Sinus Severe
- Product NDC
- 50844-572
- 11-digit product format
- 508440572
- Labeler code
- 50844
- Product ID
- 50844-572_dc7e7b50-49a8-4d8b-98df-2f5edfb9d40d
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Guaifenesin, Phenylephrine HCl
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- L.N.K. International, Inc.
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2021-03-15
- Substance
- ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 325; 200; 5 mg/1; mg/1; mg/1
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], alpha-1 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
- Sinus Severe
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ACETAMINOPHEN | 325 mg/1 |
| GUAIFENESIN | 200 mg/1 |
| PHENYLEPHRINE HYDROCHLORIDE | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 362O9ITL9D, 495W7451VQ, 04JA59TNSJ |
| Rxcui | 1243679 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50844-572-02 | Sinus Severe | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 8 |
| 50844-572-02 | Sinus Severe | 12 in 1 BLISTER PACK | TABLET, FILM COATED | 12 | | 8 |
| 50844-572-08 | Sinus Severe | 2 in 1 CARTON | TABLET, FILM COATED | 2 | | 8 |
| 50844-572-08 | Sinus Severe | 12 in 1 BLISTER PACK | TABLET, FILM COATED | 12 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50844-572 | SINUS SEVERE (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.] | 7 | Current NDC, Legacy NDC, 4 package rows | 20250221_d5c8b248-6d82-4eac-881c-0b9d0a0de8f1.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 |
|---|
| 50844-572-02 | 50844057202 | 1 BLISTER PACK in 1 CARTON (50844-572-02) / 12 TABLET, FILM COATED in 1 BLISTER PACK | 1 blister pack | 2021-03-15 | 0000-00-00 | No | No | Current |
| 50844-572-08 | 50844057208 | 2 BLISTER PACK in 1 CARTON (50844-572-08) / 12 TABLET, FILM COATED in 1 BLISTER PACK | 2 blister pack | 2021-03-15 | | No | No | Historical |