FDA.reportPublic FDA data

Sudo-Tab PE

Product NDC
50332-0126
11-digit product format
503320126
Labeler code
50332
Product ID
50332-0126_aff1a2e6-dfd0-48b3-ad03-f557602c58fd
Type
HUMAN OTC DRUG
Nonproprietary name
phenylephrine hcl
Dosage form
TABLET
Route
ORAL
Labeler
HART Health
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2005-10-03
Marketing end
0000-00-00
Substance
PHENYLEPHRINE HYDROCHLORIDE
Active strength
5 mg/1
NDC exclude flag
E
Listing certified through
2017-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50332-0126IInactivated by FDA2026-08-11
excluded packagepackage50332-012650332-0126-4IInactivated by FDA2026-08-11
excluded packagepackage50332-012650332-0126-7IInactivated by FDA2026-08-11
excluded packagepackage50332-012650332-0126-8IInactivated by FDA2026-08-11

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 · 28 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage50332-0126-8fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage50332-0126-4fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage50332-0126-7fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage50332-0126-886f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage50332-0126-486f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage50332-0126-786f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage50332-0126-8bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage50332-0126-4bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage50332-0126-7bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage50332-0126-88dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage50332-0126-48dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage50332-0126-78dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage50332-0126-8e2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage50332-0126-4e2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage50332-0126-7e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage50332-0126-89bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage50332-0126-49bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage50332-0126-79bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage50332-0126-8110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage50332-0126-4110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage50332-0126-7110d247fa046…a55b01930146…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
50332-0126-42026-01-29SUDO-TAB PE
50332-0126-72026-01-29SUDO-TAB PE
50332-0126-82026-01-29SUDO-TAB PE
50332-0126-42023-08-11SUDO-TAB PE
50332-0126-72023-08-11SUDO-TAB PE
50332-0126-82023-08-11SUDO-TAB PE
50332-0126-42019-11-27SUDO-TAB PE
50332-0126-72019-11-27SUDO-TAB PE
50332-0126-82019-11-27SUDO-TAB PE

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJSUDO-TAB PE (PHENYLEPHRINE HCL) TABLET [HART HEALTH]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVSUDO-TAB PE (PHENYLEPHRINE HCL) TABLET [HART HEALTH]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USUDO-TAB PE (PHENYLEPHRINE HCL) TABLET [HART HEALTH]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48SUDO-TAB PE (PHENYLEPHRINE HCL) TABLET [HART HEALTH]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOASUDO-TAB PE (PHENYLEPHRINE HCL) TABLET [HART HEALTH]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8SUDO-TAB PE (PHENYLEPHRINE HCL) TABLET [HART HEALTH]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GSUDO-TAB PE (PHENYLEPHRINE HCL) TABLET [HART HEALTH]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SUDO-TAB PE (PHENYLEPHRINE HCL) TABLET [HART HEALTH]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3SUDO-TAB PE (PHENYLEPHRINE HCL) TABLET [HART HEALTH]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4SUDO-TAB PE (PHENYLEPHRINE HCL) TABLET [HART HEALTH]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSUDO-TAB PE (PHENYLEPHRINE HCL) TABLET [HART HEALTH]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50332-0126SUDO-TAB PE (PHENYLEPHRINE HCL) TABLET [HART HEALTH]5Legacy NDC20241206_6f70ed59-a1f8-4daa-8614-feaf2533687b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1299145phenylephrine HCl 5 MG Oral TabletPSN6f70ed59-a1f8-4daa-8614-feaf2533687b5
1358843Sudo-Tab PE 5 MG Oral TabletPSN6f70ed59-a1f8-4daa-8614-feaf2533687b5
1358843phenylephrine hydrochloride 5 MG Oral Tablet [Sudo-Tab]SBD6f70ed59-a1f8-4daa-8614-feaf2533687b5
1299145phenylephrine hydrochloride 5 MG Oral TabletSCD6f70ed59-a1f8-4daa-8614-feaf2533687b5
1299145phenylephrine HCl 5 MG Oral TabletSY6f70ed59-a1f8-4daa-8614-feaf2533687b5
1358843Sudo-Tab 5 MG Oral TabletSY6f70ed59-a1f8-4daa-8614-feaf2533687b5
1358843Sudo-Tab PE 5 MG Oral TabletSY6f70ed59-a1f8-4daa-8614-feaf2533687b5