cold medicine

Generic: cold medicine

Labeler: allegiant health
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name cold medicine
Generic Name cold medicine
Labeler allegiant health
Dosage Form TABLET
Routes
ORAL
Active Ingredients

acetaminophen 325 mg/1, chlorpheniramine maleate 2 mg/1, phenylephrine hydrochloride 5 mg/1

Manufacturer
Allegiant Health

Identifiers & Regulatory

Product NDC 69168-004
Product ID 69168-004_1e175274-049d-41ae-bef0-2a243661be70
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2021-11-12

Pharmacologic Class

Classes
adrenergic alpha1-agonists [moa] histamine h1 receptor antagonists [moa] histamine-1 receptor antagonist [epc] alpha-1 adrenergic agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69168004
Hyphenated Format 69168-004

Supplemental Identifiers

RxCUI
1046781
UNII
362O9ITL9D V1Q0O9OJ9Z 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 cold medicine (source: ndc)
Generic Name cold medicine (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/1
  • 2 mg/1
  • 5 mg/1
source: ndc
Packaging
  • 20 TABLET in 1 CARTON (69168-004-51)
source: ndc

Packages (1)

Ingredients (3)

acetaminophen (325 mg/1) chlorpheniramine maleate (2 mg/1) phenylephrine hydrochloride (5 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "1e175274-049d-41ae-bef0-2a243661be70", "openfda": {"unii": ["362O9ITL9D", "V1Q0O9OJ9Z", "04JA59TNSJ"], "rxcui": ["1046781"], "spl_set_id": ["443fbc44-2c33-4316-ad31-dcc5a5aa8f52"], "manufacturer_name": ["Allegiant Health"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "20 TABLET in 1 CARTON (69168-004-51)", "package_ndc": "69168-004-51", "marketing_start_date": "20211123"}], "brand_name": "Cold Medicine", "product_id": "69168-004_1e175274-049d-41ae-bef0-2a243661be70", "dosage_form": "TABLET", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "69168-004", "generic_name": "Cold Medicine", "labeler_name": "Allegiant Health", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Cold Medicine", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/1"}, {"name": "CHLORPHENIRAMINE MALEATE", "strength": "2 mg/1"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20211112", "listing_expiration_date": "20261231"}