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Guaifenesin,Dextromethorphan Hbr 20 mg; 400 mg Capsule, Liquid Filled — NDC 35916-0759-03 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Guaifenesin,Dextromethorphan Hbr 20 mg; 400 mg Capsule, Liquid Filled — NDC 35916-0759-3 (Billing 35916-0759-03)

by Softgel Healthcare Pvt Ltd · 2 POUCH in 1 BOX / 2000 CAPSULE, LIQUID FILLED in 1 POUCH

This is a package of Guaifenesin,Dextromethorphan Hbr 20 mg; 400 mg Capsule, Liquid Filled from Softgel Healthcare Pvt Ltd, marketed since Jul 2025 and currently FDA-listed.

NDC 35916-0759-03
🏷️ FDA NDC (as labeled) 35916-0759-3 billing pads the package segment with a zero
This package
Contains2000 capsule, liquid filled in 1 pouch Pack sizes3 compare ↓
Product page 35916-0759-02 Also comes in: 1500 capsules 35916-0759-4 3000 capsules 35916-0759-2
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Aug 26, 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) 35916-0759-3
Product NDC 35916-0759
11-digit billing NDC 35916075903
RxCUI 1661740
UNII 495W7451VQ, 9D2RTI9KYH
Application # M012
SPL Set ID 3e5d978f-cc70-60a5-e063-6394a90a67d3
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 2025-07-11
Route ORAL
Dosage form CAPSULE, LIQUID FILLED
Substance GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE
Quick answers
  • RxCUI (RxNorm): 1661740
Why two NDCs? The FDA registers this code as 35916-0759-3 — a 5-4-1 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 package segment → 35916-0759-03. 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

📖 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 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 →

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.
Try another pack size: 1500 capsules 3000 capsules
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
35916-0759-03 You're viewing this 2 POUCH in 1 BOX / 2000 CAPSULE, LIQUID FILLED in 1 POUCH 2025-09-15 — Active
35916-0759-04 35916-0759-4 2 BAG in 1 BOX / 1500 CAPSULE, LIQUID FILLED in 1 BAG 2026-01-13 — Active
35916-0759-02 35916-0759-2 Main listing 2 POUCH in 1 BOX / 3000 CAPSULE, LIQUID FILLED in 1 POUCH 2025-07-11 — Inactivated by FDA

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 2 pouch in 1 box / 2000 capsule, liquid filled in 1 pouch.
What NDC number is used to bill for this package of Guaifenesin,Dextromethorphan Hbr 20 mg; 400 mg Capsule, Liquid Filled?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Mucus Relief Dm 400 mg/1; 20 mg 00363-9013-30 Walgreens 10 capsules — — FDA listed —
Guaifenesin,Dextromethorphan Hbr 20 mg/1; 400 mgthis 35916-0759-03 Softgel 2000 capsules — — FDA listed —
Niaflu 20 mg/1; 400 mg 55758-0507-01 Pharmadel 12 capsules — — FDA listed —
Histiacil Cough 20 mg/1; 400 mg 69729-0108-20 OPMX 20 capsules — — FDA listed —
Dextromethorphan Hbr, Guaifenesin 20 mg/1; 400 mg 69729-0781-02 OPMX 20 capsules — — FDA listed —
Guaifenesin, Dextromethorphan Hbr 400 mg/1; 20 mg 69729-0783-02 OPMX 10 capsules — — FDA listed —
TESALON Tesaperlas Severe Cold Max Relief 20 mg/1; 400 mg 69729-0788-20 OPMX 20 capsules — — 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

🏛️
2025
On the market since
Jul 2025
📍
2026
Currently FDA-listed
1 year 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
ShapeCapsule
Size22 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

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

  • UNII 2G86QN327L
    Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
  • 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 B697894SGQ
    Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • UNII U725QWY32X
    Povidone K30 is a synthetic polymer made from petroleum. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in the stomach so the medicine can be absorbed.
  • 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 506T60A25R
    Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
  • 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 gelatin, glycerin, polyethylene glycol 400, povidone k-30,propylene glycol, purified water, sorbitol sorbitan solution

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

LabelerSoftgel Healthcare Pvt Ltd
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code35916
First marketedJul 2025
Product typeHuman Otc Drug
Portfolio15 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 📄 Do Not Use 📄 Ask a Doctor 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 📄 Other Information 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 38 words ▾

Uses temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

⏱️ Dosage and Administration 40 words ▾

Directions do not exceed 6 doses in 24 hours take with a full glass of water adults and children 12 years of age and over: take 1 softgel every 4 hours children under 12 years of age: do not use

⚠️ Warnings 1 words ▾

Warnings

🧪 Active Ingredient 14 words ▾

Active ingredient (in each soft gelatin capsule) Guaifenesin USP 400mg Dextromethorphan HBr USP 20mg

🧪 Inactive Ingredients 15 words ▾

Inactive ingredients gelatin, glycerin, polyethylene glycol 400, povidone k-30,propylene glycol, purified water, sorbitol sorbitan solution

🎯 Purpose 4 words ▾

Purposes Expectorant Cough suppressant

📄 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 25 words ▾

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

📄 When Using This Product 17 words ▾

When using this product do not exceed recommended dosage do not use for more than 7 days

📄 Stop Use and Ask a Doctor If 32 words ▾

Stop use and ask a doctor if cough lasts for more than 7 days,recurs, 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 22 words ▾

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

📄 Other Information 23 words ▾

Other information store at 25°C (77°F); excursions permitted between 15° -30°C (59° -86°F) Keep in dry place and do not expose to heat

📄 Package Label / Principal Display Panel 1 words ▾

label

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 Guaifenesin,Dextromethorphan Hbr — the ingredient across all brands.

Top reported reactions

Covid-1910
Dyspnoea8
Disease Recurrence7
Asthenia6
Cough5
Fatigue5
Pneumonia5

Age at onset

Adolescent1
Adult2
Elderly4

Reporter sex

64 reports
Male · 43%
Female · 57%

Serious outcomes

Hospitalization11
Life-threatening3
Death2
Disabling1
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 6 0
Most recent year is provisional (FAERS lags ~3 months).
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 Softgel Healthcare Pvt Ltd. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 1500 capsules (35916-0759-04), 3000 capsules (35916-0759-02). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Softgel Healthcare Pvt Ltd 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.
← 35916-0710-01 · Softgel 35916-0760-01 · SOFTGEL →
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.