Naproxen Sodium and Pseudoephedrine Hydrochloride Sinus and Cold
- Product NDC
- 58602-816
- 11-digit product format
- 586020816
- Labeler code
- 58602
- Product ID
- 58602-816_554a4cb1-aaac-44f9-99c7-f342abdc3531
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Naproxen Sodium and Pseudoephedrine Hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Aurohealth LLC
- Application
- ANDA211360
- Marketing category
- ANDA
- Marketing start
- 2022-06-01
- 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
- Naproxen Sodium and Pseudoephedrine Hydrochloride Sinus and Cold
- 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 |
|---|
| 58602-816-67 | Naproxen Sodium and Pseudoephedrine Hydrochloride Sinus and Cold | 2 in 1 CARTON | TABLET, EXTENDED RELEASE | 2 | | 3 |
| 58602-816-67 | Naproxen Sodium and Pseudoephedrine Hydrochloride Sinus and Cold | 10 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 10 | | 3 |
| 58602-816-72 | Naproxen Sodium and Pseudoephedrine Hydrochloride Sinus and Cold | 3 in 1 CARTON | TABLET, EXTENDED RELEASE | 3 | | 3 |
| 58602-816-72 | Naproxen Sodium and Pseudoephedrine Hydrochloride Sinus and Cold | 8 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 8 | | 3 |
| 58602-816-83 | Naproxen Sodium and Pseudoephedrine Hydrochloride Sinus and Cold | 10 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 10 | | 3 |
| 58602-816-83 | Naproxen Sodium and Pseudoephedrine Hydrochloride Sinus and Cold | 1 in 1 CARTON | TABLET, EXTENDED RELEASE | 1 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 58602-816 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE SINUS AND COLD (NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [AUROHEALTH LLC] | 3 | Current NDC, Legacy NDC, 6 package rows | 20250304_638a9664-4129-46fd-9ba1-d660a7366c9f.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 |
|---|
| 58602-816-67 | 58602081667 | 2 BLISTER PACK in 1 CARTON (58602-816-67) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | 2 blister pack | 2022-06-01 | 0000-00-00 | No | No | Current |
| 58602-816-72 | 58602081672 | 3 BLISTER PACK in 1 CARTON (58602-816-72) / 8 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | 3 blister pack | 2025-02-12 | | No | No | Current |
| 58602-816-83 | 58602081683 | 1 BLISTER PACK in 1 CARTON (58602-816-83) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | 1 blister pack | 2022-06-01 | 0000-00-00 | No | No | Current |