Minoxidil Hair Regrowth Roll-On

Product NDC
84025-331
11-digit product format
840250331
Labeler code
84025
Product ID
84025-331_5be2085a-a758-8891-e063-6294a90a80c4
Type
HUMAN OTC DRUG
Nonproprietary name
Minoxidil Hair Regrowth Roll-On
Dosage form
SOLUTION
Route
CUTANEOUS
Labeler
Guangzhou Yanxi Biotechnology Co., Ltd
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-09-20
Substance
MINOXIDIL; BIOTIN
Active strength
2; .05 g/100g; g/100g
Pharmacologic classes
Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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
Minoxidil Hair Regrowth Roll-On
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MINOXIDIL2 g/100g
BIOTIN.05 g/100g

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 52 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PETROLEUM jellyPETROLATUMUniversal Distribution Center LLCeaaf95d7-df80-407e-b784-4e42a89d64e52024-12-04WarningsExact identifier
application number: M016
UNIVERSAL COCOA BUTTER SCENT PETROLEUMWHITE PETROLEUMUniversal Distribution Center LLCec688073-6577-6cf9-e053-2a95a90a631d2024-12-04WarningsExact identifier
application number: M016
Burts Bees Rapid Rescue Cold Sore TreatmentCAMPHOR, GLYCERINBurts Bees9f89735d-205f-4d3e-a1e1-ecc96284fe982024-12-03WarningsExact identifier
application number: M016
Mustela Diaper Rash SprayableZINC OXIDEExpanscience Laboratories d/b/a Mustelad9a2aaf6-ab71-97a3-e053-2a95a90a34982024-12-02WarningsExact identifier
application number: M016
Mustela Stelatopia Intense Eczema Relief Skin ProtectantCOLLOIDAL OATMEALExpanscience Laboratories d/b/a Mustelae9ac358e-c9bd-7091-e053-2a95a90a46092024-12-02WarningsExact identifier
application number: M016
ZINC OXIDEZINC OXIDEVIVE HEALTH LLC284dbf6a-6fa2-742b-e063-6394a90afdfd2024-12-02WarningsExact identifier
application number: M016
Readyflush Protect Wipes Fragrance FreeDIMETHICONEMedline Industries, LP743d21bd-c40a-4415-ad97-0d8aa99a8af72024-12-02WarningsExact identifier
application number: M016
Orajel Cold Sore MoisturelockBENZOCAINEChurch & Dwight Co., Inc.3761c7b3-053b-0f50-e054-00144ff88e882024-11-26WarningsExact identifier
application number: M016
Johnsons Baby Care Essentials Gift SetZINC OXIDEKenvue Brands LLCed08b690-f907-6d2f-e053-2a95a90af51c2024-11-25WarningsExact identifier
application number: M016
Johnsons First Touch Baby Gift SetZINC OXIDEKenvue Brands LLCda5469ea-3330-4f04-e053-2a95a90aff412024-11-25WarningsExact identifier
application number: M016
Lil Drug Store Petroleum JellyPETROLATUMLil Drug Store Products, Inca8a56786-20c3-43c1-a4db-8502ff08e4cb2024-11-25WarningsExact identifier
application number: M016
TerrasilMed ONCALLANTOINAidance Scientific, Inc., DBA Aidance Skincare & Topical Solutionsf0cc9448-c531-4dd1-8f5c-5310e4abe1a92024-11-25WarningsExact identifier
application number: M016
TN Dickinsons Witch Hazel AstringentWITCH HAZELDickinson Brands Inc.a9596cf1-8204-447d-90f6-622bf497a7e02024-11-25WarningsExact identifier
application number: M016
PINXAV DAIPER RASHZINC OXIDEEmjay Laboratories Inc.14daf592-8edf-4679-9abf-de1b9d0799ff2024-11-21WarningsExact identifier
application number: M016
Target Maximum Strength Zinc Oxide Diaper RashZINC OXIDE DIAPER RASHTarget Corporation6ba2761c-4c05-498b-a012-e95843c205732024-11-21WarningsExact identifier
application number: M016
Target Baby HealingPETROLATUMTarget Corporation5a445a96-1652-47e0-b9bb-6e63fc1841082024-11-21WarningsExact identifier
application number: M016
Target Vitamin A and D Diaper RashVITAMIN A AND D OINTMENTTarget Corporation6a98e4b9-2906-4207-83ac-48f41fba190e2024-11-21WarningsExact identifier
application number: M016
Walgreens Baby HealingPETROLATUMWalgreens Company54100d5a-7ae1-45ec-94c4-e165b55a6c492024-11-20WarningsExact identifier
application number: M016
Baby Petroleum JellyWHITE PETROLATUM JELLYWALGREENS2008da4f-3c3c-4311-e063-6394a90a81e72024-11-20WarningsExact identifier
application number: M016
Vitamins A and D Without LanolinSKIN PROTECTANTDynarex Corporation822db5f4-d662-0689-e053-2a91aa0ace7e2024-11-20WarningsExact identifier
application number: M016

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84025-331-018402503310115 g in 1 BOTTLE (84025-331-01) 15 g2026-09-20NoNoCurrent