FDA.reportPublic FDA data

DEFEND Sinus

Product NDC
54973-3187
11-digit product format
549733187
Labeler code
54973
Product ID
54973-3187_efa3f8c6-e263-6bc1-e053-2a95a90ae1bd
Type
HUMAN OTC DRUG
Nonproprietary name
OYSTER SHELL CALCIUM CARBONATE, CRUDE, GOLDENSEAL, POTASSIUM DICHROMATE, and PULSATILLA VULGARIS
Dosage form
TABLET, SOLUBLE
Route
ORAL
Labeler
Hyland's Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2014-07-01
Substance
GOLDENSEAL; OYSTER SHELL CALCIUM CARBONATE, CRUDE; POTASSIUM DICHROMATE; PULSATILLA VULGARIS
Active strength
6; 3; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GOLDENSEAL6 [hp_X]/1
OYSTER SHELL CALCIUM CARBONATE, CRUDE3 [hp_X]/1
POTASSIUM DICHROMATE6 [hp_X]/1
PULSATILLA VULGARIS6 [hp_X]/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZW3Z11D0JV, 2E32821G6I, T4423S18FM, I76KB35JEV

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54973-3187-1DEFEND Sinus40 in 1 BOTTLE, PLASTICTABLET, SOLUBLE403
54973-3187-1DEFEND Sinus1 in 1 CARTONTABLET, SOLUBLE13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GOLDENSEALACTIVE INGREDIENTZW3Z11D0JVDEFEND SINUS (OYSTER SHELL CALCIUM CARBONATE, CRUDE, GOLDENSEAL, POTASSIUM DICHROMATE, AND PULSATILLA VULGARIS) TABLET, SOLUBLE [HYLAND'S]1
OYSTER SHELL CALCIUM CARBONATE, CRUDEACTIVE INGREDIENT2E32821G6IDEFEND SINUS (OYSTER SHELL CALCIUM CARBONATE, CRUDE, GOLDENSEAL, POTASSIUM DICHROMATE, AND PULSATILLA VULGARIS) TABLET, SOLUBLE [HYLAND'S]1
POTASSIUM DICHROMATEACTIVE INGREDIENTT4423S18FMDEFEND SINUS (OYSTER SHELL CALCIUM CARBONATE, CRUDE, GOLDENSEAL, POTASSIUM DICHROMATE, AND PULSATILLA VULGARIS) TABLET, SOLUBLE [HYLAND'S]1
PULSATILLA VULGARISACTIVE INGREDIENTI76KB35JEVDEFEND SINUS (OYSTER SHELL CALCIUM CARBONATE, CRUDE, GOLDENSEAL, POTASSIUM DICHROMATE, AND PULSATILLA VULGARIS) TABLET, SOLUBLE [HYLAND'S]1
DICHROMATE IONACTIVE MOIETY9LKY4BFN2VDEFEND SINUS (OYSTER SHELL CALCIUM CARBONATE, CRUDE, GOLDENSEAL, POTASSIUM DICHROMATE, AND PULSATILLA VULGARIS) TABLET, SOLUBLE [HYLAND'S]1
GOLDENSEALACTIVE MOIETYZW3Z11D0JVDEFEND SINUS (OYSTER SHELL CALCIUM CARBONATE, CRUDE, GOLDENSEAL, POTASSIUM DICHROMATE, AND PULSATILLA VULGARIS) TABLET, SOLUBLE [HYLAND'S]1
OYSTER SHELL CALCIUM CARBONATE, CRUDEACTIVE MOIETY2E32821G6IDEFEND SINUS (OYSTER SHELL CALCIUM CARBONATE, CRUDE, GOLDENSEAL, POTASSIUM DICHROMATE, AND PULSATILLA VULGARIS) TABLET, SOLUBLE [HYLAND'S]1
PULSATILLA VULGARISACTIVE MOIETYI76KB35JEVDEFEND SINUS (OYSTER SHELL CALCIUM CARBONATE, CRUDE, GOLDENSEAL, POTASSIUM DICHROMATE, AND PULSATILLA VULGARIS) TABLET, SOLUBLE [HYLAND'S]1
ACACIAINACTIVE INGREDIENT5C5403N26ODEFEND SINUS (OYSTER SHELL CALCIUM CARBONATE, CRUDE, GOLDENSEAL, POTASSIUM DICHROMATE, AND PULSATILLA VULGARIS) TABLET, SOLUBLE [HYLAND'S]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GDEFEND SINUS (OYSTER SHELL CALCIUM CARBONATE, CRUDE, GOLDENSEAL, POTASSIUM DICHROMATE, AND PULSATILLA VULGARIS) TABLET, SOLUBLE [HYLAND'S]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54973-3187DEFEND SINUS (OYSTER SHELL CALCIUM CARBONATE, CRUDE, GOLDENSEAL, POTASSIUM DICHROMATE, AND PULSATILLA VULGARIS) TABLET, SOLUBLE [HYLAND'S INC.]3Current NDC, Legacy NDC, 2 package rows20221213_adc7a39f-555c-4d5a-8d88-6f4a49166982.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
54973-3187-1549733187011 BOTTLE, PLASTIC in 1 CARTON (54973-3187-1) / 40 TABLET, SOLUBLE in 1 BOTTLE, PLASTIC2014-07-010000-00-00NoNoCurrent