FDA.reportPublic FDA data

SINUSCALM

Product NDC
0220-9338
11-digit product format
002209338
Labeler code
0220
Product ID
0220-9338_30d151ea-1ab5-503e-e063-6394a90a1c1a
Type
HUMAN OTC DRUG
Nonproprietary name
ATROPA BELLADONNA, SANGUINARIA CANADENSIS ROOT, SPIGELIA ANTHELMIA
Dosage form
TABLET
Route
ORAL
Labeler
BOIRON
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2019-06-01
Substance
ATROPA BELLADONNA; SANGUINARIA CANADENSIS ROOT; 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
ATROPA BELLADONNA3 [hp_C]/1
SANGUINARIA CANADENSIS ROOT3 [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
WQZ3G9PF0HInternal UNII lookup
N9288CD508Internal 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
87fe007d-3911-c95a-e053-2995a90ad836Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0220-9338-04SINUSCALM60 in 1 CARTONTABLET604
0220-9338-29SINUSCALM120 in 1 CARTONTABLET1204
0220-9338-92SINUSCALM100 in 1 CARTONTABLET1004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0220-9338SINUSCALM (ATROPA BELLADONNA, SANGUINARIA CANADENSIS ROOT, SPIGELIA ANTHELMIA) TABLET [BOIRON]4Current NDC, Legacy NDC, 3 package rows20250323_87fe007d-3911-c95a-e053-2995a90ad836.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 ANTHELMIABOIRON87fe007d-3911-c95a-e053-2995a90ad8362025-03-20Exact identifier
ndc (product): 0220-9338

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0220-9338-040022093380460 TABLET in 1 CARTON (0220-9338-04) 60 tablet2019-06-010000-00-00NoNoCurrent
0220-9338-2900220933829120 TABLET in 1 CARTON (0220-9338-29) 120 tablet2020-12-100000-00-00NoNoCurrent
0220-9338-9200220933892100 TABLET in 1 CARTON (0220-9338-92) 100 tablet2025-03-20NoNoCurrent