Regenivade Hair Growth Foam

Product NDC
81653-007
11-digit product format
816530007
Labeler code
81653
Product ID
81653-007_529d3904-cdf3-7c04-e063-6294a90af3b5
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
2023-10-23
Substance
MINOXIDIL
Active strength
5 mg/mL
Pharmacologic classes
Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Regenivade Hair Growth FoamMINOXIDILGuangzhou Jianyuan Biological Technology.Co.,Ltd085de93f-dae3-9964-e063-6394a90a58532026-05-24WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings For external use only. Do not use if: You are a pregnant woman Your amount of hair loss is different than that shown on the sideof this carton or your hair loss is on the front of the scalp. 5%minoxidil topical foam is not intended for frontal baldness orreceding hairline. You suffer from metal allergies You have no family history of hair loss. You hair loss is sudden and/or patchy. You do not know the reason for your hair loss. You are under 18 years of age. Do not use on babies and children. You scalp is red, inflamed, infected, irritated, or painful. You use other medicines on the scalp. Ask a doctor before use if you have heart disease When using this product: Do not apply on other parts of the body Avoid contact with the eyes. In case of accidental contact, rinse eyes with large amounts of cool tap water. Some people have experienced changes in hair color and/or texture. It takes time to regrow hair. Results may occur at 2 months withtwice a day usage. For some people, you may need to use thisproduct for at least 4 months before you see results.The amount of hair regrowth is different for each person. Thisproduct will not work for all people. Stop use and ask a doctor if: Chest pain, rapid heartbeat, faintness, or dizziness occurs. Sudden, unexplained weight gain occurs. Your hands or feet swell. Scalp irritation or redness occurs. Unwanted facial hair growth occurs You do not see hair regrowth in 4 months. May be harmful if used when pregnant or breast-feeding Keep out of reach of children. lf swallowed, get medical help orcontact Poison Control Center right away.

Additional Listing Data#

Finished product
Yes
Brand name base
Regenivade Hair Growth Foam
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MINOXIDIL5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5965120SH1
Rxcui645146

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81653-007-01Regenivade Hair Growth Foam60 mL in 1 BOTTLELIQUID604
81653-007-01Regenivade Hair Growth Foam1 in 1 PACKAGELIQUID14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81653-007REGENIVADE HAIR GROWTH FOAM (MINOXIDIL) LIQUID [GUANGZHOU JIANYUAN BIOLOGICAL TECHNOLOGY.CO.,LTD]3Current NDC, 2 package rows20250212_085de93f-dae3-9964-e063-6394a90a5853.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
645146minoxidil 5 % Topical FoamPSN085de93f-dae3-9964-e063-6394a90a58534
645146minoxidil 50 MG/ML Topical FoamSCD085de93f-dae3-9964-e063-6394a90a58534
645146minoxidil 5 % Topical FoamSY085de93f-dae3-9964-e063-6394a90a58534

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
81653-007-01816530007011 BOTTLE in 1 PACKAGE (81653-007-01) / 60 mL in 1 BOTTLE1 bottle2023-10-23NoNoCurrent