Granite 30X

Product NDC
53645-2021
11-digit product format
536452021
Labeler code
53645
Product ID
53645-2021_21b271f4-a129-a54d-e063-6394a90adc6e
Type
HUMAN OTC DRUG
Nonproprietary name
Granite 30X
Dosage form
LIQUID
Route
ORAL
Labeler
True Botanica, LLC
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2024-10-07
Substance
MICA; SILICON DIOXIDE
Active strength
30; 30 [hp_X]/30mL; [hp_X]/30mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Granite 30X
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SILICON DIOXIDE30 [hp_X]/30mL
MICA30 [hp_X]/30mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ETJ7Z6XBU4Internal UNII lookup
V8A1AW0880Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
21b2bae6-8176-ccbf-e063-6394a90a97b5Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53645-2021-6Granite 30X30 mL in 1 BOTTLELIQUID301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53645-2021GRANITE 30X LIQUID [TRUE BOTANICA, LLC]1Current NDC, 1 package rows20241010_21b2bae6-8176-ccbf-e063-6394a90a97b5.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Granite 30XGRANITE 30XTrue Botanica, LLC21b2bae6-8176-ccbf-e063-6394a90a97b52024-10-07WarningsExact identifier
ndc (product): 53645-2021

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
53645-2021-65364520210630 mL in 1 BOTTLE (53645-2021-6) 30 ml2024-10-07NoNoCurrent