Severe Sinus Congestion and Pain
- Product NDC
- 83059-0107
- 11-digit product format
- 830590107
- Labeler code
- 83059
- Product ID
- 83059-0107_431b23cf-64ff-1377-e063-6394a90a3ca3
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Guaifenesin, Phenylephrine
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Shield Pharmaceuticals Corp
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-11-08
- 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 Sinus 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 |
|---|
| 83059-0107-1 | Severe Sinus Congestion and Pain | 1 in 1 CARTON | TABLET, COATED | 1 | | 2 |
| 83059-0107-1 | Severe Sinus Congestion and Pain | 12 in 1 BLISTER PACK | TABLET, COATED | 12 | | 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 |
|---|
| 83059-0107-1 | 83059010701 | 1 BLISTER PACK in 1 CARTON (83059-0107-1) / 12 TABLET, COATED in 1 BLISTER PACK | 1 blister pack | 2025-11-08 | No | No | Current |