FDA.reportPublic FDA data

SINUSCALM ALLERGY

Product NDC
0220-9339
11-digit product format
002209339
Labeler code
0220
Product ID
0220-9339_f29251a1-7d15-a1bf-e053-2a95a90a10c1
Type
HUMAN OTC DRUG
Nonproprietary name
ATROPA BELLADONNA, SANGUINARIA CANADENSIS ROOT,
Dosage form
TABLET
Route
ORAL
Labeler
Boiron
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2022-07-28
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 ALLERGY
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
0220-9339-04SINUSCALM ALLERGY1 in 1 BOXTABLET12
0220-9339-04SINUSCALM ALLERGY60 in 1 BLISTER PACKTABLET602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0220-9339SINUSCALM ALLERGY (ATROPA BELLADONNA, SANGUINARIA CANADENSIS ROOT,) TABLET [BOIRON]2Current NDC, Legacy NDC, 2 package rows20230120_e4e0b0b3-df5e-6d47-e053-2a95a90aeba8.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0220-9339-04002209339041 BLISTER PACK in 1 BOX (0220-9339-04) / 60 TABLET in 1 BLISTER PACK1 blister pack2022-07-280000-00-00NoNoCurrent