dologen

Generic: acetaminophen, dexbrompheniramine maleate

Labeler: kramer novis
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name dologen
Generic Name acetaminophen, dexbrompheniramine maleate
Labeler kramer novis
Dosage Form TABLET
Routes
ORAL
Active Ingredients

acetaminophen 500 mg/1, dexbrompheniramine maleate 2 mg/1

Manufacturer
Kramer Novis

Identifiers & Regulatory

Product NDC 52083-483
Product ID 52083-483_19820911-7642-4293-b03e-5359d59661d6
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2025-12-15

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 52083483
Hyphenated Format 52083-483

Supplemental Identifiers

RxCUI
2729424
UPC
0352083483905
UNII
362O9ITL9D BPA9UT29BS

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 dologen (source: ndc)
Generic Name acetaminophen, dexbrompheniramine maleate (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
  • 2 mg/1
source: ndc
Packaging
  • 90 TABLET in 1 BOTTLE, PLASTIC (52083-483-90)
source: ndc

Packages (1)

52083-483-90 90 TABLET in 1 BOTTLE, PLASTIC (52083-483-90)

Ingredients (2)

acetaminophen (500 mg/1) dexbrompheniramine maleate (2 mg/1)

Linked Drug Pages (1)

DOLOGEN ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "19820911-7642-4293-b03e-5359d59661d6", "openfda": {"upc": ["0352083483905"], "unii": ["362O9ITL9D", "BPA9UT29BS"], "rxcui": ["2729424"], "spl_set_id": ["656ea9ba-c9cf-44c6-af40-b8ba292ce38a"], "manufacturer_name": ["Kramer Novis"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET in 1 BOTTLE, PLASTIC (52083-483-90)", "package_ndc": "52083-483-90", "marketing_start_date": "20251215"}], "brand_name": "DOLOGEN", "product_id": "52083-483_19820911-7642-4293-b03e-5359d59661d6", "dosage_form": "TABLET", "product_ndc": "52083-483", "generic_name": "Acetaminophen, Dexbrompheniramine maleate", "labeler_name": "Kramer Novis", "product_type": "HUMAN OTC DRUG", "brand_name_base": "DOLOGEN", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "500 mg/1"}, {"name": "DEXBROMPHENIRAMINE MALEATE", "strength": "2 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20251215", "listing_expiration_date": "20261231"}