NDC 37000-508

Sinex

Acetaminophen, Doxylamine Succinate, And Phenylephrine Hydrochloride

Sinex is a Oral Capsule, Liquid Filled in the Human Otc Drug category. It is labeled and distributed by The Procter & Gamble Manufacturing Company. The primary component is Acetaminophen; Doxylamine Succinate; Phenylephrine Hydrochloride.

• Product ID: 37000-508_6cbca6a8-ebd4-6ccd-e053-2a91aa0aa400
• NDC: 37000-508
• Product Type: Human Otc Drug
• Proprietary Name: Sinex
• Generic Name: Acetaminophen, Doxylamine Succinate, And Phenylephrine Hydrochloride
• Dosage Form: Capsule, Liquid Filled
• Route of Administration: ORAL
• Marketing Start Date: 2016-07-29
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: The Procter & Gamble Manufacturing Company
• 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 37000-508-24

12 BLISTER PACK in 1 CARTON (37000-508-24) > 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

• Marketing Start Date: 2016-07-29
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 37000-508-24 [37000050824]

Sinex CAPSULE, LIQUID FILLED

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-07-29
• Marketing End Date: 2020-02-22

Drug Details

Active Ingredients

Ingredient	Strength
ACETAMINOPHEN	325 mg/1

OpenFDA Data

• SPL SET ID: 3a36815b-7974-6111-e054-00144ff88e88
• Manufacturer:
  • The Procter & Gamble Manufacturing Company
• UNII:
  • V9BI9B5YI2
  • 362O9ITL9D
  • 04JA59TNSJ
• RxNorm Concept Unique ID - RxCUI:
  • 1052647

NDC Crossover Matching brand name "Sinex" or generic name "Acetaminophen, Doxylamine Succinate, And Phenylephrine Hydrochloride"

NDC	Brand Name	Generic Name
37000-508	Sinex	Acetaminophen, Doxylamine succinate, and Phenylephrine hydrochloride
37000-509	Sinex	Acetaminophen, Phenylephrine Hydrochloride, and Doxylamine Succinate
68210-1480	N - TIME SINUS	ACETAMINOPHEN, DOXYLAMINE SUCCINATE, and PHENYLEPHRINE Hydrochloride
68016-101	Night time sinus	Acetaminophen, Doxylamine succinate, and Phenylephrine Hydrochloride