SUDAFED PE SINUS CONGESTION
- Product NDC
- 50580-239
- 11-digit product format
- 505800239
- Labeler code
- 50580
- Product ID
- 50580-239_216dcbdd-8eff-4427-e063-6294a90aed52
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- diphenhydramine hydrochloride and phenylephrine hydrochloride
- Dosage form
- KIT
- Labeler
- Kenvue Brands LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2019-06-17
- 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 SINUS CONGESTION
- Listing expiration
- 2026-12-31
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| a38fdfb8-db89-487f-9b68-aa9152b91f5f | 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 |
| 0e2e0f88-b076-afe1-4bdd-32bca4375bec | Product name | 3 | 20250127 |
| 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 |
| 3e48c9c4-918d-5d23-2f0b-d2398b06be54 | Product name | 1 | 20140508 |
| 42f3c020-f1b3-89bc-7bdc-e1f10e680485 | Product name | 1 | 20140508 |
| 865c72dd-0d94-daac-f728-ddd4ded2a79e | Product name | 1 | 20140508 |
| e949165d-714d-e548-2b76-0cb5def16f30 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50580-239-01 | 2024-02-01 | C162847 | 48780-1 | 1030e365-3d2f-111a-e063-dadaa90a10e2 | SUDAFED PE SINUS CONGESTION |
| 50580-239-01 | 2024-01-30 | C162847 | 48780-1 | 1030e365-3d2f-111a-e063-dadaa90a10e2 | SUDAFED PE SINUS CONGESTION |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50580-239-01 | SUDAFED PE SINUS CONGESTION | 1 in 1 PACKAGE | KIT | 1 | 5 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50580-239-01 | EA - Each | 50580-239 | c73d5821-9a01-4318-832e-0ce474949438 | 1 | 2020-04-20 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50580-239 | SUDAFED PE SINUS CONGESTION (DIPHENHYDRAMINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE) KIT [KENVUE BRANDS LLC] | 5 | Current NDC, Legacy NDC, 1 package rows | 20241109_a38fdfb8-db89-487f-9b68-aa9152b91f5f.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 |
|---|---|---|---|---|---|---|
| Allegra Allergy 24 hour | FEXOFENADINE HYDROCHLORIDE | Select Consumer Group | 2de81a41-8488-7e39-e063-6294a90a394b | 2026-06-01 | Warnings | M012 |
| Cough and Runny Nose Childrens Plus | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE | TOP CARE (Topco Associates LLC) | 6f04bd51-093c-4624-aef3-0145ac387386 | 2026-06-01 | Warnings | M012 |
| Nasal | PHENYLEPHRINE HYDROCHLORIDE | CVS Pharmacy | 694a3116-1b75-42cd-bbcf-d19831c2d796 | 2026-06-01 | Warnings | M012 |
| night time | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | H E B | cf31538c-9eee-4c81-80cb-66eecabf0aff | 2026-06-01 | Warnings | M012 |
| Mucinex Childrens Mighty Chews Cough | DEXTROMETHORPHAN HYDROBROMIDE | Reckitt Benckiser LLC | 155e07b3-0a08-3be8-e063-6394a90a7635 | 2026-05-31 | Warnings | M012 |
| Mucinex Childrens Mighty Chews Cough Nighttime | DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATE | Reckitt Benckiser LLC | 156033ae-b16a-007b-e063-6294a90a7445 | 2026-05-31 | Warnings | M012 |
| Cold and Flu Day | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Walgreen Company | ebf8c82d-a653-4c02-893b-61704901acbb | 2026-05-29 | Warnings | M012 |
| Allergy Relief Childrens | DIPHENHYDRAMINE HCL | Amerisource Bergen | 934c7b91-3cba-47f0-8efa-77216f3f15c4 | 2026-05-29 | Warnings | M012 |
| Allergy Medicine | DIPHENHYDRAMINE HCL | COSTCO WHOLESALE CORPORATION | d9f03e11-d11f-43ee-8ed0-9e07d1058f66 | 2026-05-29 | Warnings | M012 |
