coltalin-dm

Generic: acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride

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

Drug Facts

Product Profile

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

acetaminophen 325 mg/1, chlorpheniramine maleate 2 mg/1, dextromethorphan hydrobromide 10 mg/1, phenylephrine hydrochloride 5 mg/1

Manufacturer
FORTUNE PHARMACAL COMPANY LIMITED

Identifiers & Regulatory

Product NDC 51467-012
Product ID 51467-012_4abed885-390f-e1cb-e063-6294a90ac3b5
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] histamine h1 receptor antagonists [moa] histamine-1 receptor antagonist [epc] sigma-1 agonist [epc] sigma-1 receptor agonists [moa] uncompetitive n-methyl-d-aspartate receptor antagonist [epc] uncompetitive nmda receptor antagonists [moa] alpha-1 adrenergic agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 51467012
Hyphenated Format 51467-012

Supplemental Identifiers

RxCUI
1086991
UNII
362O9ITL9D V1Q0O9OJ9Z 9D2RTI9KYH 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-dm (source: ndc)
Generic Name acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/1
  • 2 mg/1
  • 10 mg/1
  • 5 mg/1
source: ndc
Packaging
  • 2 BLISTER PACK in 1 BOX (51467-012-01) / 12 TABLET in 1 BLISTER PACK
  • 3 BLISTER PACK in 1 BOX (51467-012-02) / 12 TABLET in 1 BLISTER PACK
source: ndc

Packages (2)

51467-012-01 2 BLISTER PACK in 1 BOX (51467-012-01) / 12 TABLET in 1 BLISTER PACK 51467-012-02 3 BLISTER PACK in 1 BOX (51467-012-02) / 12 TABLET in 1 BLISTER PACK

Ingredients (4)

acetaminophen (325 mg/1) chlorpheniramine maleate (2 mg/1) dextromethorphan hydrobromide (10 mg/1) phenylephrine hydrochloride (5 mg/1)

Linked Drug Pages (1)

COLTALIN-DM ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4abed885-390f-e1cb-e063-6294a90ac3b5", "openfda": {"unii": ["362O9ITL9D", "V1Q0O9OJ9Z", "9D2RTI9KYH", "04JA59TNSJ"], "rxcui": ["1086991"], "spl_set_id": ["33e1bec0-323b-40b7-809a-cb65a71ad0ce"], "manufacturer_name": ["FORTUNE PHARMACAL COMPANY LIMITED"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BLISTER PACK in 1 BOX (51467-012-01)  / 12 TABLET in 1 BLISTER PACK", "package_ndc": "51467-012-01", "marketing_start_date": "20260130"}, {"sample": false, "description": "3 BLISTER PACK in 1 BOX (51467-012-02)  / 12 TABLET in 1 BLISTER PACK", "package_ndc": "51467-012-02", "marketing_start_date": "20260130"}], "brand_name": "COLTALIN-DM", "product_id": "51467-012_4abed885-390f-e1cb-e063-6294a90ac3b5", "dosage_form": "TABLET", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]", "Sigma-1 Agonist [EPC]", "Sigma-1 Receptor Agonists [MoA]", "Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]", "Uncompetitive NMDA Receptor Antagonists [MoA]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "51467-012", "generic_name": "Acetaminophen, Chlorpheniramine maleate, Dextromethorphan Hydrobromide, Phenylephrine hydrochloride", "labeler_name": "FORTUNE PHARMACAL COMPANY LIMITED", "product_type": "HUMAN OTC DRUG", "brand_name_base": "COLTALIN-DM", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/1"}, {"name": "CHLORPHENIRAMINE MALEATE", "strength": "2 mg/1"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "10 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"}