FDA.reportPublic FDA data

Application 017941

Type
NDA
Sponsor
GLAXOSMITHKLINE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002SUDAFED 12 HOURPSEUDOEPHEDRINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL120MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N017941-002SUDAFED 12 HOURPSEUDOEPHEDRINE HYDROCHLORIDE120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, EXTENDED RELEASE / ORALRLD, Approved before 1982

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N017941-002SUDAFED 12 HOUR120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, EXTENDED RELEASE / ORALRLD, Approved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N017941-002SUDAFED 12 HOUR120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, EXTENDED RELEASE / ORALRLD, Approved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N017941-002SUDAFED 12 HOUR120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, EXTENDED RELEASE / ORALRLD, Approved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N017941-002SUDAFED 12 HOUR120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, EXTENDED RELEASE / ORALRLD, Approved before 1982a50c72e98297…

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 1 of 2 · 35 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
nasal decongestantPSEUDOEPHEDRINE HYDROCHLORIDEHyVee Inc8c4c786c-2b0f-4a23-a87d-effbcfe0c8572026-06-15WarningsName fallback
generic name: PSEUDOEPHEDRINE HYDROCHLORIDE
SudoGestPSEUDOEPHEDRINE HYDROCHLORIDEMajor Pharmaceuticals78faa497-6743-b85b-e053-2a91aa0ae8222026-05-12WarningsName fallback
generic name: PSEUDOEPHEDRINE HYDROCHLORIDE
nasal decongestantPSEUDOEPHEDRINE HYDROCHLORIDEPublix Super Markets Inc06092347-33fe-46b8-829c-70e4ca15ecf22026-04-01WarningsName fallback
generic name: PSEUDOEPHEDRINE HYDROCHLORIDE
leader 12 hour nasal decongestantPSEUDOEPHEDRINE HYDROCHLORIDECardinal Health 110, LLC. dba Leader8b8d374c-592e-44fc-a6cc-9f9e73ef914c2026-02-25WarningsName fallback
generic name: PSEUDOEPHEDRINE HYDROCHLORIDE
sinus and nasal decongestantPSEUDOEPHEDRINE HYDROCHLORIDECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDe39daa3c-1901-4966-b85e-ab76d7bd12162026-02-17WarningsName fallback
generic name: PSEUDOEPHEDRINE HYDROCHLORIDE
equate sinus 12 hourPSEUDOEPHEDRINE HYDROCHLORIDEWal-Mart Stores Incde65b99e-85e9-46c1-88b2-727c7ed8882a2026-02-11WarningsName fallback
generic name: PSEUDOEPHEDRINE HYDROCHLORIDE
Pseudoephedrine hydrochloridePSEUDOEPHEDRINE HYDROCHLORIDESportpharm LLC3b5c81b7-7464-129f-e063-6294a90a48c02026-02-06WarningsName fallback
generic name: PSEUDOEPHEDRINE HYDROCHLORIDE
Pseudoephedrine HydrochloridePSEUDOEPHEDRINE HYDROCHLORIDEWALGREEN CO.1425a847-bf34-1795-e063-6294a90a85b62026-02-03WarningsName fallback
generic name: PSEUDOEPHEDRINE HYDROCHLORIDE
Pseudoephedrine hydrochloridePSEUDOEPHEDRINE HYDROCHLORIDEA-S Medication Solutions0a2672f0-4e6f-48c9-8571-2d09f06253d72026-01-29WarningsName fallback
generic name: PSEUDOEPHEDRINE HYDROCHLORIDE
Pseudoephedrine HydrochloridePSEUDOEPHEDRINE HYDROCHLORIDEAurohealth LLC77e4132e-470e-4fb4-bc2f-df2e59061ba92026-01-06WarningsName fallback
generic name: PSEUDOEPHEDRINE HYDROCHLORIDE
SINUS AND NASAL DECONGESTANTPSEUDOEPHEDRINE HYDROCHLORIDECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDd7646859-f996-46cd-a0b9-56b860f609012026-01-05WarningsName fallback
generic name: PSEUDOEPHEDRINE HYDROCHLORIDE
Good Sense Suphedrine 12 HourPSEUDOEPHEDRINE HYDROCHLORIDEL. Perrigo Company1de8a7f6-e7bb-437d-8794-c4b9f43b89c92025-10-30WarningsName fallback
generic name: PSEUDOEPHEDRINE HYDROCHLORIDE
Sudafed Sinus Congestion 12 HourPSEUDOEPHEDRINE HYDROCHLORIDEA-S Medication Solutions0e4717a1-914b-466d-8bf0-d37ebc32fdb32025-09-15WarningsName fallback
generic name: PSEUDOEPHEDRINE HYDROCHLORIDE
nasal decongestantPSEUDOEPHEDRINE HYDROCHLORIDEMeijer Distribution Inc4d431663-4b6a-4b00-9bbd-87d2c6b8ddad2025-05-04WarningsName fallback
generic name: PSEUDOEPHEDRINE HYDROCHLORIDE
Pseudoephedrine HydrochloridePSEUDOEPHEDRINE HYDROCHLORIDEA-S Medication Solutions810ce630-41be-4e15-b64a-d70f63abaf622025-04-24WarningsName fallback
generic name: PSEUDOEPHEDRINE HYDROCHLORIDE
Zephrex DPSEUDOEPHEDRINE HYDROCHLORIDEL. Perrigo Company5468a7e2-361b-494f-9ca3-1b62f3819f652024-11-11WarningsName fallback
generic name: PSEUDOEPHEDRINE HYDROCHLORIDE
Sudafed Sinus Congestion 12 HourPSEUDOEPHEDRINE HYDROCHLORIDEKenvue Brands LLCd600b5d5-7d95-4ad6-a95b-6d73502743d72024-11-08WarningsName fallback
generic name: PSEUDOEPHEDRINE HYDROCHLORIDE
SUDAFED Sinus CongestionPSEUDOEPHEDRINE HYDROCHLORIDEKenvue Brands LLCc05d7e27-6821-468f-b27d-9c0b02a07b0f2024-11-08WarningsName fallback
generic name: PSEUDOEPHEDRINE HYDROCHLORIDE
Childrens Sudafed Nasal DecongestantPSEUDOEPHEDRINE HYDROCHLORIDEKenvue Brands LLC52e9307b-ad38-4f65-bb2f-4fa262e820102024-11-08WarningsName fallback
generic name: PSEUDOEPHEDRINE HYDROCHLORIDE
sinusPSEUDOEPHEDRINE HYDROCHLORIDEKroger Company18812f2a-9b66-45a7-9631-123da6fd1c1f2024-09-20WarningsName fallback
generic name: PSEUDOEPHEDRINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.