NDC 51013-156

NiteTime Sinus Relief

Acetaminophen, Phenylephrine Hydrochloride, Doxylamine Succinate

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

• Product ID: 51013-156_7df87a67-d625-4535-995b-a807adfe3cc8
• NDC: 51013-156
• Product Type: Human Otc Drug
• Proprietary Name: NiteTime Sinus Relief
• Generic Name: Acetaminophen, Phenylephrine Hydrochloride, Doxylamine Succinate
• Dosage Form: Capsule, Liquid Filled
• Route of Administration: ORAL
• Marketing Start Date: 2016-07-26
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: PuraCap Pharmaceutical LLC
• 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 51013-156-04

2 BLISTER PACK in 1 CARTON (51013-156-04) > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

• Marketing Start Date: 2016-07-26
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 51013-156-04 [51013015604]

NiteTime Sinus Relief CAPSULE, LIQUID FILLED

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2016-07-26

Drug Details

Active Ingredients

Ingredient	Strength
ACETAMINOPHEN	325 mg/1

OpenFDA Data

• SPL SET ID: cd1ec9c1-54da-4b73-8d2c-6b727234142c
• Manufacturer:
  • PuraCap Pharmaceutical LLC
• UNII:
  • V9BI9B5YI2
  • 362O9ITL9D
  • 04JA59TNSJ
• RxNorm Concept Unique ID - RxCUI:
  • 1052647

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

NDC	Brand Name	Generic Name
36800-101	Nitetime Sinus Relief	Acetaminophen, Doxylamine succinate, Phenylephrine Hydrochloride
51013-156	NiteTime Sinus Relief	Acetaminophen, Phenylephrine hydrochloride, Doxylamine succinate
51013-186	Night Time Sinus Relief	Acetaminophen, Phenylephrine hydrochloride, Doxylamine succinate
51013-160	Nighttime Sinus and Congestion Relief	Acetaminophen, Phenylephrine hydrochloride, Doxylamine succinate