Redu mineral

Product NDC
81016-0005
11-digit product format
810160005
Labeler code
81016
Product ID
81016-0005_dc576b91-2d00-5a42-e053-2a95a90ac8fd
Type
HUMAN OTC DRUG
Nonproprietary name
mineral
Dosage form
LIQUID
Route
TOPICAL
Labeler
AML Bio Co., Ltd.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2021-04-11
Marketing end
0000-00-00
Substance
WATER
Active strength
100 g/100mL
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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 productproduct81016-0005IInactivated by FDA2026-09-14
excluded packagepackage81016-000581016-0005-1IInactivated by FDA2026-09-14

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
91774e91-b249-45e3-8ff8-4b5db2927a69Product name120230718

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81016-0005-1Redu mineral500 mL in 1 BOTTLELIQUID5003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81016-0005REDU MINERAL (MINERAL) LIQUID [AML BIO CO., LTD.]3Legacy NDC, 1 package rows20240124_cbaeac99-b3ac-8eb2-e053-2a95a90ac863.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
81016-0005-181016000501500 mL in 1 BOTTLE (81016-0005-1) 500 ml2021-04-110000-00-00NoNoCurrent