Sudafed PE Head Congestion Plus Pain
- Product NDC
- 50580-436
- 11-digit product format
- 505800436
- Labeler code
- 50580
- Product ID
- 50580-436_2ffbcc44-0ef3-b149-e063-6394a90ae7f5
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Ibuprofen and Phenylephrine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Kenvue Brands LLC
- Application
- ANDA203200
- Marketing category
- ANDA
- Marketing start
- 2019-06-17
- Substance
- IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 200; 10 mg/1; mg/1
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], alpha-1 Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Sudafed PE Head Congestion Plus Pain
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| IBUPROFEN | 200 mg/1 |
| PHENYLEPHRINE HYDROCHLORIDE | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WK2XYI10QM, 04JA59TNSJ |
| Rxcui | 1369775 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50580-436-01 | Sudafed PE Head Congestion Plus Pain | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | | 5 |
| 50580-436-01 | Sudafed PE Head Congestion Plus Pain | 2 in 1 CARTON | TABLET, FILM COATED | 2 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50580-436 | SUDAFED PE HEAD CONGESTION PLUS PAIN (IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [KENVUE BRANDS LLC] | 5 | Current NDC, Legacy NDC, 2 package rows | 20250313_76513fb2-7323-4f1f-8a10-92f8f603cf97.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 50580-436-01 | 50580043601 | 2 BLISTER PACK in 1 CARTON (50580-436-01) / 10 TABLET, FILM COATED in 1 BLISTER PACK | 2 blister pack | 2019-06-17 | 0000-00-00 | No | No | Current |