| Cold Childrens, Multi Symptom | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | CVS PHARMACY | eaa07dd4-cb7e-45ca-abe4-7a3f7a9d928d | 2026-05-29 | Warnings | M012 |
| NebuClear MD | RACEPINEPHRINE HYDROCHLORIDE | Blue Echo Care LLC | 3598ac5b-29f9-f002-e063-6294a90a62cb | 2026-05-28 | Warnings | M012 |
| NebuClear MD | RACEPINEPHRINE HYDROCHLORIDE | Blue Echo Care LLC | 51badd2f-4a43-3dbe-e063-6294a90a4bd1 | 2026-05-28 | Warnings | M012 |
| Kids Cough and Chest Congestion | DEXTROMETHORPHAN HBR, GUAIFENESIN | Genexa Inc. | a7ab2140-de09-158f-e053-2a95a90a25a0 | 2026-05-28 | Warnings | M012 |
| Kids Multi Symptom Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR | Genexa Inc. | 2d918ec8-3098-1d09-e063-6294a90a9e8f | 2026-05-28 | Warnings | M012 |
| Daytime and Nighttime Kids Multi-Symptom Cold and Flu combo pack | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL | Genexa Inc. | 213fe898-dace-9a0f-e063-6394a90afd64 | 2026-05-28 | Warnings | M012 |
| MGC Health Cough Drops Honey Lemon Flavor | MENTHOL | Medical Group Care LLC | 556628ab-e233-92fe-e063-6394a90a0090 | 2026-05-28 | Warnings | M012 |
| Sinus Decongestion PE | PHENYLEPHRINE HCL | Kroger Company | 68eff734-177e-4999-9126-6b92bb204107 | 2026-05-28 | Warnings | M012 |
| Cough and Cold HBP | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | ARMY AND AIR FORCE EXCHANGE SERVICE | ff39084f-ab2f-48ed-ac62-837f7fff2b65 | 2026-05-28 | Warnings | M012 |
| Tylenol Sinus Severe | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Select Consumer Group LLC | 52c5fda0-c358-72e8-e063-6394a90a3f68 | 2026-05-27 | Warnings | M012 |
| Mucinex Childrens Mighty Chews Cough Daytime and Nighttime Combo Pack | DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATE | Reckitt Benckiser LLC | 16637d54-8049-d3ce-e063-6394a90aafc9 | 2026-05-27 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2639176 | {1 (diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Oral Tablet) / 1 (phenylephrine hydrochloride 10 MG Oral Tablet) } Pack | GPCK | a38fdfb8-db89-487f-9b68-aa9152b91f5f | 5 |
| 2639176 | 1 daytime (phenylephrine hydrochloride 10 MG Oral Tablet) / 1 nighttime (diphenhydrAMINE hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Oral Tablet) Pack | PSN | a38fdfb8-db89-487f-9b68-aa9152b91f5f | 5 |
| 1052928 | diphenhydrAMINE HCl 25 MG / phenylephrine HCl 10 MG Oral Tablet | PSN | a38fdfb8-db89-487f-9b68-aa9152b91f5f | 5 |
| 1049182 | phenylephrine HCl 10 MG Oral Tablet | PSN | a38fdfb8-db89-487f-9b68-aa9152b91f5f | 5 |
| 1052767 | SUDAFED PE 10 MG Oral Tablet | PSN | a38fdfb8-db89-487f-9b68-aa9152b91f5f | 5 |
| 1052767 | phenylephrine hydrochloride 10 MG Oral Tablet [Sudafed PE] | SBD | a38fdfb8-db89-487f-9b68-aa9152b91f5f | 5 |
| 1052928 | diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Oral Tablet | SCD | a38fdfb8-db89-487f-9b68-aa9152b91f5f | 5 |
| 1049182 | phenylephrine hydrochloride 10 MG Oral Tablet | SCD | a38fdfb8-db89-487f-9b68-aa9152b91f5f | 5 |
| 2639176 | 1 daytime (phenylephrine hydrochloride 10 MG Oral Tablet) / 1 nighttime (diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Oral Tablet) Pack | SY | a38fdfb8-db89-487f-9b68-aa9152b91f5f | 5 |
| 1052767 | Sudafed PE 10 MG Oral Tablet | SY | a38fdfb8-db89-487f-9b68-aa9152b91f5f | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 50580-239-01 | 50580023901 | 1 KIT in 1 PACKAGE (50580-239-01) * 2 BLISTER PACK in 1 CARTON / 6 TABLET, FILM COATED in 1 BLISTER PACK * 2 BLISTER PACK in 1 CARTON / 4 TABLET, FILM COATED in 1 BLISTER PACK | 1 kit | 2019-06-17 | 0000-00-00 | No | No | Current |