CareOne Nasal and Sinus Decongestant
- Product NDC
- 41520-429
- 11-digit product format
- 415200429
- Labeler code
- 41520
- Product ID
- 41520-429_88627121-1a2f-4818-a6d1-d1b06a92925e
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Pseudoephedrine HCl
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- American Sales Company
- Application
- ANDA075153
- Marketing category
- ANDA
- Marketing start
- 2016-09-15
- Substance
- PSEUDOEPHEDRINE HYDROCHLORIDE
- Active strength
- 120 mg/1
- Pharmacologic classes
- Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- CareOne Nasal and Sinus Decongestant
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PSEUDOEPHEDRINE HYDROCHLORIDE | 120 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6V9V2RYJ8N |
| Rxcui | 1049154 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 41520-429-52 | CareOne Nasal and Sinus Decongestant | 1 in 1 BLISTER PACK | TABLET, FILM COATED, EXTENDED RE | 1 | | 5 |
| 41520-429-52 | CareOne Nasal and Sinus Decongestant | 10 in 1 CARTON | TABLET, FILM COATED, EXTENDED RE | 10 | | 5 |
| 41520-429-60 | CareOne Nasal and Sinus Decongestant | 1 in 1 BLISTER PACK | TABLET, FILM COATED, EXTENDED RE | 1 | | 5 |
| 41520-429-60 | CareOne Nasal and Sinus Decongestant | 20 in 1 CARTON | TABLET, FILM COATED, EXTENDED RE | 20 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 41520-429 | CAREONE NASAL AND SINUS DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN SALES COMPANY] | 4 | Current NDC, Legacy NDC, 4 package rows | 20231031_a5aa414c-a143-44c8-9759-e84c0f032fbf.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 |
|---|
| 41520-429-52 | 41520042952 | 10 BLISTER PACK in 1 CARTON (41520-429-52) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | 10 blister pack | 2016-09-15 | 0000-00-00 | No | No | Current |
| 41520-429-60 | 41520042960 | 20 BLISTER PACK in 1 CARTON (41520-429-60) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | 20 blister pack | 2016-09-15 | 0000-00-00 | No | No | Current |