FDA.reportPublic FDA data

Keeps Minoxidil Topical Solution, 5%

Product NDC
71713-102
Requested package NDC
71713-102-09
11-digit product format
717130102
Labeler code
71713
Product ID
71713-102_3bce6383-1106-5096-e063-6294a90ae8ff
Type
HUMAN OTC DRUG
Nonproprietary name
Minoxidil Solution
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Keeps (30 Madison)
Application
ANDA217998
Marketing category
ANDA
Marketing start
2025-08-31
Substance
MINOXIDIL
Active strength
50 mg/mL
Pharmacologic classes
Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]
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 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
A217998-001MINOXIDIL EXTRA STRENGTH (FOR MEN)MINOXIDIL5%SOLUTION / TOPICAL2025-06-30

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
2026-09-14 22:38:342026-08A217998-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2025-06-3084e616aacf4f…
2026-08-18 06:07:402026-07A217998-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2025-06-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A217998-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2025-06-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217998-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2025-06-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A217998-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2025-06-306a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217998-001MINOXIDIL EXTRA STRENGTH (FOR MEN)5%SOLUTION / TOPICAL2025-06-30a50c72e98297…

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
Keeps Minoxidil Topical Solution, 5%
Listing expiration
2026-12-31

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
236d9984-d9a3-a87d-e063-6394a90a4958Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71713-102-04Keeps Minoxidil Topical Solution, 5%60 mL in 1 BOTTLESOLUTION602
71713-102-09Keeps Minoxidil Topical Solution, 5%3 in 1 CARTONSOLUTION32

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
Minoxidil Topical Solution, 5%MINOXIDIL SOLUTIONSun Pharmaceutical Industries, Inc.acc5ad74-4558-4be9-aab4-94ad9ddad6b22026-03-04WarningsExact identifier
application applno (ANDA): 217998
application number: ANDA217998
Keeps Minoxidil Topical Solution, 5%MINOXIDIL SOLUTIONKeeps (30 Madison)236d9984-d9a3-a87d-e063-6394a90a49582025-08-07WarningsExact identifier
application applno (ANDA): 217998
application number: ANDA217998
ndc (package): 71713-102-09
ndc (product): 71713-102
ndc11 (package): 71713010209

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311724minoxidil 5 % Topical SolutionPSN236d9984-d9a3-a87d-e063-6394a90a49582
311724minoxidil 50 MG/ML Topical SolutionSCD236d9984-d9a3-a87d-e063-6394a90a49582
311724minoxidil 3 GM per 60 ML Topical SolutionSY236d9984-d9a3-a87d-e063-6394a90a49582
311724minoxidil 5 % Topical SolutionSY236d9984-d9a3-a87d-e063-6394a90a49582
311724minoxidil 5 GM per 100 ML Topical SolutionSY236d9984-d9a3-a87d-e063-6394a90a49582

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71713-102-09717130102093 BOTTLE in 1 CARTON (71713-102-09) / 60 mL in 1 BOTTLE (71713-102-04) 3 bottle2025-08-31NoNoCurrent