Topcare Sinus and Cold D
- Product NDC
- 36800-417
- 11-digit product format
- 368000417
- Labeler code
- 36800
- Product ID
- 36800-417_7cdb2600-a9fa-4fe8-9161-4f051bb1243b
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Naproxen sodium, Pseudoephedrine HCl
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Topco Associates LLC
- Application
- ANDA076518
- Marketing category
- ANDA
- Marketing start
- 2013-08-14
- 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
- Topcare 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 |
|---|
| 36800-417-01 | Topcare Sinus and Cold D | 20 in 1 CARTON | TABLET, FILM COATED, EXTENDED RE | 20 | | 9 |
| 36800-417-01 | Topcare Sinus and Cold D | 1 in 1 BLISTER PACK | TABLET, FILM COATED, EXTENDED RE | 1 | | 9 |
| 36800-417-52 | Topcare Sinus and Cold D | 10 in 1 CARTON | TABLET, FILM COATED, EXTENDED RE | 10 | | 9 |
| 36800-417-52 | Topcare Sinus and Cold D | 1 in 1 BLISTER PACK | TABLET, FILM COATED, EXTENDED RE | 1 | | 9 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| NAPROXEN SODIUM | ACTIVE INGREDIENT | 9TN87S3A3C | TOPCARE SINUS AND COLD D (NAPROXEN SODIUM, PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [TOPCO ASSOCIATES LLC] | 1 | |
| PSEUDOEPHEDRINE HYDROCHLORIDE | ACTIVE INGREDIENT | 6V9V2RYJ8N | TOPCARE SINUS AND COLD D (NAPROXEN SODIUM, PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [TOPCO ASSOCIATES LLC] | 1 | |
| NAPROXEN | ACTIVE MOIETY | 57Y76R9ATQ | TOPCARE SINUS AND COLD D (NAPROXEN SODIUM, PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [TOPCO ASSOCIATES LLC] | 1 | |
| PSEUDOEPHEDRINE | ACTIVE MOIETY | 7CUC9DDI9F | TOPCARE SINUS AND COLD D (NAPROXEN SODIUM, PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [TOPCO ASSOCIATES LLC] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | TOPCARE SINUS AND COLD D (NAPROXEN SODIUM, PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [TOPCO ASSOCIATES LLC] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | TOPCARE SINUS AND COLD D (NAPROXEN SODIUM, PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [TOPCO ASSOCIATES LLC] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | TOPCARE SINUS AND COLD D (NAPROXEN SODIUM, PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [TOPCO ASSOCIATES LLC] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | TOPCARE SINUS AND COLD D (NAPROXEN SODIUM, PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [TOPCO ASSOCIATES LLC] | 1 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | TOPCARE SINUS AND COLD D (NAPROXEN SODIUM, PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [TOPCO ASSOCIATES LLC] | 1 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | TOPCARE SINUS AND COLD D (NAPROXEN SODIUM, PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [TOPCO ASSOCIATES LLC] | 1 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | TOPCARE SINUS AND COLD D (NAPROXEN SODIUM, PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [TOPCO ASSOCIATES LLC] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | TOPCARE SINUS AND COLD D (NAPROXEN SODIUM, PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [TOPCO ASSOCIATES LLC] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | TOPCARE SINUS AND COLD D (NAPROXEN SODIUM, PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [TOPCO ASSOCIATES LLC] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | TOPCARE SINUS AND COLD D (NAPROXEN SODIUM, PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [TOPCO ASSOCIATES LLC] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 36800-417 | TOPCARE SINUS AND COLD D (NAPROXEN SODIUM, PSEUDOEPHEDRINE HCL) TABLET, FILM COATED, EXTENDED RELEASE [TOPCO ASSOCIATES LLC] | 9 | Current NDC, Legacy NDC, 4 package rows | 20250425_55c177ce-1729-4a9b-a5ae-2b6c96fbc27a.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 |
|---|
| 36800-417-01 | 36800041701 | 20 BLISTER PACK in 1 CARTON (36800-417-01) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | 20 blister pack | 2013-08-14 | 0000-00-00 | No | No | Current |
| 36800-417-52 | 36800041752 | 10 in 1 CARTON | | | | | | Historical |