Hepar Sulf

Product NDC
53645-1211
Requested package NDC
53645-1211-2
11-digit product format
536451211
Labeler code
53645
Product ID
53645-1211_faa4e5ab-e0d5-75c3-e053-6394a90a744a
Type
HUMAN OTC DRUG
Nonproprietary name
Hepar Sulf
Dosage form
GLOBULE
Route
ORAL
Labeler
True Botanica, LLC
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2017-11-20
Substance
CALCIUM SULFIDE
Active strength
6 [hp_X]/23g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Hepar Sulf
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CALCIUM SULFIDE6 [hp_X]/23g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1MBW07J51QInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
5e75952a-f7f1-d2e7-e053-2a91aa0a85d7Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53645-1211-22021-01-31C16284748780-1ba0f9c33-16e3-a910-e053-dadaa90a0b85Hepar Sulf 6x
53645-1211-22021-01-29C16284748780-1ba0f9c33-16e3-a910-e053-dadaa90a0b85Hepar Sulf 6x

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53645-1211-2Hepar Sulf23 g in 1 BOTTLEGLOBULE236

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53645-1211HEPAR SULF GLOBULE [TRUE BOTANICA, LLC]6Current NDC, Legacy NDC, 1 package rows20230502_5e75952a-f7f1-d2e7-e053-2a91aa0a85d7.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
Hepar SulfHEPAR SULFTrue Botanica, LLC5e75952a-f7f1-d2e7-e053-2a91aa0a85d72023-05-01WarningsExact identifier
ndc (package): 53645-1211-2
ndc (product): 53645-1211
ndc11 (package): 53645121102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53645-1211-25364512110223 g in 1 BOTTLE (53645-1211-2) 23 g2017-11-200000-00-00NoNoCurrent