NDC 58596-001

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 Selgel M. The primary component is Acetaminophen; Chlorpheniramine Maleate; Dextromethorphan Hydrobromide; Phenylephrine Hydrochloride.

• Product ID: 58596-001_78b3e3d5-b245-6aca-e053-2a91aa0ac66c
• NDC: 58596-001
• 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: 2014-07-31
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: Selgel M
• Substance Name: ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
• Active Ingredient Strength: 250 mg/1; mg/1; mg/1; mg/1
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 58596-001-06

6 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (58596-001-06)

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

NDC SPL Data Element Entries

NDC 58596-001-12 [58596000112]

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 58596-001-06 [58596000106]

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

Drug Details

Active Ingredients

Ingredient	Strength
ACETAMINOPHEN	250 mg/1

OpenFDA Data

• SPL SET ID: 0f93eac7-c9aa-4167-acfd-de5132e24047
• Manufacturer:
  • Selgel Mxico, 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