NDC 53145-006

Defensolito

Acetaminophen, Phenylephrine Hydrochloride

Defensolito is a Oral Tablet, Chewable in the Human Otc Drug category. It is labeled and distributed by Menper Distributors, Inc.. The primary component is Acetaminophen; Phenylephrine Hydrochloride.

• Product ID: 53145-006_6c393469-4661-48e4-89e0-8414b8ee010c
• NDC: 53145-006
• Product Type: Human Otc Drug
• Proprietary Name: Defensolito
• Generic Name: Acetaminophen, Phenylephrine Hydrochloride
• Dosage Form: Tablet, Chewable
• Route of Administration: ORAL
• Marketing Start Date: 2012-02-21
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: Menper Distributors, Inc.
• Substance Name: ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE
• Active Ingredient Strength: 80 mg/1; mg/1
• NDC Exclude Flag: E
• Listing Certified Through: 2018-12-31

Packaging

NDC 53145-006-02

50 PACKET in 1 CARTON (53145-006-02) > 2 TABLET, CHEWABLE in 1 PACKET

• Marketing Start Date: 2012-02-21
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 53145-006-30 [53145000630]

Defensolito TABLET, CHEWABLE

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2012-02-21
• Inactivation Date: 2020-01-31

NDC 53145-006-02 [53145000602]

Defensolito TABLET, CHEWABLE

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2012-02-21
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
ACETAMINOPHEN	80 mg/1

OpenFDA Data

• SPL SET ID: 2a3f498d-445f-410b-818f-9f119bd6c492
• Manufacturer:
  • Menper Distributors, Inc.
• UNII:
  • 362O9ITL9D
  • 04JA59TNSJ
• RxNorm Concept Unique ID - RxCUI:
  • 1539545

NDC Crossover Matching brand name "Defensolito" or generic name "Acetaminophen, Phenylephrine Hydrochloride"

NDC	Brand Name	Generic Name
53145-006	Defensolito	Defensolito
46084-101	ACETAMINOPHEN SINUS CONGESTION AND PAIN	ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE
47682-001	Green Guard Advanced Sinus Relief	ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE
47682-002	Green Guard Advanced Sinus Relief	ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE
47682-158	Medi First Plus Sinus Pain and Pressure	ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE
47682-146	Medi First Sinus Pain and Pressure	ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE
47682-148	Otis Clapp Mygrex	ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE
47682-509	Otis Clapp Mygrex	ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE
37808-466	Sinus Congestion and Pain	Acetaminophen, Phenylephrine Hydrochloride