NDC 55316-317

Nighttime Flu Relief Therapy Severe Cold

Acetaminophen, Diphenhydramine Hcl, Phenylephrine Hcl

Nighttime Flu Relief Therapy Severe Cold is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by Healthy Accents (dza Brands, Llc). The primary component is Acetaminophen; Diphenhydramine Hydrochloride; Phenylephrine Hydrochloride.

• Product ID: 55316-317_5a7655c4-dd2c-4a7a-a7e0-4c216bfdae06
• NDC: 55316-317
• Product Type: Human Otc Drug
• Proprietary Name: Nighttime Flu Relief Therapy Severe Cold
• Generic Name: Acetaminophen, Diphenhydramine Hcl, Phenylephrine Hcl
• Dosage Form: Liquid
• Route of Administration: ORAL
• Marketing Start Date: 2015-07-31
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: Healthy Accents (DZA Brands, LLC)
• Substance Name: ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
• Active Ingredient Strength: 650 mg/30mL; mg/30mL; mg/30mL
• NDC Exclude Flag: E
• Listing Certified Through: 2018-12-31

Packaging

NDC 55316-317-08

245 mL in 1 BOTTLE, PLASTIC (55316-317-08)

• Marketing Start Date: 2015-07-31
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 55316-317-08 [55316031708]

Nighttime Flu Relief Therapy Severe Cold LIQUID

• Marketing Category: OTC MONOGRAPH FINAL
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2015-07-31
• Marketing End Date: 2020-12-31

Drug Details

Active Ingredients

Ingredient	Strength
ACETAMINOPHEN	650 mg/30mL

OpenFDA Data

• SPL SET ID: f8251301-8571-44d6-82d5-cdd884ab7e9f
• Manufacturer:
  • Healthy Accents (DZA Brands, LLC)
• UNII:
  • TC2D6JAD40
  • 362O9ITL9D
  • 04JA59TNSJ
• RxNorm Concept Unique ID - RxCUI:
  • 1298348
• UPC Code:
  • 0725439936521

NDC Crossover Matching brand name "Nighttime Flu Relief Therapy Severe Cold" or generic name "Acetaminophen, Diphenhydramine Hcl, Phenylephrine Hcl"

NDC	Brand Name	Generic Name
55316-317	Nighttime Flu Relief Therapy Severe Cold	Nighttime Flu Relief Therapy Severe Cold
13411-839	AcetaFlu NightTime	Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl
13411-841	AcetaFlu NightTime Effervescent	Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl
41250-464	Allergy Plus Sinus Headache	Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl
0363-5430	Allergy Relief	ACETAMINOPHEN, DIPHENHYDRAMINE HCl, PHENYLEPHRINE HCl
15127-862	Flu and Sore Throat	Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl
36800-317	Flu Relief Therapy	Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl
46122-016	Flu Relief Therapy	Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl
15127-922	Flu Relief Therapy Nighttime	Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl
46122-268	good neighbor pharmacy cold and flu night time	Acetaminophen, diphenhydramine HCl, phenylephrine HCl
46122-311	Nighttime Flu Relief Therapy	Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl
11822-0543	Severe Allergy And Sinus Headache	Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl
41250-543	Severe Allergy Plus Sinus Headache	Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl
49035-543	Severe Allergy Plus Sinus Headache	Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl
37808-017	Severe Cold and Cough Relief	Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl
42507-317	Severe Cold and Cough Relief	Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl
0067-6095	THERAFLU	ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL
0067-7918	THERAFLU	ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL
0067-8129	Theraflu ExpressMax	Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl
0067-8131	Theraflu ExpressMax	Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl
0067-8137	Theraflu ExpressMax	acetaminophen, diphenhydramine HCl, phenylephrine HCl
36800-999	topcare cold and flu night time	Acetaminophen, diphenhydramine HCl, phenylephrine HCl
36800-919	Topcare Tussin	Acetaminophen, diphenhydramine HCl, phenylephrine HCl
36800-902	topcare tussin cf max	Acetaminophen, diphenhydramine HCl, phenylephrine HCl
0363-0543	Wal-Dryl	Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl