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 |
|---|---|---|---|---|---|---|
| Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Walgreen Company | 54254b61-7861-4eeb-bd3c-54fd5266f4a7 | 2026-06-08 | Warnings | M012 |
| Guaifenesin | GUAIFENESIN | Major Pharmaceuticals | aa662428-e61f-4e22-af4d-8cf63df68c99 | 2026-06-08 | Warnings | M012 |
| Daytime Nighttime | ACETAMINOPHEN, GUAIFENESIN AND ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCL | TARGET CORPORATION | 47a218a0-6395-36bd-e063-6394a90a265a | 2026-06-05 | Warnings | M012 |
| Daytime Nighttime | ACETAMINOPHEN DEXTROMETHORPHAN HBR, ACETAMINOPHEN DEXTROMETHORPHAN HBR TRIPROLIDINE HCL | TARGET CORPORATION | 4779288a-9850-8490-e063-6394a90abe51 | 2026-06-05 | Warnings | M012 |
| Mucinex Fast-Max DM Max and Mucinex Fast-Max Nighttime DM Max Value Pack | DEXTROMETHORPHAN HBR, GUAIFENESIN AND TRIPROLIDINE HCL | Reckitt Benckiser LLC | 4df37cfb-299f-661f-e063-6394a90ab337 | 2026-06-04 | Warnings | M012 |
| ALKA SELTZER COLD Cold Flu Congestion Severe Fast Hot Liquid Day Night | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATE | Bayer HealthCare LLC. | 53715ea4-42b3-5887-e063-6294a90a4249 | 2026-06-04 | Warnings | M012 |
| Tussin DM | DEXTROMETHORPHAN HBR, GUAIFENESIN | Chain Drug Marketing Association, Inc. | b0d38db9-22a9-4dd8-8e0f-dd81805e724b | 2026-06-04 | Warnings | M012 |
| Cough and Cold HBP | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | CVS PHARMACY | 65d4d7ea-c080-404e-9836-7d6bdcc5ea7d | 2026-06-04 | Warnings | M012 |
| Allergy Relief Childrens | DIPHENHYDRAMINE HCL | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | fe9d6a6e-38a1-44ae-a30f-596c5ec7d057 | 2026-06-03 | Warnings | M012 |
| Severe Congestion and Cough | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Walgreen Company | b0c1d635-0f85-433a-b479-51c68d259faa | 2026-06-03 | Warnings | M012 |
| Cold and Flu Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCL | Walgreen Company | de4e8af4-d3d0-44b3-aea3-79016803ccdc | 2026-06-03 | Warnings | M012 |
| Mucus Relief DM | DEXTROMETHORPHAN HBR AND GUAIFENESIN | ARMY AND AIR FORCE EXCHANGE SERVICE | dc0a3761-bbe2-4261-a183-594f5fb12b0b | 2026-06-03 | Warnings | M012 |
| Cold and Flu Daytime, Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCL | WALMART INC. | f278cc81-65b2-4e45-be5b-41152cbb67c4 | 2026-06-03 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | Family Dollar Services Inc | 358ba91d-06a4-49c9-994d-4e4bf9499dcd | 2026-06-03 | Warnings | M012 |
| GUAIFENESIN DM | GUAIFENESIN AND DEXTROMETHORPHAN | Cardinal Health 107, LLC | c5fd53c9-81d6-4ce6-88a0-c2c24e17a7ed | 2026-06-02 | Warnings | M012 |
| ALKA SELTZER COLD Cold and Flu plus Congestion Severe Fast Hot Liquid Night | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare LLC. | 5349dbde-730c-610f-e063-6394a90a952a | 2026-06-02 | Warnings | M012 |
| Guaifenesin and Codeine Phosphate | GUAIFENESIN AND CODEINE PHOSPHATE | Cardinal Health 107, LLC | a9130f36-4761-4e6b-a383-eca3db06ea93 | 2026-06-02 | Warnings | M012 |
| Topcare Day Time Nite Time Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL | Topco Associates LLC | aed387e0-5a8b-4caf-a373-3e04496a4983 | 2026-06-02 | Warnings | M012 |
| ALKA SELTZER COLD Cold Flu And Congestion Severe Fast Hot Liquid Day | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare LLC. | 53371691-2510-5039-e063-6394a90a6ea9 | 2026-06-01 | Warnings | M012 |
| Allegra Allergy 24 hour | FEXOFENADINE HYDROCHLORIDE | Select Consumer Group | 2de81a41-8488-7e39-e063-6294a90a394b | 2026-06-01 | 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 |