FDA.reportPublic FDA data

Shilajit

Manufacturer
Shenzhen Gaoye E-commerce Co., Ltd
Effective date
2024-07-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:17:04

Label at a glance#

ProductShilajit
Active ingredientFULVIC ACID
Label structure12 sections

Dosage and administration

1. Take 1/4 spoon(600-800mg) of Shilajit Essential Extract 2. Add it to a glass of water/milk and stir for 5 seconds 3. Drink it once the shilajit gets dissolved

Storage and handling

Before use, read all information on thecarton Store at controlled room temperature20 to 25 C (68 to 77°F)

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Shilajit extract 60%

Purpose

OTC - PURPOSE SECTION

Extract beneficial nutrients from food to supplement the amino acids, trace elements, vitamins, minerals, etc. needed by the human body.

Use

INDICATIONS & USAGE SECTION

As a dietary supplement, take one 600-800mg, or as directed by your health care professional.

Warnings

WARNINGS SECTION

This product is not designed to diagnose, treat, cure, or prevent any disease.

Do not use

OTC - DO NOT USE SECTION

If safety seal is damaged or missing.

OTC - WHEN USING SECTION

In case of contact with eyes, rinse eyes thoroughly with water.

OTC - STOP USE SECTION

Pregnant or nursing mothers, children under the age of 18, and individuals with a known medical condition should consult a physician before using this or any dietary supplement.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

1. Take 1/4 spoon(600-800mg) of Shilajit Essential Extract

2. Add it to a glass of water/milk and stir for 5 seconds
3. Drink it once the shilajit gets dissolved

Other information

STORAGE AND HANDLING SECTION

Before use, read all information on thecarton Store at controlled room temperature20 to 25 C (68 to 77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Fructose syrup, Medlar extract, Maltodextrin, Citric acid, Sodium citrate, Lactistreptococcin, Potassium sorbate, Edible essence.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
d1c9d1af-bddd-448d-86f7-69052b7d5b47Product name120220627
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84322-005-01Shilajit30 g in 1 BOTTLECREAM301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84322-005SHILAJIT CREAM [SHENZHEN GAOYE E-COMMERCE CO., LTD]11 package rows20240811_1e72af6f-8b24-7b45-e063-6294a90a4b3e.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84322-00584322-005-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
ETHYL METHYLPHENYLGLYCIDATEUD51D5KR4AIACT
TRISODIUM CITRATE DIHYDRATEB22547B95KIACT
NISINEN8XKG133DIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
FULVIC ACIDXII14C5FXVACTIB
MALTOSE ANHYDROUS66Y63L379NIACT
BETAINE3SCV180C9WIACT
MALTODEXTRIN7CVR7L4A2DIACT

Source Document#

Source XML

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
1e72bace-fbdc-c0ce-e063-6294a90aed021e72af6f-8b24-7b45-e063-6294a90a4b3e2024-07-30WarningsExact identifier
spl id: 1e72bace-fbdc-c0ce-e063-6294a90aed02
spl set id: 1e72af6f-8b24-7b45-e063-6294a90a4b3e

Reported adverse events (FAERS/openFDA)#

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