Hair regrowth treatment

Product NDC
81653-005
Requested package NDC
81653-005-01
11-digit product format
816530005
Labeler code
81653
Product ID
81653-005_529d3660-75b4-6036-e063-6294a90a3170
Type
HUMAN OTC DRUG
Nonproprietary name
Minoxidil
Dosage form
LIQUID
Route
TOPICAL
Labeler
Guangzhou Jianyuan Biological Technology.Co.,Ltd
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-10-20
Substance
MINOXIDIL
Active strength
5 g/100mL
Pharmacologic classes
Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Additional Listing Data#

Finished product
Yes
Brand name base
Hair regrowth treatment
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MINOXIDIL5 g/100mL

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
645146Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
eb87ff2d-7708-4c4d-e053-2a95a90ac72bAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81653-005-01Hair regrowth treatment3 in 1 BOXLIQUID34
81653-005-01Hair regrowth treatment60 mL in 1 BOTTLE, SPRAYLIQUID604
81653-005-02Hair regrowth treatment60 mL in 1 BOTTLE, SPRAYLIQUID604
81653-005-02Hair regrowth treatment3 in 1 BOXLIQUID34

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81653-005HAIR REGROWTH TREATMENT (MINOXIDIL) LIQUID [GUANGZHOU JIANYUAN BIOLOGICAL TECHNOLOGY.CO.,LTD]3Current NDC, Legacy NDC, 4 package rows20250212_eb87ff2d-7708-4c4d-e053-2a95a90ac72b.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hair regrowth treatmentMINOXIDILGuangzhou Jianyuan Biological Technology.Co.,Ltdeb87ff2d-7708-4c4d-e053-2a95a90ac72b2026-05-24WarningsExact identifier
ndc (package): 81653-005-01
ndc (product): 81653-005
ndc11 (package): 81653000501

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
645146minoxidil 5 % Topical FoamPSNeb87ff2d-7708-4c4d-e053-2a95a90ac72b4
645146minoxidil 50 MG/ML Topical FoamSCDeb87ff2d-7708-4c4d-e053-2a95a90ac72b4
645146minoxidil 5 % Topical FoamSYeb87ff2d-7708-4c4d-e053-2a95a90ac72b4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
81653-005-01816530005013 BOTTLE, SPRAY in 1 BOX (81653-005-01) / 60 mL in 1 BOTTLE, SPRAY2022-10-250000-00-00NoNoCurrent