BUNEE Hair Growth Serum

Product NDC
81653-001
11-digit product format
816530001
Labeler code
81653
Product ID
81653-001_529cef2d-e6cd-3b37-e063-6294a90aff59
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
2021-03-05
Substance
MINOXIDIL
Active strength
5 g/100mL
Pharmacologic classes
Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct81653-001EExcluded after deficient or non-compliant submission was not corrected2026-08-03
excluded packagepackage81653-00181653-001-01EExcluded after deficient or non-compliant submission was not corrected2026-08-03

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, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage81653-001-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage81653-001-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage81653-001-010efc9e666f02…f202fb6c5f17…

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81653-001-012025-02-09C16284748780-12cef2736-978a-d83d-e063-dadaa90ab31f81653-001 Update
81653-001-012025-01-30C16284748780-12cef2736-978a-d83d-e063-dadaa90ab31f81653-001 Update

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81653-001-01BUNEE Hair Growth Serum60 mL in 1 BOTTLELIQUID605

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81653-001BUNEE HAIR GROWTH SERUM (MINOXIDIL) LIQUID [GUANGZHOU JIANYUAN BIOLOGICAL TECHNOLOGY CO., LTD.]5Current NDC, Legacy NDC, 1 package rows20250212_bcafff1c-26c8-57c8-e053-2a95a90ad5f0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311724minoxidil 5 % Topical SolutionPSNbcafff1c-26c8-57c8-e053-2a95a90ad5f05
311724minoxidil 50 MG/ML Topical SolutionSCDbcafff1c-26c8-57c8-e053-2a95a90ad5f05
311724minoxidil 3 GM per 60 ML Topical SolutionSYbcafff1c-26c8-57c8-e053-2a95a90ad5f05
311724minoxidil 5 % Topical SolutionSYbcafff1c-26c8-57c8-e053-2a95a90ad5f05
311724minoxidil 5 GM per 100 ML Topical SolutionSYbcafff1c-26c8-57c8-e053-2a95a90ad5f05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
81653-001-018165300010160 mL in 1 BOTTLE (81653-001-01) 60 ml2021-03-050000-00-00NoNoCurrent