Home NDC 69168-417 Daytime Cold and Flu
Product NDC 69168-417
11-digit product format 691680417
Labeler code 69168
Product ID 69168-417_c2498c7c-a983-4ee4-b796-e0f844c9fcd0
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen 325mg/ Dextromethorphan HBr 10mg/ Phenylephrine HCl 5mg
Dosage form CAPSULE
Route ORAL
Labeler Allegiant Health
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-11-11
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength 325; 10; 5 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 2026-12-31
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 Daytime Cold and Flu
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 325 mg/1 DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1 PHENYLEPHRINE HYDROCHLORIDE 5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 362O9ITL9D Internal UNII lookup 9D2RTI9KYH Internal UNII lookup 04JA59TNSJ 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 69168-417-93 Daytime Nighttime Cold and Flu Relief Combo Pack 12 in 1 BLISTER PACK CAPSULE 24 5 mg 6 69168-417-93 Daytime Nighttime Cold and Flu Relief Combo Pack 2 in 1 CARTON CAPSULE 5 mg 6 69168-417-29 Daytime Cold and Flu 8 in 1 BLISTER PACK CAPSULE 8 3 69168-417-51 Daytime Cold and Flu 10 in 1 BLISTER PACK CAPSULE 10 3 69168-417-51 Daytime Cold and Flu 2 in 1 CARTON CAPSULE 2 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69168-417 DAYTIME NIGHTTIME COLD AND FLU RELIEF COMBO PACK (DAYTIME NIGHTTIME COLD AND FLU) KIT [ALLEGIANT HEALTH] 5 Current NDC, Legacy NDC 20231020_fa7ed5db-4da7-46b4-a08d-1d79cb7a5674.zip 69168-417 DAYTIME COLD AND FLU (ACETAMINOPHEN 325MG/ DEXTROMETHORPHAN HBR 10MG/ PHENYLEPHRINE HCL 5MG) CAPSULE [ALLEGIANT HEALTH] 3 Current NDC, Legacy NDC, 3 package rows 20231116_bed5f9dc-45ea-4e90-86c6-86599b6f3861.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 69168-417-29 69168041729 8 CAPSULE in 1 BLISTER PACK (69168-417-29) 8 capsule 2020-11-11 0000-00-00 No No Current 69168-417-51 69168041751 2 BLISTER PACK in 1 CARTON (69168-417-51) / 10 CAPSULE in 1 BLISTER PACK 2 blister pack 2020-11-11 0000-00-00 No No Current 69168-417-93 69168041793 12 in 1 BLISTER PACK Historical