8 hour pain relief

Generic: acetaminophen

Labeler: amerisource bergen
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name 8 hour pain relief
Generic Name acetaminophen
Labeler amerisource bergen
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

acetaminophen 650 mg/1

Manufacturer
AMERISOURCE BERGEN

Identifiers & Regulatory

Product NDC 46122-630
Product ID 46122-630_1e004cc6-5802-1e62-e063-6294a90aa220
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA211544
Listing Expiration 2026-12-31
Marketing Start 2020-01-13

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 46122630
Hyphenated Format 46122-630

Supplemental Identifiers

RxCUI
1148399
UPC
0087701432484
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 8 hour pain relief (source: ndc)
Generic Name acetaminophen (source: ndc)
Application Number ANDA211544 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 650 mg/1
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 PACKAGE (46122-630-71) / 50 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
  • 1 BOTTLE, PLASTIC in 1 CARTON (46122-630-78) / 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
source: ndc

Packages (2)

46122-630-71 1 BOTTLE, PLASTIC in 1 PACKAGE (46122-630-71) / 50 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC 46122-630-78 1 BOTTLE, PLASTIC in 1 CARTON (46122-630-78) / 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC

Ingredients (1)

acetaminophen (650 mg/1)

Linked Drug Pages (1)

8 Hour Pain Relief ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "1e004cc6-5802-1e62-e063-6294a90aa220", "openfda": {"upc": ["0087701432484"], "unii": ["362O9ITL9D"], "rxcui": ["1148399"], "spl_set_id": ["9ab903aa-7170-460b-9527-e3df223f5f55"], "manufacturer_name": ["AMERISOURCE BERGEN"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 PACKAGE (46122-630-71)  / 50 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC", "package_ndc": "46122-630-71", "marketing_start_date": "20240827"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (46122-630-78)  / 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC", "package_ndc": "46122-630-78", "marketing_start_date": "20200113"}], "brand_name": "8 Hour Pain Relief", "product_id": "46122-630_1e004cc6-5802-1e62-e063-6294a90aa220", "dosage_form": "TABLET, EXTENDED RELEASE", "product_ndc": "46122-630", "generic_name": "Acetaminophen", "labeler_name": "AMERISOURCE BERGEN", "product_type": "HUMAN OTC DRUG", "brand_name_base": "8 Hour Pain Relief", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "650 mg/1"}], "application_number": "ANDA211544", "marketing_category": "ANDA", "marketing_start_date": "20200113", "listing_expiration_date": "20261231"}