FDA.reportPublic FDA data

Nasal Decongestant PE

Product NDC
55315-453
11-digit product format
553150453
Labeler code
55315
Product ID
55315-453_3bbabdd0-6783-4490-b74b-58ad451cf750
Type
HUMAN OTC DRUG
Nonproprietary name
Phenylephrine HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
FRED'S, INC.
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2005-01-14
Marketing end
2021-12-04
Substance
PHENYLEPHRINE HYDROCHLORIDE
Active strength
10 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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct55315-453DDiscontinued by firm2026-10-12
excluded packagepackage55315-45355315-453-44DDiscontinued 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 packagepackage55315-453-44d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55315-453-44f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55315-453-442ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55315-453-44a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55315-453-44cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55315-453-44cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55315-453-44302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55315-453-44ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55315-453-440efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55315-453-44ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage55315-453-44367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage55315-453-44557ba5c1ecfa…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
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJNASAL DECONGESTANT PE (PHENYLEPHRINE HCL) TABLET, COATED [FRED'S, INC.]3
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVNASAL DECONGESTANT PE (PHENYLEPHRINE HCL) TABLET, COATED [FRED'S, INC.]3
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPNASAL DECONGESTANT PE (PHENYLEPHRINE HCL) TABLET, COATED [FRED'S, INC.]3
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311NASAL DECONGESTANT PE (PHENYLEPHRINE HCL) TABLET, COATED [FRED'S, INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNASAL DECONGESTANT PE (PHENYLEPHRINE HCL) TABLET, COATED [FRED'S, INC.]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NASAL DECONGESTANT PE (PHENYLEPHRINE HCL) TABLET, COATED [FRED'S, INC.]3
DEXTROSE MONOHYDRATEINACTIVE INGREDIENTLX22YL083GNASAL DECONGESTANT PE (PHENYLEPHRINE HCL) TABLET, COATED [FRED'S, INC.]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOANASAL DECONGESTANT PE (PHENYLEPHRINE HCL) TABLET, COATED [FRED'S, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NASAL DECONGESTANT PE (PHENYLEPHRINE HCL) TABLET, COATED [FRED'S, INC.]3
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DNASAL DECONGESTANT PE (PHENYLEPHRINE HCL) TABLET, COATED [FRED'S, INC.]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NASAL DECONGESTANT PE (PHENYLEPHRINE HCL) TABLET, COATED [FRED'S, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNASAL DECONGESTANT PE (PHENYLEPHRINE HCL) TABLET, COATED [FRED'S, INC.]3
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KNASAL DECONGESTANT PE (PHENYLEPHRINE HCL) TABLET, COATED [FRED'S, INC.]3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55315-453-44553150453441 BLISTER PACK in 1 CARTON (55315-453-44) > 18 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2005-01-142021-12-04NoNoCurrent