Nighttime Severe Cold and Flu
- Product NDC
- 63868-468
- 11-digit product format
- 638680468
- Labeler code
- 63868
- Product ID
- 63868-468_90f42b4e-a242-43d1-a647-c94f51ed513f
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, Phenylephrine hydrochloride
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- Chain Drug Marketing Association, Inc.
- Application
- part341
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2022-05-03
- Marketing end
- 0000-00-00
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 325 mg/1; mg/1; mg/1; mg/1
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63868-468-24 | Nighttime Severe Cold and Flu | 2 in 1 CARTON | CAPSULE, LIQUID FILLED | 2 | | 2 |
| 63868-468-24 | Nighttime Severe Cold and Flu | 12 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 12 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63868-468 | NIGHTTIME SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [CHAIN DRUG MARKETING ASSOCIATION, INC.] | 2 | Legacy NDC, 2 package rows | 20250101_235ff7d1-9a26-48c9-b059-33e7f223886d.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 |
|---|
| 63868-468-24 | 63868046824 | 2 BLISTER PACK in 1 CARTON (63868-468-24) > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | 2 blister pack | 2022-05-03 | 0000-00-00 | No | No | Current |