coltalin-nd

Generic: acetaminophen, phenylephrine hydrochloride

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

Drug Facts

Product Profile

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

acetaminophen 325 mg/1, phenylephrine hydrochloride 5 mg/1

Manufacturer
FORTUNE PHARMACAL COMPANY LIMITED

Identifiers & Regulatory

Product NDC 51467-013
Product ID 51467-013_4abf20fb-7d7c-4af9-e063-6294a90ad924
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2027-12-31
Marketing Start 2026-01-30

Pharmacologic Class

Classes
adrenergic alpha1-agonists [moa] alpha-1 adrenergic agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 51467013
Hyphenated Format 51467-013

Supplemental Identifiers

RxCUI
1046378
UNII
362O9ITL9D 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-nd (source: ndc)
Generic Name acetaminophen, phenylephrine hydrochloride (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/1
  • 5 mg/1
source: ndc
Packaging
  • 2 BLISTER PACK in 1 BOX (51467-013-01) / 12 TABLET in 1 BLISTER PACK
  • 3 BLISTER PACK in 1 BOX (51467-013-02) / 12 TABLET in 1 BLISTER PACK
source: ndc

Packages (2)

51467-013-01 2 BLISTER PACK in 1 BOX (51467-013-01) / 12 TABLET in 1 BLISTER PACK 51467-013-02 3 BLISTER PACK in 1 BOX (51467-013-02) / 12 TABLET in 1 BLISTER PACK

Ingredients (2)

acetaminophen (325 mg/1) phenylephrine hydrochloride (5 mg/1)

Linked Drug Pages (1)

COLTALIN-ND ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4abf20fb-7d7c-4af9-e063-6294a90ad924", "openfda": {"unii": ["362O9ITL9D", "04JA59TNSJ"], "rxcui": ["1046378"], "spl_set_id": ["7373ad43-0afa-4d21-8afc-a737e9f19290"], "manufacturer_name": ["FORTUNE PHARMACAL COMPANY LIMITED"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BLISTER PACK in 1 BOX (51467-013-01)  / 12 TABLET in 1 BLISTER PACK", "package_ndc": "51467-013-01", "marketing_start_date": "20260130"}, {"sample": false, "description": "3 BLISTER PACK in 1 BOX (51467-013-02)  / 12 TABLET in 1 BLISTER PACK", "package_ndc": "51467-013-02", "marketing_start_date": "20260130"}], "brand_name": "COLTALIN-ND", "product_id": "51467-013_4abf20fb-7d7c-4af9-e063-6294a90ad924", "dosage_form": "TABLET", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "51467-013", "generic_name": "Acetaminophen, Phenylephrine hydrochloride", "labeler_name": "FORTUNE PHARMACAL COMPANY LIMITED", "product_type": "HUMAN OTC DRUG", "brand_name_base": "COLTALIN-ND", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/1"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20260130", "listing_expiration_date": "20271231"}