough Supressant Dm 10 mg/5mL; 100 mg/5mL 76281-0503-24 AptaPharma 118 ml — — FDA listed —
Revasol Tussin DM Cough Suppressant Expectorant 10 mg/5mL; 100 mg/5mL 84379-0316-16 Rnv 474 ml — — FDA listed —
Dextromethorphan HBr. and Guaifenesin 20 mg/10mL; 200 mg/10mL 84415-0011-01 Everpharm 100 cups — — FDA listed —
Dextromethorphan HBr. and Guaifenesin 10 mg/5mL; 100 mg/5mL 84415-0014-01 Everpharm 100 cups — — FDA listed —
Curewell Tussin DM 20 mg/10mL; 200 mg/10mL 85111-0802-16 RMT 473 ml — — FDA listed —
DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN 10 mg/5mL; 100 mg/5mL 85722-0001-04 KJD 118 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

🏛️
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.

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

LabelerDextrum Laboratories, Inc
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code65852
First marketedJun 2020
Product typeHuman Otc Drug
Portfolio10 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 🧪 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 84 words ▾

Indication and usage section Indication and usage section Do not take more than 6 doses in any 24 hours period use enclosed dosing cup Keep dosage cup for use with this product ml= milliliters children under 4 years of age Consult a doctor children 4 to under 6 years of age 2.5 ml every 4 hours children 6 to under 12 years of age 5 ml every 4 hours Adults and children 12 years & over 10 ml every 4 hours indication and usage

⏱️ Dosage and Administration 76 words ▾

Directions Directions Do not take more than 6 doses in any 24 hours period use enclosed dosing cup Keep dosage cup for use with this product ml= milliliters children under 4 years of age Consult a doctor children 4 to under 6 years of age 2.5 ml every 4 hours children 6 to under 12 years of age 5 ml every 4 hours Adults and children 12 years & over 10 ml every 4 hours Directions

⚠️ Warnings 58 words ▾

warnings Warnings Do not use If your child is 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 don’t know is your prescription drug contains and MAOI, ask a doctor or pharmacist before taking this product. warning

🧪 Active Ingredient 22 words ▾

Active Ingredients Active Ingredients ( in Each 5 ml) Purposes Dextromethorphan HBr, 10 mg ------------------------Cough Suppresant Guaifenesin, 100 mg --------------------------------------Expectorant Active ingredients

🧪 Inactive Ingredients 25 words ▾

Inactive ingredients Inactive ingredients Carboxymethylcellulose sodium, citric acid, glycerin, natural and artificial flavor, natural grade A honey, methylparaben, propylene glycol, propylparaben, purified water,sucralose Inactive ingredients

🎯 Purpose 52 words ▾

Uses Uses Uses Temporary 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, helps loosen phlegm ( mucus) and thin bronchial secretions to make cough more productive Uses

📄 Ask a Doctor Before Use If 40 words ▾

Ask a doctor before use if the child has Warnings Ask a doctor before use if your child has, cough that occurs with too much phlegm (mucus) , a persistent or chronic cough as occurs with asthma. Ask a doctor

📄 Stop Use and Ask a Doctor If 37 words ▾

Stop use Stop use and ask a doctor if cough lasts for more than 7 days , come back, or is accompanied by fever, rash or persistent headache. These could be signs of serious condition. Stop use

📄 Keep Out of Reach of Children 35 words ▾

Keep out of reach of children Keep out of reach of children. In case of accidental overdose, get medical or professional help or contact a Poisson Control center immediately Keep out of reach of children

📄 Other Information 25 words ▾

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

📄 Questions or Comments 26 words ▾

Questions or comments? 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. Questions

📄 Package Label / Principal Display Panel 38 words ▾

Children 4-12 Alcohol free, Dye free, Non-drowsy True source certified honey Children's Giltuss Honey Cough & Chest Congestion Cough & cold, chest congestion, liquifies and loosen phlegm and mucus Honey lemon flavor 4 floz 118 ml Principal panel

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 Childrens Giltuss Honey Cough and Chest Congestion (this brand).

Top reported reactions

Dehydration1
Dry Skin1
Feeling Hot1
Hyperhidrosis1
Limb Discomfort1
Speech Disorder1
Tremor1

Reporter sex

1 reports
Male · 100%
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 — 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 Dextrum Laboratories, Inc. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Dextrum Laboratories, Inc 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.
← 65852-0002-04 · Dextrum 65852-0004-04 · Dextrum →
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.