Guaifenesin Syrup and Dextromethorphan 100 mg/5mL; 10 mg/5mL Syrup — NDC 69339-149-19 (Billing 69339-0149-19)
This is a package of Guaifenesin Syrup and Dextromethorphan 100 mg/5mL; 10 mg/5mL Syrup from Natco Pharma USA LLC, marketed since Oct 2020 and currently FDA-listed. It is this product's only package size.
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 016414
- GCN: 53495
- GPI-14 (Medi-Span): 43997002521220
- HICL (First Databank): 000223
- AHFS class code: 48:08.00.00
- RxCUI (RxNorm): 996520
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Uncompetitive N-methyl-D-aspartate Receptor Antagonist class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
- 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.
Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
Ask a licensed pharmacist directly — free, answered by our team.
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 system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | $11.84 | $5,919.10 / 500 ml |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 69339-0149-19 You're viewing this Main listing | 10 TRAY in 1 CASE / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE | 2020-10-19 | — | Active |
Therapeutic equivalents
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Sep 3, 2026
- CMS NADAC weekly file
Availability & generic status
We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
- FDA Orange Book · refreshed Sep 3, 2026
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.
Where does this data come from?
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.- FDA label on DailyMed · label index refreshed Oct 1, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
FDA label — Drug Facts FDA SPL
🎯 Indications and Usage ▾
Uses • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive. • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold.
⏱️ Dosage and Administration ▾
DIRECTIONS: Age Dose Adults and children 12 years and over 10 mL every 4 hours Max dose is 60mL in 24-hours Children under 12 years of age Ask a doctor
⚠️ Warnings ▾
Warnings Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) or for two weeks after stopping the MAOI drug. 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 Ask a doctor or pharmacist before use if you are taking any other drug Stop use and ask a doctor if • your cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistant headache. • you are hypersensitive to any of the ingredients 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 (1-800-222-1222)
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED: Each 5 mL of Guaifenesin Syrup and Dextromethorphan contains Guaifenesin 100mg and Dextromethorphan Hydrobromide 10mg and is supplied in the following oral dosage forms: NDC 69339-149-05 (1) unit dose cup 5mL NDC 69339-149-19 100 (10x10) unit dose cups 5mL Each 10 mL of Guaifenesin Syrup and Dextromethorphan contains Guaifenesin 200mg and Dextromethorphan Hydrobromide 20mg and is supplied in the following oral dosage forms: NDC 69339-150-01 (1) unit dose cup 10mL NDC 69339-150-19 100 (10x10) unit dose cups 10mL
📦 Storage and Handling ▾
Other Information • Store at controlled room temperature 20-25ºC (68-77ºF) • Do not refrigerate • Keep tightly closed • Each 5mL contains sodium 3mg • Each 10mL contains sodium 6mg • Fruit punch flavor • Do not use if lid seal is open or damaged • See top of cup for lot number and expiration date
🧪 Active Ingredient ▾
DRUG FACTS Active Ingredient (in each 5 mL cup) Purpose Guaifenesin, USP 100mg .............................................................................................................................. Expectorant Dextromethorphan HBr, USP 10mg ...................................................................................................... Cough Suppressant Active Ingredient (in each 10 mL cup) Purpose Guaifenesin, USP 200mg ..............................................................................................................................
Expectorant Dextromethorphan HBr, USP 20mg .......................................................................................................Cough Suppressant Inactive Ingredients Anhydrous citric acid, dextrose, FD&C Red No. 40, flavor, glycerin, high fructose corn syrup, menthol, purified water, saccharin sodium, sodium benzoate.
🧪 Inactive Ingredients ▾
Inactive Ingredients Anhydrous citric acid, dextrose, FD&C Red No. 40, flavor, glycerin, high fructose corn syrup, menthol, purified water, saccharin sodium, sodium benzoate.
🎯 Purpose ▾
Non-Narcotic - Alcohol Free
📄 Do Not Use ▾
Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) or for two weeks after stopping the MAOI drug.
📄 Ask a Doctor Before Use If ▾
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 Ask a doctor or pharmacist before use if you are taking any other drug
📄 Stop Use and Ask a Doctor If ▾
Stop use and ask a doctor if • your cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistant headache. • you are hypersensitive to any of the ingredients
🤰 If Pregnant or Breast-Feeding ▾
If pregnant or breast-feeding, ask a health professional before use
📄 Keep Out of Reach of Children ▾
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL - 5 mL Unit Dose Cup Label Delivers 5 mL NDC 69339-149-05 GUAIFENESIN SYRUP & DEXTROMETHORPHAN HBr 100 mg/10 mg per 5 mL For Institutional Use Only 3 69339 14905 8 Lot # 111 Exp: 09/22/2020 See Insert Dash Pharmaceuticals LLC Upper Saddle River, NJ 07458 DASH- DOSE 5mL Cup Label
PRINCIPAL DISPLAY PANEL - 10 mL Unit Dose Cup Label Delivers 10 mL NDC 69339-150-01 GUAIFENESIN SYRUP & DEXTROMETHORPHAN HBr 200 mg/20 mg per 10 mL For Institutional Use Only 3 69339 15001 6 Lot # 111 Exp: 09/22/2020 See Insert Dash Pharmaceuticals LLC Upper Saddle River, NJ 07458 DASH- DOSE 10 mL cup label
Medicaid utilization & spend
About this NDC listing & data coverage
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) | ✓ Available |