DayTime Nitetime Sinus Relief

Product NDC
36800-102
11-digit product format
368000102
Labeler code
36800
Product ID
36800-102_ace03272-f16e-4605-94bb-0df117c7e93f
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Doxylamine succinate, Phenylephrine HCl
Dosage form
KIT
Labeler
TOP CARE (Topco Associates LLC)
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2013-01-15
Marketing end
2020-01-15
Active strength
0
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 productproduct36800-102DDiscontinued by firm2026-10-20
excluded packagepackage36800-10236800-102-48DDiscontinued by firm2026-10-20

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 packagepackage36800-102-48d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage36800-102-48f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage36800-102-482ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage36800-102-48a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage36800-102-48cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage36800-102-48cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage36800-102-48302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage36800-102-48ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage36800-102-480efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage36800-102-48ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage36800-102-48367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage36800-102-48557ba5c1ecfa…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 NITETIME SINUS RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [TOP CARE (TOPCO ASSOCIATES LLC)]4
DOXYLAMINE SUCCINATEACTIVE INGREDIENTV9BI9B5YI2DAYTIME NITETIME SINUS RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [TOP CARE (TOPCO ASSOCIATES LLC)]4
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJDAYTIME NITETIME SINUS RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [TOP CARE (TOPCO ASSOCIATES LLC)]4
ACETAMINOPHENACTIVE MOIETY362O9ITL9DDAYTIME NITETIME SINUS RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [TOP CARE (TOPCO ASSOCIATES LLC)]4
DOXYLAMINEACTIVE MOIETY95QB77JKPLDAYTIME NITETIME SINUS RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [TOP CARE (TOPCO ASSOCIATES LLC)]4
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVDAYTIME NITETIME SINUS RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [TOP CARE (TOPCO ASSOCIATES LLC)]4
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDAYTIME NITETIME SINUS RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [TOP CARE (TOPCO ASSOCIATES LLC)]4
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DAYTIME NITETIME SINUS RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [TOP CARE (TOPCO ASSOCIATES LLC)]4
GELATININACTIVE INGREDIENT2G86QN327LDAYTIME NITETIME SINUS RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [TOP CARE (TOPCO ASSOCIATES LLC)]4
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDAYTIME NITETIME SINUS RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [TOP CARE (TOPCO ASSOCIATES LLC)]4
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADAYTIME NITETIME SINUS RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [TOP CARE (TOPCO ASSOCIATES LLC)]4
POVIDONESINACTIVE INGREDIENTFZ989GH94EDAYTIME NITETIME SINUS RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [TOP CARE (TOPCO ASSOCIATES LLC)]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DAYTIME NITETIME SINUS RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [TOP CARE (TOPCO ASSOCIATES LLC)]4
SORBITANINACTIVE INGREDIENT6O92ICV9RUDAYTIME NITETIME SINUS RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [TOP CARE (TOPCO ASSOCIATES LLC)]4
SORBITOLINACTIVE INGREDIENT506T60A25RDAYTIME NITETIME SINUS RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [TOP CARE (TOPCO ASSOCIATES LLC)]4
WATERINACTIVE INGREDIENT059QF0KO0RDAYTIME NITETIME SINUS RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [TOP CARE (TOPCO ASSOCIATES LLC)]4