Quality Choice Severe Cold and Cough Nighttime
- Product NDC
- 63868-291
- 11-digit product format
- 638680291
- Labeler code
- 63868
- Product ID
- 63868-291_451d39c3-28b2-7b9b-e063-6294a90a18e3
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- ACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINE
- Dosage form
- POWDER, FOR SOLUTION
- Route
- ORAL
- Labeler
- Chain Drug Manufacturing Assn
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2018-07-16
- Substance
- ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 650; 25; 10 mg/1; mg/1; mg/1
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], 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
- Quality Choice Severe Cold and Cough Nighttime
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ACETAMINOPHEN | 650 mg/1 |
| DIPHENHYDRAMINE HYDROCHLORIDE | 25 mg/1 |
| PHENYLEPHRINE HYDROCHLORIDE | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 362O9ITL9D, TC2D6JAD40, 04JA59TNSJ |
| Rxcui | 1659960 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63868-291-06 | Quality Choice Severe Cold and Cough Nighttime | 1 in 1 PACKET | POWDER, FOR SOLUTION | 1 | | 8 |
| 63868-291-06 | Quality Choice Severe Cold and Cough Nighttime | 6 in 1 CARTON | POWDER, FOR SOLUTION | 6 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63868-291 | QUALITY CHOICE SEVERE COLD AND COUGH NIGHTTIME (ACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINE) POWDER, FOR SOLUTION [CHAIN DRUG MANUFACTURING ASSN] | 7 | Current NDC, Legacy NDC, 2 package rows | 20241220_ce658dd5-b683-436e-b16b-0c06f6f87fd9.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 |
|---|
| 63868-291-06 | 63868029106 | 6 PACKET in 1 CARTON (63868-291-06) / 1 POWDER, FOR SOLUTION in 1 PACKET | 6 packet | 2018-07-16 | 0000-00-00 | No | No | Current |