phexxi

Generic: lactic acid, l-, citric acid monohydrate, and potassium bitartrate

Labeler: evofem, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name phexxi
Generic Name lactic acid, l-, citric acid monohydrate, and potassium bitartrate
Labeler evofem, inc.
Dosage Form GEL
Routes
VAGINAL
Active Ingredients

citric acid monohydrate 50 mg/5g, lactic acid, l- 90 mg/5g, potassium bitartrate 20 mg/5g

Manufacturer
Evofem, Inc.

Identifiers & Regulatory

Product NDC 69751-100
Product ID 69751-100_11e3cfeb-3ae2-4e97-88f9-3e4cdf770659
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA208352
Listing Expiration 2026-12-31
Marketing Start 2020-08-01

Pharmacologic Class

Classes
acidifying activity [moa] anti-coagulant [epc] calcium chelating activity [moa] calculi dissolution agent [epc] decreased coagulation factor activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69751100
Hyphenated Format 69751-100

Supplemental Identifiers

RxCUI
2385348 2385353
UNII
2968PHW8QP F9S9FFU82N NPT6P8P3UU

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 phexxi (source: ndc)
Generic Name lactic acid, l-, citric acid monohydrate, and potassium bitartrate (source: ndc)
Application Number NDA208352 (source: ndc)
Routes
VAGINAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/5g
  • 90 mg/5g
  • 20 mg/5g
source: ndc
Packaging
  • 3 APPLICATOR in 1 BOX (69751-100-03) / 5 g in 1 APPLICATOR (69751-100-01)
  • 12 APPLICATOR in 1 BOX (69751-100-12) / 5 g in 1 APPLICATOR (69751-100-01)
source: ndc

Packages (2)

69751-100-03 3 APPLICATOR in 1 BOX (69751-100-03) / 5 g in 1 APPLICATOR (69751-100-01) 69751-100-12 12 APPLICATOR in 1 BOX (69751-100-12) / 5 g in 1 APPLICATOR (69751-100-01)

Ingredients (3)

citric acid monohydrate (50 mg/5g) lactic acid, l- (90 mg/5g) potassium bitartrate (20 mg/5g)

Linked Drug Pages (1)

Phexxi ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["VAGINAL"], "spl_id": "11e3cfeb-3ae2-4e97-88f9-3e4cdf770659", "openfda": {"unii": ["2968PHW8QP", "F9S9FFU82N", "NPT6P8P3UU"], "rxcui": ["2385348", "2385353"], "spl_set_id": ["173ff411-7227-47b0-94dc-844e1ebaf14e"], "manufacturer_name": ["Evofem, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": true, "description": "3 APPLICATOR in 1 BOX (69751-100-03)  / 5 g in 1 APPLICATOR (69751-100-01)", "package_ndc": "69751-100-03", "marketing_start_date": "20210524"}, {"sample": false, "description": "12 APPLICATOR in 1 BOX (69751-100-12)  / 5 g in 1 APPLICATOR (69751-100-01)", "package_ndc": "69751-100-12", "marketing_start_date": "20200901"}], "brand_name": "Phexxi", "product_id": "69751-100_11e3cfeb-3ae2-4e97-88f9-3e4cdf770659", "dosage_form": "GEL", "pharm_class": ["Acidifying Activity [MoA]", "Anti-coagulant [EPC]", "Calcium Chelating Activity [MoA]", "Calculi Dissolution Agent [EPC]", "Decreased Coagulation Factor Activity [PE]"], "product_ndc": "69751-100", "generic_name": "lactic acid, L-, citric acid monohydrate, and potassium bitartrate", "labeler_name": "Evofem, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Phexxi", "active_ingredients": [{"name": "CITRIC ACID MONOHYDRATE", "strength": "50 mg/5g"}, {"name": "LACTIC ACID, L-", "strength": "90 mg/5g"}, {"name": "POTASSIUM BITARTRATE", "strength": "20 mg/5g"}], "application_number": "NDA208352", "marketing_category": "NDA", "marketing_start_date": "20200801", "listing_expiration_date": "20261231"}