acetaminophen

Generic: acetaminophen

Labeler: softgel healthcare pvt ltd
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name acetaminophen
Generic Name acetaminophen
Labeler softgel healthcare pvt ltd
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

acetaminophen 500 mg/1

Manufacturer
Softgel Healthcare Pvt Ltd

Identifiers & Regulatory

Product NDC 35916-0183
Product ID 35916-0183_47ca0abf-72ca-1cf1-e063-6394a90a4990
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M013
Listing Expiration 2027-12-31
Marketing Start 2025-05-17

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 359160183
Hyphenated Format 35916-0183

Supplemental Identifiers

RxCUI
198439
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 acetaminophen (source: ndc)
Generic Name acetaminophen (source: ndc)
Application Number M013 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 3000 CAPSULE, LIQUID FILLED in 1 POUCH (35916-0183-2)
  • 2 POUCH in 1 BOX (35916-0183-3) / 2000 CAPSULE, LIQUID FILLED in 1 POUCH
  • 2 BAG in 1 BOX (35916-0183-4) / 1500 CAPSULE, LIQUID FILLED in 1 BAG
source: ndc

Packages (3)

35916-0183-2 3000 CAPSULE, LIQUID FILLED in 1 POUCH (35916-0183-2) 35916-0183-3 2 POUCH in 1 BOX (35916-0183-3) / 2000 CAPSULE, LIQUID FILLED in 1 POUCH 35916-0183-4 2 BAG in 1 BOX (35916-0183-4) / 1500 CAPSULE, LIQUID FILLED in 1 BAG

Ingredients (1)

acetaminophen (500 mg/1)

Linked Drug Pages (1)

Acetaminophen ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "47ca0abf-72ca-1cf1-e063-6394a90a4990", "openfda": {"unii": ["362O9ITL9D"], "rxcui": ["198439"], "spl_set_id": ["352bb451-ffdc-411a-e063-6294a90a8cf5"], "manufacturer_name": ["Softgel Healthcare Pvt Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3000 CAPSULE, LIQUID FILLED in 1 POUCH (35916-0183-2)", "package_ndc": "35916-0183-2", "marketing_start_date": "20250517"}, {"sample": false, "description": "2 POUCH in 1 BOX (35916-0183-3)  / 2000 CAPSULE, LIQUID FILLED in 1 POUCH", "package_ndc": "35916-0183-3", "marketing_start_date": "20250924"}, {"sample": false, "description": "2 BAG in 1 BOX (35916-0183-4)  / 1500 CAPSULE, LIQUID FILLED in 1 BAG", "package_ndc": "35916-0183-4", "marketing_start_date": "20260113"}], "brand_name": "Acetaminophen", "product_id": "35916-0183_47ca0abf-72ca-1cf1-e063-6394a90a4990", "dosage_form": "CAPSULE, LIQUID FILLED", "product_ndc": "35916-0183", "generic_name": "Acetaminophen", "labeler_name": "Softgel Healthcare Pvt Ltd", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Acetaminophen", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "500 mg/1"}], "application_number": "M013", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250517", "listing_expiration_date": "20271231"}