Home NDC 69729-808 Coldtac Severe Cold
Product NDC 69729-808
11-digit product format 697290808
Labeler code 69729
Product ID 69729-808_5ce4594f-3bf4-f1f5-e063-6394a90accb5
Type HUMAN OTC DRUG
Nonproprietary name Acetaminohpen, Dextromethorphan Hydrobromide
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler OPMX LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-01-29
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE
Active strength 325; 10 mg/1; mg/1
Pharmacologic classes Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
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 Severe Cold
Brand name suffix Max Relief
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 325 mg/1 DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69729-808-10 Coldtac Severe ColdMax Relief 10 in 1 BLISTER PACK CAPSULE, LIQUID FILLED 10 1 69729-808-10 Coldtac Severe ColdMax Relief 1 in 1 CARTON CAPSULE, LIQUID FILLED 1 1
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 69729-808-10 69729080810 1 BLISTER PACK in 1 CARTON (69729-808-10) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 1 blister pack 2026-01-29 No No Current