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 | 2026-10-21 |
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 |
|---|---|---|---|---|---|---|
| SINUS PAIN AND CONGESTION | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL | CVS Pharmacy | 697dffdd-5b56-4395-8e69-6b4360d9fdc5 | 2025-12-02 | Warnings | M012 |
| Maximum Strength Mucus Relief Severe Congestion and Cough | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Wal-Mart Stores,Inc., | 9c8c1974-f931-4493-abb5-ecdc32764ab3 | 2025-12-02 | Warnings | M012 |
| Maximum Strength Mucus Relief Severe Congestion and Cough | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Wal-Mart Stores,Inc., | 770c0e4f-0eed-4b8c-85a5-761b6a84db62 | 2025-12-02 | Warnings | M012 |
| Multi Symptom Severe Cold and Nighttime Severe Cold and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | WAL-MART STORES INC | a2a7e568-bff8-4818-a31d-7c2efa1859c3 | 2025-12-02 | Warnings | M012 |
| DayTime Severe, Cold and Flu, 24-7 Life by 7-Eleven | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL TABLET, FILM COATED TABLET | Lil' Drug Store Products, Inc. | 44fa0193-2a19-bdc1-e063-6394a90a60e8 | 2025-12-02 | Warnings | M012 |
| Nighttime Severe, Cold and Flu, 24-7 Life by 7-Eleven | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL TABLET, FILM COATED | Lil' Drug Store Products, Inc. | 44fb9958-d771-f4b3-e063-6294a90a9135 | 2025-12-02 | Warnings | M012 |
| Quality Choice Mucus Relief | GUAIFENESIN | Chain Drug Marketing Association | f1a73da7-0dbb-49bd-857e-7dd6bc11b63c | 2025-12-02 | Warnings | M012 |
| Cold and Flu Relief Daytime | ACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCL | CARDINAL HEALTH 110, LLC. DBA LEADER 70000 | ac74be47-30f0-418b-bd07-502feaa9723f | 2025-12-01 | Warnings | M012 |
| Walgreens High Blood Pressure Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN | WALGREENS CO. | bc83b55e-c3d8-460f-8ef9-ff7b2e4f7272 | 2025-12-01 | Warnings | M012 |
| Walgreen High Blood Pressure Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE | WALGREENS CO. | f1b7b58f-bbc3-441f-926f-d66e6a9b4e3a | 2025-12-01 | Warnings | M012 |
| Walgreens Nighttime Kids Honey Cold Cough Congestion | DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE | WALGREENS CO | c0f317cd-723d-47f2-b600-aaeae6399482 | 2025-12-01 | Warnings | M012 |
| Walgreen Maximum Strength Severe Congestion and cough | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | WALGREENS CO. | b4abcb6d-f3e1-4d63-98cf-ff556ec423b6 | 2025-12-01 | Warnings | M012 |
| Walgreens Daytime Childrens | COUGH AND CHEST CONGESTION | WALGREENS CO. | dd99675f-3860-42ef-999c-d9a3746a38c0 | 2025-12-01 | Warnings | M012 |
| Adult Cough plus Chest Congestion DM with Honey | DEXTROMETHORPHAN HBR, GUAIFENESIN | WALGREEN COMPANY | 5f5af13a-c2a3-4bbe-880e-9c57b36e9234 | 2025-12-01 | Warnings | M012 |
| Walgreens Maximum Strength Severe Congestion and Cough | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | WALGREEN COMPANY | b2e08f4d-9753-4767-a8eb-3740dd1034cc | 2025-12-01 | Warnings | M012 |
| WALGREENS Cold Cough and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | WALGREENS CO. | 1e903034-942e-4c6e-9f96-eb097c266580 | 2025-12-01 | Warnings | M012 |
| Walgreens DAY and NIGHT PACK | DEXTROMETHORPHAN HBR, GUAIFENESIN, CHLORPHENIRAMINE MALEATE | WALGREEN CO | cb87e57b-ff06-4973-9751-137c7021e272 | 2025-12-01 | Warnings | M012 |
| WALGREEN Multi Symptom Flu Relief Combo Pack | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | WALGREENS CO. | b7b1d604-921d-4ae7-93de-dcf690d421b4 | 2025-12-01 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | Meijer Distribution Inc | 235b2866-bbda-7148-e063-6394a90a898f | 2025-12-01 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | Whole Foods Market, INC. | 32352109-31dc-8e6f-e063-6294a90a2f92 | 2025-12-01 | 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 |