NDC 63654-800

Cough and Cold XL3 Xtra

Acetaminophen Chlorpheniramine Maleate Dextromethorphan Hydrobromide Phenylepherine Hydrochloride

Cough and Cold XL3 Xtra is a Oral Capsule, Liquid Filled in the Human Otc Drug category. It is labeled and distributed by Selder, S.a. De C.v.. The primary component is Acetaminophen; Phenylephrine Hydrochloride; Chlorpheniramine Maleate; Dextromethorphan Hydrobromide.

• Product ID: 63654-800_798de183-426c-b616-e053-2a91aa0a2534
• NDC: 63654-800
• Product Type: Human Otc Drug
• Proprietary Name: Cough and Cold XL3 Xtra
• Generic Name: Acetaminophen Chlorpheniramine Maleate Dextromethorphan Hydrobromide Phenylepherine Hydrochloride
• Dosage Form: Capsule, Liquid Filled
• Route of Administration: ORAL
• Marketing Start Date: 2011-11-15
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: Selder, S.A. de C.V.
• Substance Name: ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE
• Active Ingredient Strength: 250 mg/1; mg/1; mg/1; mg/1
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 63654-800-06

6 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (63654-800-06)

• Marketing Start Date: 2018-10-15
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 63654-800-12 [63654080012]

Cough and Cold XL3 Xtra CAPSULE, LIQUID FILLED

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2014-08-22

NDC 63654-800-06 [63654080006]

Cough and Cold XL3 Xtra CAPSULE, LIQUID FILLED

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2018-10-15

NDC 63654-800-20 [63654080020]

Cough and Cold XL3 Xtra CAPSULE, LIQUID FILLED

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2011-11-15
• Marketing End Date: 2018-10-15

Drug Details

Active Ingredients

Ingredient	Strength
ACETAMINOPHEN	250 mg/1

OpenFDA Data

• SPL SET ID: da5b31dd-becd-471a-9392-d0ee4b8f9539
• Manufacturer:
  • Selder, S.A. de C.V.
• UNII:
  • V1Q0O9OJ9Z
  • 362O9ITL9D
  • 04JA59TNSJ
  • 9D2RTI9KYH
• RxNorm Concept Unique ID - RxCUI:
  • 1193292

NDC Crossover Matching brand name "Cough and Cold XL3 Xtra" or generic name "Acetaminophen Chlorpheniramine Maleate Dextromethorphan Hydrobromide Phenylepherine Hydrochloride"

NDC	Brand Name	Generic Name
28623-250	Cough and Cold	Acetaminophen Chlorpheniramine Maleate Dextromethorphan Hydrobromide Phenylepherine Hydrochloride
58596-001	Cough and Cold	Acetaminophen Chlorpheniramine Maleate Dextromethorphan Hydrobromide Phenylepherine Hydrochloride
63654-800	Cough and Cold	Acetaminophen Chlorpheniramine Maleate Dextromethorphan Hydrobromide Phenylepherine Hydrochloride
76095-015	Cough and Cold	Acetaminophen Chlorpheniramine Maleate Dextromethorphan Hydrobromide Phenylepherine Hydrochloride