major oral rinse

Generic: 0.12% chlorhexidine gluconate

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name major oral rinse
Generic Name 0.12% chlorhexidine gluconate
Labeler major pharmaceuticals
Dosage Form RINSE
Routes
ORAL
Active Ingredients

chlorhexidine gluconate 1.2 mg/mL

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-7035
Product ID 0904-7035_451400e3-e507-c11a-e063-6394a90a6991
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077789
Listing Expiration 2026-12-31
Marketing Start 2020-11-20

Pharmacologic Class

Classes
decreased cell wall integrity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 09047035
Hyphenated Format 0904-7035

Supplemental Identifiers

RxCUI
834127
UPC
0309047035885
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 major oral rinse (source: ndc)
Generic Name 0.12% chlorhexidine gluconate (source: ndc)
Application Number ANDA077789 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1.2 mg/mL
source: ndc
Packaging
  • 1500 mL in 1 PACKAGE (0904-7035-80)
  • 600 mL in 1 PACKAGE (0904-7035-87)
  • 15 mL in 1 CUP, UNIT-DOSE (0904-7035-88)
source: ndc

Packages (3)

0904-7035-80 1500 mL in 1 PACKAGE (0904-7035-80) 0904-7035-87 600 mL in 1 PACKAGE (0904-7035-87) 0904-7035-88 15 mL in 1 CUP, UNIT-DOSE (0904-7035-88)

Ingredients (1)

chlorhexidine gluconate (1.2 mg/mL)

Linked Drug Pages (1)

Major Oral Rinse ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "451400e3-e507-c11a-e063-6394a90a6991", "openfda": {"upc": ["0309047035885"], "unii": ["MOR84MUD8E"], "rxcui": ["834127"], "spl_set_id": ["b48e69dc-0913-423f-e053-2a95a90a53df"], "manufacturer_name": ["Major Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1500 mL in 1 PACKAGE (0904-7035-80)", "package_ndc": "0904-7035-80", "marketing_start_date": "20201120"}, {"sample": false, "description": "600 mL in 1 PACKAGE (0904-7035-87)", "package_ndc": "0904-7035-87", "marketing_start_date": "20201120"}, {"sample": false, "description": "15 mL in 1 CUP, UNIT-DOSE (0904-7035-88)", "package_ndc": "0904-7035-88", "marketing_start_date": "20201120"}], "brand_name": "Major Oral Rinse", "product_id": "0904-7035_451400e3-e507-c11a-e063-6394a90a6991", "dosage_form": "RINSE", "pharm_class": ["Decreased Cell Wall Integrity [PE]"], "product_ndc": "0904-7035", "generic_name": "0.12% Chlorhexidine Gluconate", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Major Oral Rinse", "active_ingredients": [{"name": "CHLORHEXIDINE GLUCONATE", "strength": "1.2 mg/mL"}], "application_number": "ANDA077789", "marketing_category": "ANDA", "marketing_start_date": "20201120", "listing_expiration_date": "20261231"}