NDC 63654-600

Cold Medicine XL3

Acetaminophen Chlorpheniramine Maleate Phenylepherine Hydrochloride

Cold Medicine XL3 is a Oral Tablet in the Human Otc Drug category. It is labeled and distributed by Selder, S.a. De C.v.. The primary component is Acetaminophen; Chlorpheniramine Maleate; Phenylephrine Hydrochloride.

• Product ID: 63654-600_09cc48f3-e043-4da8-a9f1-00cb6ccbee95
• NDC: 63654-600
• Product Type: Human Otc Drug
• Proprietary Name: Cold Medicine XL3
• Generic Name: Acetaminophen Chlorpheniramine Maleate Phenylepherine Hydrochloride
• Dosage Form: Tablet
• 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; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE
• Active Ingredient Strength: 325 mg/1; mg/1; mg/1
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 63654-600-02

25 TABLET in 1 BLISTER PACK (63654-600-02)

• Marketing Start Date: 2011-11-15
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 63654-600-02 [63654060002]

Cold Medicine XL3 TABLET

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2011-11-15
• Inactivation Date: 2019-11-13

NDC 63654-600-68 [63654060068]

Cold Medicine XL3 TABLET

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2011-11-15
• Inactivation Date: 2019-11-13

Drug Details

Active Ingredients

Ingredient	Strength
ACETAMINOPHEN	325 mg/1

OpenFDA Data

• SPL SET ID: fc4d100b-eaa9-4e46-a27a-74094aa11d0f
• Manufacturer:
  • Selder, S.A. de C.V.
• UNII:
  • V1Q0O9OJ9Z
  • 362O9ITL9D
  • 04JA59TNSJ
• RxNorm Concept Unique ID - RxCUI:
  • 1193293
• UPC Code:
  • 0645981000214

NDC Crossover Matching brand name "Cold Medicine XL3" or generic name "Acetaminophen Chlorpheniramine Maleate Phenylepherine Hydrochloride"

NDC	Brand Name	Generic Name
58596-002	Cold Medicine	Acetaminophen Chlorpheniramine Maleate Phenylepherine Hydrochloride
63654-600	Cold Medicine	Acetaminophen Chlorpheniramine Maleate Phenylepherine Hydrochloride
63654-601	Cold Medicine	Acetaminophen Chlorpheniramine Maleate Phenylepherine Hydrochloride
63654-605	Cold Medicine	Acetaminophen Chlorpheniramine Maleate Phenylepherine Hydrochloride
76095-010	Cold Medicine	Acetaminophen Chlorpheniramine Maleate Phenylepherine Hydrochloride
76095-011	Cold Medicine	Acetaminophen Chlorpheniramine Maleate Phenylepherine Hydrochloride