Leader All Day Sinus and Cold D
- Product NDC
- 70000-0605
- 11-digit product format
- 700000605
- Labeler code
- 70000
- Product ID
- 70000-0605_4d33af2f-53b6-49d2-927b-55d7f9273103
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Naproxen sodium, Pseudoephedrine HCl
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Cardinal Health 110, LLC. dba Leader
- Application
- ANDA076518
- Marketing category
- ANDA
- Marketing start
- 2022-05-19
- 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
- Leader All Day Sinus and Cold D
- 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 |
|---|
| 70000-0605-1 | Leader All Day Sinus and Cold D | 20 in 1 CARTON | TABLET, FILM COATED, EXTENDED RE | 20 | | 3 |
| 70000-0605-1 | Leader All Day Sinus and Cold D | 1 in 1 BLISTER PACK | TABLET, FILM COATED, EXTENDED RE | 1 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70000-0605 | LEADER ALL DAY SINUS AND COLD D (NAPROXEN SODIUM, PSEUDOEPHEDRINE HCL) TABLET, FILM COATED, EXTENDED RELEASE [CARDINAL HEALTH 110, LLC. DBA LEADER] | 3 | Current NDC, Legacy NDC, 2 package rows | 20250429_83f7cfbb-ab84-4594-ae7a-4a657385c8a7.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 |
|---|
| 70000-0605-1 | 70000060501 | 20 BLISTER PACK in 1 CARTON (70000-0605-1) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | 20 blister pack | 2022-05-19 | 0000-00-00 | No | No | Current |