nasal and chest decongestant
- Product NDC
- 56062-614
- 11-digit product format
- 560620614
- Labeler code
- 56062
- Product ID
- 56062-614_6e895cf0-1ff9-464a-b315-49c0cab394fb
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- guaifenesin, pseudoephedrine hydrochloride
- Dosage form
- TABLET, MULTILAYER, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Publix Super Markets Inc
- Application
- ANDA214407
- Marketing category
- ANDA
- Marketing start
- 2026-04-02
- Substance
- GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
- Active strength
- 1200; 120 mg/1; mg/1
- Pharmacologic classes
- Adrenergic alpha-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], 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
- nasal and chest decongestant
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| GUAIFENESIN | 1200 mg/1 |
| PSEUDOEPHEDRINE HYDROCHLORIDE | 120 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 495W7451VQ, 6V9V2RYJ8N |
| Rxcui | 1244675 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 56062-614-62 | nasal and chest decongestant | 6 in 1 BLISTER PACK | TABLET, MULTILAYER, EXTENDED REL | 6 | | 2 |
| 56062-614-62 | nasal and chest decongestant | 4 in 1 CARTON | TABLET, MULTILAYER, EXTENDED REL | 4 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 56062-614-62 | 56062061462 | 4 BLISTER PACK in 1 CARTON (56062-614-62) / 6 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BLISTER PACK | 4 blister pack | 2026-04-02 | No | No | Current |