Severe Cold and Cough Relief
- Product NDC
- 49580-0501
- 11-digit product format
- 495800501
- Labeler code
- 49580
- Product ID
- 49580-0501_a105492f-6843-463d-8a44-01d89916d833
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- ACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCL
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- P & L Development, LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2021-03-26
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 650; 20; 10 mg/30mL; mg/30mL; mg/30mL
- 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 Relief
- Brand name suffix
- Daytime
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ACETAMINOPHEN | 650 mg/30mL |
| DEXTROMETHORPHAN HYDROBROMIDE | 20 mg/30mL |
| PHENYLEPHRINE HYDROCHLORIDE | 10 mg/30mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 362O9ITL9D, 9D2RTI9KYH, 04JA59TNSJ |
| Rxcui | 1113705 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 49580-0501-8 | Severe Cold and Cough ReliefDaytime | 245 mL in 1 BOTTLE, PLASTIC | LIQUID | 245 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 49580-0501 | SEVERE COLD AND COUGH RELIEF DAYTIME (ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [P & L DEVELOPMENT, LLC] | 3 | Current NDC, Legacy NDC, 1 package rows | 20240417_2af496a1-6fdd-4acf-9944-8b7cdf302275.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 |
|---|
| 49580-0501-8 | 49580050108 | 245 mL in 1 BOTTLE, PLASTIC (49580-0501-8) | 245 ml | 2021-03-26 | 0000-00-00 | No | No | Current |