FDA.reportPublic FDA data

Wal-phed

Product NDC
0363-0112
11-digit product format
003630112
Labeler code
0363
Product ID
0363-0112_50960681-a8cd-4e4f-87cf-34ea7c3b9ae4
Type
HUMAN OTC DRUG
Nonproprietary name
Pseudoephedrine HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Walgreen Company
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
1981-08-25
Marketing end
2024-11-07
Substance
PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength
30 mg/1
Pharmacologic classes
Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0363-0112DDiscontinued by firm2026-08-17
excluded packagepackage0363-01120363-0112-08DDiscontinued by firm2026-08-17
excluded packagepackage0363-01120363-0112-22DDiscontinued by firm2026-08-17
excluded packagepackage0363-01120363-0112-46DDiscontinued by firm2026-08-17

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 · 40 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 packagepackage0363-0112-22d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0363-0112-08d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0363-0112-46d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0363-0112-22f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0363-0112-08f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0363-0112-46f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0363-0112-222ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0363-0112-082ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0363-0112-462ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0363-0112-22a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0363-0112-08a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0363-0112-46a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0363-0112-22cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0363-0112-08cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0363-0112-46cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0363-0112-22cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0363-0112-08cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0363-0112-46cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0363-0112-22302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0363-0112-08302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0363-0112-46302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0363-0112-22ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0363-0112-08ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0363-0112-46ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0363-0112-220efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0363-0112-080efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0363-0112-460efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0363-0112-22ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0363-0112-08ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0363-0112-46ad56d346431e…cc804d4bbf1e…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-0112-08EA - Each0363-011235b7e6d4-bc88-4a51-a092-1b481b18dc4812013-09-04
0363-0112-22EA - Each0363-011226695352-accf-4b1a-8e67-ba468cb2e31612013-09-04
0363-0112-46EA - Each0363-011292bc93aa-c56c-4514-a666-410cb9325f6312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PSEUDOEPHEDRINE HYDROCHLORIDEACTIVE INGREDIENT6V9V2RYJ8NWAL-PHED (PSEUDOPHEDRINE HCL) TABLET, FILM COATED [WALGREEN CO.]10
PSEUDOEPHEDRINEACTIVE MOIETY7CUC9DDI9FWAL-PHED (PSEUDOPHEDRINE HCL) TABLET, FILM COATED [WALGREEN CO.]10
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JWAL-PHED (PSEUDOPHEDRINE HCL) TABLET, FILM COATED [WALGREEN CO.]10
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UWAL-PHED (PSEUDOPHEDRINE HCL) TABLET, FILM COATED [WALGREEN CO.]10
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48WAL-PHED (PSEUDOPHEDRINE HCL) TABLET, FILM COATED [WALGREEN CO.]10
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8WAL-PHED (PSEUDOPHEDRINE HCL) TABLET, FILM COATED [WALGREEN CO.]10
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOWAL-PHED (PSEUDOPHEDRINE HCL) TABLET, FILM COATED [WALGREEN CO.]10
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30WAL-PHED (PSEUDOPHEDRINE HCL) TABLET, FILM COATED [WALGREEN CO.]10
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEWAL-PHED (PSEUDOPHEDRINE HCL) TABLET, FILM COATED [WALGREEN CO.]10
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AWAL-PHED (PSEUDOPHEDRINE HCL) TABLET, FILM COATED [WALGREEN CO.]10
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPWAL-PHED (PSEUDOPHEDRINE HCL) TABLET, FILM COATED [WALGREEN CO.]10
TRIACETININACTIVE INGREDIENTXHX3C3X673WAL-PHED (PSEUDOPHEDRINE HCL) TABLET, FILM COATED [WALGREEN CO.]10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-0112-08003630112081 BLISTER PACK in 1 CARTON (0363-0112-08) > 24 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack1981-08-252024-11-07NoNoCurrent
0363-0112-22003630112222 BLISTER PACK in 1 CARTON (0363-0112-22) > 24 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack1981-08-252024-11-07NoNoCurrent
0363-0112-46003630112464 BLISTER PACK in 1 CARTON (0363-0112-46) > 24 TABLET, FILM COATED in 1 BLISTER PACK4 blister pack1981-08-252024-11-07NoNoCurrent