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
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.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 0904-5053 | 0904-5053-24 | D | Discontinued by firm | 2026-10-16 |
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 | 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 |
|---|---|
| PSEUDOEPHEDRINE HYDROCHLORIDE | 30 mg/1 |
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 |
DailyMed Package Descriptions#
| 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 Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0904-5053-24 | EA - Each | 0904-5053 | 5f294304-939e-4c0b-af84-6c0bb2f9bb11 | 1 | 2012-07-24 |
| 0904-5053-59 | EA - Each | 0904-5053 | e6ec7cb2-becd-49b9-bed7-a75f6e1d8887 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| Mucinex Fast-Max Severe Congestion and Cough | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Reckitt Benckiser LLC | 3270f369-7a40-186d-e063-6394a90a8526 | 2026-05-19 | Warnings | M012 |
| Mucinex Fast-Max Day Cold and Flu and Night Cold and Flu Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | fe44d1ee-1e03-b74f-e053-6294a90a8bb4 | 2026-05-19 | Warnings | M012 |
| Mucinex Fast-Max Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | Reckitt Benckiser LLC | 31ac6883-ffcd-39de-e063-6294a90a52dd | 2026-05-19 | Warnings | M012 |
| MUCINEX DAY TIME PAIN, HEADACHE and MUCUS CONGESTION and MUCINEX NIGHT TIME HEADACHE, COUGH and FEVER Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, TRIPROLIDINE HYDROCHLORIDE | Reckitt Benckiser LLC | 325b41e1-f8d2-02ee-e063-6394a90aafff | 2026-05-19 | Warnings | M012 |
| Mucinex Fast-Max Day Cold and Flu and Mucinex Nightshift Night Severe Cold and Flu Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND TRIPROLIDINE HYDROCHLORIDE | Reckitt Benckiser LLC | 326f1fd3-73ab-e515-e063-6294a90ab222 | 2026-05-19 | Warnings | M012 |
| Mucinex Fast-Max Day Cold and Flu and Night Cold and Flu Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | 6c85df30-a601-4de6-9fd6-818265d799ff | 2026-05-19 | Warnings | M012 |
| Mucinex Fast-Max Cold, Flu and Sore Throat Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | 7050b583-c09b-4457-9a9c-70c0923b62c0 | 2026-05-19 | Warnings | M012 |
| Mucinex Fast-Max Cold and Flu Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | 27312ee4-d1f4-4a95-9c45-91fa5a01f5ba | 2026-05-19 | Warnings | M012 |
| Mucinex Rapid Clear Daytime Pain, Headache, and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | Reckitt Benckiser LLC | 37de53a7-5546-3804-e063-6294a90a0fb5 | 2026-05-19 | Warnings | M012 |
| Mucinex Fast-Max Cold and Flu Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | Reckitt Benckiser LLC | 36b07e49-c72c-45e5-e063-6394a90a804a | 2026-05-19 | Warnings | M012 |
| Mucinex Sinus Max Clear and Cool Severe Congestion | OXYMETAZOLINE HCI | Reckitt Benckiser LLC | 2ee95e17-bd94-d717-e063-6294a90a2173 | 2026-05-19 | Warnings | M012 |
| Mucinex Sinus Max Sinus Pressure Severe Congestion | OXYMETAZOLINE HCI | Reckitt Benckiser LLC | 2eeafd83-230c-af92-e063-6294a90a984e | 2026-05-19 | Warnings | M012 |
| Mucinex Fast-Max Congestion and Headache Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | d7017328-f8af-4601-9232-dc1104feaa0a | 2026-05-19 | Warnings | M012 |
| Mucinex Rapid Clear Pain Headache and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | Reckitt Benckiser LLC | 32375b12-75ed-d605-e063-6294a90ad004 | 2026-05-19 | Warnings | M012 |
| Mucinex Sinus-Max Pressure, Pain and Cough Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | 07da45b5-d05e-41b1-b233-f7034d556a8d | 2026-05-19 | Warnings | M012 |
| Mucinex Sinus-Max Severe Congestion and Pain Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | ad4e0e4d-cc1f-4176-835f-3ba76564c634 | 2026-05-19 | Warnings | M012 |
| Childrens Mucinex Multi-Symptom Cold | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | 60daf6e2-ded8-44e6-bd8d-9d221384adde | 2026-05-19 | Warnings | M012 |
| Mucinex Childrens Mini Melts Cold and Flu | ACETAMINOPHEN AND GUAIFENESIN | Reckitt Benckiser LLC | 401fe0a0-ec97-5248-e063-6394a90af27f | 2026-05-19 | Warnings | M012 |
| Childrens Cough and Congestion, Childrens Cold and Cough Day, Night | DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN | WALMART INC. | 312ae879-1124-40a4-b2ba-3f3070840021 | 2026-05-19 | Warnings | M012 |
| GOOD SENSE DAYTIME | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | L. Perrigo Company | 2597e84c-18b4-41a9-8e6a-ff0c4c1f0612 | 2026-05-18 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1049160 | pseudoephedrine HCl 30 MG Oral Tablet | PSN | d46577aa-7fd7-2130-6ed6-4b3f7562491f | 25 |
| 1049162 | SudoGest 30 MG Oral Tablet | PSN | d46577aa-7fd7-2130-6ed6-4b3f7562491f | 25 |
| 1049162 | pseudoephedrine hydrochloride 30 MG Oral Tablet [Sudogest] | SBD | d46577aa-7fd7-2130-6ed6-4b3f7562491f | 25 |
| 1049160 | pseudoephedrine hydrochloride 30 MG Oral Tablet | SCD | d46577aa-7fd7-2130-6ed6-4b3f7562491f | 25 |
| 1049162 | Sudogest 30 MG Oral Tablet | SY | d46577aa-7fd7-2130-6ed6-4b3f7562491f | 25 |
| 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 |
| 1049160 | pseudoephedrine HCl 30 MG Oral Tablet | PSN | 2bedd920-8546-4019-964d-96c622fffc2e | 10 |
| 1049162 | SudoGest 30 MG Oral Tablet | PSN | 2bedd920-8546-4019-964d-96c622fffc2e | 10 |
| 1049162 | pseudoephedrine hydrochloride 30 MG Oral Tablet [Sudogest] | SBD | 2bedd920-8546-4019-964d-96c622fffc2e | 10 |
| 1049160 | pseudoephedrine hydrochloride 30 MG Oral Tablet | SCD | 2bedd920-8546-4019-964d-96c622fffc2e | 10 |
| 1049162 | Sudogest 30 MG Oral Tablet | SY | 2bedd920-8546-4019-964d-96c622fffc2e | 10 |
| 1049160 | pseudoephedrine HCl 30 MG Oral Tablet | PSN | 656726ed-50cd-4f7e-8e51-e242afd1d9c9 | 1 |
| 1049162 | SudoGest 30 MG Oral Tablet | PSN | 656726ed-50cd-4f7e-8e51-e242afd1d9c9 | 1 |
| 1049162 | pseudoephedrine hydrochloride 30 MG Oral Tablet [Sudogest] | SBD | 656726ed-50cd-4f7e-8e51-e242afd1d9c9 | 1 |
| 1049160 | pseudoephedrine hydrochloride 30 MG Oral Tablet | SCD | 656726ed-50cd-4f7e-8e51-e242afd1d9c9 | 1 |
| 1049162 | Sudogest 30 MG Oral Tablet | SY | 656726ed-50cd-4f7e-8e51-e242afd1d9c9 | 1 |
Packages#
| 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 |