NDC 53345-012

DayTime Sinus Relief

Acetaminophen, Phenylephrine Hydrochloride

DayTime 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; Phenylephrine Hydrochloride.

• Product ID: 53345-012_16f8c0c3-70c1-4836-b6fd-9e2986531c3c
• NDC: 53345-012
• Product Type: Human Otc Drug
• Proprietary Name: DayTime Sinus Relief
• Generic Name: Acetaminophen, 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; PHENYLEPHRINE HYDROCHLORIDE
• Active Ingredient Strength: 325 mg/1; mg/1
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 53345-012-01

1 BAG in 1 BOX (53345-012-01) > 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 53345-012-01 [53345001201]

DayTime 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: 4361912e-4b56-4743-b11d-acfb94482a2e
• Manufacturer:
  • Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.
• UNII:
  • 362O9ITL9D
  • 04JA59TNSJ
• RxNorm Concept Unique ID - RxCUI:
  • 1052670

NDC Crossover Matching brand name "DayTime Sinus Relief" or generic name "Acetaminophen, Phenylephrine Hydrochloride"

NDC	Brand Name	Generic Name
33992-1100	Daytime Sinus Relief	Acetaminophen and Phenylephrine Hydrochloride
36800-098	Daytime Sinus Relief	Acetaminophen and Phenylephrine Hydrochloride
53345-012	DayTime Sinus Relief	DayTime Sinus Relief
46084-101	ACETAMINOPHEN SINUS CONGESTION AND PAIN	ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE
47682-001	Green Guard Advanced Sinus Relief	ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE
47682-002	Green Guard Advanced Sinus Relief	ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE
47682-158	Medi First Plus Sinus Pain and Pressure	ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE
47682-146	Medi First Sinus Pain and Pressure	ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE
47682-148	Otis Clapp Mygrex	ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE
47682-509	Otis Clapp Mygrex	ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE
37808-466	Sinus Congestion and Pain	Acetaminophen, Phenylephrine Hydrochloride