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 |
|---|---|---|---|---|---|---|
| Allergy Childrens Allergy | DIPHENHYDRAMINE HYDROCHLORIDE | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 047102c4-3d03-4b2d-961d-0ac75980147b | 2026-05-06 | Warnings | M012 |
| GOOD SENSE COMBO PACK DAYTIME AND NIGHTTIME | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | L. Perrigo Company | d25f2649-4f8a-4339-8443-faa0b98bdd70 | 2026-05-06 | Warnings | M012 |
| Allergy Relief 4 Hour | CHLORPHENIRAMINE MALEATE | WinCo Foods, LLC | 27e911e1-6d22-4a50-8413-1809c8973cbd | 2026-05-06 | Warnings | M012 |
| ALKA SELTZER COLD Cold Cough Maximum Strength Fast Gels | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare LLC. | 51173330-d537-fb9c-e063-6394a90ae342 | 2026-05-05 | Warnings | M012 |
| Equate daytime severe vaporice cold and flu nighttime severe vapor ice cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE | Wal-Mart Stores Inc | 08e74a8d-8e8d-4cda-9adc-ea2ff4068353 | 2026-05-05 | Warnings | M012 |
| GOODSENSE COMBO PACK DAYTIME AND NIGHTTIME | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL | L. Perrigo Company | e42f9e0d-f990-4c33-af43-75acf5d77638 | 2026-05-05 | Warnings | M012 |
| Rugby Mucus and Chest Congestion 541 | GUAIFENESIN | Rugby Laboratories | 76472912-b66f-4bb4-937a-4a589683a78c | 2026-05-04 | Warnings | M012 |
| Sinus Congestion and Pain Daytime Non-Drowsy | ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE | H E B | e9dd2d7b-0a19-4a42-b51e-b9914f02406e | 2026-05-04 | Warnings | M012 |
| Sanatos Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Pharmadel LLC | 3dd3ed85-0c0a-8390-e063-6294a90a668e | 2026-05-04 | Warnings | M012 |
| Good Sense Daytime non drowsy cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | L. Perrigo Company | 0122cd34-5817-4af5-a51a-8d176dee0a30 | 2026-05-04 | Warnings | M012 |
| COLD AND FLU RELIEF | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Safeway | d810a6a9-6112-4e9d-a396-36084b7e110e | 2026-05-04 | Warnings | M012 |
| Doue Vaporizing Chest Rub Cough Suppressant | CAMPHOR, MENTHOL, EUCALYPTUS OIL | ONEST LIMITED | 2089c28b-98fd-4797-8940-b0749d8b5df7 | 2026-05-01 | Warnings | M012 |
| Benadryl Allergy Ultratab | DIPHENHYDRAMINE HYDROCHLORIDE | Savings Distributors LLC | 8d59d121-62a8-c43b-e053-2a95a90a5847 | 2026-05-01 | Warnings | M012 |
| Tylenol Cold Plus Flu Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Savings Distributors LLC | 8e87f8de-f83e-0f8d-e053-2a95a90a8d6a | 2026-05-01 | Warnings | M012 |
| Tylenol Sinus Severe | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Savings Distributors LLC | 8eecb3f0-eb5e-e847-e053-2995a90a86bd | 2026-05-01 | Warnings | M012 |
| Sinus Pressure and Congestion Relief PE Maximum Strength | PHENYLEPHRINE HCL | Rite Aid Corporation | fccea3c5-42af-4939-82bc-d9409b75f91f | 2026-05-01 | Warnings | M012 |
| Night Time Cold and Flu original | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Harris Teeter, LLC | cfaf4b3d-fab4-424d-adbe-aaedca58912d | 2026-04-30 | Warnings | M012 |
| Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Harris Teeter, LLC | 21e7d323-5b78-43aa-b0fc-34c2a864ab9a | 2026-04-30 | Warnings | M012 |
| daytime severe cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | H E B | ec0b5f4b-b58c-445f-acf1-c7ce301bba64 | 2026-04-30 | Warnings | M012 |
| Mucus Relief DM Max Maximum Strength | DEXTROMETHORPHAN HBR, GUAIFENESIN | Harris Teeter, LLC | 098428ae-e87d-4c29-8f02-1590530da58e | 2026-04-29 | 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 |