cold and flu severe daytime/nighttime

Generic: acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, doxylamine succinate

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

Drug Facts

Product Profile

Brand Name cold and flu severe daytime/nighttime
Generic Name acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, doxylamine succinate
Labeler topco associates llc
Dosage Form KIT
Manufacturer
Topco Associates LLC

Identifiers & Regulatory

Product NDC 76162-823
Product ID 76162-823_1cf9fc29-a15e-4aa0-b169-7eab1ff6d123
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2023-11-03

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76162823
Hyphenated Format 76162-823

Supplemental Identifiers

RxCUI
1297288 1656815 2634364

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 cold and flu severe daytime/nighttime (source: ndc)
Generic Name acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, doxylamine succinate (source: ndc)
Application Number M012 (source: ndc)

Resolved Composition

Strengths
  • 325 mg
  • 10 mg
  • 200 mg
  • 5 mg
  • 6.25 mg
source: label
Packaging
  • 1 KIT in 1 CARTON (76162-823-12) * 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK * 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
source: ndc

Packages (1)

76162-823-12 1 KIT in 1 CARTON (76162-823-12) * 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK * 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

Cold and Flu Severe Daytime/Nighttime ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "1cf9fc29-a15e-4aa0-b169-7eab1ff6d123", "openfda": {"rxcui": ["1297288", "1656815", "2634364"], "spl_set_id": ["27ade5f8-2003-4dc6-9244-42676791e1f8"], "manufacturer_name": ["Topco Associates LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 KIT in 1 CARTON (76162-823-12)  *  12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK *  12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK", "package_ndc": "76162-823-12", "marketing_start_date": "20231103"}], "brand_name": "Cold and Flu Severe Daytime/Nighttime", "product_id": "76162-823_1cf9fc29-a15e-4aa0-b169-7eab1ff6d123", "dosage_form": "KIT", "product_ndc": "76162-823", "generic_name": "Acetaminophen, Dextromethorphan hydrobromide, Guaifenesin, Phenylephrine hydrochloride, Doxylamine succinate", "labeler_name": "Topco Associates LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Cold and Flu Severe Daytime/Nighttime", "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20231103", "listing_expiration_date": "20261231"}