Severe Congestion and Pain
- Product NDC
- 55319-815
- 11-digit product format
- 553190815
- Labeler code
- 55319
- Product ID
- 55319-815_65750131-b822-4b6a-943b-1f460acdbe01
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Guaifenesin, Phenylephrine HCl
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Family Dollar Services Inc
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2023-12-13
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Severe Congestion and Pain
- Listing expiration
- 2026-12-31
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 |
|---|
| 55319-815-19 | Severe Congestion and Pain | 8 in 1 BLISTER PACK | TABLET, FILM COATED | 8 | | 3 |
| 55319-815-19 | Severe Congestion and Pain | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55319-815 | SEVERE CONGESTION AND PAIN (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [FAMILY DOLLAR SERVICES INC] | 2 | Current NDC, 2 package rows | 20241206_ce590997-3cae-4f22-ac39-2b14d39494bc.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 55319-815-19 | 55319081519 | 1 BLISTER PACK in 1 CARTON (55319-815-19) / 8 TABLET, FILM COATED in 1 BLISTER PACK | 1 blister pack | 2023-12-13 | No | No | Historical |