Home NDC 69729-802 AGRIFEN
Product NDC 69729-802
11-digit product format 697290802
Labeler code 69729
Product ID 69729-802_5ca4675d-7cf1-fc94-e063-6394a90a194e
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Dextomethorphan Hydrobromide, Phenylephrine Hydrochloride
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler OPMX LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-03-31
Substance ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
Active strength 325; 5; 10 mg/1; mg/1; mg/1
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], 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
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 AGRIFEN
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 325 mg/1 PHENYLEPHRINE HYDROCHLORIDE 5 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 69729-802-10 AGRIFEN 10 in 1 BLISTER PACK CAPSULE, LIQUID FILLED 10 1 69729-802-10 AGRIFEN 1 in 1 CARTON CAPSULE, LIQUID FILLED 1 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69729-802 AGRIFEN (ACETAMINOPHEN, DEXTOMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [OPMX LLC] 1 Current NDC, 2 package rows 20250403_31aaa8e7-7980-1e00-e063-6294a90a18d0.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 69729-802-10 69729080210 1 BLISTER PACK in 1 CARTON (69729-802-10) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 1 blister pack 2025-03-31 No No Current