coltalin

Generic: acetaminophen, chlorpheniramine maleate, phenylephrine hydrochloride

Labeler: fortune pharmacal company limited
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name coltalin
Generic Name acetaminophen, chlorpheniramine maleate, phenylephrine hydrochloride
Labeler fortune pharmacal company limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

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

Manufacturer
FORTUNE PHARMACAL COMPANY LIMITED

Identifiers & Regulatory

Product NDC 51467-005
Product ID 51467-005_4abe57bb-45ad-ba3e-e063-6394a90a2df6
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2027-12-31
Marketing Start 2004-03-01

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 51467005
Hyphenated Format 51467-005

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 coltalin (source: ndc)
Generic Name acetaminophen, chlorpheniramine maleate, phenylephrine hydrochloride (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
  • 2 BLISTER PACK in 1 BOX (51467-005-01) / 12 TABLET in 1 BLISTER PACK
  • 3 BLISTER PACK in 1 BOX (51467-005-02) / 12 TABLET in 1 BLISTER PACK
source: ndc

Packages (2)

51467-005-01 2 BLISTER PACK in 1 BOX (51467-005-01) / 12 TABLET in 1 BLISTER PACK 51467-005-02 3 BLISTER PACK in 1 BOX (51467-005-02) / 12 TABLET in 1 BLISTER PACK

Ingredients (3)

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

Linked Drug Pages (1)

COLTALIN ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4abe57bb-45ad-ba3e-e063-6394a90a2df6", "openfda": {"unii": ["362O9ITL9D", "V1Q0O9OJ9Z", "04JA59TNSJ"], "rxcui": ["1046781"], "spl_set_id": ["01ab1152-06c9-4afe-8f2a-e110365275a5"], "manufacturer_name": ["FORTUNE PHARMACAL COMPANY LIMITED"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BLISTER PACK in 1 BOX (51467-005-01)  / 12 TABLET in 1 BLISTER PACK", "package_ndc": "51467-005-01", "marketing_start_date": "20040301"}, {"sample": false, "description": "3 BLISTER PACK in 1 BOX (51467-005-02)  / 12 TABLET in 1 BLISTER PACK", "package_ndc": "51467-005-02", "marketing_start_date": "20160426"}], "brand_name": "COLTALIN", "product_id": "51467-005_4abe57bb-45ad-ba3e-e063-6394a90a2df6", "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": "51467-005", "generic_name": "Acetaminophen, Chlorpheniramine maleate, Phenylephrine hydrochloride", "labeler_name": "FORTUNE PHARMACAL COMPANY LIMITED", "product_type": "HUMAN OTC DRUG", "brand_name_base": "COLTALIN", "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": "20040301", "listing_expiration_date": "20271231"}