NDC 51013-189

DAY TIME Cold Flu Medicine

Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride

DAY TIME Cold Flu Medicine 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; Phenylephrine Hydrochloride.

• Product ID: 51013-189_502b3ea9-76ea-481f-8a82-2bd413528958
• NDC: 51013-189
• Product Type: Human Otc Drug
• Proprietary Name: DAY TIME Cold Flu Medicine
• Generic Name: Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
• Dosage Form: Capsule, Liquid Filled
• Route of Administration: ORAL
• Marketing Start Date: 2016-10-06
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: PuraCap Pharmaceutical LLC
• Substance Name: ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
• Active Ingredient Strength: 325 mg/1; mg/1; mg/1
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 51013-189-08

2 BLISTER PACK in 1 CARTON (51013-189-08) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

• Marketing Start Date: 2016-10-06
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 51013-189-08 [51013018908]

DAY TIME Cold Flu Medicine CAPSULE, LIQUID FILLED

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2016-10-06

Drug Details

Active Ingredients

Ingredient	Strength
ACETAMINOPHEN	325 mg/1

OpenFDA Data

• SPL SET ID: 2c8a072b-80af-4e20-9650-83f392baf40f
• Manufacturer:
  • PuraCap Pharmaceutical LLC
• UNII:
  • 362O9ITL9D
  • 04JA59TNSJ
  • 9D2RTI9KYH
• RxNorm Concept Unique ID - RxCUI:
  • 1086997

NDC Crossover Matching brand name "DAY TIME Cold Flu Medicine" or generic name "Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride"

NDC	Brand Name	Generic Name
51013-187	DAY TIME Cold Flu Medicine	DAY TIME Cold Flu Medicine
51013-189	DAY TIME Cold Flu Medicine	DAY TIME Cold Flu Medicine
0280-1590	Alka-Seltzer Plus Maximum Strength Day Cold and Flu	Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
0280-1630	Alka-Seltzer Plus Maximum Strength Day Cold and Flu PowerMax Gels	acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride
0280-1221	Alka-Seltzer Plus Severe Sinus Congestion and Cough Liquid Gels Day	Acetaminophen, Dextromethorphan hydrobromide, Phenylephrine hydrochloride
0113-7656	basic care daytime cold and flu	acetaminophen, dextromethorphan hydrobromide, Phenylephrine hydrochloride
21130-598	Cold and Flu	Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
21130-650	Cold and Flu	Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
21130-868	Cold and Flu	Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
11868-311	Cold Preparation	Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
11868-466	Cold Preparation	Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
21130-468	Day time	Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
15127-466	Day Time Cold and Flu	Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
0904-5763	Day Time Cold and Flu Relief	Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
21130-866	Day Time Cold and Flu Relief	Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
0363-1140	Daytime Cold and Flu	acetaminophen, dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
11822-1583	Daytime Cold and Flu	Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
0363-1000	Daytime Cold and Flu Relief	acetaminophen, dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
0363-1003	Daytime Cold and Flu Relief	acetaminophen, dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
21130-311	Daytime Cold and Flu Relief	Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
21130-471	Daytime Cold and Flu Relief	Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
0113-0096	good sense flu and severe cold and cough	Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
11822-0096	severe cold cough and flu relief	Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
21130-937	signature care daytime severe cold	acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride