Triacting Day Time Cold and Cough

Product NDC
41520-378
Requested package NDC
41520-378-04
11-digit product format
415200378
Labeler code
41520
Product ID
41520-378_91e65d0c-2deb-4cdc-9aa2-debb9e482988
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr, Phenylephrine HCl
Dosage form
LIQUID
Route
ORAL
Labeler
Care One (American Sales Company)
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2015-06-30
Marketing end
2023-12-29
Substance
DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
5 mg/5mL; mg/5mL
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage41520-37841520-378-04DDiscontinued by firm2026-10-15

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 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHTRIACTING DAY TIME COLD AND COUGH CHILDRENS (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [CARE ONE (AMERICAN SALES COMPANY)]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJTRIACTING DAY TIME COLD AND COUGH CHILDRENS (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [CARE ONE (AMERICAN SALES COMPANY)]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSTRIACTING DAY TIME COLD AND COUGH CHILDRENS (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [CARE ONE (AMERICAN SALES COMPANY)]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVTRIACTING DAY TIME COLD AND COUGH CHILDRENS (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [CARE ONE (AMERICAN SALES COMPANY)]1
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G9TRIACTING DAY TIME COLD AND COUGH CHILDRENS (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [CARE ONE (AMERICAN SALES COMPANY)]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MTRIACTING DAY TIME COLD AND COUGH CHILDRENS (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [CARE ONE (AMERICAN SALES COMPANY)]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLTRIACTING DAY TIME COLD AND COUGH CHILDRENS (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [CARE ONE (AMERICAN SALES COMPANY)]1
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMTRIACTING DAY TIME COLD AND COUGH CHILDRENS (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [CARE ONE (AMERICAN SALES COMPANY)]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KTRIACTING DAY TIME COLD AND COUGH CHILDRENS (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [CARE ONE (AMERICAN SALES COMPANY)]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOATRIACTING DAY TIME COLD AND COUGH CHILDRENS (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [CARE ONE (AMERICAN SALES COMPANY)]1
MALTITOLINACTIVE INGREDIENTD65DG142WKTRIACTING DAY TIME COLD AND COUGH CHILDRENS (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [CARE ONE (AMERICAN SALES COMPANY)]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3TRIACTING DAY TIME COLD AND COUGH CHILDRENS (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [CARE ONE (AMERICAN SALES COMPANY)]1
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KTRIACTING DAY TIME COLD AND COUGH CHILDRENS (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [CARE ONE (AMERICAN SALES COMPANY)]1
WATERINACTIVE INGREDIENT059QF0KO0RTRIACTING DAY TIME COLD AND COUGH CHILDRENS (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [CARE ONE (AMERICAN SALES COMPANY)]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
41520-378-04415200378041 BOTTLE, PLASTIC in 1 BOX (41520-378-04) > 118 mL in 1 BOTTLE, PLASTIC2015-06-302023-12-29NoNoCurrent