severe cold and cough
- Product NDC
- 68163-540
- 11-digit product format
- 681630540
- Labeler code
- 68163
- Product ID
- 68163-540_3fc2f39e-6e41-a802-e063-6394a90a1cc5
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
- Dosage form
- POWDER, FOR SOLUTION
- Route
- ORAL
- Labeler
- RARITAN PHARMACEUTICALS INC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2019-03-14
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 650; 20; 10 mg/1; mg/1; mg/1
- Pharmacologic classes
- Adrenergic alpha1-Agonists [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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- severe cold and cough
- Brand name suffix
- daytime
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ACETAMINOPHEN | 650 mg/1 |
| DEXTROMETHORPHAN HYDROBROMIDE | 20 mg/1 |
| PHENYLEPHRINE HYDROCHLORIDE | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 362O9ITL9D, 9D2RTI9KYH, 04JA59TNSJ |
| Rxcui | 1659967 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68163-540-06 | severe cold and coughdaytime | 6 in 1 CARTON | POWDER, FOR SOLUTION | 6 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68163-540 | SEVERE COLD AND COUGH DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [RARITAN PHARMACEUTICALS INC] | 6 | Current NDC, Legacy NDC, 1 package rows | 20241124_3ce8508e-7d9d-4413-858a-8f952e760c01.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68163-540-06 | 68163054006 | 6 POWDER, FOR SOLUTION in 1 CARTON (68163-540-06) | 2019-03-14 | 0000-00-00 | No | No | Current |