chlorhexidine gluconate oral rinse

Generic: chlorhexidine gluconate oral rinse

Labeler: rising pharma holdings, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name chlorhexidine gluconate oral rinse
Generic Name chlorhexidine gluconate oral rinse
Labeler rising pharma holdings, inc.
Dosage Form SOLUTION
Routes
DENTAL
Active Ingredients

chlorhexidine gluconate 1.2 mg/mL

Manufacturer
Rising Pharma Holdings, Inc.

Identifiers & Regulatory

Product NDC 16571-128
Product ID 16571-128_ef0aace4-0140-4eb9-8756-83414d6dd2e3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075561
Listing Expiration 2027-12-31
Marketing Start 2023-07-27

Pharmacologic Class

Classes
decreased cell wall integrity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 16571128
Hyphenated Format 16571-128

Supplemental Identifiers

RxCUI
834127
UNII
MOR84MUD8E

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 chlorhexidine gluconate oral rinse (source: ndc)
Generic Name chlorhexidine gluconate oral rinse (source: ndc)
Application Number ANDA075561 (source: ndc)
Routes
DENTAL
source: ndc

Resolved Composition

Strengths
  • 1.2 mg/mL
source: ndc
Packaging
  • 473 mL in 1 BOTTLE (16571-128-48)
  • 100 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (16571-128-52) / 15 mL in 1 CUP, UNIT-DOSE (16571-128-15)
source: ndc

Packages (2)

16571-128-48 473 mL in 1 BOTTLE (16571-128-48) 16571-128-52 100 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (16571-128-52) / 15 mL in 1 CUP, UNIT-DOSE (16571-128-15)

Ingredients (1)

chlorhexidine gluconate (1.2 mg/mL)

Linked Drug Pages (1)

Chlorhexidine Gluconate Oral Rinse ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["DENTAL"], "spl_id": "ef0aace4-0140-4eb9-8756-83414d6dd2e3", "openfda": {"unii": ["MOR84MUD8E"], "rxcui": ["834127"], "spl_set_id": ["b6b45b87-aa53-4d3a-be59-f3d3b0774a7b"], "manufacturer_name": ["Rising Pharma Holdings, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "473 mL in 1 BOTTLE (16571-128-48)", "package_ndc": "16571-128-48", "marketing_start_date": "20230727"}, {"sample": false, "description": "100 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (16571-128-52)  / 15 mL in 1 CUP, UNIT-DOSE (16571-128-15)", "package_ndc": "16571-128-52", "marketing_start_date": "20240401"}], "brand_name": "Chlorhexidine Gluconate Oral Rinse", "product_id": "16571-128_ef0aace4-0140-4eb9-8756-83414d6dd2e3", "dosage_form": "SOLUTION", "pharm_class": ["Decreased Cell Wall Integrity [PE]"], "product_ndc": "16571-128", "generic_name": "Chlorhexidine Gluconate Oral Rinse", "labeler_name": "Rising Pharma Holdings, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Chlorhexidine Gluconate Oral Rinse", "active_ingredients": [{"name": "CHLORHEXIDINE GLUCONATE", "strength": "1.2 mg/mL"}], "application_number": "ANDA075561", "marketing_category": "ANDA", "marketing_start_date": "20230727", "listing_expiration_date": "20271231"}