NDC 53666-617

Desenfriol-D

Chlorpheniramine Maleate, Phenylephrine Hydrochloride, Acetaminophen

Desenfriol-D is a Oral Tablet in the Human Otc Drug category. It is labeled and distributed by Salimex, S.a.. The primary component is Chlorpheniramine Maleate; Phenylephrine Hydrochloride; Acetaminophen.

• Product ID: 53666-617_5bee1a0b-7c7a-cdca-e053-2991aa0a95ed
• NDC: 53666-617
• Product Type: Human Otc Drug
• Proprietary Name: Desenfriol-D
• Generic Name: Chlorpheniramine Maleate, Phenylephrine Hydrochloride, Acetaminophen
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2017-10-18
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: Salimex, S.A.
• Substance Name: CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN
• Active Ingredient Strength: 0 g/g; g/g; g/g
• NDC Exclude Flag: E
• Listing Certified Through: 2018-12-31

Packaging

NDC 53666-617-01

30 BLISTER PACK in 1 BOX (53666-617-01) > .05 g in 1 BLISTER PACK

• Marketing Start Date: 2017-10-18
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 53666-617-01 [53666061701]

Desenfriol-D TABLET

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2017-10-18
• Inactivation Date: 2020-01-31
• Reactivation Date: 2020-03-02

Drug Details

Active Ingredients

Ingredient	Strength
CHLORPHENIRAMINE MALEATE	.002 g/g

OpenFDA Data

• SPL SET ID: 5bee1a0b-7c79-cdca-e053-2991aa0a95ed
• Manufacturer:
  • Salimex, S.A.
• UNII:
  • V1Q0O9OJ9Z
  • 362O9ITL9D
  • 04JA59TNSJ
• RxNorm Concept Unique ID - RxCUI:
  • 1052679
• UPC Code:
  • 0048201008067

NDC Crossover Matching brand name "Desenfriol-D" or generic name "Chlorpheniramine Maleate, Phenylephrine Hydrochloride, Acetaminophen"

NDC	Brand Name	Generic Name
53666-417	Desenfriol-D	CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN
53666-517	Desenfriol-D	CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN
53666-617	Desenfriol-D	CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN