chlorhexidine gluconate

Generic: chlorhexidine gluconate

Labeler: rising pharma holdings, inc.
NDC Directory HUMAN OTC DRUG NDA Inactive Finished

Drug Facts

Product Profile

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

chlorhexidine gluconate 40 mg/mL

Manufacturer
Rising Pharma Holdings, Inc.

Identifiers & Regulatory

Product NDC 16571-111
Product ID 16571-111_32cca440-c887-49ab-9c52-0b43fdf87b78
Product Type HUMAN OTC DRUG
Marketing Category NDA
Application Number NDA019258
Listing Expiration 2027-12-31
Marketing Start 2023-07-26

Pharmacologic Class

Classes
decreased cell wall integrity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 16571111
Hyphenated Format 16571-111

Supplemental Identifiers

RxCUI
211365
UPC
0316571111480
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 (source: ndc)
Generic Name chlorhexidine gluconate (source: ndc)
Application Number NDA019258 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/mL
source: ndc
Packaging
  • 118 mL in 1 BOTTLE (16571-111-12)
  • 237 mL in 1 BOTTLE (16571-111-24)
  • 473 mL in 1 BOTTLE (16571-111-48)
  • 946 mL in 1 BOTTLE (16571-111-95)
source: ndc

Packages (4)

16571-111-12 118 mL in 1 BOTTLE (16571-111-12) 16571-111-24 237 mL in 1 BOTTLE (16571-111-24) 16571-111-48 473 mL in 1 BOTTLE (16571-111-48) 16571-111-95 946 mL in 1 BOTTLE (16571-111-95)

Ingredients (1)

chlorhexidine gluconate (40 mg/mL)

Linked Drug Pages (1)

CHLORHEXIDINE GLUCONATE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "32cca440-c887-49ab-9c52-0b43fdf87b78", "openfda": {"upc": ["0316571111480"], "unii": ["MOR84MUD8E"], "rxcui": ["211365"], "spl_set_id": ["d53a01eb-7213-4f19-b74f-acbf0fd54418"], "manufacturer_name": ["Rising Pharma Holdings, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "118 mL in 1 BOTTLE (16571-111-12)", "package_ndc": "16571-111-12", "marketing_start_date": "20230726"}, {"sample": false, "description": "237 mL in 1 BOTTLE (16571-111-24)", "package_ndc": "16571-111-24", "marketing_start_date": "20230726"}, {"sample": false, "description": "473 mL in 1 BOTTLE (16571-111-48)", "package_ndc": "16571-111-48", "marketing_start_date": "20230726"}, {"sample": false, "description": "946 mL in 1 BOTTLE (16571-111-95)", "package_ndc": "16571-111-95", "marketing_start_date": "20230726"}], "brand_name": "CHLORHEXIDINE GLUCONATE", "product_id": "16571-111_32cca440-c887-49ab-9c52-0b43fdf87b78", "dosage_form": "SOLUTION", "pharm_class": ["Decreased Cell Wall Integrity [PE]"], "product_ndc": "16571-111", "generic_name": "chlorhexidine gluconate", "labeler_name": "Rising Pharma Holdings, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "CHLORHEXIDINE GLUCONATE", "active_ingredients": [{"name": "CHLORHEXIDINE GLUCONATE", "strength": "40 mg/mL"}], "application_number": "NDA019258", "marketing_category": "NDA", "marketing_start_date": "20230726", "listing_expiration_date": "20271231"}