Over-the-counter drug · OTC MONOGRAPH DRUG
Broncochem Cold And Flu Caplets NDC 65131-111
acetaminophen-dextromethorphan hbr-phenylephrine hcl-chlorpheniramine maleate · Acetaminophen 325 mg/1 + 3 more ingredients · Tablet, Coated · Oral · LABORATORIO MAGNACHEM INTERNATIONAL SRL
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65131-111-95 | 6513101119565131011195 | 50 POUCH in 1 BOX (65131-111-95) / 2 TABLET, COATED in 1 POUCHMarketed from Jan 2, 2024 |
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 Cold And Flu CapletsSuffix: COLD AND FLU CAPLETS
- Generic name (nonproprietary)
- acetaminophen-dextromethorphan hbr-phenylephrine hcl-chlorpheniramine maleate
- Active ingredients
- Acetaminophen — 325 mg/1Dextromethorphan hydrobromide — 30 mg/1Phenylephrine hydrochloride — 5 mg/1Chlorpheniramine maleate — 3 mg/1
- Dosage form
- Tablet, Coated
- Route
- Oral
- Labeler
- LABORATORIO MAGNACHEM INTERNATIONAL SRLNDC labeler code 65131
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication C 200263
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha1-Agonists (Mechanism)Histamine H1 Receptor Antagonists (Mechanism)Sigma-1 Receptor Agonists (Mechanism)Uncompetitive NMDA Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 65131-111_75397c61-93f4-4d4d-9e3a-81107ecb0932SPL ID 75397c61-93f4-4d4d-9e3a-81107ecb0932SPL set ID ac4f6a39-e455-4d33-8bb8-ae8dc6ebc2f6RxCUI 1744049UNII 362O9ITL9D, 9D2RTI9KYH, 04JA59TNSJ, V1Q0O9OJ9Z
- Pharmacologic class
- Histamine-1 Receptor Antagonist; Sigma-1 Agonist; Uncompetitive N-methyl-D-aspartate Receptor Antagonist; alpha-1 Adrenergic Agonist
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
N465131011195followed by a unit qualifier and the quantityPackage 65131-0111-95. 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 Bronchial congestion, irritation of the respiratory passages, nasal congestion. Antitussive, temporary reliev of allergy symptoms including runny nose, sneezing, stuffy nose, itchy nose, itchy throat, irritated and watery eyes, allergy rhinitis
Excerpt only. Read the full label for complete information.
About NDC 65131-111
- What is NDC 65131-111?
- 65131-111 is the product NDC for Broncochem Cold And Flu Caplets, Acetaminophen 325 mg/1 + 3 more ingredients tablet, coated, 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 Cold And Flu Caplets (Acetaminophen-Dextromethorphan HBr-Phenylephrine HCl-Chlorpheniramine Maleate).
- What is the active ingredient?
- Acetaminophen, Dextromethorphan hydrobromide, Phenylephrine hydrochloride, Chlorpheniramine 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 Cold And Flu Caplets?
- 1 other product NDC are listed under this name. See all Broncochem Cold And Flu Caplets NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Broncochem Cold And Flu Caplets 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 Cold And Flu Capletsacetaminophen-dextromethorphan hbr-phenylephrine hcl-chlorpheniramine maleate | Acetaminophen 325 mg/1 + 3 more ingredients | Tablet, CoatedOral | LABORATORIO MAGNACHEM INTERNATIONAL SRL | 65131-101 | 65131-0101-11 |
Other NDCs under C 200263
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 Cold And Flu Capletsacetaminophen-dextromethorphan hbr-phenylephrine hcl-chlorpheniramine maleate | Acetaminophen 325 mg/1 + 3 more ingredients | Tablet, CoatedOral | LABORATORIO MAGNACHEM INTERNATIONAL SRL | 65131-101 |