Nighttime Severe Cold and Cough
- Product NDC
- 68163-541
- 11-digit product format
- 681630541
- Labeler code
- 68163
- Product ID
- 68163-541_3fc356a6-ea68-ed5b-e063-6394a90a02c6
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- ACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINE
- Dosage form
- POWDER, FOR SOLUTION
- Route
- ORAL
- Labeler
- RARITAN PHARMACEUTICALS INC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2019-03-22
- 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
- Nighttime Severe Cold and Cough
- 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#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68163-541-06 | Nighttime Severe Cold and Cough | 6 in 1 CARTON | POWDER, FOR SOLUTION | 6 | | 7 |
| 68163-541-06 | Nighttime Severe Cold and Cough | 1 in 1 PACKET | POWDER, FOR SOLUTION | 1 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68163-541 | NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINE) POWDER, FOR SOLUTION [RARITAN PHARMACEUTICALS INC] | 6 | Current NDC, Legacy NDC, 2 package rows | 20241124_9819155b-2713-42be-867e-16605e7643d0.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 |
|---|
| 68163-541-06 | 68163054106 | 6 PACKET in 1 CARTON (68163-541-06) / 1 POWDER, FOR SOLUTION in 1 PACKET | 6 packet | 2019-03-22 | 0000-00-00 | No | No | Current |