SUDAFED PE Pressure Plus Pain
- Product NDC
- 50580-547
- 11-digit product format
- 505800547
- Labeler code
- 50580
- Product ID
- 50580-547_217318f0-e484-c909-e063-6294a90a1bd1
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- acetaminophen and phenylephrine hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Kenvue Brands LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2012-07-01
- Substance
- ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 325; 5 mg/1; mg/1
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], alpha-1 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 | 50580-547 | 50580-547-73 | 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
- SUDAFED PE Pressure Plus Pain
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 325 mg/1 |
| PHENYLEPHRINE HYDROCHLORIDE | 5 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
| 04JA59TNSJ | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1046378 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 8538c291-9ce9-4866-b268-f4cbdb52f5bd | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e4e263da-1c53-440f-bb80-b7a575843b5a | Product name | 1 | 20260313 |
| d2168cac-a261-415a-9c78-3522859fa720 | Product name | 3 | 20251124 |
| 05a8cdd1-eeb8-409e-b938-0778225eca7d | Product name | 4 | 20250221 |
| e5b5c132-b15d-435b-9faa-2f74e5cadcf9 | Product name | 8 | 20250220 |
| f489e8f3-5c9e-4818-b539-a73587edcfc7 | Product name | 2 | 20240229 |
| 0f7ae452-206d-4fc4-868d-56fc47074084 | Product name | 1 | 20231011 |
| b5abe2e3-39a1-43eb-9bff-f3c1653fe3df | Product name | 2 | 20190930 |
| e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814 | Product name | 3 | 20150910 |
| 42f3c020-f1b3-89bc-7bdc-e1f10e680485 | Product name | 1 | 20140508 |
| e949165d-714d-e548-2b76-0cb5def16f30 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Related label |
|---|---|---|
| 50580-547-25 | 2024-02-06 | SUDAFED PE ® Pressure+Pain |
| 50580-547-73 | 2024-02-06 | SUDAFED PE ® Pressure+Pain |
| 50580-547-25 | 2024-01-30 | SUDAFED PE ® Pressure+Pain |
| 50580-547-73 | 2024-01-30 | SUDAFED PE ® Pressure+Pain |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50580-547-25 | SUDAFED PE Pressure Plus Pain | 2 in 1 CARTON | TABLET, FILM COATED | 2 | 15 | |
| 50580-547-25 | SUDAFED PE Pressure Plus Pain | 12 in 1 BLISTER PACK | TABLET, FILM COATED | 12 | 15 | |
| 50580-547-73 | SUDAFED PE Pressure Plus Pain | 2 in 1 CARTON | TABLET, FILM COATED | 2 | 15 | |
| 50580-547-73 | SUDAFED PE Pressure Plus Pain | 12 in 1 BLISTER PACK | TABLET, FILM COATED | 12 | 15 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50580-547-25 | EA - Each | 50580-547 | b3b25d88-3b75-466c-a7f0-b08a4e2194b7 | 1 | 2015-08-04 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50580-547 | SUDAFED PE PRESSURE PLUS PAIN (ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [KENVUE BRANDS LLC] | 15 | Current NDC, Legacy NDC, 4 package rows | 20241109_8538c291-9ce9-4866-b268-f4cbdb52f5bd.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 |
|---|---|---|---|---|---|---|
| DayTime Cold/Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | ARMY AND AIR FORCE EXCHANGE SERVICE | 04f9134e-1311-4843-90db-9244b9e61e1d | 2025-12-19 | Warnings | M012 |
| Nighttime Cold/Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | ARMY AND AIR FORCE EXCHANGE SERVICE | 029e6215-b72d-4fd0-8918-db1abcc4490a | 2025-12-19 | Warnings | M012 |
| DayTime and Nighttime Cold/Flu Relief Softgels - Combo Pack | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DOXYLAMINE SUCCINATE | ARMY AND AIR FORCE EXCHANGE SERVICE | 5f680f37-b3db-450f-b8ca-f9e31a04dc04 | 2025-12-19 | Warnings | M012 |
| Childrens Allergy Relief | DIPHENHYDRAMINE HCL | Marc Glassman, Inc. | e916ef86-ca73-42dd-83dc-6033f56d96f2 | 2025-12-19 | Warnings | M012 |
