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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N208352-001PHEXXCITRIC ACID; LACTIC ACID; POTASSIUM BITARTRATE1%;1.8%;0.4%GEL / VAGINALRLD, RS2020-05-22

Orange Book patents#

Current patent rows page 1 of 1 · 4 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N208352-001105688552033-03-15U-12020-06-03
N208352-001113379892033-03-15U-12022-09-06
N208352-001114396102033-03-15Drug substance, Drug product2022-09-15
N208352-001119924722033-03-15U-12024-06-26

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N208352-001PHEXX1%;1.8%;0.4%GEL / VAGINALRLD, RS2020-05-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N208352-001PHEXXI1%;1.8%;0.4%GEL / VAGINALRLD, RS2020-05-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208352-001PHEXXI1%;1.8%;0.4%GEL / VAGINALRLD, RS2020-05-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08N208352-001PHEXXI1%;1.8%;0.4%GEL / VAGINALRLD, RS2020-05-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208352-001PHEXXI1%;1.8%;0.4%GEL / VAGINALRLD, RS2020-05-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N208352-001PHEXXI1%;1.8%;0.4%GEL / VAGINALRLD, RS2020-05-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N208352-001PHEXXI1%;1.8%;0.4%GEL / VAGINALRLD, RS2020-05-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N208352-001PHEXXI1%;1.8%;0.4%GEL / VAGINALRLD, RS2020-05-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N208352-001PHEXXI1%;1.8%;0.4%GEL / VAGINALRLD, RS2020-05-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N208352-001PHEXXI1%;1.8%;0.4%GEL / VAGINALRLD, RS2020-05-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N208352-001PHEXXI1%;1.8%;0.4%GEL / VAGINALRLD, RS2020-05-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N208352-001PHEXXI1%;1.8%;0.4%GEL / VAGINALRLD, RS2020-05-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N208352-001PHEXXI1%;1.8%;0.4%GEL / VAGINALRLD, RS2020-05-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N208352-001PHEXXI1%;1.8%;0.4%GEL / VAGINALRLD, RS2020-05-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05N208352-001PHEXXI1%;1.8%;0.4%GEL / VAGINALRLD, RS2020-05-228072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N208352-001PHEXXI1%;1.8%;0.4%GEL / VAGINALRLD, RS2020-05-225c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N208352-001PHEXXI1%;1.8%;0.4%GEL / VAGINALRLD, RS2020-05-225d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N208352-001PHEXXI1%;1.8%;0.4%GEL / VAGINALRLD, RS2020-05-224b0b4de00fa7…
2022-03-09 01:35 UTC2022-03N208352-001PHEXXI1%;1.8%;0.4%GEL / VAGINALRLD, RS2020-05-22bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N208352-001PHEXXI1%;1.8%;0.4%GEL / VAGINALRLD, RS2020-05-22782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N208352-001PHEXXI1%;1.8%;0.4%GEL / VAGINALRLD, RS2020-05-2287673890dc5c…
2021-03-12 10:30 UTC2021-03N208352-001PHEXXI1%;1.8%;0.4%GEL / VAGINALRLD, RS2020-05-225aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N208352-001PHEXXI1%;1.8%;0.4%GEL / VAGINALRLD, RS2020-05-228869cabd3fbd…
2020-11-12 02:37 UTC2020-11N208352-001PHEXXI1%;1.8%;0.4%GEL / VAGINALRLD, RS2020-05-22c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N208352-001PHEXXI1%;1.8%;0.4%GEL / VAGINALRLD, RS2020-05-226a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N208352-001PHEXXI1%;1.8%;0.4%GEL / VAGINALRLD, RS2020-05-221c564ffb4f44…
2023-12-20 04:57 UTC2023-12N208352-001PHEXXI1%;1.8%;0.4%GEL / VAGINALRLD, RS2020-05-22ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N208352-001PHEXXI1%;1.8%;0.4%GEL / VAGINALRLD, RS2020-05-22a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N208352-001PHEXXI1%;1.8%;0.4%GEL / VAGINALRLD, RS2020-05-229b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N208352-001PHEXXI1%;1.8%;0.4%GEL / VAGINALRLD, RS2020-05-22a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N208352-001PHEXXI1%;1.8%;0.4%GEL / VAGINALRLD, RS2020-05-223f0d92c62455…
2023-05-13 08:27 UTC2023-05N208352-001PHEXXI1%;1.8%;0.4%GEL / VAGINALRLD, RS2020-05-22053a50430f4f…
2023-01-26 05:58 UTC2023-01N208352-001PHEXXI1%;1.8%;0.4%GEL / VAGINALRLD, RS2020-05-223bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N208352-001PHEXXI1%;1.8%;0.4%GEL / VAGINALRLD, RS2020-05-223a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N208352-001PHEXXI1%;1.8%;0.4%GEL / VAGINALRLD, RS2020-05-22f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N208352-001PHEXXI1%;1.8%;0.4%GEL / VAGINALRLD, RS2020-05-22e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N208352-001PHEXXI1%;1.8%;0.4%GEL / VAGINALRLD, RS2020-05-22cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N208352-001PHEXX1%;1.8%;0.4%GEL / VAGINALRLD, RS2020-05-22a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 4 · 136 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-18 06:07:402026-07N208352-001105688552033-03-15U-12020-06-03caaa826d4ba7…
2026-08-18 06:07:402026-07N208352-001113379892033-03-15U-12022-09-06caaa826d4ba7…
2026-08-18 06:07:402026-07N208352-001114396102033-03-15Drug substance, Drug product2022-09-15caaa826d4ba7…
