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

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 Identifiers#

Field, Values table
FieldValues
UniiWQZ3G9PF0H, N9288CD508, WYT05213GE

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

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