FDA.reportPublic FDA data

Crataegus Combination

Product NDC
63083-9220
11-digit product format
630839220
Labeler code
63083
Product ID
63083-9220_a4cf1cd9-4742-4698-95a6-d7601dda94ea
Type
HUMAN OTC DRUG
Nonproprietary name
Crataegus Combination
Dosage form
LIQUID
Route
ORAL
Labeler
Professional Complementary Health Formulas
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
1984-08-15
Substance
ARNICA MONTANA WHOLE; CASTOR FIBER SCENT GLAND SECRETION; GELSEMIUM SEMPERVIRENS ROOT; HAWTHORN LEAF WITH FLOWER; NITROGLYCERIN; POTASSIUM CARBONATE; RANUNCULUS BULBOSUS WHOLE; SELENICEREUS GRANDIFLORUS STEM; SPIGELIA ANTHELMIA WHOLE; SULFUR
Active strength
4; 6; 4; 1; 6; 3; 6; 4; 2; 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
Pharmacologic classes
Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Crataegus Combination
Brand name suffix
9220
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARNICA MONTANA WHOLE4 [hp_X]/29.5mL
CASTOR FIBER SCENT GLAND SECRETION6 [hp_X]/29.5mL
GELSEMIUM SEMPERVIRENS ROOT4 [hp_X]/29.5mL
HAWTHORN LEAF WITH FLOWER1 [hp_X]/29.5mL
NITROGLYCERIN6 [hp_X]/29.5mL
POTASSIUM CARBONATE3 [hp_X]/29.5mL
RANUNCULUS BULBOSUS WHOLE6 [hp_X]/29.5mL
SELENICEREUS GRANDIFLORUS STEM4 [hp_X]/29.5mL
SPIGELIA ANTHELMIA WHOLE2 [hp_X]/29.5mL
SULFUR12 [hp_X]/29.5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiO80TY208ZW, 9X8XFD5ZQX, 639KR60Q1Q, 6OM09RPY36, G59M7S0WS3, BQN1B9B9HA, AEQ8NXJ0MB, 7114SV0MYK, WYT05213GE, 70FD1KFU70

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7480e90b-004b-ebe4-2243-4f2fefdd9e78Product name220260128
3f158398-73f2-4b90-47d1-5c60e8719a98Product name920250721
ca6149a6-ded3-9f17-6c41-3e88f2c0c9c0Product name220250117
00358076-c817-430b-b924-11d717dc307cProduct name120160718
669af5aa-14f3-3df7-f100-5f580ffd43c1Product name120140508
6ff3bab7-2dce-8bea-d7ce-54687f0c01fbProduct name120140508
8bb82a1c-d0d0-fc27-011f-172e545f0382Product name120140508
cb03406d-e223-80bb-67d8-be80f9b6a4f2Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63083-9220-12026-01-09C16284748780-11030e365-1b87-111a-e063-dadaa90a10e2R220
63083-9220-12026-01-09C16284748780-11030e365-1b87-111a-e063-dadaa90a10e2R220
63083-9220-12024-01-30C16284748780-11030e365-1b87-111a-e063-dadaa90a10e2R220
63083-9220-12024-01-30C16284748780-11030e365-1b87-111a-e063-dadaa90a10e2R220

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63083-9220-1Crataegus Combination922029.5 mL in 1 BOTTLE, DROPPERLIQUID29.52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63083-9220CRATAEGUS COMBINATION 9220 (CRATAEGUS COMBINATION) LIQUID [PROFESSIONAL COMPLEMENTARY HEALTH FORMULAS]1Current NDC, Legacy NDC, 1 package rows20220210_ad44d561-9004-43f1-8271-ef52b715fa66.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63083-9220-16308392200129.5 mL in 1 BOTTLE, DROPPER (63083-9220-1) 29.5 ml1985-08-150000-00-00NoNoCurrent