onexton

Generic: clindamycin phosphate and benzoyl peroxide

Labeler: bausch health us, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name onexton
Generic Name clindamycin phosphate and benzoyl peroxide
Labeler bausch health us, llc
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

benzoyl peroxide 37.5 mg/g, clindamycin phosphate 10 mg/g

Manufacturer
Bausch Health US, LLC

Identifiers & Regulatory

Product NDC 0187-3050
Product ID 0187-3050_bcf2f805-f7d5-45b4-b352-a1e114e00e48
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA050819
Listing Expiration 2026-12-31
Marketing Start 2014-11-24

Pharmacologic Class

Classes
decreased sebaceous gland activity [pe] lincosamide antibacterial [epc] lincosamides [cs] neuromuscular blockade [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01873050
Hyphenated Format 0187-3050

Supplemental Identifiers

RxCUI
1598470 1598826
UPC
0301873050506
UNII
W9WZN9A0GM EH6D7113I8

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 onexton (source: ndc)
Generic Name clindamycin phosphate and benzoyl peroxide (source: ndc)
Application Number NDA050819 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 37.5 mg/g
  • 10 mg/g
source: ndc
Packaging
  • 3.5 g in 1 TUBE (0187-3050-35)
  • 1 BOTTLE, PUMP in 1 CARTON (0187-3050-50) / 50 g in 1 BOTTLE, PUMP
source: ndc

Packages (2)

0187-3050-35 3.5 g in 1 TUBE (0187-3050-35) 0187-3050-50 1 BOTTLE, PUMP in 1 CARTON (0187-3050-50) / 50 g in 1 BOTTLE, PUMP

Ingredients (2)

benzoyl peroxide (37.5 mg/g) clindamycin phosphate (10 mg/g)

Linked Drug Pages (1)

ONEXTON ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "bcf2f805-f7d5-45b4-b352-a1e114e00e48", "openfda": {"upc": ["0301873050506"], "unii": ["W9WZN9A0GM", "EH6D7113I8"], "rxcui": ["1598470", "1598826"], "spl_set_id": ["697e760a-c206-4565-8f4e-a8085e215827"], "manufacturer_name": ["Bausch Health US, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3.5 g in 1 TUBE (0187-3050-35)", "package_ndc": "0187-3050-35", "marketing_start_date": "20141124"}, {"sample": false, "description": "1 BOTTLE, PUMP in 1 CARTON (0187-3050-50)  / 50 g in 1 BOTTLE, PUMP", "package_ndc": "0187-3050-50", "marketing_start_date": "20141124"}], "brand_name": "ONEXTON", "product_id": "0187-3050_bcf2f805-f7d5-45b4-b352-a1e114e00e48", "dosage_form": "GEL", "pharm_class": ["Decreased Sebaceous Gland Activity [PE]", "Lincosamide Antibacterial [EPC]", "Lincosamides [CS]", "Neuromuscular Blockade [PE]"], "product_ndc": "0187-3050", "generic_name": "Clindamycin Phosphate and Benzoyl Peroxide", "labeler_name": "Bausch Health US, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ONEXTON", "active_ingredients": [{"name": "BENZOYL PEROXIDE", "strength": "37.5 mg/g"}, {"name": "CLINDAMYCIN PHOSPHATE", "strength": "10 mg/g"}], "application_number": "NDA050819", "marketing_category": "NDA", "marketing_start_date": "20141124", "listing_expiration_date": "20261231"}