SUDOGEST
- Product NDC
- 50090-1961
- 11-digit product format
- 500901961
- Labeler code
- 50090
- Product ID
- 50090-1961_294456fb-9ad8-4175-a119-2c5caef72c01
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Pseudoephedrine HCl
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- 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
- 2026-12-31
- 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.
| Captured / source date | Dataset | Scope | Package NDC | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded product | product | I | Inactivated by FDA | 8af77b9d5b6f… | d9bbb34c5368… | |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 50090-1961-0 | I | Inactivated by FDA | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded product | product | I | Inactivated by FDA | 834df4deac94… | adcc014656a3… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 50090-1961-0 | I | Inactivated by FDA | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded product | product | I | Inactivated by FDA | 1332a3947898… | d4bfe170f9cd… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 50090-1961-0 | I | Inactivated by FDA | 1332a3947898… | d4bfe170f9cd… |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded product | product | I | Inactivated by FDA | fb8cb913e6d1… | eb8c232b6be0… | |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 50090-1961-0 | I | Inactivated by FDA | fb8cb913e6d1… | eb8c232b6be0… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded product | product | I | Inactivated by FDA | 86f5da6cb304… | a595104c45d7… | |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 50090-1961-0 | I | Inactivated by FDA | 86f5da6cb304… | a595104c45d7… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded product | product | I | Inactivated by FDA | bd6a592717d7… | 303034d00443… | |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 50090-1961-0 | I | Inactivated by FDA | bd6a592717d7… | 303034d00443… |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded product | product | I | Inactivated by FDA | 8dfbde2a14a4… | c9ff85d89658… | |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded package | package | 50090-1961-0 | I | Inactivated by FDA | 8dfbde2a14a4… | c9ff85d89658… |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded product | product | I | Inactivated by FDA | e2bbac7714bc… | 27bdfed8d636… | |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded package | package | 50090-1961-0 | I | Inactivated by FDA | e2bbac7714bc… | 27bdfed8d636… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded product | product | I | Inactivated by FDA | 9bebd1f3094a… | 5416666fcb17… | |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded package | package | 50090-1961-0 | I | Inactivated by FDA | 9bebd1f3094a… | 5416666fcb17… |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded product | product | E | Excluded after deficient or non-compliant submission was not corrected | 110d247fa046… | a55b01930146… | |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded package | package | 50090-1961-0 | E | Excluded after deficient or non-compliant submission was not corrected | 110d247fa046… | a55b01930146… |
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
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| PSEUDOEPHEDRINE HYDROCHLORIDE | 30 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 6V9V2RYJ8N | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1811199f-bf88-475f-8f94-b372db4bead3 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| ba088a92-ab5e-b2d4-e908-f5ea691b7587 | Product name | 7 | 20210201 |
| 0fdb98e2-b951-a1ce-5715-2b187ba500ef | Product name | 4 | 20170718 |
| e974e22d-8688-7d92-1e87-40c1079e170c | Product name | 3 | 20151125 |
| e8718272-64cb-4436-969b-176c3067c8f4 | Product name | 1 | 20150609 |
| 30c51294-7ae9-8007-7de6-58222684a0be | Product name | 1 | 20140508 |
| 4f26f669-fc6c-40ef-9e26-1c7b2390ee66 | Product name | 1 | 20140508 |
| 70a83adc-6047-bbea-5a08-dfd304aa47d2 | Product name | 1 | 20140508 |
| 858ce051-9941-aafc-8c7c-44a8e0227463 | Product name | 1 | 20140508 |
| b893258d-0942-3d8a-3411-056ea0788ff5 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50090-1961-0 | 2024-06-22 | C162847 | 48780-1 | 9d75b9d1-1fc8-f424-e053-dadaa90a57ce | SUDOGEST |
