FDA.reportPublic FDA data

Hendel Homeopathic Calm

Product NDC
62795-1118
11-digit product format
627951118
Labeler code
62795
Product ID
62795-1118_e1c0ca8c-7465-4e50-bf67-ea9b15560ce2
Type
HUMAN OTC DRUG
Nonproprietary name
AVENA SATIVA FLOWERING TOP, MATRICARIA CHAMOMILLA, HOPS, PASSIFLORA INCARNATA FLOWERING TOP, ZINC VALERATE DIHYDRATE, ARABICA COFFEE BEAN, STRYCHNOS NUX-VOMICA SEED, and SULFUR
Dosage form
TABLET
Route
ORAL
Labeler
MediNatura Inc
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2016-08-01
Marketing end
2026-09-30
Substance
ARABICA COFFEE BEAN; AVENA SATIVA FLOWERING TOP; HOPS; MATRICARIA CHAMOMILLA; PASSIFLORA INCARNATA FLOWERING TOP; STRYCHNOS NUX-VOMICA SEED; SULFUR; ZINC VALERATE DIHYDRATE
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
Pharmacologic classes
Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS], Seed Storage Proteins [CS]
NDC exclude flag
No
Listing certified through
0000-00-00
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct62795-1118DDiscontinued by firm2026-10-12
excluded packagepackage62795-111862795-1118-2DDiscontinued by firm2026-10-12

Reported adverse events (FAERS/openFDA)#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62795-1118-2Hendel Homeopathic Calm100 in 1 BOTTLETABLET1003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62795-1118-2EA - Each62795-1118a7a2e6fa-7e17-4cd3-941d-d3c07259ce9412018-05-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62795-1118HENDEL HOMEOPATHIC CALM (AVENA SATIVA FLOWERING TOP, MATRICARIA CHAMOMILLA, HOPS, PASSIFLORA INCARNATA FLOWERING TOP, ZINC VALERATE DIHYDRATE, ARABICA COFFEE BEAN, STRYCHNOS NUX-VOMICA SEED, AND SULFUR) TABLET [MEDINATURA INC]3Legacy NDC, 1 package rows20220823_3f87c276-9676-4935-b541-24ef84b6e9cc.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62795-1118-262795111802100 TABLET in 1 BOTTLE (62795-1118-2) 100 tablet2016-08-010000-00-00NoNoCurrent