Childrens Sudafed PE
- Product NDC
- 50580-784
- 11-digit product format
- 505800784
- Labeler code
- 50580
- Product ID
- 50580-784_23506802-1f31-c967-e063-6394a90a2e7f
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Phenylephrine hydrochloride
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Kenvue Brands LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2008-10-01
- Substance
- PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 2.5 mg/5mL
- 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
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
- Childrens Sudafed PE
- Brand name suffix
- NASAL DECONGESTANT
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| PHENYLEPHRINE HYDROCHLORIDE | 2.5 mg/5mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 04JA59TNSJ | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 692479 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 4dfd46e4-b9f9-464d-aa47-e8fa9e526a5d | 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 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50580-784-04 | Childrens Sudafed PENASAL DECONGESTANT | 1 in 1 CARTON | SOLUTION | 1 | 11 | |
| 50580-784-04 | Childrens Sudafed PENASAL DECONGESTANT | 118 mL in 1 BOTTLE | SOLUTION | 118 | 11 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50580-784-04 | ML - Milliliter | 50580-784 | fc782f1b-f268-49e0-baa7-c76b72f6d059 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| Pain Relief Sinus Congestion | ACETAMINOPHEN, PHENYLEPHRINE HCL | Better Living Brands, LLC | 1d3d6397-0d92-4145-9a70-8bcc45bd0322 | 2026-06-15 | Warnings | M012 |
| Goodmeds Allergy Relief Diphenhydramine HCl | DIPHENHYDRAMINE HYDROCHLORIDE | Cabinet Health P.B.C. | c1cc40f4-9bbb-47f2-ba3b-a5c46ec10f11 | 2026-06-15 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | Rite Aid Corporation | d5d9334d-3db6-4f45-ab84-3e1ec5a752c6 | 2026-06-15 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | Geiss, Destin & Dunn Inc. | fac64ddc-a89b-4d73-b9e5-edc4e5cc3c4b | 2026-06-15 | Warnings | M012 |
| equate daytime cold and flu nighttime cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Wal-Mart Stores Inc | 983a4783-d826-41b6-8087-ca66bcd5b6ca | 2026-06-12 | Warnings | M012 |
| Equate Daytime Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Wal-Mart Stores Inc | 4173ecde-a2d7-4836-a6e9-fef2270d1b4e | 2026-06-12 | Warnings | M012 |
| PAIN RELIEVER PM Extra Strength | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | Best Choice (Valu Merchandisers Company) | cf370a59-42d5-42fe-882f-09885c55f570 | 2026-06-11 | Warnings | M012 |
| Sudafed Sinus Congestion Plus Cold Severe Day | ACETAMINOPHEN, PSEUDOEPHEDRINE | Kenvue Brands LLC | 537e1a0d-820d-c3f7-e063-6294a90a56ea | 2026-06-10 | Warnings | M012 |
| Sudafed Sinus Congestion plus Cold Severe Day and Night | ACETAMINOPHEN, DIPHENHYDRAMINE, PSEUDOEPHEDRINE | Kenvue Brands LLC | 5382dcad-0337-4440-e063-6394a90a706e | 2026-06-10 | Warnings | M012 |
| good neighbor pharmacy nasal | OXYMETAZOLINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 21cfa71c-7a8f-4100-a42e-9190260653d1 | 2026-06-09 | Warnings | M012 |
| Daytime Nighttime | ACETAMINOPHEN DEXTROMETHORPHAN HBR, ACETAMINOPHEN DEXTROMETHORPHAN HBR TRIPROLIDINE HCL | WALGREENS | 47f1d92f-cb4b-1635-e063-6294a90a2c71 | 2026-06-09 | Warnings | M012 |
| Vicks DayQuil and Vicks NyQuil Intense Flu Rapid Release LiquiCaps | ACETAMINOPHEN, DOXYLAMINE SUCCINATE, DEXTROMETHORPHAN HBR | The Procter & Gamble Manufacturing Company | bfff40f6-8586-4e4b-8db1-d96ba4819a09 | 2026-06-09 | Warnings | M012 |
| HALLS Honey | MENTHOL | Mondelez Global LLC | 837f5ded-8efb-402b-a1bc-b5c142755660 | 2026-06-09 | Warnings | M012 |
| Vicks NyQuil Intense Flu Rapid Release LiquiCaps | ACETAMINOPHEN, DOXYLAMINE SUCCINATE, DEXTROMETHORPHAN HBR | The Procter & Gamble Manufacturing Company | 354906d1-455b-460c-8283-984e73c09d7e | 2026-06-09 | Warnings | M012 |
| Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Meijer Distribution Inc | 932b11b1-f4a0-417a-bfa1-05261a172155 | 2026-06-08 | Warnings | M012 |
| NO DRIP NASAL MIST | OXYMETAZOLINE HYDROCHLORIDE | Kroger Company | 957efbcf-b6d3-4793-bb6e-27e99c9be905 | 2026-06-08 | Warnings | M012 |
| DAYTIME SEVERE COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 493caecb-e687-49ea-b7a1-2a5b9376896d | 2026-06-08 | Warnings | M012 |
| Severe Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | CVS PHARMACY | 4ad10fd7-c088-4356-9d34-a95cfe3a4133 | 2026-06-08 | Warnings | M012 |
| Theraflu Severe Congestion Relief Nasal Mist | OXYMETAZOLINE HCL | Haleon US Holdings LLC | 4ec42064-7390-4137-a93e-57343c3c76a7 | 2026-06-08 | Warnings | M012 |
| Theraflu Severe Congestion Relief Cooling Nasal Mist | OXYMETAZOLINE HCL | Haleon US Holdings LLC | 90125a19-eed7-4ca4-a6dc-f38026c74d54 | 2026-06-08 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 692479 | phenylephrine HCl 2.5 MG in 5 mL Oral Solution | PSN | 4dfd46e4-b9f9-464d-aa47-e8fa9e526a5d | 11 |
| 692479 | phenylephrine hydrochloride 0.5 MG/ML Oral Solution | SCD | 4dfd46e4-b9f9-464d-aa47-e8fa9e526a5d | 11 |
| 692479 | phenylephrine hydrochloride 2.5 MG per 5 ML Oral Solution | SY | 4dfd46e4-b9f9-464d-aa47-e8fa9e526a5d | 11 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 50580-784-04 | 50580078404 | 1 BOTTLE in 1 CARTON (50580-784-04) / 118 mL in 1 BOTTLE | 1 bottle | 2008-10-01 | 0000-00-00 | No | No | Current |