Day Time

Product NDC
11822-3416
11-digit product format
118223416
Labeler code
11822
Product ID
11822-3416_2f10aec5-a077-4443-8dc6-53b76f031e0c
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine HCI
Dosage form
LIQUID
Route
ORAL
Labeler
Rite Aid Corporation
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2009-08-13
Marketing end
2019-12-30
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
325 mg/15mL; mg/15mL; mg/15mL
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct11822-3416DDiscontinued by firm2026-10-12
excluded packagepackage11822-341611822-3416-1DDiscontinued by firm2026-10-12

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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage11822-3416-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage11822-3416-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage11822-3416-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage11822-3416-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage11822-3416-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage11822-3416-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage11822-3416-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage11822-3416-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage11822-3416-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage11822-3416-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage11822-3416-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage11822-3416-1557ba5c1ecfa…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
AcetaminophenACTIVE INGREDIENT362O9ITL9DDAY TIME WITH PE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCI) LIQUID [RITE AID]1
Dextromethorphan HydrobromideACTIVE INGREDIENT9D2RTI9KYHDAY TIME WITH PE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCI) LIQUID [RITE AID]1
Phenylephrine HydrochlorideACTIVE INGREDIENT04JA59TNSJDAY TIME WITH PE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCI) LIQUID [RITE AID]1
AcetaminophenACTIVE MOIETY362O9ITL9DDAY TIME WITH PE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCI) LIQUID [RITE AID]1
DextromethorphanACTIVE MOIETY7355X3ROTSDAY TIME WITH PE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCI) LIQUID [RITE AID]1
PhenylephrineACTIVE MOIETY1WS297W6MVDAY TIME WITH PE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCI) LIQUID [RITE AID]1
Citric Acid MonohydrateINACTIVE INGREDIENT2968PHW8QPDAY TIME WITH PE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCI) LIQUID [RITE AID]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DAY TIME WITH PE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCI) LIQUID [RITE AID]1
GlycerinINACTIVE INGREDIENTPDC6A3C0OXDAY TIME WITH PE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCI) LIQUID [RITE AID]1
Polyethylene Glycol 300INACTIVE INGREDIENT5655G9Y8AQDAY TIME WITH PE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCI) LIQUID [RITE AID]1
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3DAY TIME WITH PE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCI) LIQUID [RITE AID]1
Saccharin Sodium AnhydrousINACTIVE INGREDIENTI4807BK602DAY TIME WITH PE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCI) LIQUID [RITE AID]1
Sodium CitrateINACTIVE INGREDIENT1Q73Q2JULRDAY TIME WITH PE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCI) LIQUID [RITE AID]1
SucroseINACTIVE INGREDIENTC151H8M554DAY TIME WITH PE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCI) LIQUID [RITE AID]1
WaterINACTIVE INGREDIENT059QF0KO0RDAY TIME WITH PE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCI) LIQUID [RITE AID]1