Aleve-D Sinus and Headache
- Product NDC
- 0280-6045
- 11-digit product format
- 002806045
- Labeler code
- 0280
- Product ID
- 0280-6045_4526bb5e-f2d9-1c3e-e063-6394a90a62ae
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- naproxen sodium, pseudoephedrine hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bayer HealthCare LLC.
- Application
- ANDA076518
- Marketing category
- ANDA
- Marketing start
- 2014-01-01
- 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
- Aleve-D Sinus and Headache
- 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 |
|---|
| 0280-6045-10 | Aleve-D Sinus and Headache | 1 in 1 CARTON | TABLET | 1 | | 8 |
| 0280-6045-10 | Aleve-D Sinus and Headache | 10 in 1 BLISTER PACK | TABLET | 10 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0280-6045 | ALEVE-D SINUS AND HEADACHE (NAPROXEN SODIUM, PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [BAYER HEALTHCARE LLC.] | 7 | Current NDC, Legacy NDC, 2 package rows | 20241208_5ab980c0-c48a-233b-e053-2991aa0a4fd1.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 |
|---|
| 0280-6045-10 | 00280604510 | 1 BLISTER PACK in 1 CARTON (0280-6045-10) / 10 TABLET in 1 BLISTER PACK | 1 blister pack | 2014-01-01 | 0000-00-00 | No | No | Current |