NDC 55758-141

Sanatos

Acetaminophen, Dextromethorphan Hbr, Phenylephrine Hci, Doxylamine Succinate

Sanatos is a Oral Capsule, Liquid Filled in the Human Otc Drug category. It is labeled and distributed by Pharmadel Llc. The primary component is Dextromethorphan Hydrobromide; Doxylamine Succinate; Phenylephrine Hydrochloride; Acetaminophen.

• Product ID: 55758-141_937a8bab-9212-089f-e053-2a95a90abf22
• NDC: 55758-141
• Product Type: Human Otc Drug
• Proprietary Name: Sanatos
• Generic Name: Acetaminophen, Dextromethorphan Hbr, Phenylephrine Hci, Doxylamine Succinate
• Dosage Form: Capsule, Liquid Filled
• Route of Administration: ORAL
• Marketing Start Date: 2019-09-26
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: Pharmadel LLC
• Substance Name: DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN
• Active Ingredient Strength: 10 mg/1; mg/1; mg/1; mg/1
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 55758-141-24

1 CAPSULE, LIQUID FILLED in 1 PACKAGE, COMBINATION (55758-141-24)

• Marketing Start Date: 2019-09-26
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 55758-141-24 [55758014124]

Sanatos CAPSULE, LIQUID FILLED

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2019-09-26
• Marketing End Date: 2020-02-28

Drug Details

Active Ingredients

Ingredient	Strength
DEXTROMETHORPHAN HYDROBROMIDE	10 mg/1

OpenFDA Data

• SPL SET ID: 937a8bab-9211-089f-e053-2a95a90abf22
• Manufacturer:
  • Pharmadel LLC
• UNII:
  • V9BI9B5YI2
  • 362O9ITL9D
  • 04JA59TNSJ
  • 9D2RTI9KYH

NDC Crossover Matching brand name "Sanatos" or generic name "Acetaminophen, Dextromethorphan Hbr, Phenylephrine Hci, Doxylamine Succinate"

NDC	Brand Name	Generic Name
14505-398	Sanatos	Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine
14505-399	Sanatos	Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate
55758-141	Sanatos	Acetaminophen, Dextromethorphan HBr, Phenylephrine HCI, Doxylamine Succinate