FDA.reportPublic FDA data

Calm Plus

Product NDC
62795-1115
11-digit product format
627951115
Labeler code
62795
Product ID
62795-1115_c0eeb7b9-388c-410e-a8d0-00e2860b16e0
Type
HUMAN OTC DRUG
Nonproprietary name
AVENA SATIVA FLOWERING TOP, MATRICARIA RECUTITA, PASSIFLORA INCARNATA FLOWERING, TRIBASIC CALCIUM PHOSPHATE, DIBASIC POTASSIUM PHOSPHATE, POTASSIUM SULFATE, MAGNESIUM PHOSPHATE, DIBASIC, SODIUM CHLORIDE, SODIUM SULFATE, 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
2016-09-01
Marketing end
2026-04-30
Substance
ARABICA COFFEE BEAN; AVENA SATIVA FLOWERING TOP; DIBASIC POTASSIUM PHOSPHATE; MAGNESIUM PHOSPHATE, DIBASIC; MATRICARIA RECUTITA; PASSIFLORA INCARNATA FLOWERING TOP; POTASSIUM SULFATE; SODIUM CHLORIDE; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; SULFUR; TRIBASIC CALCIUM PHOSPHATE; 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; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1
Pharmacologic classes
Allergens [CS], Allergens [CS], Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Coagulation Factor Activity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], 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 productproduct62795-1115DDiscontinued by firm2026-10-05
excluded packagepackage62795-111562795-1115-2DDiscontinued by firm2026-10-05

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62795-1115-2EA - Each62795-1115d8324841-0901-477c-bf7e-2381e304744b12017-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62795-1115CALM PLUS (AVENA SATIVA FLOWERING TOP, MATRICARIA RECUTITA, PASSIFLORA INCARNATA FLOWERING, TRIBASIC CALCIUM PHOSPHATE, DIBASIC POTASSIUM PHOSPHATE, POTASSIUM SULFATE, MAGNESIUM PHOSPHATE, DIBASIC, SODIUM CHLORIDE, SODIUM SULFATE, ZINC VALERATE DIHYDRATE, ARABICA COFFEE BEAN, STRYCHNOS NUX-VOMICA SEED, AND SULFUR) TABLET [MEDINATURA INC]3Legacy NDC20220820_23b540c5-ed00-4858-b23e-33537969a03e.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62795-1115-262795111502100 TABLET in 1 BOTTLE (62795-1115-2) 100 tablet2016-09-010000-00-00NoNoCurrent