FDA.reportPublic FDA data

Calm Eczema Therapy Cream

Product NDC
50718-0011
11-digit product format
507180011
Labeler code
50718
Product ID
50718-0011_0e574a00-33bc-40d9-8ffb-21ce88215401
Type
HUMAN OTC DRUG
Nonproprietary name
Sulphur 12X
Dosage form
CREAM
Route
TOPICAL
Labeler
Kamedis
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2018-01-01
Substance
SULFUR
Active strength
12 [hp_X]/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Calm Eczema Therapy Cream
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SULFUR12 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
70FD1KFU70Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
304d3afc-dc81-4e8b-821c-47c5402ddf45Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50718-0011-12024-02-13C16284748780-11030e365-6c31-111a-e063-dadaa90a10e2Calm Eczema Therapy Cream
50718-0011-12024-01-30C16284748780-11030e365-6c31-111a-e063-dadaa90a10e2Calm Eczema Therapy Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50718-0011-1Calm Eczema Therapy Cream150 mL in 1 TUBECREAM1505
50718-0011-1Calm Eczema Therapy Cream1 in 1 CARTONCREAM15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50718-0011CALM ECZEMA THERAPY CREAM (SULPHUR 12X) CREAM [KAMEDIS]5Current NDC, Legacy NDC, 2 package rows20240214_304d3afc-dc81-4e8b-821c-47c5402ddf45.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
Calm Eczema Therapy CreamSULPHUR 12XKamedis304d3afc-dc81-4e8b-821c-47c5402ddf452024-02-12WarningsExact identifier
ndc (product): 50718-0011

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50718-0011-1507180011011 TUBE in 1 CARTON (50718-0011-1) / 150 mL in 1 TUBE1 tube2018-01-010000-00-00NoNoCurrent