SinusCalm

Product NDC
0220-9347
11-digit product format
002209347
Labeler code
0220
Product ID
0220-9347_08f2e848-c96f-4947-e063-6394a90a7310
Type
HUMAN OTC DRUG
Nonproprietary name
ATROPA BELLADONNA, SANGUINARIA CANADENSIS ROOT, SPIGELIA ANTHELMIA
Dosage form
PELLET
Route
ORAL
Labeler
Boiron
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2019-12-01
Substance
SANGUINARIA CANADENSIS ROOT; ATROPA BELLADONNA; SPIGELIA ANTHELMIA
Active strength
3; 3; 3 [hp_C]/1; [hp_C]/1; [hp_C]/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SANGUINARIA CANADENSIS ROOT3 [hp_C]/1
ATROPA BELLADONNA3 [hp_C]/1
SPIGELIA ANTHELMIA3 [hp_C]/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
N9288CD508Internal UNII lookup
WQZ3G9PF0HInternal UNII lookup
WYT05213GEInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
95872748-6d70-5c80-e053-2995a90a570cAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0220-9347-422023-10-31C16284748780-1f386c64a-31ff-0266-e053-dadaa90a7c1aSinusCalm
0220-9347-422023-01-30C16284748780-1f386c64a-31ff-0266-e053-dadaa90a7c1aSinusCalm

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0220-9347-41SinusCalm80 in 1 TUBEPELLET804
0220-9347-42SinusCalm1 in 1 BOXPELLET14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0220-9347SINUSCALM (ATROPA BELLADONNA, SANGUINARIA CANADENSIS ROOT, SPIGELIA ANTHELMIA) PELLET [BOIRON]4Current NDC, Legacy NDC, 2 package rows20231031_95872748-6d70-5c80-e053-2995a90a570c.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
SinusCalmATROPA BELLADONNA, SANGUINARIA CANADENSIS ROOT, SPIGELIA ANTHELMIABoiron95872748-6d70-5c80-e053-2995a90a570c2023-10-30Exact identifier
ndc (product): 0220-9347

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0220-9347-410022093474180 in 1 TUBEHistorical
0220-9347-42002209347421 TUBE in 1 BOX (0220-9347-42) / 80 PELLET in 1 TUBE (0220-9347-41) 1 tube2019-12-010000-00-00NoNoCurrent