NDC 53345-013

NightTime Sinus Relief

Acetaminophen, Doxylamine Succinate, Phenylephrine Hydrochloride

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

• Product ID: 53345-013_3f2c8791-6ee2-47a4-a4c0-955f8c985b68
• NDC: 53345-013
• Product Type: Human Otc Drug
• Proprietary Name: NightTime Sinus Relief
• Generic Name: Acetaminophen, Doxylamine Succinate, Phenylephrine Hydrochloride
• Dosage Form: Capsule, Liquid Filled
• Route of Administration: ORAL
• Marketing Start Date: 2013-06-15
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: Humanwell PuraCap Pharmaceutical (Wuhan), 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: 2019-12-31

Packaging

NDC 53345-013-01

1 BAG in 1 BOX (53345-013-01) > 4000 CAPSULE, LIQUID FILLED in 1 BAG

• Marketing Start Date: 2013-06-15
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 53345-013-01 [53345001301]

NightTime Sinus Relief CAPSULE, LIQUID FILLED

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2013-06-15

Drug Details

Active Ingredients

Ingredient	Strength
ACETAMINOPHEN	325 mg/1

OpenFDA Data

• SPL SET ID: 413d82d3-a896-4f15-9fca-c1b7b9a1ee63
• Manufacturer:
  • Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.
• UNII:
  • V9BI9B5YI2
  • 362O9ITL9D
  • 04JA59TNSJ
• RxNorm Concept Unique ID - RxCUI:
  • 1052647

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

NDC	Brand Name	Generic Name
53345-013	NightTime Sinus Relief	Acetaminophen, Doxylamine succinate, Phenylephrine hydrochloride
59726-101	Nighttime Sinus Relief	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
53345-031	NightTime Sinus	Acetaminophen, Doxylamine succinate, Phenylephrine hydrochloride
36800-101	Nitetime Sinus Relief	Acetaminophen, Doxylamine succinate, Phenylephrine Hydrochloride