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 | 2026-10-23 |
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 |
|---|---|---|---|---|---|---|
| Coricidin HBP Maximum Strength Cold and Flu Day and Night | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, DOXYLAMINE SUCCINATE | Bayer HealthCare LLC. | e4f3f906-2252-21d1-e053-2a95a90a85df | 2025-12-04 | Warnings | M012 |
| Afrin No Drip Pump Mist Bundle Pack | OXYMETAZOLINE HYDROCHLORIDE | Bayer HealthCare LLC. | 16c52c79-baec-87db-e063-6294a90a3b3b | 2025-12-04 | Warnings | M012 |
| Afrin Original Pump Mist | OXYMETAZOLINE HYDROCHLORIDE | Bayer HealthCare LLC. | 0f5ec576-f788-40aa-9088-0dd672e3cc7c | 2025-12-04 | Warnings | M012 |
| Adult Long Lasting Cough Relief | DEXTROMETHORPHAN HBR | Shield Pharmaceuticals Corp | 432a79a9-c69d-4514-894a-7832e1b745ef | 2025-12-04 | Warnings | M012 |
| GENCONTUSS | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | KRAMER NOVIS | 69d16d25-b09b-430e-8e01-0962d840dc21 | 2025-12-04 | Warnings | M012 |
| Nasal Decongestant PE | PHENYLEPHRINE HCL | H E B | 7c04ab14-af28-4598-90ef-56ac11902c7d | 2025-12-04 | Warnings | M012 |
| Desgen Pediatric | DEXTROMETHORPHAN HBR, GUIAFENESIN, PHENYLEPHRINE HCL | Kramer Novis | 12425c1b-8bdc-446b-83dd-95e05a4d9b8c | 2025-12-04 | Warnings | M012 |
| Presgen B | DEXTROMETHORPHAN HYDROBROMIDE, BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE | KRAMER NOVIS | 5befa829-32bd-4978-8a0e-1d6513ff37a4 | 2025-12-03 | Warnings | M012 |
| TUSSLIN | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Kramer Novis | 987e19a5-032f-44e9-b4c7-8a764d502695 | 2025-12-03 | Warnings | M012 |
| DayTime Relief, Cold and Flu, 24-7 Life by 7-Eleven | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL SOLUTION | Lil' Drug Store Products, Inc. | 450e8974-8ff8-4b82-e063-6394a90a9366 | 2025-12-03 | Warnings | M012 |
| Nighttime Relief, Cold and Flu, 24-7 Life by 7-Eleven | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE SOLUTION | Lil' Drug Store Products, Inc. | 4510223f-1c88-2796-e063-6394a90a18ac | 2025-12-03 | Warnings | M012 |
| Carolina Crud Crusher | DEXTROMETHORPHAN HBR, GUAIFENESIN | Weeks & Leo Co., Inc. | 0b606683-7d68-cca5-e063-6394a90a6f58 | 2025-12-03 | Warnings | M012 |
| Capmist DM | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | Capital Pharmaceutical, LLC | 63733ac3-859e-4a8e-8717-d852bd303408 | 2025-12-03 | Warnings | M012 |
| ALA-HIST IR | DEXBROMPHENIRAMINE MALEATE | Poly Pharmaceuticals, Inc. | 0d203b5c-8b10-428b-8703-17be6b4ce6eb | 2025-12-03 | Warnings | M012 |
| ALAHIST DM | DEXTROMETHORPHAN HBR, PHENIRAMINE MALEATE, PHENYLEPHRINE HCL | Poly Pharmaceuticals, Inc. | fdaa062d-110e-798d-e053-6394a90a755c | 2025-12-03 | Warnings | M012 |
| Alahist D | PHENIRAMINE MALEATE, PHENYLEPHRINE HCL | Poly Pharmaceuticals, Inc. | a1b8533a-ef8b-57cc-e053-2995a90a5d9e | 2025-12-03 | Warnings | M012 |
| Alahist PE | DEXBROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE | Poly Pharmaceuticals, Inc. | ada2d582-5813-2029-e053-2a95a90ae567 | 2025-12-03 | Warnings | M012 |
| Benadryl Allergy Extra Strength Liqui-Gels | DIPHENHYDRAMINE HYDROCHLORIDE | Kenvue Brands LLC | 30aca3ab-b091-3939-e063-6294a90a9819 | 2025-12-03 | Warnings | M012 |
| Cough and Cold HBP | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | L.N.K. International, Inc. | 9f2daffc-1904-4d64-9f84-689c88601e06 | 2025-12-03 | Warnings | M012 |
| Childrens Multi-symptom Cold | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Wal-Mart Stores, Inc. | d291faa9-894e-421c-8115-8a8c2a937172 | 2025-12-03 | 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 |