8hr muscle aches and pain

Generic: acetaminophen

Labeler: fsa store inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name 8hr muscle aches and pain
Generic Name acetaminophen
Labeler fsa store inc.
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

acetaminophen 650 mg/1

Manufacturer
FSA STORE INC.

Identifiers & Regulatory

Product NDC 81522-201
Product ID 81522-201_1acc0f41-33af-f7b1-e063-6294a90a6385
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA211544
Listing Expiration 2026-12-31
Marketing Start 2024-03-20

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 81522201
Hyphenated Format 81522-201

Supplemental Identifiers

RxCUI
1148399
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 8hr muscle aches and pain (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 CARTON (81522-201-03) / 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

81522-201-03 1 BOTTLE, PLASTIC in 1 CARTON (81522-201-03) / 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC

Ingredients (1)

acetaminophen (650 mg/1)

Linked Drug Pages (1)

8HR Muscle Aches and Pain ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "1acc0f41-33af-f7b1-e063-6294a90a6385", "openfda": {"unii": ["362O9ITL9D"], "rxcui": ["1148399"], "spl_set_id": ["13268603-0080-22cf-e063-6394a90a7db4"], "manufacturer_name": ["FSA STORE INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (81522-201-03)  / 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC", "package_ndc": "81522-201-03", "marketing_start_date": "20240320"}], "brand_name": "8HR Muscle Aches and Pain", "product_id": "81522-201_1acc0f41-33af-f7b1-e063-6294a90a6385", "dosage_form": "TABLET, EXTENDED RELEASE", "product_ndc": "81522-201", "generic_name": "Acetaminophen", "labeler_name": "FSA STORE INC.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "8HR Muscle Aches and Pain", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "650 mg/1"}], "application_number": "ANDA211544", "marketing_category": "ANDA", "marketing_start_date": "20240320", "listing_expiration_date": "20261231"}