Home NDC 69729-133 COLDTAC ULTRA
Product NDC 69729-133
11-digit product format 697290133
Labeler code 69729
Product ID 69729-133_5d1ffdea-dd95-21e2-e063-6294a90a0bbe
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl
Dosage form TABLET
Route ORAL
Labeler OPMX LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-01-10
Substance PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE
Active strength 10; 500; 4 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
Listing certified through 2027-12-31
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 COLDTAC ULTRA
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 ACETAMINOPHEN 500 mg/1 CHLORPHENIRAMINE MALEATE 4 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69729-133 COLDTAC ULTRA (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) TABLET [OPMX LLC] 2 Current NDC, 7 package rows 20240127_0e9d506d-8c0c-ab6b-e063-6294a90a5ab6.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 Sample Exclude flag Status 69729-133-06 69729013306 3 POUCH in 1 CARTON (69729-133-06) / 2 TABLET in 1 POUCH 3 pouch 2024-01-10 No No Current 69729-133-27 69729013327 2 TABLET in 1 POUCH (69729-133-27) 2 tablet 2024-01-10 No No Current 69729-133-37 69729013337 6 POUCH in 1 CARTON (69729-133-37) / 2 TABLET in 1 POUCH 6 pouch 2024-01-10 No No Current 69729-133-38 69729013338 72 POUCH in 1 CARTON (69729-133-38) / 2 TABLET in 1 POUCH 72 pouch 2024-01-10 No No Current 69729-133-50 69729013350 50 POUCH in 1 CARTON (69729-133-50) / 2 TABLET in 1 POUCH 50 pouch 2026-07-23 No No Current