DayTime Cold and Flu Relief

Product NDC
69517-102
Requested package NDC
69517-102-16
11-digit product format
695170102
Labeler code
69517
Product ID
69517-102_ea529736-0cf2-9f85-e053-2a95a90ab414
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan, Phenylephrine
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
HealthLife of USA
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2015-08-26
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
325 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
2023-12-31
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 packagepackage69517-10269517-102-16DDiscontinued 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
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DDAYTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) CAPSULE, LIQUID FILLED [HEALTHLIFE OF USA]2
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHDAYTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) CAPSULE, LIQUID FILLED [HEALTHLIFE OF USA]2
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJDAYTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) CAPSULE, LIQUID FILLED [HEALTHLIFE OF USA]2
ACETAMINOPHENACTIVE MOIETY362O9ITL9DDAYTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) CAPSULE, LIQUID FILLED [HEALTHLIFE OF USA]2
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSDAYTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) CAPSULE, LIQUID FILLED [HEALTHLIFE OF USA]2
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVDAYTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) CAPSULE, LIQUID FILLED [HEALTHLIFE OF USA]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADAYTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) CAPSULE, LIQUID FILLED [HEALTHLIFE OF USA]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DAYTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) CAPSULE, LIQUID FILLED [HEALTHLIFE OF USA]2
GELATININACTIVE INGREDIENT2G86QN327LDAYTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) CAPSULE, LIQUID FILLED [HEALTHLIFE OF USA]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDAYTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) CAPSULE, LIQUID FILLED [HEALTHLIFE OF USA]2
POLYETHYLENE GLYCOL 1000INACTIVE INGREDIENTU076Q6Q621DAYTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) CAPSULE, LIQUID FILLED [HEALTHLIFE OF USA]2
POVIDONEINACTIVE INGREDIENTFZ989GH94EDAYTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) CAPSULE, LIQUID FILLED [HEALTHLIFE OF USA]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DAYTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) CAPSULE, LIQUID FILLED [HEALTHLIFE OF USA]2
SORBITOLINACTIVE INGREDIENT506T60A25RDAYTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) CAPSULE, LIQUID FILLED [HEALTHLIFE OF USA]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDAYTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) CAPSULE, LIQUID FILLED [HEALTHLIFE OF USA]2
WATERINACTIVE INGREDIENT059QF0KO0RDAYTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) CAPSULE, LIQUID FILLED [HEALTHLIFE OF USA]2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69517-102-166951701021616 CAPSULE, LIQUID FILLED in 1 BOTTLE (69517-102-16) 2015-08-260000-00-00NoNoCurrent