Over-the-counter drug · OTC MONOGRAPH DRUG
Broncochem Maximum Cough (Dextromethorphan hbr-gyaifenesin) NDC 65131-100
Dextromethorphan hydrobromide 20 mg/10mL; Guaifenesin 400 mg/10mL · Syrup · Oral · LABORATORIO MAGNACHEM INTERNATIONAL SRL
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65131-100-91 | 6513101009165131010091 | 1 BOTTLE, PLASTIC in 1 BOX (65131-100-91) / 120 mL in 1 BOTTLE, PLASTICMarketed from Apr 21, 2025 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Broncochem Maximum CoughSuffix: MAXIMUM COUGH
- Generic name (nonproprietary)
- dextromethorphan hbr-gyaifenesin
- Active ingredients
- Dextromethorphan hydrobromide — 20 mg/10mLGuaifenesin — 400 mg/10mL
- Dosage form
- Syrup
- Route
- Oral
- Labeler
- LABORATORIO MAGNACHEM INTERNATIONAL SRLNDC labeler code 65131
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Respiratory Secretion Viscosity (Physiologic effect)Increased Respiratory Secretions (Physiologic effect)Sigma-1 Receptor Agonists (Mechanism)Uncompetitive NMDA Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 65131-100_cc073936-6e23-479a-a8cc-63e844f4bfb0SPL ID cc073936-6e23-479a-a8cc-63e844f4bfb0SPL set ID deecdb72-4cdb-4d6f-972f-a425a91afa5aRxCUI 1046631UNII 9D2RTI9KYH, 495W7451VQUPC 0805418091080
- Pharmacologic class
- Expectorant; Sigma-1 Agonist; Uncompetitive N-methyl-D-aspartate Receptor Antagonist
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N465131010091followed by a unit qualifier and the quantityPackage 65131-0100-91. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Indications and Usage Temporarily relieves cough due to minor throat and bronchial irritation occuring with common cold. Helps loosen phlegm (mucus) and dilute bronchial secretions to make coughs more productive. This new formulation with aloe results a natural cleanser, penetrates tissue, bactericidal, viruscidal, and fungicidal, enhances normal cell proliferation and moisturizes tissues (this statements are not yet evaluated by the Food and Drugs Administration "FDA") Broncochem Maximum Cough has not drowsiness effect. Work in chest congestion, its specially formulated for children and adults.
Excerpt only. Read the full label for complete information.
About NDC 65131-100
- What is NDC 65131-100?
- 65131-100 is the product NDC for Broncochem Maximum Cough (dextromethorphan hbr-gyaifenesin), Dextromethorphan hydrobromide 20 mg/10mL; Guaifenesin 400 mg/10mL syrup, listed with the FDA by LABORATORIO MAGNACHEM INTERNATIONAL SRL. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Broncochem Maximum Cough (DEXTROMETHORPHAN HBr-GYAIFENESIN).
- What is the active ingredient?
- Dextromethorphan hydrobromide, Guaifenesin.
- Who is the labeler?
- LABORATORIO MAGNACHEM INTERNATIONAL SRL, NDC labeler code 65131. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Broncochem Maximum Cough?
- 1 other product NDC are listed under this name. See all Broncochem Maximum Cough NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Broncochem Maximum Cough products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Broncochem Maximum Coughdextromethorphan hbr-gyaifenesin | Dextromethorphan hydrobromide 30 mg/10mL; Guaifenesin 200 mg/10mL | SyrupOral | LABORATORIO MAGNACHEM INTERNATIONAL SRL | 65131-091 | 65131-0091-08 |
Other NDCs under M
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Broncochem Maximum Cough Kidsdextromethorphan hbr-guaifenesin | Dextromethorphan hydrobromide 10 mg/15mL; Guaifenesin 100 mg/15mL | SyrupOral | LABORATORIO MAGNACHEM INTERNATIONAL SRL | 65131-180 |
| Hydrocortisonehydrocortisone cream | Hydrocortisone acetate 10 mg/g | CreamTopical | HART Health | 50332-0092 |
| First Aid and Burnbenzalkonium chloride, lidocaine | Benzalkonium chloride .13 g/100g; Lidocaine .5 g/100g | CreamTopical | HART Health | 50332-0091 |
| Tribioticbacitracin zinc, neomycin sulfate, polymyxin b sulfate | Bacitracin zinc 400 [iU]/g + 2 more ingredients | OintmentTopical | HART Health | 50332-0093 |
| Hand Sanitizerantiseptic gel | Alcohol 62 g/100g | GelTopical | HART Health | 50332-0094 |
| Tribioticbacitracin zinc, neomycin sulfate, polymyxin b sulfate | Bacitracin zinc 400 [iU]/g + 2 more ingredients | OintmentTopical | HART Health | 50332-0095 |
| Therastatcherry cough drops | Menthol 5.8 mg/1 | LozengeOral | HART Health | 50332-0137 |
| Aspirin | Aspirin 325 mg/1 | TabletOral | HART Health | 50332-0139 |
| CETAFEN COUGH and COLDacetaminophen, dextromethorphan hbr, phenylephrine hcl , guaifenesin, , | Guaifenesin 100 mg/1 + 3 more ingredients | Tablet, Film coatedOral | HART Health | 50332-0141 |
| Hand Sanitizer Solution 101benzalkonium chloride | Benzalkonium chloride 13 kg/100kg | LiquidTopical | Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc. | 50241-224 |
| Histaprindiphenhydramine | Diphenhydramine hydrochloride 25 mg/1 | TabletOral | NorMed | 50332-0150 |
| IT Cosmetics Your Skin But Better CC Plus Color Correcting Broad Spectrum SPF 50 Plus Sunscreen Full Coverage Deep Deep Honey Deep Bronze Neutral Deep Deep Mocha Tan Cool Rich Cool Deep Cool Neutral Richhomosalate, octisalate and octocrylene | Homosalate 100 mg/mL + 2 more ingredients | CreamTopical | LOreal USA Products Inc | 49967-904 |
| Cetafenacetaminophen | Acetaminophen 325 mg/1 | TabletOral | HART Health | 50332-0148 |
| MG DermaClean | Benzalkonium chloride .13 g/100g | LiquidTopical | Morgan Gallacher Inc. | 50241-014 |
| MG FoamSan 70ethyl alcohol | Alcohol .7 L/L | LiquidTopical | Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc. | 50241-223 |
| Cetafen Extraacetaminophen | Acetaminophen 500 mg/1 | TabletOral | HART Health | 50332-0149 |
| MG DermaGel 62ethyl alcohol | Alcohol .62 L/L | LiquidTopical | Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc. | 50241-326 |
| Cetirzacetirizine hcl | Cetirizine hydrochloride 10 mg/1 | TabletOral | HART Health | 50332-0154 |
| MG DermaSan | Benzalkonium chloride .1 g/100g | LiquidTopical | Morgan Gallacher Inc. | 50241-259 |
| Nutraloxcalcium carbonate | Calcium carbonate 420 mg/1 | Tablet, ChewableOral | HART Health | 50332-0151 |
Showing 20 of 40.