Home NDC 81653-013-01 SOTI HAIR GROWTH SERUM
Product NDC 81653-013
Requested package NDC 81653-013-01
11-digit product format 816530013
Labeler code 81653
Product ID 81653-013_529d33c1-574b-29bc-e063-6294a90a3474
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 2023-12-04
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 · 3 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 81653-013 81653-013-01 U Excluded because listing certification expired excluded / ndc_excluded.zip 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 81653-013 81653-013-01 U Excluded because listing certification expired excluded / ndc_excluded.zip ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 81653-013 81653-013-01 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…
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 SOTI HAIR GROWTH SERUM
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MINOXIDIL 5 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 5965120SH1 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 311724 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 81653-013-01 SOTI HAIR GROWTH SERUM 60 mL in 1 BOTTLE LIQUID 60 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 81653-013 SOTI HAIR GROWTH SERUM (MINOXIDIL) LIQUID [GUANGZHOU JIANYUAN BIOLOGICAL TECHNOLOGY CO., LTD.] 3 Current NDC, 1 package rows 20250212_0d8beb7c-48be-54de-e063-6394a90a4149.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 81653-013-01 81653001301 60 mL in 1 BOTTLE (81653-013-01) 60 ml 2023-12-04 No No Current