Genexa Leg Cramps

Product NDC
69676-0045
Requested package NDC
69676-0045-2
11-digit product format
696760045
Labeler code
69676
Product ID
69676-0045_e4914aab-4d72-4762-e053-2995a90a29f4
Type
HUMAN OTC DRUG
Nonproprietary name
Angustura vera, Berberis vulgaris, Chamomilla, Colchicum autumnale, Colocynthis, Ignatia amara, Jatropha curcas, Lycopodium clavatum, Nux moshchata, Rhus toxicodendron, Secale cornutum, Veratrum album
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Genexa Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2020-09-15
Marketing end
0000-00-00
Substance
ANGOSTURA BARK; BERBERIS VULGARIS ROOT BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; CLAVICEPS PURPUREA SCLEROTIUM; COLCHICUM AUTUMNALE BULB; JATROPHA CURCAS SEED; LYCOPODIUM CLAVATUM SPORE; MATRICARIA CHAMOMILLA; NUTMEG; STRYCHNOS IGNATII SEED; TOXICODENDRON PUBESCENS LEAF; VERATRUM ALBUM ROOT
Active strength
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; [hp_X]/1; [hp_X]/1; [hp_X]/1
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage69676-004569676-0045-2IInactivated by FDA2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 9 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
69676-0045-22025-01-30C16284748780-12cef2736-643e-d83d-e063-dadaa90ab31fLEG CRAMPS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69676-0045-2Genexa Leg Cramps100 in 1 BOTTLE, PLASTICTABLET, CHEWABLE1003
69676-0045-2Genexa Leg Cramps1 in 1 CARTONTABLET, CHEWABLE13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69676-0045GENEXA LEG CRAMPS (ANGUSTURA VERA, BERBERIS VULGARIS, CHAMOMILLA, COLCHICUM AUTUMNALE, COLOCYNTHIS, IGNATIA AMARA, JATROPHA CURCAS, LYCOPODIUM CLAVATUM, NUX MOSHCHATA, RHUS TOXICODENDRON, SECALE CORNUTUM, VERATRUM ALBUM) TABLET, CHEWABLE [GENEXA INC.]3Legacy NDC, 2 package rows20220727_b012df58-15fb-5c73-e053-2995a90a9d2b.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69676-0045-2696760045021 BOTTLE, PLASTIC in 1 CARTON (69676-0045-2) > 100 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC2020-09-150000-00-00NoNoCurrent