FDA.reportPublic FDA data

5% MINOXIDIL HAIR REGROWTH SERUM With Biotin

Product NDC
84614-001
11-digit product format
846140001
Labeler code
84614
Product ID
84614-001_3e97f3b5-fc6a-bf6a-e063-6394a90aebc1
Type
HUMAN OTC DRUG
Nonproprietary name
Minoxidil
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Shenzhen Ctrip Technology Co., Ltd.
Application
M032
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-08-02
Substance
MINOXIDIL; BIOTIN
Active strength
5; .2 g/100mL; g/100mL
Pharmacologic classes
Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-08-27 00:01 UTC · source 2025-08-26excluded productproduct84614-001IInactivated by FDAexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage84614-00184614-001-01IInactivated by FDAexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

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
5% MINOXIDIL HAIR REGROWTH SERUM With Biotin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MINOXIDIL5 g/100mL
BIOTIN.2 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5965120SH1Internal UNII lookup
6SO6U10H04Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1eae27bc-1b18-ae5d-e063-6394a90a4610Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
84614-001-012025-09-12C16284748780-13b156c62-30da-fb37-e063-e6dba90a4e0784614-001 5% MINOXIDIL HAIR REGROWTH SERUM With Biotin
84614-001-012025-07-29C16284748780-13b156c62-30da-fb37-e063-e6dba90a4e0784614-001 5% MINOXIDIL HAIR REGROWTH SERUM With Biotin

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84614-001-015% MINOXIDIL HAIR REGROWTH SERUM With Biotin60 mL in 1 BOTTLESOLUTION602
84614-001-015% MINOXIDIL HAIR REGROWTH SERUM With Biotin2 in 1 PACKAGESOLUTION22
84614-001-025% MINOXIDIL HAIR REGROWTH SERUM With Biotin4 in 1 PACKAGESOLUTION42
84614-001-025% MINOXIDIL HAIR REGROWTH SERUM With Biotin60 mL in 1 BOTTLESOLUTION602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84614-0015% MINOXIDIL HAIR REGROWTH SERUM WITH BIOTIN (MINOXIDIL) SOLUTION [SHENZHEN CTRIP TECHNOLOGY CO., LTD.]1Current NDC, 4 package rows20240805_1eae27bc-1b18-ae5d-e063-6394a90a4610.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 7 of 31 · 615 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Head and Shoulders Itchy ScalpPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company54df1acc-4265-494c-879e-c690184d7ae22026-03-13WarningsExact identifier
application number: M032
2 in 1 DandruffPYRITHIONE ZINCH E Ba58b9119-2adb-459f-86f4-95df28a430c52026-03-13Warnings, Adverse reactionsExact identifier
application number: M032
Dry Scalp CarePYRITHIONE ZINCBetter Living Brands, LLCf90d1fb2-4bd7-4d70-81b4-4541f4e3a3d62026-03-13Warnings, Adverse reactionsExact identifier
application number: M032
Head and Shoulders Smooth and Silky ConditionerPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company4cec08cb-aba5-41ce-e063-6294a90adfdf2026-03-13WarningsExact identifier
application number: M032
OLIVITA MinoxidilMINOXIDILShenzhen Xinxin Yunhai Technology Co., Ltd.4cf37b0b-bbb8-1d9c-e063-6294a90af8182026-03-13WarningsExact identifier
application number: M032
DandruffPYRITHIONE ZINCNice-Pak Products, LLC3c55b70f-7627-8667-e063-6394a90a5cf82026-03-12Warnings, Adverse reactionsExact identifier
application number: M032
Head and Shoulders 2in1 Classic CleanPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company65a4082f-227b-49bf-b88c-b1c651ed13a02026-03-12WarningsExact identifier
application number: M032
Head and Shoulders Green Apple 2in1PYRITHIONE ZINCThe Procter & Gamble Manufacturing Companyc036c9a6-6507-4037-b97b-1b015dd950c12026-03-12WarningsExact identifier
application number: M032
Anti-FungalANTI-FUNGAL SHAMPOOShenzhen Mengyue Technology Co., Ltd.4ca9a661-fa39-ab7f-e063-6294a90aed142026-03-10WarningsExact identifier
application number: M032
iBeaLee 5% Minoxidil Hair Regrowth Treatment5% MINOXIDILShenzhen Earth Surface Trading Co., Ltd.4cb728d0-6abe-6645-e063-6394a90acb4c2026-03-10WarningsExact identifier
application number: M032
DHS TarCOAL TARPerson and Covey4c5f7278-c53a-cef6-e063-6394a90a00082026-03-09WarningsExact identifier
application number: M032
DHS ZINCPYRITHIONE ZINCPerson and Covey4c98c0af-c3d0-211e-e063-6294a90a8e122026-03-09WarningsExact identifier
application number: M032
DHS SALSALICYLIC ACIDPerson and Covey4c9b75b5-9c7d-c4a8-e063-6394a90a4a6b2026-03-09WarningsExact identifier
application number: M032
DHS BODY WASHZINC PYRITHIONE WASHPerson and Covey4c9d5b33-9a1e-9db1-e063-6294a90adbae2026-03-09WarningsExact identifier
application number: M032
BiotinBIOTINShenzhen yuehaotong Technology Co.,Ltd4c6ec616-a84e-6e1a-e063-6294a90a2aae2026-03-07WarningsExact identifier
application number: M032
2 in 1 DandruffPYRITHIONE ZINCOld East Main Co.5368b466-a804-471c-8287-0dd120c0d5092026-03-03Warnings, Adverse reactionsExact identifier
application number: M032
DandruffPYRITHIONE ZINCAmazon.com Services LLCc187bb79-8190-4a3d-a966-af74198ee5462026-03-03Warnings, Adverse reactionsExact identifier
application number: M032
Simply Clean DandruffPYRITHIONE ZINCOld East Main Co.643f571a-cf08-4f1f-9ad4-2bc68730ff572026-03-02Warnings, Adverse reactionsExact identifier
application number: M032
Dry Scalp CarePYRITHIONE ZINCOld East Main Co.3c433aa9-9451-4820-8b58-632cf6d0c92a2026-03-02Warnings, Adverse reactionsExact identifier
application number: M032
2 in 1 DandruffPYRITHIONE ZINCOld East Main Co.3afc97ff-6a83-40af-9a61-26f00cfe4fa82026-03-02Warnings, Adverse reactionsExact identifier
application number: M032

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84614-001-01846140001012 BOTTLE in 1 PACKAGE (84614-001-01) / 60 mL in 1 BOTTLE2 bottle2024-08-02NoNoCurrent
84614-001-02846140001024 BOTTLE in 1 PACKAGE (84614-001-02) / 60 mL in 1 BOTTLE4 bottle2024-08-02NoNoCurrent