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 |
|---|---|---|---|---|---|---|
| topcare day time cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Topco Associates LLC | 1a8e2e03-e11b-4da1-945b-e2caadea7243 | 2024-11-07 | Warnings | M012 |
| SUDOGEST NASAL DECONGESTANT | PSEUDOEPHEDRINE HCL | A-S Medication Solutions | 09feb5f0-c22d-4a1b-97a0-d5767e5f7730 | 2024-11-07 | Warnings | M012 |
| up and up childrens allergy melts | DIPHENHYDRAMINE HCL | Target Corporation | f98d1d54-8e11-4bb1-825a-ab5447d37847 | 2024-11-07 | Warnings | M012 |
| good sense severe day time cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | L. Perrigo Company | 44130a1b-63cc-42ac-9590-fdf21a12d164 | 2024-11-07 | Warnings | M012 |
| foster and thrive daytime severe cold and flu relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Strategic Sourcing Services LLC | a5ff1134-8985-4585-8e61-a5fd5f60afeb | 2024-11-07 | Warnings | M012 |
| basic care daytime severe cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Amazon.com Services LLC | 50528d29-ce8c-4efb-a86c-17246b017db0 | 2024-11-07 | Warnings | M012 |
| cooling severe daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | CVS Pharmacy | d4a21760-b2bd-4e26-bff0-6fc1b05d26b3 | 2024-11-07 | Warnings | M012 |
| dg health day time severe cold and flu relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Dolgencorp, LLC | 60870311-3234-44ba-95dd-09cf4ea3d508 | 2024-11-07 | Warnings | M012 |
| adult dm max cough and chest congestion | DEXTROMETHORPHAN HBR, GUAIFENESIN | Meijer Distribution Inc | 3a6855c1-da6d-4fa9-81fe-d2e61355989f | 2024-11-06 | Warnings | M012 |
| oxymetazoline hcl | OXYMETAZOLINE HYDROCHLORIDE | A-S Medication Solutions | e51dfb62-40d0-4bec-9574-90057cb35bcc | 2024-11-06 | Warnings | M012 |
| Foster and Thrive Adult Tussin DM MAX | DEXTROMETHORPHAN HBR, GUAIFENESIN | Strategic Sourcing Services LLC | 5f6e4d56-4a66-4dbd-97c8-550310dea358 | 2024-11-05 | Warnings | M012 |
| Cough Drops Honey Lemon with Sugar | MENTHOL | Lidl US LLC | 4ad9398f-7488-6eaf-e054-00144ff8d46c | 2024-11-05 | Warnings | M012 |
| rexall dm cough and congestion relief | DEXTROMETHORPHAN HBR, GUAIFENESIN | Dolgencorp, LLC | 906838b1-a742-4728-944d-42b687b8cd59 | 2024-11-05 | Warnings | M012 |
| tussin | DEXTROMETHORPHAN HBR, GUAIFENESIN | H E B | 7c24c59c-7549-4c64-95f8-4bf755cd6f61 | 2024-11-05 | Warnings | M012 |
| equate adult tussin dm max | DEXTROMETHORPHAN HBR, GUAIFENESIN | Wal-Mart Stores Inc | 3592e000-a6c6-47fe-8bb0-9341c65c2959 | 2024-11-05 | Warnings | M012 |
| tussin dm max | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Walgreen Company | 756794b0-8d3b-4732-947c-a407caf400e2 | 2024-11-05 | Warnings | M012 |
| basic care tussin dm max | DEXTROMETHORPHAN HBR, GUAIFENESIN | Amazon.com Services LLC | c6863e31-e1b9-40ff-ae2e-4aec86b4acc0 | 2024-11-05 | Warnings | M012 |
| topcare tussin dm max | DEXTROMETHORPHAN HBR, GUAIFENESIN | Topco Associates LLC | 94c35025-7bb4-4cb0-8bf3-4b44bb7fa59a | 2024-11-05 | Warnings | M012 |
| Childrens Sudafed PE NASAL DECONGESTANT | PHENYLEPHRINE HYDROCHLORIDE | Kenvue Brands LLC | 4dfd46e4-b9f9-464d-aa47-e8fa9e526a5d | 2024-11-04 | Warnings | M012 50580-784 |
| Nighttime Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Safeway, Inc. | 164b2559-2d3f-431e-a03c-07e86731af5c | 2024-11-04 | 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 |