Sudafed Sinus 12 Hour Pressure plus Pain
- Product NDC
- 50580-434
- 11-digit product format
- 505800434
- Labeler code
- 50580
- Product ID
- 50580-434_21abbf03-2010-4650-e063-6294a90a6edb
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Naproxen sodium and Pseudoephedrine Hydrochloride
- Dosage form
- TABLET, MULTILAYER, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Kenvue Brands LLC
- Application
- ANDA076518
- Marketing category
- ANDA
- Marketing start
- 2019-06-17
- Substance
- NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE
- Active strength
- 220; 120 mg/1; mg/1
- Pharmacologic classes
- Adrenergic alpha-Agonists [MoA], Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], alpha-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 Sinus 12 Hour Pressure plus Pain
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NAPROXEN SODIUM | 220 mg/1 |
| PSEUDOEPHEDRINE HYDROCHLORIDE | 120 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9TN87S3A3C, 6V9V2RYJ8N |
| Rxcui | 1367426 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50580-434-01 | Sudafed Sinus 12 Hour Pressure plus Pain | 2 in 1 CARTON | TABLET, MULTILAYER, EXTENDED REL | 2 | | 6 |
| 50580-434-01 | Sudafed Sinus 12 Hour Pressure plus Pain | 8 in 1 BLISTER PACK | TABLET, MULTILAYER, EXTENDED REL | 8 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50580-434 | SUDAFED SINUS 12 HOUR PRESSURE PLUS PAIN (NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, MULTILAYER, EXTENDED RELEASE [KENVUE BRANDS LLC] | 6 | Current NDC, Legacy NDC, 2 package rows | 20241109_305adca3-cdae-41e5-a10a-99d9dd0fe390.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 |
|---|
| 50580-434-01 | 50580043401 | 2 BLISTER PACK in 1 CARTON (50580-434-01) / 8 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BLISTER PACK | 2 blister pack | 2019-06-17 | 0000-00-00 | No | No | Current |