Day Time Cold and Flu Non drowsy

Product NDC
69168-356
11-digit product format
691680356
Labeler code
69168
Product ID
69168-356_b10c4ac9-4d1e-46d4-95ed-111f23dedc2d
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen 325 mg, Dextromethorphan HBr 10 mg, Phenylephrine HCI 5 mg
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Allegiant Health
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2015-03-03
Marketing end
2022-04-30
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
325 mg/1; mg/1; mg/1
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct69168-356DDiscontinued by firm2026-10-12
excluded packagepackage69168-35669168-356-29DDiscontinued by firm2026-10-12
excluded packagepackage69168-35669168-356-51DDiscontinued 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 · 36 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 packagepackage69168-356-51d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage69168-356-29d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage69168-356-51f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage69168-356-29f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage69168-356-512ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage69168-356-292ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage69168-356-51a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage69168-356-29a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage69168-356-51cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage69168-356-29cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage69168-356-51cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage69168-356-29cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage69168-356-51302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage69168-356-29302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage69168-356-51ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage69168-356-29ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage69168-356-510efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage69168-356-290efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage69168-356-51ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage69168-356-29ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage69168-356-51367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage69168-356-29367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage69168-356-51557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage69168-356-29557ba5c1ecfa…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 COLD AND FLUE NON DROWSY (ACETAMINOPHEN 325 MG, DEXTROMETHORPHAN HBR 10 MG, PHENYLEPHRINE HCI 5 MG) CAPSULE, LIQUID FILLED [ALLEGIANT HEALTH]1
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHDAY TIME COLD AND FLUE NON DROWSY (ACETAMINOPHEN 325 MG, DEXTROMETHORPHAN HBR 10 MG, PHENYLEPHRINE HCI 5 MG) CAPSULE, LIQUID FILLED [ALLEGIANT HEALTH]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJDAY TIME COLD AND FLUE NON DROWSY (ACETAMINOPHEN 325 MG, DEXTROMETHORPHAN HBR 10 MG, PHENYLEPHRINE HCI 5 MG) CAPSULE, LIQUID FILLED [ALLEGIANT HEALTH]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DDAY TIME COLD AND FLUE NON DROWSY (ACETAMINOPHEN 325 MG, DEXTROMETHORPHAN HBR 10 MG, PHENYLEPHRINE HCI 5 MG) CAPSULE, LIQUID FILLED [ALLEGIANT HEALTH]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSDAY TIME COLD AND FLUE NON DROWSY (ACETAMINOPHEN 325 MG, DEXTROMETHORPHAN HBR 10 MG, PHENYLEPHRINE HCI 5 MG) CAPSULE, LIQUID FILLED [ALLEGIANT HEALTH]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVDAY TIME COLD AND FLUE NON DROWSY (ACETAMINOPHEN 325 MG, DEXTROMETHORPHAN HBR 10 MG, PHENYLEPHRINE HCI 5 MG) CAPSULE, LIQUID FILLED [ALLEGIANT HEALTH]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADAY TIME COLD AND FLUE NON DROWSY (ACETAMINOPHEN 325 MG, DEXTROMETHORPHAN HBR 10 MG, PHENYLEPHRINE HCI 5 MG) CAPSULE, LIQUID FILLED [ALLEGIANT HEALTH]1
GELATININACTIVE INGREDIENT2G86QN327LDAY TIME COLD AND FLUE NON DROWSY (ACETAMINOPHEN 325 MG, DEXTROMETHORPHAN HBR 10 MG, PHENYLEPHRINE HCI 5 MG) CAPSULE, LIQUID FILLED [ALLEGIANT HEALTH]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDAY TIME COLD AND FLUE NON DROWSY (ACETAMINOPHEN 325 MG, DEXTROMETHORPHAN HBR 10 MG, PHENYLEPHRINE HCI 5 MG) CAPSULE, LIQUID FILLED [ALLEGIANT HEALTH]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQDAY TIME COLD AND FLUE NON DROWSY (ACETAMINOPHEN 325 MG, DEXTROMETHORPHAN HBR 10 MG, PHENYLEPHRINE HCI 5 MG) CAPSULE, LIQUID FILLED [ALLEGIANT HEALTH]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADAY TIME COLD AND FLUE NON DROWSY (ACETAMINOPHEN 325 MG, DEXTROMETHORPHAN HBR 10 MG, PHENYLEPHRINE HCI 5 MG) CAPSULE, LIQUID FILLED [ALLEGIANT HEALTH]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EDAY TIME COLD AND FLUE NON DROWSY (ACETAMINOPHEN 325 MG, DEXTROMETHORPHAN HBR 10 MG, PHENYLEPHRINE HCI 5 MG) CAPSULE, LIQUID FILLED [ALLEGIANT HEALTH]1
SORBITOLINACTIVE INGREDIENT506T60A25RDAY TIME COLD AND FLUE NON DROWSY (ACETAMINOPHEN 325 MG, DEXTROMETHORPHAN HBR 10 MG, PHENYLEPHRINE HCI 5 MG) CAPSULE, LIQUID FILLED [ALLEGIANT HEALTH]1
WATERINACTIVE INGREDIENT059QF0KO0RDAY TIME COLD AND FLUE NON DROWSY (ACETAMINOPHEN 325 MG, DEXTROMETHORPHAN HBR 10 MG, PHENYLEPHRINE HCI 5 MG) CAPSULE, LIQUID FILLED [ALLEGIANT HEALTH]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69168-356-29691680356298 CAPSULE, LIQUID FILLED in 1 BOX (69168-356-29) 2015-03-030000-00-00NoNoCurrent
69168-356-516916803565120 CAPSULE, LIQUID FILLED in 1 BOX (69168-356-51) 2015-03-030000-00-00NoNoCurrent