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Dr. SANA COUGH AND CHEST CONGESTION DM SUGAR FREE Dextromethorphan Hydrobromide, Guaifenesin 20 mg/30mL; 200 mg/30mL Syrup — NDC 53113-0515-06 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Dr. SANA COUGH AND CHEST CONGESTION DM SUGAR FREE Dextromethorphan Hydrobromide, Guaifenesin 20 mg/30mL; 200 mg/30mL Syrup — NDC 53113-515-06 (Billing 53113-0515-06)

by GADAL Laboratories, Inc · 1 BOTTLE in 1 BOX / 180 mL in 1 BOTTLE

This is a package of Dr. SANA COUGH AND CHEST CONGESTION DM SUGAR FREE Dextromethorphan Hydrobromide, Guaifenesin 20 mg/30mL; 200 mg/30mL Syrup from GADAL Laboratories, Inc, marketed since Apr 2025 and currently FDA-listed. It is this product's only package size.

NDC 53113-0515-06
🏷️ FDA NDC (as labeled) 53113-515-06 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) 53113-515-06
Product NDC 53113-515
11-digit billing NDC 53113051506
RxCUI 2719927
UNII 9D2RTI9KYH, 495W7451VQ
Application # M012
SPL Set ID 5fb2438b-8f2d-4af2-9981-42d278d26800
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 2025-04-14
Route ORAL
Dosage form SYRUP
Substance DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Quick answers
  • RxCUI (RxNorm): 2719927
Why two NDCs? The FDA registers this code as 53113-515-06 — 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 → 53113-0515-06. 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.
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
53113-0515-06 You're viewing this Main listing 1 BOTTLE in 1 BOX / 180 mL in 1 BOTTLE 2025-04-14 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Dr. Sana Cough And Chest Congestion Dm 20 mg/30mL; 200 mg/30mL 53113-0514-06 GADAL 1 bottle — — FDA listed —
Dr. SANA COUGH AND CHEST CONGESTION DM SUGAR FREE 20 mg/30mL; 200 mg/30mLthis 53113-0515-06 GADAL 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

🏛️
2025
On the market since
Apr 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.

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

LabelerGADAL Laboratories, Inc
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code53113
First marketedApr 2025
Product typeHuman Otc Drug
Portfolio3 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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 33 words ▾

Uses • temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold and helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.

⏱️ Dosage and Administration 45 words ▾

Directions: • do not exceed more than 6 doses in any 24-hour period • shake well before use • mL=milliliter age dose adults and children 12 years & more 2 tablespoons (30 mL) every 4 hours children under 12 years of age consult your doctor

⚠️ Warnings 160 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 that is accompanied by excessive phlegm (mucus) • a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema.

Stop use and ask the doctor if • cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition. If pregnant or breast-feeding, ask 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 35 words ▾

Other information • Each 30 ml contains: Sodium 4.8 mg • Store Between 15°C to 30°C (59°F to 86°F) • Tamper Evident Feature: Do not use if seal under cap is torn, broken or missing.

🧪 Active Ingredient 14 words ▾

Active Ingredients: (in each 30 ml) Dextromethorphan HBr 20 mg Guaifenesin USP 200 mg

🧪 Inactive Ingredients 33 words ▾

Inactive ingredients Aloe Vera, Citric Acid, Caramel Color, Eucalyptus Oil, Ginger Root PE, Glycerin, Natural and Artificial Honey Flavor, Menthol, Methylparaben, Potassium Sorbate, Propylene Glycol, Propylparaben, Purified Water, Sodium Benzoate, Sucralose, Xanthan Gum.

🎯 Purpose 4 words ▾

Purpose Cough Suppressant Expectorant

📄 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 13 words ▾

Questions? call Weekdays from 9:30 AM to 5 PM EST at Tel. 305-633-7900

📄 Package Label / Principal Display Panel 3 words ▾

Packaging COUGH&CHEST 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 Dr. SANA COUGH AND CHEST CONGESTION DM SUGAR FREE (this brand).

Top reported reactions

Blister1
Clonus1
Dermatitis1
Diarrhoea1
Drug Abuse1
Erythema1
Fixed Eruption1

Age at onset

Adult1

Reporter sex

0 reports
Male · 75%
Female · 25%

Serious outcomes

Hospitalization3
Reports over time (by year) — tap or hover for the count & year
2024 2025 2026 1 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) — 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 GADAL Laboratories, Inc. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
GADAL 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.
← 53113-0514-06 · GADAL 53113-0516-06 · GADAL →
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.