| Original Night-Time MULTI-SYMPTOM COLD/FLU RELIEF | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Discount Drug Mart | e243033b-6603-4c3e-a330-e7c7de51f69d | 2025-12-19 | Warnings | M012 |
| CHILDRENS ALLERGY | DIPHENHYDRAMINE HYDROCHLORIDE | Discount Drug Mart | 6fa4f913-de83-4175-9dad-0dedab5b69a1 | 2025-12-19 | Warnings | M012 |
| Day-Time COLD/FLU RELIEF | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCL | Discount Drug Mart | 426db906-9aa4-448f-a361-09c1516efc25 | 2025-12-19 | Warnings | M012 |
| MAXIUM STRENGTH SEVERE CONGESTION and COUGH MAX | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Discount Drug Mart | f17385bc-82bb-4183-a4c9-067d8afb3757 | 2025-12-19 | Warnings | M012 |
| MAXIUM STRENGTH DM MAX | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Discount Drug Mart | 9654fdcd-d660-471f-bc5d-aa7dead7a4a8 | 2025-12-19 | Warnings | M012 |
| Night Time Multi-Symptom Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Discount Drug Mart | 8148c2b1-f6ec-4597-8e18-a6597cda5705 | 2025-12-19 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL 25 MG | NUVICARE LLC | 621ba20e-75c5-42fb-9692-7800f764c978 | 2025-12-19 | Warnings | M012 |
| Nasal Decongestant PE | PHENYLEPHRINE HCL 10 MG | NUVICARE LLC | 4cde41dd-a0a7-45e7-aff3-ee9402dfdff2 | 2025-12-19 | Warnings | M012 |
| COMBINATION PACK TopCare health DayTime SEVERE and NiteTime SEVERE Cold and Flu Relief SOFTGELS - 24 ct | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Topco Associates LLC | ceb27ff3-cf42-44f9-9ee6-8ea86a0cbe3e | 2025-12-19 | Warnings | M012 |
| NeoTuss S/F Grape-Menthol Flavor | GUAIFENESIN, DEXTROMETHORPHAN HBR | DORAL PHARMAMEDICS INC dba A.G. Marin Pharmaceuticals | 2f3df82c-1926-5238-e063-6294a90a7bbf | 2025-12-18 | Warnings | M012 |
| NeoTuss S/F Grape-Menthol Flavor | GUAIFENESIN, DEXTROMETHORPHAN HBR | DORAL PHARMAMEDICS INC dba A.G. Marin Pharmaceuticals | 2fac3425-32f0-38d6-e063-6394a90a6e7a | 2025-12-18 | Warnings | M012 |
| NAFASOLINA | NAPHAZOLINE HYDROCHLORIDE | Doral Pharmamedics Inc DBA AG Marin Pharmaceuticals | 30cade3d-208f-8594-e063-6394a90ad2a0 | 2025-12-18 | Warnings | M012 |
| Honey Lemon Flavor Cough Drop | HONEY LEMON FLAVOR COUGH DROP | Army & Air Force Exchange Service | 20ac8a20-206c-0024-e063-6394a90a9d06 | 2025-12-18 | Warnings | M012 |
| Menthol Flavor Cough Drop | MENTHOL FLAVOR COUGH DROP | Army & Air Force Exchange Service | 20ace10f-4257-b20e-e063-6394a90a3c7b | 2025-12-18 | Warnings | M012 |
| NeoTuss Plus | DEXTROMETHORPHAN HBR, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL | DORAL PHARMAMEDICS INC dba A.G. Marin Pharmaceuticals | 2fabd782-14dc-1d1b-e063-6394a90af428 | 2025-12-18 | Warnings | M012 |
| NeoTuss Plus | DEXTROMETHORPHAN HBR, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL | DORAL PHARMAMEDICS INC dba A.G. Marin Pharmaceuticals | 2f3c6b38-7236-899b-e063-6294a90aabde | 2025-12-18 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1046378 | acetaminophen 325 MG / phenylephrine HCl 5 MG Oral Tablet | PSN | 8538c291-9ce9-4866-b268-f4cbdb52f5bd | 15 |
| 1046378 | acetaminophen 325 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SCD | 8538c291-9ce9-4866-b268-f4cbdb52f5bd | 15 |
| 1046378 | APAP 325 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SY | 8538c291-9ce9-4866-b268-f4cbdb52f5bd | 15 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 50580-547-25 | 50580054725 | 2 BLISTER PACK in 1 CARTON (50580-547-25) / 12 TABLET, FILM COATED in 1 BLISTER PACK | 2 blister pack | 2012-07-01 | 0000-00-00 | No | No | Current |
| 50580-547-73 | 50580054773 | 2 BLISTER PACK in 1 CARTON (50580-547-73) > 12 TABLET, FILM COATED in 1 BLISTER PACK | 2 blister pack | 2018-12-21 | 0000-00-00 | No | No | Current |