Mens Jivexa Extra Strength Minoxidil

Product NDC
87688-955
11-digit product format
876880955
Labeler code
87688
Product ID
87688-955_51c82743-0258-8266-e063-6394a90a5bb2
Type
HUMAN OTC DRUG
Nonproprietary name
MINOXIDIL
Dosage form
SOLUTION
Route
TOPICAL
Labeler
SMC Essentials LLC
Application
ANDA076239
Marketing category
ANDA
Marketing start
2026-05-04
Substance
MINOXIDIL
Active strength
50 mg/mL
Pharmacologic classes
Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A076239-001THEROXIDILMINOXIDIL5%SOLUTION / TOPICAL2004-08-24

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.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-2484e616aacf4f…
2026-08-18 06:07:402026-07A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-248072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-245c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-245d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-244b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-2474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-24bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-24782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-2487673890dc5c…
2021-03-12 10:30 UTC2021-03A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-245aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-248869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-24c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-243f01610625f2…
2019-09-15 20:21 UTC2019-09A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-24b00525d2431f…
2019-07-19 19:46 UTC2019-07A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-24ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-246a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-241c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-24ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-24a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-249b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-24a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-243f0d92c62455…
2023-05-13 08:27 UTC2023-05A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-24053a50430f4f…
2023-01-26 05:58 UTC2023-01A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-243bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-243a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-24f41ea6bd6efb…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Mens Jivexa Extra Strength Minoxidil
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MINOXIDIL50 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5965120SH1Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
311724Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
7f77f4de-e66a-4352-a6d3-809c78824953Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
87688-955-00Mens Jivexa Extra Strength Minoxidil60 mL in 1 BOTTLE, DROPPERSOLUTION601
87688-955-00Mens Jivexa Extra Strength Minoxidil1 in 1 BOXSOLUTION11

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 2 of 2 · 31 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Minoxidil Extra Strength for MenMINOXIDILRoman Health Ventures Inc.a568aba1-1016-4380-e053-2a95a90a396d2025-01-08WarningsExact identifier
application applno (ANDA): 076239
application number: ANDA076239
Tomum Hair Growth Treatment For Men Minoxidil UnscentedMINOXIDILBELLEKA INC4c0582a3-f2be-4e53-a174-12269f7ddad02024-12-04WarningsExact identifier
application applno (ANDA): 076239
application number: ANDA076239
Colorsmith Hair Regrowth Treatment Mens Minoxidil Topical Solution Extra StrengthMINOXIDILESALON.COM, LLC69b01eab-df9f-4ae8-87e4-add18883874b2024-11-05WarningsExact identifier
application applno (ANDA): 076239
application number: ANDA076239
Elevate Hair Regrowth Treatment 5MINOXIDILVAPOR PRO SHOPPE, LLC0d5e4258-a58d-4378-9be8-631114588cdb2024-10-31WarningsExact identifier
application applno (ANDA): 076239
application number: ANDA076239
DAVV Minoxidil Topical Solution Mens Hair Regrowth TreatmentMINOXIDILGood Manager Holdings Inc16b36a38-72c3-4a19-a28c-757ae02e097a2024-10-28WarningsExact identifier
application applno (ANDA): 076239
application number: ANDA076239
Elevate Hair Regrowth Treatment 5 Minoxidil SolutionMINOXIDILVAPOR PRO SHOPPE, LLC12737299-1052-4c93-afab-20016b9d90012024-07-22WarningsExact identifier
application applno (ANDA): 076239
application number: ANDA076239
GROWELL Mens Hair Regrowth Treatment 5 MinoxidilMINOXIDILAPIRA SCIENCE, INC.8cd4a3a9-94ba-48c7-8516-b50504c2c4402024-05-16WarningsExact identifier
application applno (ANDA): 076239
application number: ANDA076239
BOSLEY Minoxidil Topical Solution 5 (for men)MINOXIDILScientific Hair Research, LLC90d96eb1-a478-42ce-9389-642c57bbf2802024-05-01WarningsExact identifier
application applno (ANDA): 076239
application number: ANDA076239
BOSLEY Man 5 Minoxidil Topical SolutionMINOXIDILScientific Hair Research, LLCc692b47d-12c3-4225-9eee-b08ca76e4daa2023-10-26WarningsExact identifier
application applno (ANDA): 076239
application number: ANDA076239
SUAVECITO 5% Minoxidil SolutionMINOXIDILSUAVECITO, INC.a6d3c488-f943-4edf-9d6b-21a3dee92d782023-07-18WarningsExact identifier
application applno (ANDA): 076239
application number: ANDA076239
Regenpure PrecisionMINOXIDILSalonceuticals, Inc.4a113921-b2a9-42cc-e054-00144ff8d46c2017-03-06WarningsExact identifier
application applno (ANDA): 076239
application number: ANDA076239

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311724minoxidil 5 % Topical SolutionPSN7f77f4de-e66a-4352-a6d3-809c788249531
311724minoxidil 50 MG/ML Topical SolutionSCD7f77f4de-e66a-4352-a6d3-809c788249531
311724minoxidil 3 GM per 60 ML Topical SolutionSY7f77f4de-e66a-4352-a6d3-809c788249531
311724minoxidil 5 % Topical SolutionSY7f77f4de-e66a-4352-a6d3-809c788249531
311724minoxidil 5 GM per 100 ML Topical SolutionSY7f77f4de-e66a-4352-a6d3-809c788249531

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
87688-955-00876880955001 BOTTLE, DROPPER in 1 BOX (87688-955-00) / 60 mL in 1 BOTTLE, DROPPER2026-05-04NoNoCurrent