Home NDC 0904-5053 SudoGest
Product NDC 0904-5053
11-digit product format 009045053
Labeler code 0904
Product ID 0904-5053_dea7c710-ba53-44d1-a05b-6254995679b8
Type HUMAN OTC DRUG
Nonproprietary name Pseudoephedrine HCl
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Major Pharmaceuticals
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 1981-08-25
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 2027-12-31
Current FDA listing Yes 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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base SudoGest
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0904-5053-24 SudoGest 24 in 1 BLISTER PACK TABLET, FILM COATED 24 25 0904-5053-24 SudoGest 1 in 1 CARTON TABLET, FILM COATED 1 25 0904-5053-59 SudoGest 100 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 100 25 0904-5053-59 SudoGest 1 in 1 CARTON TABLET, FILM COATED 1 25
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded PSEUDOEPHEDRINE HYDROCHLORIDE ACTIVE INGREDIENT 6V9V2RYJ8N SUDOGEST (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 11 PSEUDOEPHEDRINE ACTIVE MOIETY 7CUC9DDI9F SUDOGEST (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 11 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 SUDOGEST (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 11 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 SUDOGEST (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 11 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO SUDOGEST (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 11 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 SUDOGEST (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 11 POLYDEXTROSE INACTIVE INGREDIENT VH2XOU12IE SUDOGEST (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 11 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A SUDOGEST (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 11 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP SUDOGEST (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 11 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 SUDOGEST (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 11 Pseudoephedrine Hydrochloride ACTIVE INGREDIENT 6V9V2RYJ8N SUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP] 1 PSEUDOEPHEDRINE HYDROCHLORIDE ACTIVE INGREDIENT 6V9V2RYJ8N SUDOGEST (PSEUDOEPHEDRINE HCL) TABLET [A-S MEDICATION SOLUTIONS LLC] 1 PSEUDOEPHEDRINE ACTIVE MOIETY 7CUC9DDI9F SUDOGEST (PSEUDOEPHEDRINE HCL) TABLET [A-S MEDICATION SOLUTIONS LLC] 1 Pseudoephedrine ACTIVE MOIETY 7CUC9DDI9F SUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 SUDOGEST (PSEUDOEPHEDRINE HCL) TABLET [A-S MEDICATION SOLUTIONS LLC] 1 Croscarmellose Sodium INACTIVE INGREDIENT M28OL1HH48 SUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 SUDOGEST (PSEUDOEPHEDRINE HCL) TABLET [A-S MEDICATION SOLUTIONS LLC] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 SUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO SUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO SUDOGEST (PSEUDOEPHEDRINE HCL) TABLET [A-S MEDICATION SOLUTIONS LLC] 1 Magnesium Stearate INACTIVE INGREDIENT 70097M6I30 SUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 SUDOGEST (PSEUDOEPHEDRINE HCL) TABLET [A-S MEDICATION SOLUTIONS LLC] 1 Polydextrose INACTIVE INGREDIENT VH2XOU12IE SUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP] 1 POLYDEXTROSE INACTIVE INGREDIENT VH2XOU12IE SUDOGEST (PSEUDOEPHEDRINE HCL) TABLET [A-S MEDICATION SOLUTIONS LLC] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A SUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A SUDOGEST (PSEUDOEPHEDRINE HCL) TABLET [A-S MEDICATION SOLUTIONS LLC] 1 Titanium Dioxide INACTIVE INGREDIENT 15FIX9V2JP SUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP SUDOGEST (PSEUDOEPHEDRINE HCL) TABLET [A-S MEDICATION SOLUTIONS LLC] 1 Triacetin INACTIVE INGREDIENT XHX3C3X673 SUDOGEST (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP] 1 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 SUDOGEST (PSEUDOEPHEDRINE HCL) TABLET [A-S MEDICATION SOLUTIONS LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0904-5053 SUDOGEST (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 23 Current NDC, Legacy NDC, 4 package rows 20241113_d46577aa-7fd7-2130-6ed6-4b3f7562491f.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 74 of 180 · 3,583 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0904-5053-24 00904505324 1 BLISTER PACK in 1 CARTON (0904-5053-24) > 24 TABLET, FILM COATED in 1 BLISTER PACK 1 blister pack 1981-08-25 2021-11-11 No No Current 0904-5053-59 00904505359 1 BOTTLE, PLASTIC in 1 CARTON (0904-5053-59) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 1981-08-25 0000-00-00 No No Current