Home NDC 51467-010 Extra Fast Coltalin
Product NDC 51467-010
11-digit product format 514670010
Labeler code 51467
Product ID 51467-010_5ba0cc05-e11e-e36d-e063-6394a90abb69
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Chlorpheniramine maleate, 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; PHENYLEPHRINE HYDROCHLORIDE
Active strength 325; 2; 5 mg/1; mg/1; mg/1
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], 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 Extra Fast Coltalin Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 325 mg/1 CHLORPHENIRAMINE MALEATE 2 mg/1 PHENYLEPHRINE HYDROCHLORIDE 5 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 51467-010-01 Extra Fast Coltalin 12 in 1 BLISTER PACK TABLET 12 7 51467-010-01 Extra Fast Coltalin 2 in 1 BOX TABLET 2 7 51467-010-02 Extra Fast Coltalin 3 in 1 BOX TABLET 3 7 51467-010-02 Extra Fast Coltalin 12 in 1 BLISTER PACK TABLET 12 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51467-010 EXTRA FAST COLTALIN (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) TABLET [FORTUNE PHARMACAL COMPANY LIMITED] 6 Current NDC, Legacy NDC, 4 package rows 20241121_ec1e59a0-bcad-49f0-b731-d15445d99370.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 51467-010-01 51467001001 2 BLISTER PACK in 1 BOX (51467-010-01) / 12 TABLET in 1 BLISTER PACK 2 blister pack 2025-07-01 2029-06-30 No No Current 51467-010-02 51467001002 3 BLISTER PACK in 1 BOX (51467-010-02) / 12 TABLET in 1 BLISTER PACK 3 blister pack 2025-07-01 2029-06-30 No No Current