NDC 55316-316

Severe Cold and Cough Relief Daytime

Acetaminohpen, Dextromethorphan Hbr, Phenylephrine Hcl

Severe Cold and Cough Relief Daytime 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; Dextromethorphan Hydrobromide; Phenylephrine Hydrochloride.

• Product ID: 55316-316_79f38840-1c39-4e23-96b5-36dce8439011
• NDC: 55316-316
• Product Type: Human Otc Drug
• Proprietary Name: Severe Cold and Cough Relief Daytime
• Generic Name: Acetaminohpen, Dextromethorphan Hbr, Phenylephrine Hcl
• Dosage Form: Liquid
• Route of Administration: ORAL
• Marketing Start Date: 2015-10-31
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: Healthy Accents (DZA Brands, LLC)
• Substance Name: ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
• Active Ingredient Strength: 650 mg/30mL; mg/30mL; mg/30mL
• NDC Exclude Flag: E
• Listing Certified Through: 2018-12-31

Packaging

NDC 55316-316-08

245 mL in 1 BOTTLE, PLASTIC (55316-316-08)

• Marketing Start Date: 2015-10-31
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 55316-316-08 [55316031608]

Severe Cold and Cough Relief Daytime LIQUID

• Marketing Category: OTC MONOGRAPH FINAL
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2015-10-31
• Marketing End Date: 2020-12-31

Drug Details

Active Ingredients

Ingredient	Strength
ACETAMINOPHEN	650 mg/30mL

OpenFDA Data

• SPL SET ID: 95ca40c9-4e41-458a-a355-6470c7863628
• Manufacturer:
  • Healthy Accents (DZA Brands, LLC)
• UNII:
  • 362O9ITL9D
  • 04JA59TNSJ
  • 9D2RTI9KYH
• RxNorm Concept Unique ID - RxCUI:
  • 1113705
• UPC Code:
  • 0725439936538

NDC Crossover Matching brand name "Severe Cold and Cough Relief Daytime" or generic name "Acetaminohpen, Dextromethorphan Hbr, Phenylephrine Hcl"

NDC	Brand Name	Generic Name
55316-316	Severe Cold and Cough Relief Daytime	Severe Cold and Cough Relief Daytime
55910-801	Severe Cold and Cough Relief Daytime	Severe Cold and Cough Relief Daytime
63868-021	Severe Cold and Cough Relief Daytime	Severe Cold and Cough Relief Daytime
55319-701	Severe Cold and Cough Relief Daytime	Severe Cold and Cough Relief Daytime
33992-0742	Cold and Flu	ACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCl
55315-742	Cold and Flu	ACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCl
0904-6793	Cold and Flu Relief	ACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCl
0904-6995	Cold and Flu Relief	ACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCL
49348-738	Day Time PE	ACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCl
41520-473	DAYTIME	ACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCl
50804-468	Daytime	ACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCl
41250-568	DayTime Cold and Flu	ACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCl
41250-646	DayTime Cold and Flu	ACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCl
50804-742	Daytime Cold Flu	ACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCl
49738-470	DayTime Cold Flu Non-Drowsy	ACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCL
55315-316	Daytime Flu Relief Therapy	ACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCL
33992-0468	DayTime Multi-Symptom	ACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCl
37808-016	Flu Relief Therapy	ACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCL
46122-015	Flu Relief Therapy	ACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCL
15127-923	Flu Relief Therapy Daytime	ACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCL
41520-068	Multi-Symptom Cold and Flu	ACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCl
36800-316	Severe Cold and Cough	ACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCL
42507-316	Severe Cold and Cough Relief	ACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCL
46122-336	Severe Cold and Cough Relief	ACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCL
49580-0501	Severe Cold and Cough Relief	ACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCL
50804-316	Severe Cold and Cough Relief	ACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCL