FDA.reportPublic FDA data

Application 073585

Type
ANDA
Sponsor
MCNEIL CONS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SUDAFED 12 HOURPSEUDOEPHEDRINE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL120MGNoYes

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
A073585-001SUDAFED 12 HOURPSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORAL1991-10-31

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 UTC2022-10A073585-001SUDAFED 12 HOUR120MGTABLET, EXTENDED RELEASE / ORAL1991-10-31f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A073585-001SUDAFED 12 HOUR120MGTABLET, EXTENDED RELEASE / ORAL1991-10-31e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A073585-001SUDAFED 12 HOUR120MGTABLET, EXTENDED RELEASE / ORAL1991-10-31cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A073585-001SUDAFED 12 HOUR120MGTABLET, EXTENDED RELEASE / ORAL1991-10-31a50c72e98297…

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.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-1106Sudafed 12 HourPseudoephedrine hydrochlorideA-S Medication SolutionsANDACurrent
50090-1106Sudafed 12 HourPseudoephedrine hydrochlorideA-S Medication SolutionsANDACurrent
50580-670Sudafed 12 HourPseudoephedrine hydrochlorideJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
42832ORIG2012-03-27