FDA.reportPublic FDA data

Calendula Combination

Product NDC
63083-9260
11-digit product format
630839260
Labeler code
63083
Product ID
63083-9260_f0f14b42-549c-4f37-982d-0a8a72b932b7
Type
HUMAN OTC DRUG
Nonproprietary name
Calendula Combination
Dosage form
LIQUID
Route
ORAL
Labeler
Professional Complementary Health Formulas
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
1984-08-15
Substance
ACHILLEA MILLEFOLIUM WHOLE; ACONITUM NAPELLUS WHOLE; ACTIVATED CHARCOAL; AMARYLLIS BELLADONNA WHOLE; ARNICA MONTANA WHOLE; ARTEMISIA ANNUA FLOWERING TOP; BELLIS PERENNIS WHOLE; CALCIUM SULFIDE; CALENDULA OFFICINALIS FLOWERING TOP; COMFREY ROOT; ECHINACEA ANGUSTIFOLIA WHOLE; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM WHOLE; MERCURIUS SOLUBILIS
Active strength
3; 3; 12; 4; 3; 3; 2; 5; 2; 6; 2; 2; 3; 12 [hp_X]/29.5mL; [hp_X]/29.5mL; [hp_X]/29.5mL; [hp_X]/29.5mL; [hp_X]/29.5mL; [hp_X]/29.5mL; [hp_X]/29.5mL; [hp_X]/29.5mL; [hp_X]/29.5mL; [hp_X]/29.5mL; [hp_X]/29.5mL; [hp_X]/29.5mL; [hp_X]/29.5mL; [hp_X]/29.5mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Calendula Combination
Brand name suffix
9260
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACHILLEA MILLEFOLIUM WHOLE3 [hp_X]/29.5mL
ACONITUM NAPELLUS WHOLE3 [hp_X]/29.5mL
ACTIVATED CHARCOAL12 [hp_X]/29.5mL
AMARYLLIS BELLADONNA WHOLE4 [hp_X]/29.5mL
ARNICA MONTANA WHOLE3 [hp_X]/29.5mL
ARTEMISIA ANNUA FLOWERING TOP3 [hp_X]/29.5mL
BELLIS PERENNIS WHOLE2 [hp_X]/29.5mL
CALCIUM SULFIDE5 [hp_X]/29.5mL
CALENDULA OFFICINALIS FLOWERING TOP2 [hp_X]/29.5mL
COMFREY ROOT6 [hp_X]/29.5mL
ECHINACEA ANGUSTIFOLIA WHOLE2 [hp_X]/29.5mL
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK2 [hp_X]/29.5mL
HYPERICUM PERFORATUM WHOLE3 [hp_X]/29.5mL
MERCURIUS SOLUBILIS12 [hp_X]/29.5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2FXJ6SW4PK, U0NQ8555JD, 2P3VWU3H10, 11B89M58UN, O80TY208ZW, 0UQK6O82OW, 2HU33I03UY, 1MBW07J51Q, 18E7415PXQ, M9VVZ08EKQ, VB06AV5US8, T7S323PKJS, XK4IUX8MNB, 324Y4038G2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63083-9260-12026-01-09C16284748780-11030e365-1416-111a-e063-dadaa90a10e2R260
63083-9260-12026-01-09C16284748780-11030e365-1416-111a-e063-dadaa90a10e2R260
63083-9260-12024-01-30C16284748780-11030e365-1416-111a-e063-dadaa90a10e2R260
63083-9260-12024-01-30C16284748780-11030e365-1416-111a-e063-dadaa90a10e2R260

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63083-9260-1Calendula Combination926029.5 mL in 1 BOTTLE, DROPPERLIQUID29.52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63083-9260CALENDULA COMBINATION 9260 (CALENDULA COMBINATION) LIQUID [PROFESSIONAL COMPLEMENTARY HEALTH FORMULAS]1Current NDC, Legacy NDC, 1 package rows20220210_0e0770d8-680a-471a-b496-7105631ca6f4.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63083-9260-16308392600129.5 mL in 1 BOTTLE, DROPPER (63083-9260-1) 29.5 ml1985-08-150000-00-00NoNoCurrent