Over-the-counter drug · OTC MONOGRAPH FINAL
Broncochem Kids Allergy Control NDC 65131-418
chlorpheniramine maleate-dextromethrophan hbr · Chlorpheniramine maleate 2 mg/10mL; Dextromethorphan hydrobromide 10 mg/10mL · Syrup · Oral · LABORATORIO MAGANCEHM INTERNATIONAL SRL
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65131-418-09 | 6513104180965131041809 | 1 BOTTLE, PLASTIC in 1 BOX (65131-418-09) / 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 Allergy ControlSuffix: KIDS ALLERGY CONTROL
- Generic name (nonproprietary)
- chlorpheniramine maleate-dextromethrophan hbr
- Active ingredients
- Chlorpheniramine maleate — 2 mg/10mLDextromethorphan hydrobromide — 10 mg/10mL
- Dosage form
- Syrup
- Route
- Oral
- Labeler
- LABORATORIO MAGANCEHM 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
- Histamine H1 Receptor Antagonists (Mechanism)Sigma-1 Receptor Agonists (Mechanism)Uncompetitive NMDA Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 65131-418_d42910c8-7859-41af-ae13-a7e442b6924fSPL ID d42910c8-7859-41af-ae13-a7e442b6924fSPL set ID 36574266-a6ca-443d-9e1d-85240aabe8a2RxCUI 636568UNII V1Q0O9OJ9Z, 9D2RTI9KYHUPC 0805418098461
- Pharmacologic class
- Histamine-1 Receptor Antagonist; 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
N465131041809followed by a unit qualifier and the quantityPackage 65131-0418-09. 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 cold symptoms, cough, helps loosen phlegm (mucus) and dilute bronchial secretions to make coughs more productive. Reduces allergic symptoms like runny nose and sneezing, irritated ans watery eyes, Itchy nose, Itchy throat, Allergy rhinitis
Excerpt only. Read the full label for complete information.
About NDC 65131-418
- What is NDC 65131-418?
- 65131-418 is the product NDC for Broncochem Kids Allergy Control, Chlorpheniramine maleate 2 mg/10mL; Dextromethorphan hydrobromide 10 mg/10mL syrup, listed with the FDA by LABORATORIO MAGANCEHM INTERNATIONAL SRL. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Broncochem Kids Allergy Control (Chlorpheniramine maleate-Dextromethrophan HBr).
- What is the active ingredient?
- Chlorpheniramine maleate, Dextromethorphan hydrobromide.
- Who is the labeler?
- LABORATORIO MAGANCEHM 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 Allergy Control?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
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 |
|---|---|---|---|---|
| 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 Kids Cold And Fluacetaminophen-phenylephrine hcl-guaifenesin | Acetaminophen 325 mg/10mL + 2 more ingredients | SyrupOral | LABORATORIO MAGNACHEM INTERNATIONAL SRL | 65131-054 |
| 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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