Home NDC 55319-378-04 Cold and Cough Day Time
Product NDC 55319-378
Requested package NDC 55319-378-04
11-digit product format 553190378
Labeler code 55319
Product ID 55319-378_ef7da258-6fbf-4011-b1a4-35286fea41fc
Type HUMAN OTC DRUG
Nonproprietary name Dextromethorphan HBr, Phenylephrine HCl
Dosage form LIQUID
Route ORAL
Labeler Family Dollar (FAMILY WELLNESS)
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2015-08-31
Marketing end 0000-00-00
Substance DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength 5 mg/5mL; mg/5mL
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record 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 · 1 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 55319-378 55319-378-04 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH COLD AND COUGH DAY TIME CHILDRENS (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [FAMILY DOLLAR (FAMILY WELLNESS)] 1 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ COLD AND COUGH DAY TIME CHILDRENS (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [FAMILY DOLLAR (FAMILY WELLNESS)] 1 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS COLD AND COUGH DAY TIME CHILDRENS (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [FAMILY DOLLAR (FAMILY WELLNESS)] 1 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV COLD AND COUGH DAY TIME CHILDRENS (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [FAMILY DOLLAR (FAMILY WELLNESS)] 1 ACESULFAME POTASSIUM INACTIVE INGREDIENT 23OV73Q5G9 COLD AND COUGH DAY TIME CHILDRENS (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [FAMILY DOLLAR (FAMILY WELLNESS)] 1 ALCOHOL INACTIVE INGREDIENT 3K9958V90M COLD AND COUGH DAY TIME CHILDRENS (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [FAMILY DOLLAR (FAMILY WELLNESS)] 1 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL COLD AND COUGH DAY TIME CHILDRENS (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [FAMILY DOLLAR (FAMILY WELLNESS)] 1 BENZOIC ACID INACTIVE INGREDIENT 8SKN0B0MIM COLD AND COUGH DAY TIME CHILDRENS (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [FAMILY DOLLAR (FAMILY WELLNESS)] 1 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K COLD AND COUGH DAY TIME CHILDRENS (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [FAMILY DOLLAR (FAMILY WELLNESS)] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA COLD AND COUGH DAY TIME CHILDRENS (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [FAMILY DOLLAR (FAMILY WELLNESS)] 1 MALTITOL INACTIVE INGREDIENT D65DG142WK COLD AND COUGH DAY TIME CHILDRENS (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [FAMILY DOLLAR (FAMILY WELLNESS)] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 COLD AND COUGH DAY TIME CHILDRENS (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [FAMILY DOLLAR (FAMILY WELLNESS)] 1 TRISODIUM CITRATE DIHYDRATE INACTIVE INGREDIENT B22547B95K COLD AND COUGH DAY TIME CHILDRENS (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [FAMILY DOLLAR (FAMILY WELLNESS)] 1 WATER INACTIVE INGREDIENT 059QF0KO0R COLD AND COUGH DAY TIME CHILDRENS (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [FAMILY DOLLAR (FAMILY WELLNESS)] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55319-378 COLD AND COUGH DAY TIME CHILDRENS (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [FAMILY DOLLAR (FAMILY WELLNESS)] 5 Legacy NDC 20230131_f776569e-3ad0-4898-89be-8d5a4bf8422d.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 55319-378-04 55319037804 1 BOTTLE, PLASTIC in 1 BOX (55319-378-04) > 118 mL in 1 BOTTLE, PLASTIC 2015-08-31 0000-00-00 No No Current