| 50090-1961-0 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-1fc8-f424-e053-dadaa90a57ce | SUDOGEST |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50090-1961-0 | SUDOGEST | 28 in 1 BOTTLE | TABLET, FILM COATED | 28 | 13 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50090-1961-0 | EA - Each | 50090-1961 | 93eca24e-72b8-44db-a84c-43ffe0a1d4ba | 1 | 2018-11-06 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50090-1961 | SUDOGEST (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS] | 13 | Current NDC, Legacy NDC, 1 package rows | 20240622_1811199f-bf88-475f-8f94-b372db4bead3.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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| MUCUS RELIEF | GUAIFENESIN | Geri-Care Pharmaceuticals, Corp | 5afb242f-fac9-dc81-e063-6394a90a8448 | 2026-08-27 | Warnings | M012 |
| daytime cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | Amazon.com Services LLC | 6de619d3-0ab0-43e7-8dac-7bbd5368ac65 | 2026-08-27 | Warnings | M012 |
| Daytime Mucus Relief Severe Congestion and Cough and Nighttime Cold and Flu Maximum Strength | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI, ACETAMINOPHEN, DIPHENHYDRAMINE HCI | Walgreens | 366ddac8-9e8a-41bd-a7f7-48213485a5f8 | 2026-08-27 | Warnings | M012 |
| Nighttime Cold and Flu Maximum Strength | ACETAMINOPHEN, DIPHENHYDRAMINE HCI, PHENYLEPHRINE HCI | Walgreens | 37896933-3ed3-457f-8a32-ee0d784a19e8 | 2026-08-27 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | Amazon.com Services LLC | 298e9164-e378-4b39-a944-bfc8f8baa4de | 2026-08-27 | Warnings | M012 |
| DayTime Mucus Relief Severe Cold and Nighttime Cold and Flu Maximum Strength | DAYTIME ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI, NIGHTTIME ACETAMINOPHEN, DIPHENHYDRAMINE HCI, PHENYLEPHRINE HCI | Walgreens | 3b4b3b04-eff9-4e06-8b37-f6729671d07f | 2026-08-27 | Warnings | M012 |
| Daytime Cold and Flu mini Softgels | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Shield Pharmaceuticals Corp | dfb0fe2e-b0c7-409a-bd1a-fd12485665ba | 2026-08-26 | Warnings | M012 |
| Nighttime Severe Cold and Flu Maximum Strength mini softgels | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Shield Pharmaceuticals Corp | 70c5517d-be4e-4317-b4f4-df660c71c699 | 2026-08-26 | Warnings | M012 |
| Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Meijer Distribution, Inc. | c1f9ec75-7eb2-405c-8cdc-097cbf2cf87d | 2026-08-26 | Warnings | M012 |
| Childrens TYLENOL COLD plus COUGH plus RUNNY NOSE | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDE | Kenvue Brands LLC | 5b95905e-b729-4caf-921a-fc4ef815289c | 2026-08-25 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | Wal-Mart Stores Inc | c88e93d4-66b6-4327-b9e5-0e0a95a18d66 | 2026-08-25 | Warnings | M012 |
| Sleep Aid NightTime | DIPHENHYDRAMINE HCL | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 4fff664b-4ff0-4007-95ab-cb273807b9b4 | 2026-08-25 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | Walgreen Company | 7d972559-6184-476b-9cbf-1bc5663ea00d | 2026-08-24 | Warnings | M012 |
| Cold, Flu and Sore Throat | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Meijer Distribution, Inc. | 9be8437c-6053-4ed4-bdd2-97f556b5289e | 2026-08-24 | Warnings | M012 |
| Extra Strength Tylenol Cold Plus Flu Multi-Symptom Day Night | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATE | Kenvue Brands LLC | 594f515c-b369-816d-e063-6294a90a59a1 | 2026-08-21 | Warnings | M012 |
| DG HEALTH MULTI SYMPTOM SEVERE COLD | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Dolgencorp, LLC | 47ddbb0d-0823-4817-9c56-e7fff77d601c | 2026-08-21 | Warnings | M012 |
| Mucus Relief DM Max | DEXTROMETHORPHAN HBR, GUAIFENESIN | DOLGENCORP, LLC | 5be4e730-3cd6-414e-a23b-f6cad8088750 | 2026-08-21 | Warnings | M012 |
| Mucus Relief DM Cough Maximum Strength | DEXTROMETHORPHAN HBR AND GUAIFENESIN | Cardinal Health 110, LLC. DBA Leader | 6304a581-9238-4539-b157-293fc05c173e | 2026-08-21 | Warnings | M012 |
| COMBINATION PACK HyVee Daytime and Nighttime Severe Cold and Flu SOFTGEL - 24ct | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE | HyVee Inc | 82ead335-d38e-40c3-8031-222bf985a302 | 2026-08-20 | Warnings | M012 |
| HyVee Nighttime Severe Cold and Flu SOFTGEL | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | HyVee Inc | 49818610-bf4a-fb86-e063-6294a90ae598 | 2026-08-20 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1049160 | pseudoephedrine HCl 30 MG Oral Tablet | PSN | 1811199f-bf88-475f-8f94-b372db4bead3 | 13 |
| 1049162 | SudoGest 30 MG Oral Tablet | PSN | 1811199f-bf88-475f-8f94-b372db4bead3 | 13 |
| 1049162 | pseudoephedrine hydrochloride 30 MG Oral Tablet [Sudogest] | SBD | 1811199f-bf88-475f-8f94-b372db4bead3 | 13 |
| 1049160 | pseudoephedrine hydrochloride 30 MG Oral Tablet | SCD | 1811199f-bf88-475f-8f94-b372db4bead3 | 13 |
| 1049162 | Sudogest 30 MG Oral Tablet | SY | 1811199f-bf88-475f-8f94-b372db4bead3 | 13 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 50090-1961-0 | 50090196100 | 28 TABLET, FILM COATED in 1 BOTTLE (50090-1961-0) | 2015-08-19 | No | No | Current |