FDA.reportPublic FDA data

Cold Crush Adult

Product NDC
69676-0006
11-digit product format
696760006
Labeler code
69676
Product ID
69676-0006_45ff7cc5-0d0f-f979-e063-6294a90ad2c8
Type
HUMAN OTC DRUG
Nonproprietary name
Aconitum napellus, Allium cepa, Bryonia alba, Euphrasia officinalis, Gelsemium sempervirens, Nux vomica, Pulsatilla, Rhus toxicodendron, Sabadilla
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Genexa Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2018-07-11
Substance
ACONITUM NAPELLUS; BRYONIA ALBA ROOT; EUPHRASIA STRICTA; GELSEMIUM SEMPERVIRENS ROOT; ONION; PULSATILLA PRATENSIS; SCHOENOCAULON OFFICINALE SEED; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS SHOOT
Active strength
6; 12; 6; 12; 6; 6; 12; 12; 12 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1
Pharmacologic classes
Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS], Vegetable Proteins [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cold Crush Adult
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACONITUM NAPELLUS6 [hp_X]/1
BRYONIA ALBA ROOT12 [hp_X]/1
EUPHRASIA STRICTA6 [hp_X]/1
GELSEMIUM SEMPERVIRENS ROOT12 [hp_X]/1
ONION6 [hp_X]/1
PULSATILLA PRATENSIS6 [hp_X]/1
SCHOENOCAULON OFFICINALE SEED12 [hp_X]/1
STRYCHNOS NUX-VOMICA SEED12 [hp_X]/1
TOXICODENDRON PUBESCENS SHOOT12 [hp_X]/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU0NQ8555JD, T7J046YI2B, C9642I91WL, 639KR60Q1Q, 492225Q21H, 8E272251DI, 6NAF1689IO, 269XH13919, 46PYZ1F82M

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69676-0006-12025-02-21C16284748780-12cef2736-aa9a-d83d-e063-dadaa90ab31fCOLD CRUSH, ADULT
69676-0006-32025-02-21C16284748780-12cef2736-aa9a-d83d-e063-dadaa90ab31fCOLD CRUSH, ADULT
69676-0006-12025-01-30C16284748780-12cef2736-aa9a-d83d-e063-dadaa90ab31fCOLD CRUSH, ADULT
69676-0006-32025-01-30C16284748780-12cef2736-aa9a-d83d-e063-dadaa90ab31fCOLD CRUSH, ADULT

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69676-0006-1Cold Crush Adult60 in 1 BOTTLETABLET, CHEWABLE6013
69676-0006-1Cold Crush Adult1 in 1 CARTONTABLET, CHEWABLE113
69676-0006-3Cold Crush Adult2 in 1 POUCHTABLET, CHEWABLE213

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69676-0006COLD CRUSH ADULT (ACONITUM NAPELLUS, ALLIUM CEPA, BRYONIA ALBA, EUPHRASIA OFFICINALIS, GELSEMIUM SEMPERVIRENS, NUX VOMICA, PULSATILLA, RHUS TOXICODENDRON, SABADILLA) TABLET, CHEWABLE [GENEXA INC.]12Current NDC, Legacy NDC, 3 package rows20250406_78ff93d3-5c77-b951-e053-2a91aa0adda9.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69676-0006-1696760006011 BOTTLE in 1 CARTON (69676-0006-1) / 60 TABLET, CHEWABLE in 1 BOTTLE1 bottle2018-07-110000-00-00NoNoCurrent
69676-0006-3696760006032 TABLET, CHEWABLE in 1 POUCH (69676-0006-3) 2018-07-110000-00-00YesNoCurrent