Cold and Flu Relief
- Product NDC
- 68016-797
- 11-digit product format
- 680160797
- Labeler code
- 68016
- Product ID
- 68016-797_d546bd5d-e7cc-41a6-a214-0b377f9a3335
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- Chain Drug Consortium, LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2022-09-02
- Marketing end
- 2026-09-30
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 325; 10; 5 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
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Cold and Flu Relief
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ACETAMINOPHEN | 325 mg/1 |
| DEXTROMETHORPHAN HYDROBROMIDE | 10 mg/1 |
| PHENYLEPHRINE HYDROCHLORIDE | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 362O9ITL9D, 9D2RTI9KYH, 04JA59TNSJ |
| Rxcui | 1086997 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68016-797-16 | Cold and Flu Relief | 1 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 1 | | 3 |
| 68016-797-16 | Cold and Flu Relief | 16 in 1 CARTON | CAPSULE, LIQUID FILLED | 16 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68016-797 | COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [CHAIN DRUG CONSORTIUM, LLC] | 2 | Current NDC, Legacy NDC, 2 package rows | 20240308_99288aa3-e066-4a90-8887-6b4e302906fd.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 |
|---|
| 68016-797-16 | 68016079716 | 16 BLISTER PACK in 1 CARTON (68016-797-16) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | 16 blister pack | 2022-09-02 | 2026-09-30 | No | No | Current |