NDC 53345-031

NightTime Sinus

Acetaminophen, Doxylamine Succinate, Phenylephrine Hydrochloride

NightTime Sinus is a Oral Capsule, Liquid Filled in the Human Otc Drug category. It is labeled and distributed by Humanwell Puracap Pharmaceutical (wuhan) Co., Ltd.. The primary component is Acetaminophen; Doxylamine Succinate; Phenylephrine Hydrochloride.

• Product ID: 53345-031_e624ba71-5ccf-4f08-8769-675effd06b90
• NDC: 53345-031
• Product Type: Human Otc Drug
• Proprietary Name: NightTime Sinus
• Generic Name: Acetaminophen, Doxylamine Succinate, Phenylephrine Hydrochloride
• Dosage Form: Capsule, Liquid Filled
• Route of Administration: ORAL
• Marketing Start Date: 2015-02-26
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.
• Substance Name: ACETAMINOPHEN; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE
• Active Ingredient Strength: 325 mg/1; mg/1; mg/1
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 53345-031-01

1 BAG in 1 BOX (53345-031-01) > 4000 CAPSULE, LIQUID FILLED in 1 BAG

• Marketing Start Date: 2015-02-26
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 53345-031-01 [53345003101]

NightTime Sinus CAPSULE, LIQUID FILLED

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2015-02-26

Drug Details

Active Ingredients

Ingredient	Strength
ACETAMINOPHEN	325 mg/1

OpenFDA Data

• SPL SET ID: 0f3b1404-9252-470a-aa8c-b360c85731f3
• Manufacturer:
  • Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.
• UNII:
  • V9BI9B5YI2
  • 362O9ITL9D
  • 04JA59TNSJ
• RxNorm Concept Unique ID - RxCUI:
  • 1052647

NDC Crossover Matching brand name "NightTime Sinus" or generic name "Acetaminophen, Doxylamine Succinate, Phenylephrine Hydrochloride"

NDC	Brand Name	Generic Name
50804-101	Nighttime sinus	Acetaminophen, Doxylamine succinate and Phenylephrine Hydrochloride
53345-031	NightTime Sinus	Acetaminophen, Doxylamine succinate, Phenylephrine hydrochloride
68016-201	Nighttime Sinus	Acetaminophen, Doxylamine succinate and Phenylephrine Hydrochloride
51013-114	Daytime Sinus Relief and Nighttime Sinus Relief	acetaminophen, doxylamine succinate, phenylephrine hydrochloride
63868-464	Daytime Sinus Relief and Nighttime Sinus Relief	acetaminophen, doxylamine succinate, phenylephrine hydrochloride
69842-074	Daytime Sinus Relief and Nighttime Sinus Relief	acetaminophen, doxylamine succinate, phenylephrine hydrochloride
55315-102	Night Time Sinus	Acetaminophen, Doxylamine Succinate, Phenylephrine Hydrochloride
53345-013	NightTime Sinus Relief	Acetaminophen, Doxylamine succinate, Phenylephrine hydrochloride
36800-101	Nitetime Sinus Relief	Acetaminophen, Doxylamine succinate, Phenylephrine Hydrochloride