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 |
|---|---|---|---|---|---|---|
| Kids Allergy | DIPHENHYDRAMINE HCL | Genexa Inc. | a7bc5f7c-eaeb-25d0-e053-2a95a90a9ec4 | 2026-05-08 | Warnings | M012 |
| day time non drowsy | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Publix Super Markets Inc | f4fd597f-bca2-4ed4-b353-6c734f2f885c | 2026-05-08 | Warnings | M012 |
| Daytime Non Drowsy | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | CVS Pharmacy | d8339bb0-5da3-4f34-a819-339643cf4a97 | 2026-05-08 | Warnings | M012 |
| severe tussin cf | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | a26afc33-533e-4dc0-ab25-21be87356e22 | 2026-05-08 | Warnings | M012 |
| SEVERE CONGESTION and COUGH MAX | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | DeMoulas Market Basket | cdd53eba-1fa2-49c1-b03d-c32f309da7fb | 2026-05-08 | Warnings | M012 |
| Benadryl Allergy Liqui-Gels | DIPHENHYDRAMINE HYDROCHLORIDE | Kenvue Brands LLC | bfeae100-e2d1-4607-be3b-2d9b15cd4f7f | 2026-05-07 | Warnings | M012 |
| Chest Rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL | H E B | 6503761f-37ae-4f39-b727-cb75d4c4a3c9 | 2026-05-07 | Warnings, Adverse reactions | M012 |
| Mucus Relief Severe Congestion and Cough | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | TOPCO ASSOCIATES LLC | ad199488-a4be-4b6e-b806-67ce8a6e907e | 2026-05-07 | Warnings | M012 |
| good sense nasal | OXYMETAZOLINE HCL | L. Perrigo Company | 5d42adb9-3625-4072-a6b1-29a229f255c8 | 2026-05-07 | Warnings | M012 |
| Childrens Allergy Relief | DIPHENHYDRAMINE HCL | Walgreen Company | 4856cd7b-ccdf-4546-9c65-236ebaac3dca | 2026-05-06 | Warnings | M012 |
| Mucus Relief All in One Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 0f8928a1-97ef-4128-b8d2-20bdb6e5b6ac | 2026-05-06 | Warnings | M012 |
| daytime cough and chest congestion dm | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 175cc2d0-0202-4e38-8af2-9fc126b7412d | 2026-05-06 | Warnings | M012 |
| Nasal Decongestant PE | PHENYLEPHRINE HYDROCHLORIDE | HHH Pharmaceuticals | 90fae0fa-da07-4ea8-bdbd-39c2ed99ae59 | 2026-05-06 | Warnings | M012 |
| PHENYLEPHRINE HYDROCHLORIDE | PHENYLEPHRINE HYDROCHLORIDE | HHH Pharmaceuticals | 5d8b980f-0011-41e3-a881-ad10fe399079 | 2026-05-06 | Warnings | M012 |
| HALLS Mentholyptus | MENTHOL | Mondelez Global LLC | 38d12374-e2c7-444c-e063-6294a90a42b3 | 2026-05-06 | Warnings | M012 |
| HALLS Mentholyptus | MENTHOL | Mondelez Global LLC | 1ab295ff-94b1-c938-e063-6294a90a98fd | 2026-05-06 | Warnings | M012 |
| ALKA SELTZER COLD Cold and Sinus Maximum Strength Fast Gels | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE , PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare LLC. | 512af63d-2f09-4baa-e063-6394a90a86bd | 2026-05-06 | Warnings | M012 |
| Thieves Chest Rub | CHEST RUB | Young Living Essential Oils, LC. | 9b7f125e-6caa-c53e-e053-2a95a90a737e | 2026-05-06 | Warnings | M012 |
| Maximum Strength Mucus Relief Plus Pain and Headache | ACETAMINOPHEN, GUAIFENESIN | Shield Pharmaceuticals Corp | f20c0db1-dcf3-4bfc-b3e4-930398f82dc9 | 2026-05-06 | Warnings | M012 |
| Nitetime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Publix Super Markets Inc | 8aa6492b-1723-4c6b-82ee-4f800301c6ad | 2026-05-06 | 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 |