Home NDC 69751-101 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 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N208352-001 PHEXX CITRIC ACID; LACTIC ACID; POTASSIUM BITARTRATE 1%;1.8%;0.4% GEL / VAGINAL RLD, RS 2020-05-22
Orange Book patents# Current patent rows page 1 of 1 · 4 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N208352-001 10568855 2033-03-15 U-1 2020-06-03 N208352-001 11337989 2033-03-15 U-1 2022-09-06 N208352-001 11439610 2033-03-15 Drug substance, Drug product 2022-09-15 N208352-001 11992472 2033-03-15 U-1 2024-06-26
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N208352-001 PHEXX 1%;1.8%;0.4% GEL / VAGINAL RLD, RS 2020-05-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N208352-001 PHEXXI 1%;1.8%;0.4% GEL / VAGINAL RLD, RS 2020-05-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208352-001 PHEXXI 1%;1.8%;0.4% GEL / VAGINAL RLD, RS 2020-05-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208352-001 PHEXXI 1%;1.8%;0.4% GEL / VAGINAL RLD, RS 2020-05-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208352-001 PHEXXI 1%;1.8%;0.4% GEL / VAGINAL RLD, RS 2020-05-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208352-001 PHEXXI 1%;1.8%;0.4% GEL / VAGINAL RLD, RS 2020-05-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208352-001 PHEXXI 1%;1.8%;0.4% GEL / VAGINAL RLD, RS 2020-05-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208352-001 PHEXXI 1%;1.8%;0.4% GEL / VAGINAL RLD, RS 2020-05-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208352-001 PHEXXI 1%;1.8%;0.4% GEL / VAGINAL RLD, RS 2020-05-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208352-001 PHEXXI 1%;1.8%;0.4% GEL / VAGINAL RLD, RS 2020-05-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N208352-001 PHEXXI 1%;1.8%;0.4% GEL / VAGINAL RLD, RS 2020-05-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208352-001 PHEXXI 1%;1.8%;0.4% GEL / VAGINAL RLD, RS 2020-05-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208352-001 PHEXXI 1%;1.8%;0.4% GEL / VAGINAL RLD, RS 2020-05-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N208352-001 PHEXXI 1%;1.8%;0.4% GEL / VAGINAL RLD, RS 2020-05-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N208352-001 PHEXXI 1%;1.8%;0.4% GEL / VAGINAL RLD, RS 2020-05-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N208352-001 PHEXXI 1%;1.8%;0.4% GEL / VAGINAL RLD, RS 2020-05-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N208352-001 PHEXXI 1%;1.8%;0.4% GEL / VAGINAL RLD, RS 2020-05-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N208352-001 PHEXXI 1%;1.8%;0.4% GEL / VAGINAL RLD, RS 2020-05-22 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N208352-001 PHEXXI 1%;1.8%;0.4% GEL / VAGINAL RLD, RS 2020-05-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N208352-001 PHEXXI 1%;1.8%;0.4% GEL / VAGINAL RLD, RS 2020-05-22 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N208352-001 PHEXXI 1%;1.8%;0.4% GEL / VAGINAL RLD, RS 2020-05-22 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N208352-001 PHEXXI 1%;1.8%;0.4% GEL / VAGINAL RLD, RS 2020-05-22 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N208352-001 PHEXXI 1%;1.8%;0.4% GEL / VAGINAL RLD, RS 2020-05-22 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N208352-001 PHEXXI 1%;1.8%;0.4% GEL / VAGINAL RLD, RS 2020-05-22 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N208352-001 PHEXXI 1%;1.8%;0.4% GEL / VAGINAL RLD, RS 2020-05-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N208352-001 PHEXXI 1%;1.8%;0.4% GEL / VAGINAL RLD, RS 2020-05-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N208352-001 PHEXXI 1%;1.8%;0.4% GEL / VAGINAL RLD, RS 2020-05-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N208352-001 PHEXXI 1%;1.8%;0.4% GEL / VAGINAL RLD, RS 2020-05-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N208352-001 PHEXXI 1%;1.8%;0.4% GEL / VAGINAL RLD, RS 2020-05-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N208352-001 PHEXXI 1%;1.8%;0.4% GEL / VAGINAL RLD, RS 2020-05-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N208352-001 PHEXXI 1%;1.8%;0.4% GEL / VAGINAL RLD, RS 2020-05-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N208352-001 PHEXXI 1%;1.8%;0.4% GEL / VAGINAL RLD, RS 2020-05-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N208352-001 PHEXXI 1%;1.8%;0.4% GEL / VAGINAL RLD, RS 2020-05-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N208352-001 PHEXXI 1%;1.8%;0.4% GEL / VAGINAL RLD, RS 2020-05-22 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N208352-001 PHEXXI 1%;1.8%;0.4% GEL / VAGINAL RLD, RS 2020-05-22 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N208352-001 PHEXXI 1%;1.8%;0.4% GEL / VAGINAL RLD, RS 2020-05-22 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N208352-001 PHEXXI 1%;1.8%;0.4% GEL / VAGINAL RLD, RS 2020-05-22 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N208352-001 PHEXX 1%;1.8%;0.4% GEL / VAGINAL RLD, RS 2020-05-22 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 4 · 136 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N208352-001 10568855 2033-03-15 U-1 2020-06-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208352-001 11337989 2033-03-15 U-1 2022-09-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208352-001 11439610 2033-03-15 Drug substance, Drug product 2022-09-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208352-001 11992472 