2026-08-18 06:07:402026-07N208352-001119924722033-03-15U-12024-06-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N208352-001105688552033-03-15U-12020-06-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208352-001113379892033-03-15U-12022-09-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208352-001114396102033-03-15Drug substance, Drug product2022-09-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208352-001119924722033-03-15U-12024-06-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208352-001105688552033-03-15U-12020-06-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208352-001113379892033-03-15U-12022-09-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208352-001114396102033-03-15Drug substance, Drug product2022-09-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208352-001119924722033-03-15U-12024-06-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08N208352-001105688552033-03-15U-12020-06-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08N208352-001113379892033-03-15U-12022-09-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08N208352-001114396102033-03-15Drug substance, Drug product2022-09-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08N208352-001119924722033-03-15U-12024-06-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208352-001105688552033-03-15U-12020-06-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208352-001113379892033-03-15U-12022-09-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208352-001114396102033-03-15Drug substance, Drug product2022-09-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208352-001119924722033-03-15U-12024-06-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N208352-001105688552033-03-15U-12020-06-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N208352-001113379892033-03-15U-12022-09-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N208352-001114396102033-03-15Drug substance, Drug product2022-09-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N208352-001119924722033-03-15U-12024-06-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N208352-00167062762024-03-06Drug product2020-06-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N208352-001105688552033-03-15U-12020-06-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N208352-001113379892033-03-15U-12022-09-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N208352-001114396102033-03-15Drug substance, Drug product2022-09-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N208352-001119924722033-03-15U-12024-06-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N208352-00167062762024-03-06Drug product2020-06-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N208352-001105688552033-03-15U-12020-06-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N208352-001113379892033-03-15U-12022-09-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N208352-001114396102033-03-15Drug substance, Drug product2022-09-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N208352-001119924722033-03-15U-12024-06-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N208352-00167062762024-03-06Drug product2020-06-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N208352-001105688552033-03-15U-12020-06-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N208352-001113379892033-03-15U-12022-09-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N208352-001114396102033-03-15Drug substance, Drug product2022-09-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N208352-001119924722033-03-15U-12024-06-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N208352-00167062762024-03-06Drug product2020-06-03d8e5a09893c0…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N208352-001NP2023-05-225c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N208352-001NP2023-05-225d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N208352-001NP2023-05-224b0b4de00fa7…
2022-03-09 01:35 UTC2022-03N208352-001NP2023-05-22bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N208352-001NP2023-05-22782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N208352-001NP2023-05-2287673890dc5c…
2021-03-12 10:30 UTC2021-03N208352-001NP2023-05-225aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N208352-001NP2023-05-228869cabd3fbd…
2020-11-12 02:37 UTC2020-11N208352-001NP2023-05-22c0c555d07b60…
2023-12-20 04:57 UTC2023-12N208352-001NP2023-05-22ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N208352-001NP2023-05-22a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N208352-001NP2023-05-229b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N208352-001NP2023-05-22a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N208352-001NP2023-05-223f0d92c62455…
2023-05-13 08:27 UTC2023-05N208352-001NP2023-05-22053a50430f4f…
2023-01-26 05:58 UTC2023-01N208352-001NP2023-05-223bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N208352-001NP2023-05-223a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N208352-001NP2023-05-22f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N208352-001NP2023-05-22e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N208352-001NP2023-05-22cb3db0bc1861…

Additional Listing Data#

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

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
F9S9FFU82NInternal UNII lookup
2968PHW8QPInternal UNII lookup
NPT6P8P3UUInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2385348Internal RxNorm lookup
2385353Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
173ff411-7227-47b0-94dc-844e1ebaf14eAvailable on FDA.report

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PhexxLACTIC ACID, L-, CITRIC ACID MONOHYDRATE, AND POTASSIUM BITARTRATEEvofem, Inc.14b01a15-9b47-4be3-bb2e-a2010eab429e2025-05-02Warnings, Adverse reactionsExact identifier
application applno (NDA): 208352
application number: NDA208352
PhexxiLACTIC ACID, L-, CITRIC ACID MONOHYDRATE, AND POTASSIUM BITARTRATEEvofem, Inc.173ff411-7227-47b0-94dc-844e1ebaf14e2023-11-21Warnings, Adverse reactionsExact identifier
application applno (NDA): 208352
application number: NDA208352
ndc (product): 69751-100

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