ana-dent pain relief

Generic: naproxen sodium

Labeler: belmora llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ana-dent pain relief
Generic Name naproxen sodium
Labeler belmora llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

naproxen sodium 220 mg/1

Manufacturer
Belmora LLC

Identifiers & Regulatory

Product NDC 27854-701
Product ID 27854-701_5ac02446-13da-43d5-9647-fe469294acec
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA205497
Listing Expiration 2026-12-31
Marketing Start 2020-05-15

Pharmacologic Class

Classes
anti-inflammatory agents non-steroidal [cs] cyclooxygenase inhibitors [moa] nonsteroidal anti-inflammatory drug [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 27854701
Hyphenated Format 27854-701

Supplemental Identifiers

RxCUI
849574
UNII
9TN87S3A3C

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 ana-dent pain relief (source: ndc)
Generic Name naproxen sodium (source: ndc)
Application Number ANDA205497 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 220 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (27854-701-01) / 24 TABLET, FILM COATED in 1 BOTTLE
source: ndc

Packages (1)

Ingredients (1)

naproxen sodium (220 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "5ac02446-13da-43d5-9647-fe469294acec", "openfda": {"unii": ["9TN87S3A3C"], "rxcui": ["849574"], "spl_set_id": ["04721306-2850-4e0a-9dd9-7cabb575f3c7"], "manufacturer_name": ["Belmora LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (27854-701-01)  / 24 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "27854-701-01", "marketing_start_date": "20200515"}], "brand_name": "Ana-Dent PAIN RELIEF", "product_id": "27854-701_5ac02446-13da-43d5-9647-fe469294acec", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "27854-701", "generic_name": "Naproxen Sodium", "labeler_name": "Belmora LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Ana-Dent PAIN RELIEF", "active_ingredients": [{"name": "NAPROXEN SODIUM", "strength": "220 mg/1"}], "application_number": "ANDA205497", "marketing_category": "ANDA", "marketing_start_date": "20200515", "listing_expiration_date": "20261231"}