dolex children pain and fever

Generic: acetaminophen

Labeler: pharmadel llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name dolex children pain and fever
Generic Name acetaminophen
Labeler pharmadel llc
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

acetaminophen 160 mg/5mL

Manufacturer
Pharmadel LLC

Identifiers & Regulatory

Product NDC 55758-026
Product ID 55758-026_12dcac76-11bc-2c3b-e063-6394a90a35c6
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M013
Listing Expiration 2026-12-31
Marketing Start 2023-01-01

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55758026
Hyphenated Format 55758-026

Supplemental Identifiers

RxCUI
307668
UNII
362O9ITL9D

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 dolex children pain and fever (source: ndc)
Generic Name acetaminophen (source: ndc)
Application Number M013 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 160 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE in 1 BOX (55758-026-04) / 118 mL in 1 BOTTLE
source: ndc

Packages (1)

55758-026-04 1 BOTTLE in 1 BOX (55758-026-04) / 118 mL in 1 BOTTLE

Ingredients (1)

acetaminophen (160 mg/5mL)

Linked Drug Pages (1)

Dolex Children Pain and Fever ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "12dcac76-11bc-2c3b-e063-6394a90a35c6", "openfda": {"unii": ["362O9ITL9D"], "rxcui": ["307668"], "spl_set_id": ["f9158463-aeb1-5de0-e053-6294a90a748b"], "manufacturer_name": ["Pharmadel LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 BOX (55758-026-04)  / 118 mL in 1 BOTTLE", "package_ndc": "55758-026-04", "marketing_start_date": "20230101"}], "brand_name": "Dolex Children Pain and Fever", "product_id": "55758-026_12dcac76-11bc-2c3b-e063-6394a90a35c6", "dosage_form": "SUSPENSION", "product_ndc": "55758-026", "generic_name": "ACETAMINOPHEN", "labeler_name": "Pharmadel LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Dolex", "brand_name_suffix": "Children Pain and Fever", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "160 mg/5mL"}], "application_number": "M013", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20230101", "listing_expiration_date": "20261231"}