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SAFETUSSIN Non Drowsy Cough plus chest congestion Dextromethorphan Hydrobromide, and Guaifenesin 10 mg/5mL; 100 mg/5mL Liquid, 118 mL — NDC 55505-0220-33 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

SAFETUSSIN Non Drowsy Cough plus chest congestion Dextromethorphan Hydrobromide, and Guaifenesin 10 mg/5mL; 100 mg/5mL Liquid, 118 mL — NDC 55505-220-33 (Billing 55505-0220-33)

by KRAMER LABORATORIES · 118 mL in 1 BOTTLE, PLASTIC

This is a package of 118 mL of SAFETUSSIN Non Drowsy Cough plus chest congestion Dextromethorphan Hydrobromide, and Guaifenesin 10 mg/5mL; 100 mg/5mL Liquid from KRAMER LABORATORIES, marketed since Jun 2023 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 55505-0220-33
🏷️ FDA NDC (as labeled) 55505-220-33 billing pads the product segment with a zero
This package
Contains118 mL Pack sizes2 compare ↓
Main listing for product 55505-220 · Also comes in: 237 ml 55505-220-36
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

NDC database record

One package, one record: these facts belong to NDC 55505-220-33 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
55505 labeler · 220 product · 33 package
Package marketed since
Jul 1, 2025
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 5550522033 1
FDA record last changed
Oct 1, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 55505-220-33
Product NDC 55505-220
11-digit billing NDC 55505022033
UNII 9D2RTI9KYH, 495W7451VQ
Application # M012
SPL Set ID 60311ca3-8544-417e-aa29-e9f65c6692ba
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 2023-06-01
Route ORAL
Dosage form LIQUID
Substance DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Why two NDCs? The FDA registers this code as 55505-220-33 — 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 → 55505-0220-33. 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.

Clinical

🧪 What is this product?

Safetussin Non Drowsy Cough plus Chest Congestion is an over-the-counter liquid taken by mouth that contains dextromethorphan and guaifenesin. Dextromethorphan is a cough suppressant typically used to reduce cough reflex. Guaifenesin is an expectorant commonly used to help thin and loosen mucus so it may be easier to cough up. This product is marketed under the FDA's over-the-counter monograph rules for cough and cold medicines.

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: 237 ml
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
55505-0220-36 55505-220-36 237 mL in 1 BOTTLE, PLASTIC 2023-06-01 — Active
55505-0220-33 You're viewing this Main listing 118 mL in 1 BOTTLE, PLASTIC 2025-07-01 — Active

You're viewing the smallest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This package contains 118 mL — 118 ml in 1 bottle, plastic.
How does this package differ from NDC 55505-0220-36?
Both are SAFETUSSIN Non Drowsy Cough plus chest congestion Dextromethorphan Hydrobromide, and Guaifenesin 10 mg/5mL; 100 mg/5mL Liquid — the drug itself is identical. This page's package is the 118 mL one, while NDC 55505-0220-36 is the 237 ml package.
What NDC number is used to bill for this package of SAFETUSSIN Non Drowsy Cough plus chest congestion Dextromethorphan Hydrobromide, and Guaifenesin 10 mg/5mL; 100 mg/5mL Liquid?
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
SAFETUSSIN Non Drowsy Cough plus chest congestion 10 mg/5mL; 100 mg/5mLthis 55505-0220-33 KRAMER 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

🏛️
2023
On the market since
Jun 2023
📍
2026
Currently FDA-listed
3 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

FlavorMint
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 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 L7T10EIP3A
    A cooling compound from mint plants used as a flavoring agent and to create a fresh sensation in medicines. It helps mask bitter tastes and improve how the product feels in the mouth.
  • UNII FV98Z8GITP
    A natural flavoring from mint plants. It's added to medicines to mask bitter tastes and improve how the medicine tastes, making it easier to take.
  • 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 OJ245FE5EU
    Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
  • 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 statescitric acid, glycerin, menthol, natural peppermint flavor, propylene glycol, purified water, sodium benzoate, 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

LabelerKRAMER LABORATORIES
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code55505
First marketedJun 2023
Product typeHuman Otc Drug
Portfolio26 products on file

More NDCs from KRAMER LABORATORIES labeler code 55505

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 📄 Do Not Use 📄 Ask a Doctor Before Use If 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 23 words ▾

Uses ▪ temporarily relieves cough due to minor throat and bronchial irritation ▪ loosen phlegm (mucus) ▪ helps rid bronchial passages of phlegm(mucus)

⏱️ Dosage and Administration 50 words ▾

Directions ▪ do not take more than 6 doses in any 24-hours period ▪ This adult product is not intended for use in children under 12 years of age age dose Adults and children 12 years and over 10 mL every 4 hours Children under 12 years do not use

⚠️ Warnings 155 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 ▪ cough that occurs with too much phlegm (mucus) ▪ cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is 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 23 words ▾

Other information ▪ Protect from excessive heat and freezing. Store at 15° - 30°C (59° - 86°F) Save this package for complete information

