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Childrens Giltuss EX Expectorant Guaifenesin 200 mg/5mL Solution — NDC 65852-0016-04 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Childrens Giltuss EX Expectorant Guaifenesin 200 mg/5mL Solution — NDC 65852-016-04 (Billing 65852-0016-04)

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

This is a package of Childrens Giltuss EX Expectorant Guaifenesin 200 mg/5mL Solution from Dextrum Laboratories Inc., marketed since Jun 2020 and currently FDA-listed. It is this product's only package size.

NDC 65852-0016-04
🏷️ FDA NDC (as labeled) 65852-016-04 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 65852-016-04 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
65852 labeler · 016 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 6585201604 4
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 65852-016-04
Product NDC 65852-016
11-digit billing NDC 65852001604
RxCUI 310625
UNII 495W7451VQ
Application # M012
SPL Set ID 3f8d7d47-f14c-888c-e063-6394a90a5cdd
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 GUAIFENESIN
Quick answers
  • RxCUI (RxNorm): 310625
Why two NDCs? The FDA registers this code as 65852-016-04 — 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 → 65852-0016-04. 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 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

📖 What it is MedlinePlus · NLM

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 ↗
📗 Our plain-language guide HelloPharmacist
  • Guaifenesin doesn't suppress your cough — it actually makes it work better. It loosens and thins the mucus in your chest so your cough can move it out of your airways more effectiv...
  • What exactly does guaifenesin do — does it actually stop my cough?
  • No — extended-release tablets like 12 Hour Mucus Relief and 365 Whole Foods Market Guaifenesin must be swallowed whole. Crushing, chewing, or breaking them releases the medicine al...
  • Can I crush or split the extended-release tablet to make it easier to swallow?
📖 Read our full 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
65852-0016-04 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
Giltuss EX Expectorant 400 mg/10mL 58552-0145-04 Gil 1 bottle — — FDA listed —
Childrens Giltuss EX Expectorant 200 mg/5mL 58552-0146-04 Gil 1 bottle — — FDA listed —
Giltuss EX Expectorant 400 mg/10mL 65852-0008-04 Dextrum 1 bottle — — FDA listed —
Childrens Giltuss EX Expectorant 200 mg/5mLthis 65852-0016-04 Dextrum 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

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.

🧪 Avoiding an ingredient? See Guaifenesin inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • 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 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • 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 1Q73Q2JULR
    Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.
  • 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.

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

The official label also statesInactive Ingredients Citric Acid, glycerin, methylparaben, natural and artificial flavor, polyethylene glycol, propylparaben, purified water, sodium citrate, 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

LabelerDextrum Laboratories Inc.
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code65852
First marketedJun 2020
Product typeHuman Otc Drug
Portfolio11 products on file

More NDCs from Dextrum Laboratories Inc. labeler code 65852

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 📄 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 82 words ▾

indication for use section indication an user 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= mililiters 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

⏱️ 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= mililiters 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 2 words ▾

Warnings Warnings

🧪 Active Ingredient 16 words ▾

Active Ingredients Active ingredients ( in each 5 ml) Purpose Guaifenesin, 200 mg ----------------------------------------Expectorant Active ingredients

🧪 Inactive Ingredients 22 words ▾

Inactive Ingredients Inactive Ingredients Citric Acid, glycerin, methylparaben, natural and artificial flavor, polyethylene glycol, propylparaben, purified water, sodium citrate, sucralose Inactive ingredients

🎯 Purpose 2 words ▾

Uses Uses

📄 Stop Use and Ask a Doctor If 9 words ▾

Stop use section Stop use and ask a doctor

📄 Keep Out of Reach of Children 12 words ▾

Keep out of reach of children 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 34 words ▾

Children 4 -12 Children's Giltuss EX Expectorant Guaifenesin, 200 mg Alcohol free, Sugar free, Dye free, Non-Drowsy Chest congestion liquifies and loosen phlegm and mucus Tutti Frutti 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 ↗

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 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.
← 65852-0015-01 · Dextrum 65852-0017-04 · 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.