Home NDC 51467-012 COLTALIN-DM
Product NDC 51467-012
11-digit product format 514670012
Labeler code 51467
Product ID 51467-012_5bb2b1bb-0b8f-02a6-e063-6294a90a0763
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Chlorpheniramine maleate, Dextromethorphan Hydrobromide, Phenylephrine hydrochloride
Dosage form TABLET
Route ORAL
Labeler FORTUNE PHARMACAL COMPANY LIMITED
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-07-01
Marketing end 2029-06-30
Substance ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength 325; 2; 10; 5 mg/1; mg/1; mg/1; mg/1
Pharmacologic 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]
NDC exclude flag No
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base COLTALIN-DM Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 325 mg/1 CHLORPHENIRAMINE MALEATE 2 mg/1 DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1 PHENYLEPHRINE HYDROCHLORIDE 5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 4 matching rows.
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1086991 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 51467-012-01 COLTALIN-DM 2 in 1 BOX TABLET 2 3 51467-012-01 COLTALIN-DM 12 in 1 BLISTER PACK TABLET 12 3 51467-012-02 COLTALIN-DM 3 in 1 BOX TABLET 3 3 51467-012-02 COLTALIN-DM 12 in 1 BLISTER PACK TABLET 12 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51467-012 COLTALIN-DM (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) TABLET [FORTUNE PHARMACAL COMPANY LIMITED] 1 Current NDC, 4 package rows 20241228_33e1bec0-323b-40b7-809a-cb65a71ad0ce.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 74 of 180 · 3,583 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 51467-012-01 51467001201 2 BLISTER PACK in 1 BOX (51467-012-01) / 12 TABLET in 1 BLISTER PACK 2 blister pack 2025-07-01 2029-06-30 No No Historical 51467-012-02 51467001202 3 BLISTER PACK in 1 BOX (51467-012-02) / 12 TABLET in 1 BLISTER PACK 3 blister pack 2025-07-01 2029-06-30 No No Historical