topcare day time cold and flu relief multi symptom relief

Generic: acetaminophen, dextromethorphan hbr, phenylephrine hcl

Labeler: topco associates llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name topcare day time cold and flu relief multi symptom relief
Generic Name acetaminophen, dextromethorphan hbr, phenylephrine hcl
Labeler topco associates llc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

acetaminophen 325 mg/15mL, dextromethorphan hydrobromide 10 mg/15mL, phenylephrine hydrochloride 5 mg/15mL

Manufacturer
Topco Associates LLC

Identifiers & Regulatory

Product NDC 36800-522
Product ID 36800-522_df6a549c-a593-42bb-9695-07a32df43c4c
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2027-12-31
Marketing Start 2006-07-17

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 36800522
Hyphenated Format 36800-522

Supplemental Identifiers

RxCUI
1113705
UNII
362O9ITL9D 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 topcare day time cold and flu relief multi symptom relief (source: ndc)
Generic Name acetaminophen, dextromethorphan hbr, phenylephrine hcl (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/15mL
  • 10 mg/15mL
  • 5 mg/15mL
source: ndc
Packaging
  • 237 mL in 1 BOTTLE (36800-522-34)
  • 355 mL in 1 BOTTLE (36800-522-40)
source: ndc

Packages (2)

36800-522-34 237 mL in 1 BOTTLE (36800-522-34) 36800-522-40 355 mL in 1 BOTTLE (36800-522-40)

Ingredients (3)

acetaminophen (325 mg/15mL) dextromethorphan hydrobromide (10 mg/15mL) phenylephrine hydrochloride (5 mg/15mL)

Linked Drug Pages (0)

No linked drugs yet.

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "df6a549c-a593-42bb-9695-07a32df43c4c", "openfda": {"unii": ["362O9ITL9D", "9D2RTI9KYH", "04JA59TNSJ"], "rxcui": ["1113705"], "spl_set_id": ["6d08ca2d-6ae4-443f-9920-34b7fb46f2b4"], "manufacturer_name": ["Topco Associates LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "237 mL in 1 BOTTLE (36800-522-34)", "package_ndc": "36800-522-34", "marketing_start_date": "20120718"}, {"sample": false, "description": "355 mL in 1 BOTTLE (36800-522-40)", "package_ndc": "36800-522-40", "marketing_start_date": "20120710"}], "brand_name": "topcare day time cold and flu relief multi symptom relief", "product_id": "36800-522_df6a549c-a593-42bb-9695-07a32df43c4c", "dosage_form": "SOLUTION", "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": "36800-522", "generic_name": "acetaminophen, dextromethorphan Hbr, Phenylephrine HCl", "labeler_name": "Topco Associates LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "topcare day time cold and flu relief", "brand_name_suffix": "multi symptom relief", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/15mL"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "10 mg/15mL"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "5 mg/15mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20060717", "listing_expiration_date": "20271231"}