FDA.reportPublic FDA data

Phexxi

Product NDC
69751-100
11-digit product format
697510100
Labeler code
69751
Product ID
69751-100_11e3cfeb-3ae2-4e97-88f9-3e4cdf770659
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
Phexxi
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, 2385353

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
69751-100-01Phexxi5 g in 1 APPLICATORGEL57
69751-100-03Phexxi3 in 1 BOXGEL37
69751-100-12Phexxi12 in 1 BOXGEL127

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69751-100-12GM - Gram69751-100ae3c1104-bead-40ba-bb35-6563b2e941a612020-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69751-100PHEXXI (LACTIC ACID, L-, CITRIC ACID MONOHYDRATE, AND POTASSIUM BITARTRATE) GEL [EVOFEM, INC.]7Current NDC, Legacy NDC, 3 package rows20231122_173ff411-7227-47b0-94dc-844e1ebaf14e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2385348lactic acid 1.8 % / citric acid 1 % / potassium bitartrate 0.4 % Vaginal GelPSN173ff411-7227-47b0-94dc-844e1ebaf14e7
2385353PHEXXI 1.8 % / 1 % / 0.4 % Vaginal GelPSN173ff411-7227-47b0-94dc-844e1ebaf14e7
2385353citric acid 0.01 MG/MG / lactic acid 0.018 MG/MG / potassium bitartrate 0.004 MG/MG Vaginal Gel [Phexxi]SBD173ff411-7227-47b0-94dc-844e1ebaf14e7
2385348citric acid 0.01 MG/MG / lactic acid 0.018 MG/MG / potassium bitartrate 0.004 MG/MG Vaginal GelSCD173ff411-7227-47b0-94dc-844e1ebaf14e7
2385348citric acid 0.01 MG/MG / lactic acid 0.018 MG/MG / K+ bitartrate 0.004 MG/MG Vaginal GelSY173ff411-7227-47b0-94dc-844e1ebaf14e7
2385353citric acid 0.01 MG/MG / lactic acid 0.018 MG/MG / K+ bitartrate 0.004 MG/MG Vaginal Gel [Phexxi]SY173ff411-7227-47b0-94dc-844e1ebaf14e7
2385348citric acid 0.01 MG/MG / lactic acid 0.018 MG/MG / Pot bitartrate 0.004 MG/MG Vaginal GelSY173ff411-7227-47b0-94dc-844e1ebaf14e7
2385353citric acid 0.01 MG/MG / lactic acid 0.018 MG/MG / Pot bitartrate 0.004 MG/MG Vaginal Gel [Phexxi]SY173ff411-7227-47b0-94dc-844e1ebaf14e7
2385348lactic acid 1.8 % / citric acid 1 % / potassium bitartrate 0.4 % Vaginal GelSY173ff411-7227-47b0-94dc-844e1ebaf14e7
2385353Phexxi (lactic acid 1.8 % / citric acid 1 % / potassium bitartrate 0.4 % ) Vaginal GelSY173ff411-7227-47b0-94dc-844e1ebaf14e7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69751-100-01697510100015 g in 1 APPLICATOR5 gHistorical
69751-100-03697510100033 APPLICATOR in 1 BOX (69751-100-03) / 5 g in 1 APPLICATOR (69751-100-01) 3 applicator2021-05-240000-00-00YesNoCurrent
69751-100-126975101001212 APPLICATOR in 1 BOX (69751-100-12) / 5 g in 1 APPLICATOR (69751-100-01) 12 applicator2020-09-010000-00-00NoNoCurrent