SUDOGEST NASAL DECONGESTANT
- Product NDC
- 50090-4345
- 11-digit product format
- 500904345
- Labeler code
- 50090
- Product ID
- 50090-4345_72064c3e-8348-4230-b2e3-47a03e3467df
- 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
- 1991-09-10
- 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
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 | 50090-4345 | 50090-4345-0 | D | Discontinued by firm | 2026-10-20 | |
| excluded package | package | 50090-4345 | 50090-4345-2 | D | Discontinued by firm | 2026-10-20 | |
| excluded package | package | 50090-4345 | 50090-4345-3 | D | Discontinued by firm | 2026-10-20 | |
| excluded package | package | 50090-4345 | 50090-4345-4 | D | Discontinued by firm | 2026-10-20 | |
| excluded package | package | 50090-4345 | 50090-4345-5 | D | Discontinued by firm | 2026-10-20 |
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 | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | 50090-4345-4 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 50090-4345-3 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 50090-4345-2 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 50090-4345-5 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 50090-4345-0 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 50090-4345-4 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 50090-4345-3 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 50090-4345-2 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 50090-4345-5 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 50090-4345-0 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 50090-4345-4 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 50090-4345-3 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 50090-4345-2 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 50090-4345-5 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 50090-4345-0 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 50090-4345-4 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 50090-4345-3 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 50090-4345-2 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 50090-4345-5 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 50090-4345-0 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 50090-4345-4 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 50090-4345-3 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 50090-4345-2 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 50090-4345-5 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 50090-4345-0 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 50090-4345-4 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 50090-4345-3 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 50090-4345-2 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 50090-4345-5 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 50090-4345-0 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 50090-4345-4 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 50090-4345-3 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 50090-4345-2 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 50090-4345-5 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 50090-4345-0 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 50090-4345-4 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 50090-4345-3 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 50090-4345-2 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 50090-4345-5 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 50090-4345-0 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 50090-4345-4 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 50090-4345-3 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 50090-4345-2 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 50090-4345-5 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 50090-4345-0 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 50090-4345-4 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 50090-4345-3 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 50090-4345-2 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 50090-4345-5 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 50090-4345-0 | ad56d346431e… | cc804d4bbf1e… |
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 NASAL DECONGESTANT
- 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 |
|---|---|
| 09feb5f0-c22d-4a1b-97a0-d5767e5f7730 | 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 | Related label |
|---|---|---|
| 50090-4345-0 | 2023-02-07 | SUDOGEST NASAL DECONGESTANT |
| 50090-4345-1 | 2023-02-07 | SUDOGEST NASAL DECONGESTANT |
| 50090-4345-2 | 2023-02-07 | SUDOGEST NASAL DECONGESTANT |
| 50090-4345-3 | 2023-02-07 | SUDOGEST NASAL DECONGESTANT |
| 50090-4345-4 | 2023-02-07 | SUDOGEST NASAL DECONGESTANT |
| 50090-4345-5 | 2023-02-07 | SUDOGEST NASAL DECONGESTANT |
| 50090-4345-0 | 2023-01-30 | SUDOGEST NASAL DECONGESTANT |
| 50090-4345-1 | 2023-01-30 | SUDOGEST NASAL DECONGESTANT |
| 50090-4345-2 | 2023-01-30 | SUDOGEST NASAL DECONGESTANT |
| 50090-4345-3 | 2023-01-30 | SUDOGEST NASAL DECONGESTANT |
| 50090-4345-4 | 2023-01-30 | SUDOGEST NASAL DECONGESTANT |
| 50090-4345-5 | 2023-01-30 | SUDOGEST NASAL DECONGESTANT |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50090-4345-0 | SUDOGEST NASAL DECONGESTANT | 48 in 1 BOTTLE | TABLET, FILM COATED | 48 | 10 | |
| 50090-4345-1 | SUDOGEST NASAL DECONGESTANT | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | 10 | |
| 50090-4345-1 | SUDOGEST NASAL DECONGESTANT | 24 in 1 CARTON | TABLET, FILM COATED | 24 | 10 | |
