defensolito

Generic: acetaminophen, phenylephrine hydrochloride

Labeler: menper distributors, inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name defensolito
Generic Name acetaminophen, phenylephrine hydrochloride
Labeler menper distributors, inc.
Dosage Form TABLET, CHEWABLE
Routes
ORAL
Active Ingredients

acetaminophen 80 mg/1, phenylephrine hydrochloride 2.5 mg/1

Manufacturer
Menper Distributors, Inc.

Identifiers & Regulatory

Product NDC 53145-006
Product ID 53145-006_3a875ad3-8a76-b446-e063-6294a90a1a63
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2012-02-21

Pharmacologic Class

Classes
adrenergic alpha1-agonists [moa] alpha-1 adrenergic agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 53145006
Hyphenated Format 53145-006

Supplemental Identifiers

RxCUI
1539545
UNII
362O9ITL9D 04JA59TNSJ

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name defensolito (source: ndc)
Generic Name acetaminophen, phenylephrine hydrochloride (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 80 mg/1
  • 2.5 mg/1
source: ndc
Packaging
  • 50 PACKET in 1 CARTON (53145-006-02) / 2 TABLET, CHEWABLE in 1 PACKET
  • 1 BOTTLE in 1 BOX (53145-006-30) / 30 TABLET, CHEWABLE in 1 BOTTLE
source: ndc

Packages (2)

53145-006-02 50 PACKET in 1 CARTON (53145-006-02) / 2 TABLET, CHEWABLE in 1 PACKET 53145-006-30 1 BOTTLE in 1 BOX (53145-006-30) / 30 TABLET, CHEWABLE in 1 BOTTLE

Ingredients (2)

acetaminophen (80 mg/1) phenylephrine hydrochloride (2.5 mg/1)

Linked Drug Pages (1)

Defensolito ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3a875ad3-8a76-b446-e063-6294a90a1a63", "openfda": {"unii": ["362O9ITL9D", "04JA59TNSJ"], "rxcui": ["1539545"], "spl_set_id": ["2a3f498d-445f-410b-818f-9f119bd6c492"], "manufacturer_name": ["Menper Distributors, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "50 PACKET in 1 CARTON (53145-006-02)  / 2 TABLET, CHEWABLE in 1 PACKET", "package_ndc": "53145-006-02", "marketing_start_date": "20120221"}, {"sample": false, "description": "1 BOTTLE in 1 BOX (53145-006-30)  / 30 TABLET, CHEWABLE in 1 BOTTLE", "package_ndc": "53145-006-30", "marketing_start_date": "20120221"}], "brand_name": "Defensolito", "product_id": "53145-006_3a875ad3-8a76-b446-e063-6294a90a1a63", "dosage_form": "TABLET, CHEWABLE", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "53145-006", "generic_name": "Acetaminophen, Phenylephrine Hydrochloride", "labeler_name": "Menper Distributors, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Defensolito", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "80 mg/1"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "2.5 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20120221", "listing_expiration_date": "20261231"}