pediacare childrens cough and cold grape

Generic: brompheniramine maleate, dextromethorphan hydrobromide, and phenylephrine hydrochloride

Labeler: randob labs,ltd. dba crossingwell consumer health
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name pediacare childrens cough and cold grape
Generic Name brompheniramine maleate, dextromethorphan hydrobromide, and phenylephrine hydrochloride
Labeler randob labs,ltd. dba crossingwell consumer health
Dosage Form SYRUP
Routes
ORAL
Active Ingredients

brompheniramine maleate 2 mg/10mL, dextromethorphan hydrobromide 10 mg/10mL, phenylephrine hydrochloride 5 mg/10mL

Manufacturer
RANDOB LABS,LTD. DBA CROSSINGWELL CONSUMER HEALTH

Identifiers & Regulatory

Product NDC 52412-920
Product ID 52412-920_2a813b38-77a1-e4a0-e063-6394a90a9303
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2023-01-03

Pharmacologic Class

Classes
adrenergic alpha1-agonists [moa] sigma-1 agonist [epc] sigma-1 receptor agonists [moa] uncompetitive n-methyl-d-aspartate receptor antagonist [epc] uncompetitive nmda receptor antagonists [moa] alpha-1 adrenergic agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 52412920
Hyphenated Format 52412-920

Supplemental Identifiers

RxCUI
1090463
UNII
IXA7C9ZN03 9D2RTI9KYH 04JA59TNSJ

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name pediacare childrens cough and cold grape (source: ndc)
Generic Name brompheniramine maleate, dextromethorphan hydrobromide, and phenylephrine hydrochloride (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/10mL
  • 10 mg/10mL
  • 5 mg/10mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (52412-920-01) / 118 mL in 1 BOTTLE
source: ndc

Packages (1)

52412-920-01 1 BOTTLE in 1 CARTON (52412-920-01) / 118 mL in 1 BOTTLE

Ingredients (3)

brompheniramine maleate (2 mg/10mL) dextromethorphan hydrobromide (10 mg/10mL) phenylephrine hydrochloride (5 mg/10mL)

Linked Drug Pages (1)

Pediacare Childrens Cough and Cold Grape ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2a813b38-77a1-e4a0-e063-6394a90a9303", "openfda": {"unii": ["IXA7C9ZN03", "9D2RTI9KYH", "04JA59TNSJ"], "rxcui": ["1090463"], "spl_set_id": ["fabafdc1-9dd8-4258-af49-bab1e29ad109"], "manufacturer_name": ["RANDOB LABS,LTD. DBA CROSSINGWELL CONSUMER HEALTH"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (52412-920-01)  / 118 mL in 1 BOTTLE", "package_ndc": "52412-920-01", "marketing_start_date": "20230103"}], "brand_name": "Pediacare Childrens Cough and Cold Grape", "product_id": "52412-920_2a813b38-77a1-e4a0-e063-6394a90a9303", "dosage_form": "SYRUP", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "Sigma-1 Agonist [EPC]", "Sigma-1 Receptor Agonists [MoA]", "Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]", "Uncompetitive NMDA Receptor Antagonists [MoA]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "52412-920", "generic_name": "BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE", "labeler_name": "RANDOB LABS,LTD. DBA CROSSINGWELL CONSUMER HEALTH", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Pediacare Childrens Cough and Cold Grape", "active_ingredients": [{"name": "BROMPHENIRAMINE MALEATE", "strength": "2 mg/10mL"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "10 mg/10mL"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "5 mg/10mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20230103", "listing_expiration_date": "20261231"}