| 50090-4345-2 | SUDOGEST NASAL DECONGESTANT | 12 in 1 BOTTLE | TABLET, FILM COATED | 12 | 10 | |
| 50090-4345-3 | SUDOGEST NASAL DECONGESTANT | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | 10 | |
| 50090-4345-4 | SUDOGEST NASAL DECONGESTANT | 4 in 1 BOTTLE | TABLET, FILM COATED | 4 | 10 | |
| 50090-4345-5 | SUDOGEST NASAL DECONGESTANT | 15 in 1 BOTTLE | TABLET, FILM COATED | 15 | 10 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50090-4345-1 | EA - Each | 50090-4345 | a510bcc2-0b21-485b-b9e5-434600a49171 | 1 | 2022-09-12 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50090-4345 | SUDOGEST NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS] | 10 | Current NDC, Legacy NDC, 7 package rows | 20241109_09feb5f0-c22d-4a1b-97a0-d5767e5f7730.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 |
|---|---|---|---|---|---|---|
| Tukol Max Action Cold and Flu Nighttime Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE | Genomma Lab USA | cf0987a3-2c1d-4f40-8551-df9a8e08cd3d | 2026-08-03 | Warnings | M012 |
| Pressure, Pain and Mucus | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL | Meijer Distribution, Inc. | 7d42e164-86e9-4baa-a389-3271cf99920e | 2026-08-03 | Warnings | M012 |
| DG Health Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | Dolgencorp Inc | ed754d5c-74e1-4dee-a5c5-10ccec1b81db | 2026-08-03 | Warnings | M012 |
| RIGHT REMEDIES Mucus Relief DM | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Strive Pharmaceuticals Inc. | 51c4dcfb-8725-d547-e063-6394a90ac04c | 2026-07-31 | Warnings | M012 |
| Stona for Children | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE | Sato Pharmaceutical Co., Ltd. | 18f3d694-9dff-407e-a264-916dbd201f9a | 2026-07-31 | Warnings | M012 |
| Stonarhini | CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE | Sato Pharmaceutical Co., Ltd. | cc353280-0b4c-418c-93fe-850125955009 | 2026-07-31 | Warnings | M012 |
| cold and flu HBP | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE | Meijer Distribution Inc | 5519e918-71cb-4430-ae57-e03cd5ac6002 | 2026-07-31 | Warnings | M012 |
| Good Neighbor Pharmacy allergy | DIPHENHYDRAMINE HYDROCHLORIDE | Amerisource Bergen | 9819522f-f3db-4cb8-9680-423114ace2f6 | 2026-07-31 | Warnings | M012 |
| Sinus Relief Daytime, Nighttime | ACETAMINOPHEN, DIPHENHYDRAMINE HCL, GUAIFENESIN, PHENYLEPHRINE HCL | Rite Aid Corporation | 352b89b5-6995-4873-a103-e8f89074fdc9 | 2026-07-30 | Warnings | M012 |
| Severe Congestion and Pain | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL | Family Dollar Services Inc | ce590997-3cae-4f22-ac39-2b14d39494bc | 2026-07-30 | Warnings | M012 |
| allergy | DIPHENHYDRAMINE HYDROCHLORIDE | Meijer Distribution Inc | f1e83e43-011c-4470-bd55-fb2818a9fc84 | 2026-07-30 | Warnings | M012 |
| Robitussin Direct Cough | DEXTROMETHORPHAN HYDROBROMIDE | Haleon US Holdings LLC | 70c9556b-063a-4fb3-96f6-1d4ffa495ed4 | 2026-07-30 | Warnings | M012 |
| Major Nasal Decongestant | OXYMETAZOLINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | a302e341-1c00-4c3d-b71f-c4c0b307aa67 | 2026-07-29 | Warnings | M012 |
| Pain Reliever PM Extra Strength | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | Walgreens | 4c737cd6-fe56-4cef-887c-cd6cf83b254c | 2026-07-29 | Warnings | M012 |
| ROBITUSSIN LONG-ACTING COUGHGELS | DEXTROMETHORPHAN HYDROBROMIDE | Haleon US Holdings LLC | 472c5c1f-eb5a-444b-a17e-f0d71007fb15 | 2026-07-29 | Warnings | M012 |
| TOPCARE NITE TIME COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Topco Associates LLC | 905d1c5c-65c8-47a3-ad7a-61a4b4b98f0d | 2026-07-29 | Warnings | M012 |
| DAYTIME COLD AND FLU NITETIME COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Meijer Distribution Inc | 3a33c6ce-aada-4099-8c61-49c86c0fc1a8 | 2026-07-29 | Warnings | M012 |
| Tussin DM Max Nighttime | DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Wal-Mart Stores Inc | 668c92ce-6c1f-4ab3-b0dd-822b0768cb5e | 2026-07-29 | Warnings | M012 |
| Benadryl | DIPHENHYDRAMINE HYDROCHLORIDE | Kenvue Brands LLC | 702f9786-7ce9-43e4-921d-e1db09612127 | 2026-07-28 | Warnings | M012 |
| LoHist-D | CHLORPHENIRAMINE MALEATE / PSEUDOEPHEDRINE HCL | Larken Laboratories, Inc. | efaa354e-c25c-405b-9d30-001c2796978c | 2026-07-28 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1049160 | pseudoephedrine HCl 30 MG Oral Tablet | PSN | 09feb5f0-c22d-4a1b-97a0-d5767e5f7730 | 10 |
| 1049162 | SudoGest 30 MG Oral Tablet | PSN | 09feb5f0-c22d-4a1b-97a0-d5767e5f7730 | 10 |
| 1049162 | pseudoephedrine hydrochloride 30 MG Oral Tablet [Sudogest] | SBD | 09feb5f0-c22d-4a1b-97a0-d5767e5f7730 | 10 |
| 1049160 | pseudoephedrine hydrochloride 30 MG Oral Tablet | SCD | 09feb5f0-c22d-4a1b-97a0-d5767e5f7730 | 10 |
| 1049162 | Sudogest 30 MG Oral Tablet | SY | 09feb5f0-c22d-4a1b-97a0-d5767e5f7730 | 10 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 50090-4345-0 | 50090434500 | 48 TABLET, FILM COATED in 1 BOTTLE (50090-4345-0) | 2019-10-09 | 0000-00-00 | No | No | Current | |
| 50090-4345-1 | 50090434501 | 24 BLISTER PACK in 1 CARTON (50090-4345-1) / 1 TABLET, FILM COATED in 1 BLISTER PACK | 24 blister pack | 2019-06-10 | 0000-00-00 | No | No | Current |
| 50090-4345-2 | 50090434502 | 12 TABLET, FILM COATED in 1 BOTTLE (50090-4345-2) | 2019-10-09 | 0000-00-00 | No | No | Current | |
| 50090-4345-3 | 50090434503 | 30 TABLET, FILM COATED in 1 BOTTLE (50090-4345-3) | 2019-10-09 | 0000-00-00 | No | No | Current | |
| 50090-4345-4 | 50090434504 | 4 TABLET, FILM COATED in 1 BOTTLE (50090-4345-4) | 2019-10-09 | 0000-00-00 | No | No | Current | |
| 50090-4345-5 | 50090434505 | 15 TABLET, FILM COATED in 1 BOTTLE (50090-4345-5) | 2019-10-09 | 0000-00-00 | No | No | Current |