Daytime PE Nitetime

Product NDC
56062-580
11-digit product format
560620580
Labeler code
56062
Product ID
56062-580_b0c4a4a1-a61f-4a06-aac7-c41a78d6e9ba
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl
Dosage form
KIT
Labeler
Publix Super Markets Inc
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2014-07-07
Marketing end
0000-00-00
Active strength
0
NDC exclude flag
No
Listing certified through
2020-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct56062-580DDiscontinued by firm2026-10-05
excluded packagepackage56062-58056062-580-72DDiscontinued by firm2026-10-05

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 · 18 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 packagepackage56062-580-72d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage56062-580-72f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage56062-580-722ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage56062-580-72a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage56062-580-72cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage56062-580-72cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage56062-580-72302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage56062-580-72ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage56062-580-720efc9e666f02…f202fb6c5f17…

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 PE NITETIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [PUBLIX SUPER MARKETS INC]2
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHDAYTIME PE NITETIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [PUBLIX SUPER MARKETS INC]2
DOXYLAMINE SUCCINATEACTIVE INGREDIENTV9BI9B5YI2DAYTIME PE NITETIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [PUBLIX SUPER MARKETS INC]2
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJDAYTIME PE NITETIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [PUBLIX SUPER MARKETS INC]2
ACETAMINOPHENACTIVE MOIETY362O9ITL9DDAYTIME PE NITETIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [PUBLIX SUPER MARKETS INC]2
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSDAYTIME PE NITETIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [PUBLIX SUPER MARKETS INC]2
DOXYLAMINEACTIVE MOIETY95QB77JKPLDAYTIME PE NITETIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [PUBLIX SUPER MARKETS INC]2
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVDAYTIME PE NITETIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [PUBLIX SUPER MARKETS INC]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GDAYTIME PE NITETIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [PUBLIX SUPER MARKETS INC]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDAYTIME PE NITETIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [PUBLIX SUPER MARKETS INC]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADAYTIME PE NITETIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [PUBLIX SUPER MARKETS INC]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DAYTIME PE NITETIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [PUBLIX SUPER MARKETS INC]2
GELATININACTIVE INGREDIENT2G86QN327LDAYTIME PE NITETIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [PUBLIX SUPER MARKETS INC]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDAYTIME PE NITETIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [PUBLIX SUPER MARKETS INC]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADAYTIME PE NITETIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [PUBLIX SUPER MARKETS INC]2
POVIDONESINACTIVE INGREDIENTFZ989GH94EDAYTIME PE NITETIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [PUBLIX SUPER MARKETS INC]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DAYTIME PE NITETIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [PUBLIX SUPER MARKETS INC]2
WATERINACTIVE INGREDIENT059QF0KO0RDAYTIME PE NITETIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [PUBLIX SUPER MARKETS INC]2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
56062-580-72560620580721 KIT in 1 CARTON (56062-580-72) * 8 BLISTER PACK in 1 CARTON > 2 CAPSULE, GELATIN COATED in 1 BLISTER PACK * 16 BLISTER PACK in 1 CARTON > 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK1 kit2014-07-070000-00-00NoNoCurrent