NDC 51013-400

Nite Time Cold and Flu

Acetaminophen, Phenylephrine Hydrochloride, Doxylamine Succinate, Dextromethorphan Hydrobromide

Nite Time 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: 51013-400_044f9fbe-939c-4bee-8fb8-fe9059dab1ae
• NDC: 51013-400
• Product Type: Human Otc Drug
• Proprietary Name: Nite Time Cold and Flu
• Generic Name: Acetaminophen, Phenylephrine Hydrochloride, Doxylamine Succinate, Dextromethorphan Hydrobromide
• Dosage Form: Capsule, Liquid Filled
• Route of Administration: ORAL
• Marketing Start Date: 2017-07-17
• 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 51013-400-01

1 BLISTER PACK in 1 CARTON (51013-400-01) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

• Marketing Start Date: 2017-07-17
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 51013-400-01 [51013040001]

Nite Time Cold and Flu CAPSULE, LIQUID FILLED

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2017-07-17

NDC 51013-400-06 [51013040006]

Nite Time Cold and Flu CAPSULE, LIQUID FILLED

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2017-07-17

Drug Details

Active Ingredients

Ingredient	Strength
ACETAMINOPHEN	325 mg/1

OpenFDA Data

• SPL SET ID: 684ac9c9-a46d-4a14-935a-4b81c65d63c0
• Manufacturer:
  • PuraCap Pharmaceutical LLC
• UNII:
  • V9BI9B5YI2
  • 362O9ITL9D
  • 04JA59TNSJ
  • 9D2RTI9KYH
• RxNorm Concept Unique ID - RxCUI:
  • 1297288

NDC Crossover Matching brand name "Nite Time Cold and Flu" or generic name "Acetaminophen, Phenylephrine Hydrochloride, Doxylamine Succinate, Dextromethorphan Hydrobromide"

NDC	Brand Name	Generic Name
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
55301-344	Nite Time Cold and Flu	Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate
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
51013-164	Nighttime SEVERE 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