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SanaTos Boost DEXTROMETHORPHAN HBR 20 mg/100mL; 400 mg/100mL Liquid, 177 mL — NDC 55758-0323-06 package photo

SanaTos Boost DEXTROMETHORPHAN HBR 20 mg/100mL; 400 mg/100mL Liquid, 177 mL

by Pharmadel LLC · 177 mL in 1 BOTTLE, PLASTIC (55758-323-06)
NDC 55758-0323-06
🏷️ FDA NDC (as labeled) 55758-323-06 billing pads the product segment with a zero
OTC On market Non-controlled
🗂️ Data synced Sep 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

🆔 Identity & classification

FDA NDC (as labeled) 55758-323-06
Product NDC 55758-323
11-digit billing NDC 55758032306
UNII 9D2RTI9KYH, 495W7451VQ
Application # M012
SPL Set ID ae6a424f-f3f0-3f6c-e053-2995a90a972d
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 2020-09-03
Route ORAL
Dosage form LIQUID
Substance DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Why two NDCs? The FDA registers this code as 55758-323-06 — 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 → 55758-0323-06. 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.

🏭 Manufacturer & labeler

LabelerPharmadel LLC
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code55758
First marketedSep 2020
Product typeHuman Otc Drug
Portfolio67 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.

🩺 Clinical

🧪 What is this product?

SanaTos Boost is an over-the-counter oral liquid cough and cold product that contains dextromethorphan hydrobromide and guaifenesin. Dextromethorphan is typically used to help reduce cough, while guaifenesin functions as an expectorant, commonly used to help thin mucus and make it easier to clear from the airway. This product is marketed under FDA's OTC monograph rules for cough and cold medicines.

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.

🧪 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.

💲 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
SanaTos Boost 20 mg/100mL; 400 mg/100mLthis 55758-0323-06 Pharmadel 177 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
Sep 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.

🔬 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 SanaTos Boost (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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
55758-0323-06 You're viewing this 177 mL in 1 BOTTLE, PLASTIC (55758-323-06) 2020-09-03 Active

🧭 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 FDA registers it as 55758-323-06, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 55758-0323-06, written without dashes as 55758032306. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 55758-0323-06, the first segment (55758) is the labeler code FDA assigned to Pharmadel LLC; the middle segment (0323) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (06) identifies this exact package size and type. Together they name one specific package of one specific product.
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 Pharmadel LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Pharmadel LLC 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.

📄 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
🎯 Indications and Usage 27 words ▾

Uses helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive temporarily relieves common cold/flu symptoms: cough due to minor throat and bronchial irritation

⏱️ Dosage and Administration 46 words ▾

Directions do not exceed recommended dosage use dosage cup mL = milliliter do not take more than 6 doses in any 24-hour period Age Dose adults & children 12 years and older 20 mL every 4 hours children under 12 years of age do not use

⚠️ Warnings 170 words ▾

Warnings Do not use for children under 12 years of age 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 two 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 persistent or chronic cough such occurs with smoking, asthma or emphysema trouble urinating due to an enlarged prostate gland When using this product do not use more than directed Stop use and ask a doctor if a persistent or chronic cough lasts for more than 7 days, tends to recur, or 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 20 words ▾

Other information each 20 mL contains: sodium 12 mg use provided dosage cup store between 15-30°C (59-86°F) do not refrigerate

🧪 Active Ingredient 21 words ▾

Active ingredients & Purposes Active ingredient (in each 20 mL) Purpose Guaifenesin 400 mg............................................... Expectorant Dextromethorphan HBr 20 mg............................... Cough suppressant

🧪 Inactive Ingredients 26 words ▾

Inactive ingredients anhydrous citric acid, dextrose, D&C red # 33, FD&C red #40, flavors, glycerin, maltitol, propylene glycol, saccharin sodium, sodium benzoate, sucralose, xanthan gum, water

🎯 Purpose 17 words ▾

Active ingredient (in each 20 mL) Purpose Guaifenesin 400 mg............................................... Expectorant Dextromethorphan HBr 20 mg............................... Cough suppressant

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 55758-0322-06 · Pharmadel 55758-0326-25 · Pharmadel →
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.