SUDAFED 12 HOUR

Product NDC
50090-3287
Requested package NDC
50090-3287-0
11-digit product format
500903287
Labeler code
50090
Product ID
50090-3287_a16e147c-8841-437f-ac0a-f2427eaa8c08
Type
HUMAN OTC DRUG
Nonproprietary name
Pseudoephedrine Hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA075153
Marketing category
ANDA
Marketing start
2017-09-01
Marketing end
0000-00-00
Substance
PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength
120 mg/1
NDC exclude flag
No
Listing certified through
2021-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50090-328750090-3287-0IInactivated by FDA2026-08-03

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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A075153-001PSEUDOEPHEDRINE HYDROCHLORIDEPSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORALRS1999-02-26

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 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A075153-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORALRS1999-02-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075153-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORALRS1999-02-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A075153-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORALRS1999-02-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075153-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORALRS1999-02-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075153-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORALRS1999-02-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075153-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORALRS1999-02-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075153-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORALRS1999-02-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075153-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORALRS1999-02-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075153-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORALRS1999-02-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075153-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORALRS1999-02-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075153-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORALRS1999-02-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075153-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORALRS1999-02-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075153-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORALRS1999-02-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075153-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORALRS1999-02-268072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075153-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORAL1999-02-265c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075153-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORAL1999-02-265d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075153-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORAL1999-02-264b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075153-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORAL1999-02-2674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075153-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORAL1999-02-26bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075153-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORAL1999-02-26782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075153-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORAL1999-02-2687673890dc5c…
2021-03-12 10:30 UTC2021-03A075153-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORAL1999-02-265aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075153-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORAL1999-02-268869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075153-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORAL1999-02-26c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075153-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORAL1999-02-263f01610625f2…
2019-09-15 20:21 UTC2019-09A075153-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORAL1999-02-26b00525d2431f…
2019-07-19 19:46 UTC2019-07A075153-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORAL1999-02-26ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075153-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORALRS1999-02-266a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075153-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORALRS1999-02-261c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075153-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORALRS1999-02-26ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075153-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORALRS1999-02-26a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075153-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORALRS1999-02-269b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075153-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORALRS1999-02-26a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075153-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORALRS1999-02-263f0d92c62455…
2023-05-13 08:27 UTC2023-05A075153-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORALRS1999-02-26053a50430f4f…
2023-01-26 05:58 UTC2023-01A075153-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORALRS1999-02-263bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075153-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORALRS1999-02-263a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075153-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORALRS1999-02-26f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A075153-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORALRS1999-02-26e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A075153-001PSEUDOEPHEDRINE HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORALRS1999-02-26cb3db0bc1861…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
e974e22d-8688-7d92-1e87-40c1079e170cProduct name320151125
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66Product name120140508
70a83adc-6047-bbea-5a08-dfd304aa47d2Product name120140508
858ce051-9941-aafc-8c7c-44a8e0227463Product name120140508
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-3287-02023-01-30C16284748780-1f386c649-c2ea-0266-e053-dadaa90a7c1aSUDAFED 12 HOUR

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3287-0SUDAFED 12 HOUR1 in 1 CARTONTABLET, FILM COATED, EXTENDED RE17
50090-3287-0SUDAFED 12 HOUR10 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE107

