NDC 51013-164

Nighttime SEVERE COLD and FLU

Acetaminophen, Phenylephrine Hydrochloride, Doxylamine Succinate, Dextromethorphan Hydrobromide

Nighttime SEVERE COLD and FLU 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; Dextromethorphan Hydrobromide; Doxylamine Succinate; Phenylephrine Hydrochloride.

• Product ID: 51013-164_08ff2d9a-0ed4-493d-8f8c-7d92fb6a1b1c
• NDC: 51013-164
• Product Type: Human Otc Drug
• Proprietary Name: Nighttime SEVERE COLD and FLU
• Generic Name: Acetaminophen, Phenylephrine Hydrochloride, Doxylamine Succinate, Dextromethorphan Hydrobromide
• Dosage Form: Capsule, Liquid Filled
• Route of Administration: ORAL
• Marketing Start Date: 2016-07-20
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: PuraCap Pharmaceutical LLC
• Substance Name: ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE
• Active Ingredient Strength: 325 mg/1; mg/1; mg/1; mg/1
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 51013-164-04

2 BLISTER PACK in 1 CARTON (51013-164-04) > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

• Marketing Start Date: 2016-07-20
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 51013-164-04 [51013016404]

Nighttime SEVERE COLD and FLU CAPSULE, LIQUID FILLED

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2016-07-20

Drug Details

Active Ingredients

Ingredient	Strength
ACETAMINOPHEN	325 mg/1

OpenFDA Data

• SPL SET ID: 874ec0e0-92d4-4d4c-a0ab-866bac36fa07
• Manufacturer:
  • PuraCap Pharmaceutical LLC
• UNII:
  • V9BI9B5YI2
  • 362O9ITL9D
  • 04JA59TNSJ
  • 9D2RTI9KYH
• RxNorm Concept Unique ID - RxCUI:
  • 1297288

NDC Crossover Matching brand name "Nighttime SEVERE COLD and FLU" or generic name "Acetaminophen, Phenylephrine Hydrochloride, Doxylamine Succinate, Dextromethorphan Hydrobromide"

NDC	Brand Name	Generic Name
0363-5900	nighttime severe cold and flu	acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride
30142-763	NightTime Severe Cold and Flu	Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl
37808-763	nighttime severe cold and flu	Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl
41226-626	NIGHTTIME SEVERE COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL
49035-967	Nighttime Severe Cold and Flu	Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl
51013-164	Nighttime SEVERE COLD and FLU	Acetaminophen, Phenylephrine hydrochloride, Doxylamine succinate, Dextromethorphan hydrobromide
63868-468	Nighttime Severe Cold and Flu	Acetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, Phenylephrine hydrochloride
79903-134	NIGHTTIME SEVERE COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, and PHENYLEPHRINE HYDROCHLORIDE
51013-162	NIGHT TIME COLD and FLU FORMULA	Acetaminophen, Phenylephrine hydrochloride, Doxylamine succinate, Dextromethorphan hydrobromide
51013-175	Night Time Severe Cold and Flu Relief	Acetaminophen, Phenylephrine hydrochloride, Doxylamine succinate, Dextromethorphan hydrobromide
63868-460	NightTime Maximum Strength Cold and Flu	Acetaminophen, Phenylephrine hydrochloride, Doxylamine succinate, Dextromethorphan hydrobromide
51013-154	Nighttime Severe Cold and Flu Relief	Acetaminophen, Phenylephrine hydrochloride, Doxylamine succinate, Dextromethorphan hydrobromide
51013-135	Nite Time Cold and Flu	Acetaminophen, Phenylephrine hydrochloride, Doxylamine succinate, Dextromethorphan hydrobromide
51013-400	Nite Time Cold and Flu	Acetaminophen, Phenylephrine hydrochloride, Doxylamine succinate, Dextromethorphan hydrobromide