topcare day time nite time cold and flu

Generic: acetaminophen, dextromethorphan hbr, doxylamine succinate, 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 nite time cold and flu
Generic Name acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl
Labeler topco associates llc
Dosage Form KIT
Manufacturer
Topco Associates LLC

Identifiers & Regulatory

Product NDC 36800-597
Product ID 36800-597_a7aa4962-fcb9-4261-99b7-486197c0d1aa
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2014-06-28

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 36800597
Hyphenated Format 36800-597

Supplemental Identifiers

RxCUI
1369842 1431245 2637731

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 nite time cold and flu (source: ndc)
Generic Name acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl (source: ndc)
Application Number M012 (source: ndc)

Resolved Composition

Strengths
  • 30 ml
  • 650 mg
  • 20 mg
  • 12.5 mg
  • 10 mg
  • 15 ml
  • 325 mg
  • 200 mg
  • 5 mg
source: label
Packaging
  • 1 KIT in 1 CARTON (36800-597-02) * 355 mL in 1 BOTTLE (36800-763-40) * 355 mL in 1 BOTTLE (36800-603-40)
source: ndc

Packages (1)

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"spl_id": "a7aa4962-fcb9-4261-99b7-486197c0d1aa", "openfda": {"rxcui": ["1369842", "1431245", "2637731"], "spl_set_id": ["aed387e0-5a8b-4caf-a373-3e04496a4983"], "manufacturer_name": ["Topco Associates LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 KIT in 1 CARTON (36800-597-02)  *  355 mL in 1 BOTTLE (36800-763-40)  *  355 mL in 1 BOTTLE (36800-603-40)", "package_ndc": "36800-597-02", "marketing_start_date": "20140628"}], "brand_name": "Topcare Day Time Nite Time Cold and Flu", "product_id": "36800-597_a7aa4962-fcb9-4261-99b7-486197c0d1aa", "dosage_form": "KIT", "product_ndc": "36800-597", "generic_name": "acetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl", "labeler_name": "Topco Associates LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Topcare Day Time Nite Time Cold and Flu", "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20140628", "listing_expiration_date": "20261231"}