Home NDC 68210-5053 Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride
Product NDC 68210-5053
11-digit product format 682105053
Labeler code 68210
Product ID 68210-5053_575a1070-780c-5032-e063-6294a90a642a
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Prodose, Inc.
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-07-29
Substance PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE
Active strength 5; 325; 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 Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PHENYLEPHRINE HYDROCHLORIDE 5 mg/1 ACETAMINOPHEN 325 mg/1 DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 04JA59TNSJ Internal UNII lookup 362O9ITL9D Internal UNII lookup 9D2RTI9KYH Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1086997 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 68210-5053-1 Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride 3000 in 1 POUCH CAPSULE, LIQUID FILLED 3000 2 68210-5053-1 Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride 2 in 1 CARTON CAPSULE, LIQUID FILLED 2 2
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 73 of 178 · 3,551 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 68210-5053-1 68210505301 2 POUCH in 1 CARTON (68210-5053-1) / 3000 CAPSULE, LIQUID FILLED in 1 POUCH 2 pouch 2025-07-29 No No Current