SUDAFED PE Head Congestion Plus Flu Severe
- Product NDC
- 50580-450
- 11-digit product format
- 505800450
- Labeler code
- 50580
- Product ID
- 50580-450_21c26e65-49b8-35f4-e063-6394a90a8e0b
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Kenvue Brands LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2019-06-17
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 325; 10; 100; 5 mg/1; mg/1; mg/1; mg/1
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
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 Head Congestion Plus Flu Severe
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 325 mg/1 |
| DEXTROMETHORPHAN HYDROBROMIDE | 10 mg/1 |
| GUAIFENESIN | 100 mg/1 |
| PHENYLEPHRINE HYDROCHLORIDE | 5 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
| 9D2RTI9KYH | Internal UNII lookup |
| 495W7451VQ | Internal UNII lookup |
| 04JA59TNSJ | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1098435 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1e528f78-0ced-4a06-935a-84056c921727 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50580-450-01 | SUDAFED PE Head Congestion Plus Flu Severe | 2 in 1 CARTON | TABLET, FILM COATED | 2 | 9 | |
| 50580-450-01 | SUDAFED PE Head Congestion Plus Flu Severe | 12 in 1 BLISTER PACK | TABLET, FILM COATED | 12 | 9 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50580-450-01 | EA - Each | 50580-450 | 2b3e284c-c2d5-47be-b574-f24d41e868c4 | 1 | 2020-01-03 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50580-450 | SUDAFED PE HEAD CONGESTION PLUS FLU SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [KENVUE BRANDS LLC] | 9 | Current NDC, Legacy NDC, 2 package rows | 20241109_1e528f78-0ced-4a06-935a-84056c921727.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 |
|---|---|---|---|---|---|---|
| WALMART DAYTIME AND NIGHTTIME MS SEVERE RELIEF VALUE PACK | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL | WAL-MART STORES INC | 888bd90a-a059-4814-bd65-6b735ecfaf3a | 2026-08-31 | Warnings | M012 |
| Severe Cold and Flu Daytime and Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Kroger | 49a98411-aa5a-6de3-e063-6294a90a148f | 2026-08-31 | Warnings | M012 |
| equate daytime nighttime cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESEN, PHENYLEPHRINE HYDROCHLORIDE | Sixarp, LLC | 5a5a6917-9fb5-e6ca-e063-6394a90af9dc | 2026-08-31 | Warnings | M012 |
| Zicam Intense Sinus Relief | OXYMETAZOLINE HYDROCHLORIDE | Church & Dwight Co., Inc. | d916f7ff-84b7-57ef-e053-2995a90a3efa | 2026-08-31 | Warnings | M012 |
| Afrin Original Nasal | OXYMETAZOLINE HYDROCHLORIDE | JC World Bell Wholesale Co., Inc. | ecfa14b8-a3f3-4569-b489-c9e1a51cf09e | 2026-08-31 | Warnings | M012 |
| Dextromethorphan HBr | DEXTROMETHORPHAN HBR | BIONPHARMA INC. | 5a5dde85-8785-8149-e063-6294a90a4d57 | 2026-08-31 | Warnings | M012 |
| Equate Nasal | OXYMETAZOLINE HCL | Sixarp, LLC | 5a5e2458-bab0-4931-e063-6394a90ad606 | 2026-08-31 | Warnings | M012 |
| MUCINEX INSTASOOTHE SORE THROAT PLUS COUGH RELIEF | DEXTROMETHORPHAN HYDROBROMIDE AND HEXYLRESORCINOL | Reckitt Benckiser LLC | 8d670d91-9e22-45b9-b568-5b62c2133d32 | 2026-08-31 | Warnings | M012 |
| Daytime Cold and Flu Multi Symptom Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Shield Pharmaceuticals Corp | e85b4c2a-d4e0-452c-9a08-fcc0ff6eaa21 | 2026-08-31 | Warnings | M012 |
| Daytime Cold and Flu Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Shield Pharmaceuticals Corp | 67849e09-2056-4013-98b1-d003ed3250a2 | 2026-08-31 | Warnings | M012 |
| MAX Tussin Mucus and Chest Congestion Sugar Free | GUAIFENESIN | Akron Pharma Inc. | 3b023b91-e703-4599-9864-96d8c328b45c | 2026-08-31 | Warnings | M012 |
| MAX Tussin Mucus and Chest Congestion | GUAIFENESIN | Akron Pharma Inc. | ac874a31-5556-4669-937f-dcb52aaecd8a | 2026-08-31 | Warnings | M012 |
| MAX Tussin Cough and Chest Congestion DM | DEXTROMETHORPHAN HBR, GUAIFENESIN | Akron Pharma Inc. | e0ce4287-bfa1-4413-97c8-4fe2e39bda36 | 2026-08-31 | Warnings | M012 |
| Acetaminophen PM Extra Strength | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | United Natural Foods, Inc. dba UNFI | 24173e77-92ec-4a87-a471-d6867837c180 | 2026-08-31 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | DOLGENCORP, LLC | 69af44c2-390c-4223-889a-d5555aef5778 | 2026-08-28 | Warnings | M012 |
| Tussin DM Daytime | DEXTROMETHORPHAN HBR, GUAIFENESIN | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 432d4833-2eaf-4f7c-b6b4-41043a6b7e2a | 2026-08-28 | Warnings | M012 |
| Chest Rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL | Your Military Exchanges | 13fcc43c-bdda-4b65-b6d7-23b39e683651 | 2026-08-28 | Warnings, Adverse reactions | M012 |
| Multi-Symptom Allergy | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL | Walgreen Company | 5170c450-989d-44fa-ab38-86c78feae3b6 | 2026-08-28 | Warnings | M012 |
| Pain Reliever PM Extra strength | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | Walgreens | 54cbbc5f-908b-47b2-b37f-3646354d3568 | 2026-08-27 | Warnings | M012 |
| Maximum Strength Mucus Relief | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Hyvee Inc | 4e578c7a-88d4-e4cd-e063-6394a90aac44 | 2026-08-27 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1098435 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 100 MG / phenylephrine HCl 5 MG Oral Tablet | PSN | 1e528f78-0ced-4a06-935a-84056c921727 | 9 |
| 1098435 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SCD | 1e528f78-0ced-4a06-935a-84056c921727 | 9 |
| 1098435 | APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / Guaifenesin 100 MG / Phenylephrine Hydrochloride 5 MG Oral Tablet | SY | 1e528f78-0ced-4a06-935a-84056c921727 | 9 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 50580-450-01 | 50580045001 | 2 BLISTER PACK in 1 CARTON (50580-450-01) / 12 TABLET, FILM COATED in 1 BLISTER PACK | 2 blister pack | 2019-06-17 | 0000-00-00 | No | No | Current |