Over-the-counter drug · OTC MONOGRAPH FINAL
Broncochem Kids Cold And Flu NDC 65131-054
acetaminophen-phenylephrine hcl-guaifenesin · Acetaminophen 325 mg/10mL + 2 more ingredients · Syrup · Oral · LABORATORIO MAGNACHEM INTERNATIONAL SRL
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65131-054-18 | 6513100541865131005418 | 1 BOTTLE, PLASTIC in 1 BOX (65131-054-18) / 120 mL in 1 BOTTLE, PLASTICMarketed from May 1, 2017 |
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 Kids Cold And FluSuffix: KIDS COLD AND FLU
- Generic name (nonproprietary)
- acetaminophen-phenylephrine hcl-guaifenesin
- Active ingredients
- Acetaminophen — 325 mg/10mLPhenylephrine hydrochloride — 5 mg/10mLGuaifenesin — 200 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 (final)Application part341
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha1-Agonists (Mechanism)
- Identifiers
- Product ID 65131-054_7ec85034-cc70-4465-bc25-9c700731eb02SPL ID 7ec85034-cc70-4465-bc25-9c700731eb02SPL set ID 523561fb-f6a7-4cde-9be2-bba02e60e208RxCUI 1116568UNII 362O9ITL9D, 04JA59TNSJ, 495W7451VQUPC 0805418098447
- Pharmacologic class
- 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
N465131005418followed by a unit qualifier and the quantityPackage 65131-0054-18. 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 Bronchial congestion, irritation of the respiratory passages, helps loosen phlegm (mucus) and dilute bronchial secretions, temporarily reduces fever and minor pains associated with cold, headache, and sore throat.
Excerpt only. Read the full label for complete information.
About NDC 65131-054
- What is NDC 65131-054?
- 65131-054 is the product NDC for Broncochem Kids Cold And Flu, Acetaminophen 325 mg/10mL + 2 more ingredients 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 Kids Cold And Flu (ACETAMINOPHEN-PHENYLEPHRINE HCl-GUAIFENESIN).
- What is the active ingredient?
- Acetaminophen, Phenylephrine hydrochloride, 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 Kids Cold And Flu?
- 1 other product NDC are listed under this name. See all Broncochem Kids Cold And Flu NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Broncochem Kids Cold And Flu 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 Kids Cold And Fluacetaminophen-phenylephrine hcl-guaifenesin | Acetaminophen 325 mg/10mL + 2 more ingredients | SyrupOral | LABORATORIO MAGNACHEM INTERNATIONAL SRL | 65131-109 | 65131-0109-84 |
Other NDCs under part341
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 Kids Allergy Controlchlorpheniramine maleate-dextromethrophan hbr | Chlorpheniramine maleate 2 mg/10mL; Dextromethorphan hydrobromide 10 mg/10mL | SyrupOral | LABORATORIO MAGANCEHM INTERNATIONAL SRL | 65131-418 |
| Weeks and Leo Medicated Vaporizing Steamcamphor (synthetic) | Camphor (Synthetic) .623 g/10mL | LiquidRespiratory (Inhalation) | Weeks & Leo Co., Inc. | 11383-256 |
| Best Choice Effervescent Cold Reliefaspirin, chlorpheniramine maleate, phenylephrine bitartrate | Aspirin 325 mg/1 + 2 more ingredients | Tablet, EffervescentOral | Valu Merchandiser Company | 63941-873 |
| CVS Health Nighttime Sleep Aiddiphenhydramine hydrochloride | Diphenhydramine hydrochloride 50 mg/30mL | LiquidOral | CVS Pharmacy,Inc. | 69842-753 |
| Broncochem Maximum Coughdextromethorphan hbr-gyaifenesin | Dextromethorphan hydrobromide 30 mg/10mL; Guaifenesin 200 mg/10mL | SyrupOral | LABORATORIO MAGNACHEM INTERNATIONAL SRL | 65131-091 |
| Assured Vaporizing Chest Rubcamphor and eucalyptus oil and menthol | Camphor (Synthetic) 4.7 g/100g + 2 more ingredients | OintmentTopical | Greenbrier International, Inc. | 33992-7991 |
| Assured Vaporizing Chest Rubcamphor and eucalyptus oil and menthol | Camphor (Synthetic) 4.7 g/100g + 2 more ingredients | OintmentTopical | Greenbrier International, Inc. | 33992-7992 |
| Broncochem Allergy Controlcholpheniramine maleate-phenylephrine hcl | Chlorpheniramine maleate 4 mg/10mL; Phenylephrine hydrochloride 10 mg/10mL | SyrupOral | LABORATORIO MAGNACHEM INTERNATIONAL SRL | 65131-098 |
| Diphenhydramine Hydrochloride | Diphenhydramine hydrochloride 50 mg/1 | TabletOral | Advance Pharmaceutical Inc. | 17714-023 |
| Diphenhydramine Hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | CapsuleOral | Advance Pharmaceutical Inc. | 17714-020 |
| Diphenhydramine Hydrochloride | Diphenhydramine hydrochloride 50 mg/1 | CapsuleOral | Advance Pharmaceutical Inc. | 17714-021 |
| Diphenhydramine Hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | TabletOral | Advance Pharmaceutical Inc. | 17714-135 |
| Childrens Multi-symptom Cold Daytimedextromethorphan hbr, guaifenesin, phenylephrine hcl | Dextromethorphan hydrobromide 5 mg/5mL + 2 more ingredients | LiquidOral | Wal-Mart Stores, Inc. | 79903-270 |
| Effervescent Cold Reliefaspirin, chlorpheniramine maleate, phenylephrine bitartrate | Aspirin 325 mg/1 + 2 more ingredients | Tablet, EffervescentOral | Discount Drug Mart | 53943-873 |
| Acetaminophen PM | Acetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1 | TabletOral | Advance Pharmaceutical Inc. | 17714-133 |
| Mucus Relief Cough and Congestion DMguaifenesin and dextromethorphan hbr | Dextromethorphan hydrobromide 20 mg/1; Guaifenesin 400 mg/1 | TabletOral | Advance Pharmaceutical Inc. | 17714-150 |
| Childrens Multi-symptom Cold and Fever Liquidacetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl | Acetaminophen 325 mg/10mL + 3 more ingredients | LiquidOral | Wal-Mart Stores, Inc. | 49035-772 |
| Mucus Reliefguaifenesin 400 mg | Guaifenesin 400 mg/1 | TabletOral | Advance Pharmaceutical Inc. | 17714-152 |
| Childrens Mucus and Cough Reliefdextromethorphan hbr, guaifenesin | Dextromethorphan hydrobromide 5 mg/5mL; Guaifenesin 100 mg/5mL | LiquidOral | Family Dollar Services, Inc. | 55319-924 |
| Tukol Adextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride | Dextromethorphan hydrobromide 5 mg/5mL + 2 more ingredients | LiquidOral | Genomma Lab USA, Inc. | 50066-536 |
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