salonpas

Generic: diclofenac sodium

Labeler: hisamitsu america, inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name salonpas
Generic Name diclofenac sodium
Labeler hisamitsu america, inc.
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

diclofenac sodium 10 mg/g

Manufacturer
Hisamitsu America, Inc.

Identifiers & Regulatory

Product NDC 55328-801
Product ID 55328-801_f4f1cff3-d484-46cc-ac7a-639874afd71a
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA208077
Listing Expiration 2026-12-31
Marketing Start 2016-03-21

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55328801
Hyphenated Format 55328-801

Supplemental Identifiers

RxCUI
855633
UNII
QTG126297Q

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 salonpas (source: ndc)
Generic Name diclofenac sodium (source: ndc)
Application Number ANDA208077 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (55328-801-10) / 100 g in 1 TUBE
source: ndc

Packages (1)

55328-801-10 1 TUBE in 1 CARTON (55328-801-10) / 100 g in 1 TUBE

Ingredients (1)

diclofenac sodium (10 mg/g)

Linked Drug Pages (1)

Salonpas ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "f4f1cff3-d484-46cc-ac7a-639874afd71a", "openfda": {"unii": ["QTG126297Q"], "rxcui": ["855633"], "spl_set_id": ["f439445d-046e-4220-a4a7-13d750ee0949"], "manufacturer_name": ["Hisamitsu America, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (55328-801-10)  / 100 g in 1 TUBE", "package_ndc": "55328-801-10", "marketing_start_date": "20160321"}], "brand_name": "Salonpas", "product_id": "55328-801_f4f1cff3-d484-46cc-ac7a-639874afd71a", "dosage_form": "GEL", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Decreased Prostaglandin Production [PE]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "55328-801", "generic_name": "Diclofenac Sodium", "labeler_name": "Hisamitsu America, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Salonpas", "active_ingredients": [{"name": "DICLOFENAC SODIUM", "strength": "10 mg/g"}], "application_number": "ANDA208077", "marketing_category": "ANDA", "marketing_start_date": "20160321", "listing_expiration_date": "20261231"}