Over-the-counter drug · OTC MONOGRAPH DRUG
Broncochem Maximum Cough Night (Dextromethorphan hbr-pyrilamine maleate) NDC 65131-110
Dextromethorphan hydrobromide 30 mg/5mL; Pyrilamine maleate 50 mg/5mL · Syrup · Oral · LABORATORIO MAGNACHEM INTERNATIONAL SRL
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65131-110-35 | 6513101103565131011035 | 1 BOTTLE, PLASTIC in 1 BOX (65131-110-35) / 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 Cough NightSuffix: MAXIMUM COUGH NIGHT
- Generic name (nonproprietary)
- dextromethorphan hbr-pyrilamine maleate
- Active ingredients
- Dextromethorphan hydrobromide — 30 mg/5mLPyrilamine maleate — 50 mg/5mL
- 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
- Sigma-1 Receptor Agonists (Mechanism)Uncompetitive NMDA Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 65131-110_daa4b9dd-bc1f-429e-a32b-613f1b6987e8SPL ID daa4b9dd-bc1f-429e-a32b-613f1b6987e8SPL set ID dffdfa2c-a52e-4606-9b07-c8993e499f09RxCUI 2712157UNII 9D2RTI9KYH, R35D29L3ZAUPC 0805418103585
- Pharmacologic class
- 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
N465131011035followed by a unit qualifier and the quantityPackage 65131-0110-35. 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)
Uses Temporarily relieves these symptoms in all formsof acute, subacute, and cronical cough of any origin, it is very effective in colds, rhinitis, pharyngitis, laryngitis, dry cough, smokers cough, ashma, nervous cough.
Excerpt only. Read the full label for complete information.
About NDC 65131-110
- What is NDC 65131-110?
- 65131-110 is the product NDC for Broncochem Maximum Cough Night (dextromethorphan hbr-pyrilamine maleate), Dextromethorphan hydrobromide 30 mg/5mL; Pyrilamine maleate 50 mg/5mL 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 Night (Dextromethorphan hbr-pyrilamine maleate).
- What is the active ingredient?
- Dextromethorphan hydrobromide, Pyrilamine maleate.
- 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 Night?
- 1 other product NDC are listed under this name. See all Broncochem Maximum Cough Night 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 Night 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 Cough Nightdextromethorphan hbr-pyrilamine maleate | Dextromethorphan hydrobromide 15 mg/5mL; Pyrilamine maleate 6 mg/5mL | SyrupOral | LABORATORIO MAGNACHEM INTERNATIONAL SRL | 65131-035 | 65131-0035-80 |
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 |
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| 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 |
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