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3287SUDAFED 12 HOUR (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]7Legacy NDC, 2 package rows20200122_da2934cf-4940-4bea-905e-77938be9460d.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 1 of 1 · 20 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
nasal decongestantPSEUDOEPHEDRINE HYDROCHLORIDEHyVee Inc8c4c786c-2b0f-4a23-a87d-effbcfe0c8572026-06-15WarningsExact identifier
application applno (ANDA): 075153
application number: ANDA075153
nasal decongestantPSEUDOEPHEDRINE HYDROCHLORIDEPublix Super Markets Inc06092347-33fe-46b8-829c-70e4ca15ecf22026-04-01WarningsExact identifier
application applno (ANDA): 075153
application number: ANDA075153
CareOne Nasal and Sinus DecongestantPSEUDOEPHEDRINE HCLAmerican Sales Companya5aa414c-a143-44c8-9759-e84c0f032fbf2026-04-01WarningsExact identifier
application applno (ANDA): 075153
application number: ANDA075153
leader 12 hour nasal decongestantPSEUDOEPHEDRINE HYDROCHLORIDECardinal Health 110, LLC. dba Leader8b8d374c-592e-44fc-a6cc-9f9e73ef914c2026-02-25WarningsExact identifier
application applno (ANDA): 075153
application number: ANDA075153
sinus and nasal decongestantPSEUDOEPHEDRINE HYDROCHLORIDECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDe39daa3c-1901-4966-b85e-ab76d7bd12162026-02-17WarningsExact identifier
application applno (ANDA): 075153
application number: ANDA075153
equate sinus 12 hourPSEUDOEPHEDRINE HYDROCHLORIDEWal-Mart Stores Incde65b99e-85e9-46c1-88b2-727c7ed8882a2026-02-11WarningsExact identifier
application applno (ANDA): 075153
application number: ANDA075153
SudoGest 12 HourPSEUDOEPHEDRINE HCLMajor Pharmaceuticalse829aab0-3ef0-4149-8197-96c5ce0b31d22025-10-30WarningsExact identifier
application applno (ANDA): 075153
application number: ANDA075153
Good Sense Suphedrine 12 HourPSEUDOEPHEDRINE HYDROCHLORIDEL. Perrigo Company1de8a7f6-e7bb-437d-8794-c4b9f43b89c92025-10-30WarningsExact identifier
application applno (ANDA): 075153
application number: ANDA075153
sinus 12 hourPSEUDOEPHEDRINE HCLL. Perrigo Company26206f75-648f-47c9-8bad-25127c33961d2025-10-03WarningsExact identifier
application applno (ANDA): 075153
application number: ANDA075153
Sudafed Sinus Congestion 12 HourPSEUDOEPHEDRINE HYDROCHLORIDEA-S Medication Solutions0e4717a1-914b-466d-8bf0-d37ebc32fdb32025-09-15WarningsExact identifier
application applno (ANDA): 075153
application number: ANDA075153
Leader 12 Hour Sinus Nasal DecongestantPSEUDOEPHEDRINE HCLCardinal Health 110, LLC. dba Leadera647e822-c4dd-46fd-bd55-bd92269903572025-08-07WarningsExact identifier
application applno (ANDA): 075153
application number: ANDA075153
nasal decongestantPSEUDOEPHEDRINE HYDROCHLORIDEMeijer Distribution Inc4d431663-4b6a-4b00-9bbd-87d2c6b8ddad2025-05-04WarningsExact identifier
application applno (ANDA): 075153
application number: ANDA075153
pseudoephedrine hydrochloridePSEUDOEPHEDRINE HCLPadagis Israel Pharmaceuticals Ltd4a4da1e6-2ad1-47f7-a9b3-7d845962ef3b2024-12-26WarningsExact identifier
application applno (ANDA): 075153
application number: ANDA075153
Sudafed Sinus Congestion 12 HourPSEUDOEPHEDRINE HYDROCHLORIDEKenvue Brands LLCd600b5d5-7d95-4ad6-a95b-6d73502743d72024-11-08WarningsExact identifier
application applno (ANDA): 075153
application number: ANDA075153
good neighbor pharmacy nasal decongestantPSEUDOEPHEDRINE HYDROCHLORIDEAmerisource Bergend84a0c76-ad50-4616-9252-84ca25a19ca02024-05-30WarningsExact identifier
application applno (ANDA): 075153
application number: ANDA075153
Equaline 12 Hour DecongestantPSEUDOEPHEDRINE HYDROCHLORIDEUnited Natural Foods, Inc. dba UNFIbd5c2093-f812-4dfe-80ea-68cb4e65a09c2023-08-03WarningsExact identifier
application applno (ANDA): 075153
application number: ANDA075153
Nasal Decongestant DPSEUDOEPHEDRINE HYDROCHLORIDEWalgreen Company9572b6c9-172b-459e-82d1-7f92f0eaec8e2022-10-20WarningsExact identifier
application applno (ANDA): 075153
application number: ANDA075153
topcare 12 hour decongestantPSEUDOEPHEDRINE HYDROCHLORIDETopco Associates LLC4841c79a-fb92-4209-929a-e4ea0c4015dd2022-10-05WarningsExact identifier
application applno (ANDA): 075153
application number: ANDA075153
sinus pressure and congestion relief maximum strengthPSEUDOEPHEDRINE HCLRite Aid Corporationaa52d998-cab8-439c-ac95-6c1f5da48ba42022-08-04WarningsExact identifier
application applno (ANDA): 075153
application number: ANDA075153
12 Hour Nasal DecongestantPSEUDOEPHEDRINE HYDROCHLORIDECVS Pharmacy85955336-3f79-457d-822c-f8be019729d12019-05-23WarningsExact identifier
application applno (ANDA): 075153
application number: ANDA075153

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049154pseudoephedrine HCl 120 MG 12HR Extended Release Oral TabletPSNda2934cf-4940-4bea-905e-77938be9460d7
1049668SUDAFED 120 MG 12HR Extended Release Oral TabletPSNda2934cf-4940-4bea-905e-77938be9460d7
104966812 HR pseudoephedrine hydrochloride 120 MG Extended Release Oral Tablet [Sudafed]SBDda2934cf-4940-4bea-905e-77938be9460d7
104915412 HR pseudoephedrine hydrochloride 120 MG Extended Release Oral TabletSCDda2934cf-4940-4bea-905e-77938be9460d7
104966812 HR Sudafed 120 MG Extended Release Oral TabletSYda2934cf-4940-4bea-905e-77938be9460d7
1049154pseudoephedrine HCl 120 MG 12 HR Extended Release Oral TabletSYda2934cf-4940-4bea-905e-77938be9460d7
1049668Sudafed 120 MG 12 HR Extended Release Oral TabletSYda2934cf-4940-4bea-905e-77938be9460d7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-3287-0500903287001 BLISTER PACK in 1 CARTON (50090-3287-0) > 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK1 blister pack2017-11-300000-00-00NoNoCurrent