🧪 Active Ingredient 17 words ▾

Active ingredients (in each 5 mL) Purpose Dextromethorphan HBr 10 mg Cough suppressant Guaifenesin 100 mg Expectorant

🧪 Inactive Ingredients 16 words ▾

Inactive ingredients citric acid, glycerin, menthol, natural peppermint flavor, propylene glycol, purified water, sodium benzoate, sucralose,

🎯 Purpose 17 words ▾

Active ingredients (in each 5 mL) Purpose Dextromethorphan HBr 10 mg Cough suppressant Guaifenesin 100 mg Expectorant

📄 Do Not Use 56 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 34 words ▾

Ask a doctor before use if you have ▪ cough that occurs with too much phlegm (mucus) ▪ cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema

📄 Stop Use and Ask a Doctor If 32 words ▾

Stop use and ask a doctor if cough lasts more than 7 days, comes back, 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 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 4 words ▾

Questions? Comments? Call 1-800-824-4894

📄 Package Label / Principal Display Panel ~2 min read ▾

PRINCIPAL DISPLAY PANEL - 237 ml Bottle Label SAFE FOR ADULTS WITH HIGH BLOOD PRESSURE & DIABETES Safe tussin ® DM NON-DROWSY Cough + Chest Congestion Dextromethorphan HBr 10mg / Cough Suppressant Guaifenesin 100mg / Expectorant Safe for adults with ● High Blood Pressure ● Diabetes ✓ Controls cough ✓ Loosens mucus ✓ Relieves chest congestion SUGAR & ALCOHOL FREE

8.0FL OZ (237mL) SEGURO PARA ADULTOS CON PRESIÓN ALTA Y DIABETES Safe tussin ® DM NO SOMNOLIENTO Tos + Congestión en el Pecho Dextromethorphan HBr 10mg / Antitusivo Guaifenesin 100mg / Expectorante Seguro para adultos con ● Presión Alta ● Diabetes ✓ Controla la tos ✓ Afloja la muscosidad ✓ Alivia l a congestion en el pecho SIN AZÚCAR Y SIN ALCOHOL

8.0FL OZ (237mL) SAFE FOR ADULTS WITH HIGH BLOOD PRESSURE & DIABETES Safe tussin ® DM NON-DROWSY Cough + Chest Congestion Safetussin ® contains: ✓ No decongestants ✓ No acetaminophen ✓ No sugar ✓ No alcohol ✓ No sorbitol ✓ No fructose ✓ No gluten ✓ No dyes Pharmacist Recommended Brand Always read and follow label directions. Do not use longer than 7 consecutive days unless directed by a doctor. Ask a doctor if you have individual health questions.

Questions? Comments? Call 1-800-824-4894 ©2020 Kramer Laboratories, Inc., Bridgewater, NJ 08807 K0423 Safetussin Non Drowsy Cough plus chest congestion 8 FL OZ (237 ml)

PRINCIPAL DISPLAY PANEL - 118 ml Bottle Label SAFE FOR ADULTS WITH HIGH BLOOD PRESSURE & DIABETES Safe tussin ® DM clear sugar free syrup Cough + Chest Congestion Dextromethorphan HBr 10mg / Cough Suppressant Guaifenesin 100mg / Expectorant Safe for adults with ● High Blood Pressure ● Diabetes ✓ Controls cough ✓ Loosens mucus ✓ Relieves chest congestion SUGAR & ALCOHOL FREE

4.0FL OZ (118mL) SEGURO PARA ADULTOS CON PRESIÓN ALTA Y DIABETES Safe tussin ® DM almíbar claro sin azúcar Tos + Congestión en el Pecho Dextromethorphan HBr 10mg / Antitusivo Guaifenesin 100mg / Expectorante Seguro para adultos con ● Presión Alta ● Diabetes ✓ Controla la tos ✓ Afloja la muscosidad ✓ Alivia l a congestion en el pecho SIN AZÚCAR Y SIN ALCOHOL

4.0FL OZ (118mL) SAFE FOR ADULTS WITH HIGH BLOOD PRESSURE & DIABETES Safe tussin ® DM clear sugar free syrup Cough + Chest Congestion Safetussin ® contains: ✓ No decongestants ✓ No acetaminophen ✓ No sugar ✓ No alcohol ✓ No sorbitol ✓ No fructose ✓ No gluten ✓ No dyes Pharmacist Recommended Brand Always read and follow label directions. Do not use longer than 7 consecutive days unless directed by a doctor. Ask a doctor if you have individual health questions.

Questions? Comments? Call 1-800-824-4894 ©2020 Kramer Laboratories, Inc., Bridgewater, NJ 08807 K1124 TAMPER-EVIDENT: DO NOT USE IF PRINTED INNER SEAL UNDER CAP IS TORN OR MISSING.

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 KRAMER LABORATORIES. 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 1 other package presentation of this same product, including 237 ml (55505-0220-36). 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?
KRAMER LABORATORIES 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.
← 55505-0219-67 · Kramer 55505-0221-33 · Kramer →
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.