FDA.reportPublic FDA data

Keylosa

Manufacturer
Novian Pharmaceuticals
Effective date
2023-10-06
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 20:53:52

Label at a glance#

ProductKeylosa
Active ingredientCHOLECALCIFEROL, FOLIC ACID, MANGANESE SULFATE, VITAMIN A, ASCORBIC ACID, PYRIDOXINE, CHROMIUM, RIBOFLAVIN, MAGNESIUM OXIDE, SELENIUM, MOLYBDENUM, ZINC OXIDE, CYANOCOBALAMIN, FERROUS FUMARATE, .ALPHA.-TOCOPHEROL, THIAMINE MONONITRATE, NIACINAMIDE, CALCIUM CARBONATE
Label structure4 sections

Storage and handling

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Label contents#

Full prescribing information#

WARNINGS SECTION

Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of
reach of children. In case of accidental overdose, call a doctor or poison control.

STORAGE AND HANDLING SECTION

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

INACTIVE INGREDIENT SECTION

Other Ingredients: Cellulose (capsule), Magnesium Stearate

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ASCORBIC ACID Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
CALCIUM CATION Pharmacologic Class Indexing3Indexing - Pharmacologic Class20230427
CHOLECALCIFEROL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
CHROMIUM Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
CYANOCOBALAMIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
MAGNESIUM CATION Pharmacologic Class Indexing4Indexing - Pharmacologic Class20180813
MANGANESE CATION (2+) Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
PYRIDOXINE Pharmacologic Class Indexing1Indexing - Pharmacologic Class20170310
VITAMIN A Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
86fffa7b-d382-4771-a253-25cccb64b590Product name320251124
95250459-30e4-45c1-b08a-993044f49109Product name220250805
cf050ccd-1144-f76a-e00d-e5698d8597d4Product name620250625
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
b82b4008-22fd-05f5-6cc6-c0a6e81c65b8Product name220240805
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
efd58652-cb8f-4018-91ca-4b0eb2ff729fProduct name720240226
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
91c62db0-0295-c81c-d10a-0856c259edd6Product name220200428
d32bc2b8-0bb7-2216-87aa-24639646e202Product name320190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
d206bb34-ea65-399d-70d9-834f22dc2c18Product name320170724
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
e7e58cd3-cacb-49df-8d34-1ee335614abbProduct name120150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83146-003-302025-01-30C16284748780-12cef2736-6ddb-d83d-e063-dadaa90ab31fKeylosa

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83146-003-30Keylosa30 in 1 BOTTLECAPSULE, COATED301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83146-003KEYLOSA (MULTIVITAMIN) CAPSULE, COATED [NOVIAN PHARMACEUTICALS]11 package rows20231012_07131644-0195-8510-e063-6294a90acd0f.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83146-00383146-003-30

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
CHOLECALCIFEROL1C6V77QF41ACTIB
FOLIC ACID935E97BOY8ACTIB
MANGANESE SULFATEW00LYS4T26ACTIM
VITAMIN A81G40H8B0TACTIB
ASCORBIC ACIDPQ6CK8PD0RACTIB
PYRIDOXINEKV2JZ1BI6ZACTIB
MAGNESIUM STEARATE70097M6I30IACT
CHROMIUM0R0008Q3JBACTIB
RIBOFLAVINTLM2976OFRACTIB
MAGNESIUM OXIDE3A3U0GI71GACTIM
SELENIUMH6241UJ22BACTIB
MOLYBDENUM81AH48963UACTIB
ZINC OXIDESOI2LOH54ZACTIB
CYANOCOBALAMINP6YC3EG204ACTIB
FERROUS FUMARATER5L488RY0QACTIM
.ALPHA.-TOCOPHEROLH4N855PNZ1ACTIB
THIAMINE MONONITRATE8K0I04919XACTIR
NIACINAMIDE25X51I8RD4ACTIB
CALCIUM CARBONATEH0G9379FGKACTIM

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
07131644-0196-8510-e063-6294a90acd0f07131644-0195-8510-e063-6294a90acd0f2023-10-06WarningsExact identifier
spl id: 07131644-0196-8510-e063-6294a90acd0f
spl set id: 07131644-0195-8510-e063-6294a90acd0f

Reported adverse events (FAERS/openFDA)#

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