Cold plus Flu Congestion Severe
- Product NDC
- 83324-114
- 11-digit product format
- 833240114
- Labeler code
- 83324
- Product ID
- 83324-114_1f193f57-c3a8-efce-e063-6394a90a3b9c
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- CHAIN DRUG MARKETING ASSOCIATION, INC.
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-08-07
- 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
- Cold plus Flu Congestion Severe
- 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 |
|---|
| 83324-114-24 | Cold plus Flu Congestion Severe | 2 in 1 CARTON | TABLET, COATED | 2 | | 2 |
| 83324-114-24 | Cold plus Flu Congestion Severe | 12 in 1 BLISTER PACK | TABLET, COATED | 12 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 83324-114 | COLD PLUS FLU CONGESTION SEVERE (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION, INC.] | 2 | Current NDC, 2 package rows | 20240808_0199aea2-a9c1-4c9d-8786-28b9dadc832e.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 |
|---|
| 83324-114-24 | 83324011424 | 2 BLISTER PACK in 1 CARTON (83324-114-24) / 12 TABLET, COATED in 1 BLISTER PACK | 2 blister pack | 2024-08-07 | No | No | Current |