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.
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 |