Home NDC 55319-933 MAXIMUM STRENGHT DAY COLD AND FLU FORMULA
Product NDC 55319-933
11-digit product format 553190933
Labeler code 55319
Product ID 55319-933_2e2d13f2-9446-dd98-e063-6394a90a9abb
Type HUMAN OTC DRUG
Nonproprietary name ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE HCL
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler FAMILY DOLLAR
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-08-05
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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 6 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 55319-933-22 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 55319-933-22 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 55319-933-22 0efc9e666f02…f202fb6c5f17…
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 MAXIMUM STRENGHT DAY COLD AND FLU FORMULA
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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 55319-933-22 MAXIMUM STRENGTH DAY-NIGHT COLD AND FLU FORMULA 12 in 1 BLISTER PACK CAPSULE, LIQUID FILLED 12 5 mg 4 55319-933-22 MAXIMUM STRENGHT DAY COLD AND FLU FORMULA 12 in 1 BLISTER PACK CAPSULE, LIQUID FILLED 12 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55319-933 MAXIMUM STRENGHT DAY COLD AND FLU FORMULA (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [FAMILY DOLLAR] 4 Current NDC, Legacy NDC, 1 package rows 20250217_aa8ebccf-6813-2dca-e053-2a95a90a032b.zip 55319-933 MAXIMUM STRENGTH DAY-NIGHT COLD AND FLU FORMULA (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE HCL) KIT [FAMILY DOLLAR] 4 Current NDC, Legacy NDC 20250217_aa8f6dd0-d19f-0c10-e053-2a95a90a1e8a.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 Marketing start Marketing end Sample Exclude flag Status 55319-933-22 55319093322 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (55319-933-22) 2020-08-05 0000-00-00 No No Current