2033-03-15 U-1 2024-06-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N208352-001 10568855 2033-03-15 U-1 2020-06-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208352-001 11337989 2033-03-15 U-1 2022-09-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208352-001 11439610 2033-03-15 Drug substance, Drug product 2022-09-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208352-001 11992472 2033-03-15 U-1 2024-06-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208352-001 10568855 2033-03-15 U-1 2020-06-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208352-001 11337989 2033-03-15 U-1 2022-09-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208352-001 11439610 2033-03-15 Drug substance, Drug product 2022-09-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208352-001 11992472 2033-03-15 U-1 2024-06-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208352-001 10568855 2033-03-15 U-1 2020-06-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208352-001 11337989 2033-03-15 U-1 2022-09-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208352-001 11439610 2033-03-15 Drug substance, Drug product 2022-09-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208352-001 11992472 2033-03-15 U-1 2024-06-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208352-001 10568855 2033-03-15 U-1 2020-06-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208352-001 11337989 2033-03-15 U-1 2022-09-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208352-001 11439610 2033-03-15 Drug substance, Drug product 2022-09-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208352-001 11992472 2033-03-15 U-1 2024-06-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208352-001 10568855 2033-03-15 U-1 2020-06-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208352-001 11337989 2033-03-15 U-1 2022-09-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208352-001 11439610 2033-03-15 Drug substance, Drug product 2022-09-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208352-001 11992472 2033-03-15 U-1 2024-06-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208352-001 6706276 2024-03-06 Drug product 2020-06-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208352-001 10568855 2033-03-15 U-1 2020-06-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208352-001 11337989 2033-03-15 U-1 2022-09-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208352-001 11439610 2033-03-15 Drug substance, Drug product 2022-09-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208352-001 11992472 2033-03-15 U-1 2024-06-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208352-001 6706276 2024-03-06 Drug product 2020-06-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208352-001 10568855 2033-03-15 U-1 2020-06-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208352-001 11337989 2033-03-15 U-1 2022-09-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208352-001 11439610 2033-03-15 Drug substance, Drug product 2022-09-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208352-001 11992472 2033-03-15 U-1 2024-06-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208352-001 6706276 2024-03-06 Drug product 2020-06-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208352-001 10568855 2033-03-15 U-1 2020-06-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208352-001 11337989 2033-03-15 U-1 2022-09-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208352-001 11439610 2033-03-15 Drug substance, Drug product 2022-09-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208352-001 11992472 2033-03-15 U-1 2024-06-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208352-001 6706276 2024-03-06 Drug product 2020-06-03 d8e5a09893c0…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base Phexx
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LACTIC ACID, L- 90 mg/5g CITRIC ACID MONOHYDRATE 50 mg/5g POTASSIUM BITARTRATE 20 mg/5g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination F9S9FFU82N Internal UNII lookup 2968PHW8QP Internal UNII lookup NPT6P8P3UU Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2385348 Internal RxNorm lookup 2700386 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69751-101-01 Phexx 5 g in 1 APPLICATOR GEL 5 2 69751-101-12 Phexx 12 in 1 BOX GEL 12 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69751-101 PHEXX (LACTIC ACID, L-, CITRIC ACID MONOHYDRATE, AND POTASSIUM BITARTRATE) GEL [EVOFEM, INC.] 2 Current NDC, 2 package rows 20250507_14b01a15-9b47-4be3-bb2e-a2010eab429e.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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Phexx LACTIC ACID, L-, CITRIC ACID MONOHYDRATE, AND POTASSIUM BITARTRATE Evofem, Inc. 14b01a15-9b47-4be3-bb2e-a2010eab429e 2025-05-02 Warnings, Adverse reactions Exact identifier application applno (NDA): 208352 application number: NDA208352 ndc (product): 69751-101 Phexxi LACTIC ACID, L-, CITRIC ACID MONOHYDRATE, AND POTASSIUM BITARTRATE Evofem, Inc. 173ff411-7227-47b0-94dc-844e1ebaf14e 2023-11-21 Warnings, Adverse reactions Exact identifier application applno (NDA): 208352 application number: NDA208352
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 69751-101-01 69751010101 5 g in 1 APPLICATOR 5 g Historical 69751-101-12 69751010112 12 APPLICATOR in 1 BOX (69751-101-12) / 5 g in 1 APPLICATOR (69751-101-01) 12 applicator 2020-09-01 No No Current