FDA.reportPublic FDA data

Phexx

Product NDC
69751-101
11-digit product format
697510101
Labeler code
69751
Product ID
69751-101_7c67c2d2-59fd-423a-b446-a528f43a0916
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lactic acid, L-, citric acid monohydrate, and potassium bitartrate
Dosage form
GEL
Route
VAGINAL
Labeler
Evofem, Inc.
Application
NDA208352
Marketing category
NDA
Marketing start
2020-08-01
Substance
CITRIC ACID MONOHYDRATE; LACTIC ACID, L-; POTASSIUM BITARTRATE
Active strength
50; 90; 20 mg/5g; mg/5g; mg/5g
Pharmacologic classes
Acidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Phexx
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CITRIC ACID MONOHYDRATE50 mg/5g
LACTIC ACID, L-90 mg/5g
POTASSIUM BITARTRATE20 mg/5g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2968PHW8QP, F9S9FFU82N, NPT6P8P3UU
Rxcui2385348, 2700386

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69751-101-01Phexx5 g in 1 APPLICATORGEL52
69751-101-12Phexx12 in 1 BOXGEL122

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69751-101PHEXX (LACTIC ACID, L-, CITRIC ACID MONOHYDRATE, AND POTASSIUM BITARTRATE) GEL [EVOFEM, INC.]2Current NDC, 2 package rows20250507_14b01a15-9b47-4be3-bb2e-a2010eab429e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2385348lactic acid 1.8 % / citric acid 1 % / potassium bitartrate 0.4 % Vaginal GelPSN14b01a15-9b47-4be3-bb2e-a2010eab429e2
2700386phexx 1.8 % / 1 % / 0.4 % Vaginal GelPSN14b01a15-9b47-4be3-bb2e-a2010eab429e2
2700386citric acid 0.01 MG/MG / lactic acid 0.018 MG/MG / potassium bitartrate 0.004 MG/MG Vaginal Gel [Phexx]SBD14b01a15-9b47-4be3-bb2e-a2010eab429e2
2385348citric acid 0.01 MG/MG / lactic acid 0.018 MG/MG / potassium bitartrate 0.004 MG/MG Vaginal GelSCD14b01a15-9b47-4be3-bb2e-a2010eab429e2
2385348citric acid 0.01 MG/MG / lactic acid 0.018 MG/MG / K+ bitartrate 0.004 MG/MG Vaginal GelSY14b01a15-9b47-4be3-bb2e-a2010eab429e2
2700386citric acid 0.01 MG/MG / lactic acid 0.018 MG/MG / K+ bitartrate 0.004 MG/MG Vaginal Gel [Phexx]SY14b01a15-9b47-4be3-bb2e-a2010eab429e2
2385348citric acid 0.01 MG/MG / lactic acid 0.018 MG/MG / Pot bitartrate 0.004 MG/MG Vaginal GelSY14b01a15-9b47-4be3-bb2e-a2010eab429e2
2700386citric acid 0.01 MG/MG / lactic acid 0.018 MG/MG / Pot bitartrate 0.004 MG/MG Vaginal Gel [Phexx]SY14b01a15-9b47-4be3-bb2e-a2010eab429e2
2385348lactic acid 1.8 % / citric acid 1 % / potassium bitartrate 0.4 % Vaginal GelSY14b01a15-9b47-4be3-bb2e-a2010eab429e2
2700386Phexx 1.8 % / 1 % / 0.4 % Vaginal GelSY14b01a15-9b47-4be3-bb2e-a2010eab429e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69751-101-01697510101015 g in 1 APPLICATOR5 gHistorical
69751-101-126975101011212 APPLICATOR in 1 BOX (69751-101-12) / 5 g in 1 APPLICATOR (69751-101-01) 12 applicator2020-09-01NoNoCurrent