FDA.reportPublic FDA data

NDC 13811-527 - TL Gard Rx

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
13811-527
Package NDCs from labels
13811-527-01
Manufacturer
Trigen Laboratories, LLC
Effective date
2019-11-07
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
TL Gard Rx - Trigen Laboratories, LLCTrigen Laboratories, LLC2019-11-07DIETARY SUPPLEMENT

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13811-527-01EA - Each13811-527ab786c7c-9d48-4249-8b55-173c2b2ae04f12013-06-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
cyanocobalaminACTIVE INGREDIENTP6YC3EG204TL GARD RX (FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, AND CYANOCOBALAMIN) TABLET, FILM COATED [TRIGEN LABORATORIES, INC.]2
Folic AcidACTIVE INGREDIENT935E97BOY8TL GARD RX (FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, AND CYANOCOBALAMIN) TABLET, FILM COATED [TRIGEN LABORATORIES, INC.]2
pyridoxine HydrochlorideACTIVE INGREDIENT68Y4CF58BVTL GARD RX (FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, AND CYANOCOBALAMIN) TABLET, FILM COATED [TRIGEN LABORATORIES, INC.]2
cyanocobalaminACTIVE MOIETYP6YC3EG204TL GARD RX (FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, AND CYANOCOBALAMIN) TABLET, FILM COATED [TRIGEN LABORATORIES, INC.]2
Folic AcidACTIVE MOIETY935E97BOY8TL GARD RX (FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, AND CYANOCOBALAMIN) TABLET, FILM COATED [TRIGEN LABORATORIES, INC.]2
PYRIDOXINEACTIVE MOIETYKV2JZ1BI6ZTL GARD RX (FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, AND CYANOCOBALAMIN) TABLET, FILM COATED [TRIGEN LABORATORIES, INC.]2
Calcium Phosphate, Dibasic, AnhydrousINACTIVE INGREDIENTL11K75P92JTL GARD RX (FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, AND CYANOCOBALAMIN) TABLET, FILM COATED [TRIGEN LABORATORIES, INC.]2
carboxymethylcellulose sodiumINACTIVE INGREDIENTK679OBS311TL GARD RX (FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, AND CYANOCOBALAMIN) TABLET, FILM COATED [TRIGEN LABORATORIES, INC.]2
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UTL GARD RX (FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, AND CYANOCOBALAMIN) TABLET, FILM COATED [TRIGEN LABORATORIES, INC.]2
citric acid monohydrateINACTIVE INGREDIENT2968PHW8QPTL GARD RX (FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, AND CYANOCOBALAMIN) TABLET, FILM COATED [TRIGEN LABORATORIES, INC.]2
dextroseINACTIVE INGREDIENTIY9XDZ35W2TL GARD RX (FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, AND CYANOCOBALAMIN) TABLET, FILM COATED [TRIGEN LABORATORIES, INC.]2
icodextrinINACTIVE INGREDIENT2NX48Z0A9GTL GARD RX (FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, AND CYANOCOBALAMIN) TABLET, FILM COATED [TRIGEN LABORATORIES, INC.]2
potassium citrate anhydrousINACTIVE INGREDIENT86R1NVR0HWTL GARD RX (FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, AND CYANOCOBALAMIN) TABLET, FILM COATED [TRIGEN LABORATORIES, INC.]2
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4TL GARD RX (FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, AND CYANOCOBALAMIN) TABLET, FILM COATED [TRIGEN LABORATORIES, INC.]2
sodium citrateINACTIVE INGREDIENT1Q73Q2JULRTL GARD RX (FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, AND CYANOCOBALAMIN) TABLET, FILM COATED [TRIGEN LABORATORIES, INC.]2
stearic acidINACTIVE INGREDIENT4ELV7Z65APTL GARD RX (FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, AND CYANOCOBALAMIN) TABLET, FILM COATED [TRIGEN LABORATORIES, INC.]2

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 7 of 54 · 1,067 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DentaforceANTIMONIUM CRUDUM, BELLADONNA, CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, MERCURIUS SOLUBILIS, PLUMBUM METALLICUM, SEPIA, SILICEA, HYDROFLUORICUM ACIDUMBioActive Nutritional, Inc.82321547-e04a-42ff-aa39-6a192638e5a22026-05-18WarningsExact identifier
unii: ETJ7Z6XBU4
Folic AcidFOLIC ACIDCardinal Health 107, LLC624469a1-ded9-453a-973e-c5a2f0602bb02026-05-15Warnings, Adverse reactionsExact identifier
unii: 935E97BOY8
Non-proprietary nameCYANOCOBALAMINXseer Pharmaceuticals3bb870d8-128d-75ea-e063-6394a90a707b2026-05-13Exact identifier
unii: P6YC3EG204
C07 STRONG LIGAMENTS AND JOINTSARNICA MONTANA, ASCORBICUM ACIDUM, BOS TAURUS LYMPH VESSEL, INTERVERTEBRAL FIBROCARTILAGE, BOS TAURUS MESENCHYME, CALCAREA PHOSPHORICA, CARTILAGO SUIS, FORMICUM ACIDUM, LAPIS ALBUS, PINUS MONTANA LEAFY TWIG, RHAMNUS CALIFORNICA, RHUS TOXICODENDRON, RUTA GRAVEOLENS, SILICEA, SUS SCROFA JOINT ENVELOPE, SUS SCROFA LIGAMENT, SUS SCROFA MENISCUS, SUS SCROFA PARATHYROID GLAND, SUS SCROFA VEIN, SYMPHYTUM OFFICINALEApex Energetics Inc.bccf8c83-a6cd-e58c-e053-2a95a90a43d72026-05-13WarningsExact identifier
unii: ETJ7Z6XBU4
Norixa MiniNORIXA MINIFlorrax Pharmaceutical0aba2b6f-50b2-48c1-992b-d481b5394d532026-05-11Warnings, Adverse reactionsExact identifier
unii: 935E97BOY8
unii: P6YC3EG204
Acne ReliefBELLADONNA, SILICEA, GRAPHITES, HEPAR SULPHURIS CALCAREUM, KALI BROMATUM, LEDUM PALUSTRE, NATRUM MURIATICUM, SELENIUM, SULPHURNaturalCare487b1373-b78c-4510-964a-6ab0fe781ff42026-05-08WarningsExact identifier
unii: ETJ7Z6XBU4
DentastatALLIUM SATIVUM, BERBERIS VULGARIS, FUCUS VESICULOSUS, PHYTOLACCA DECANDRA, ARGENTUM METALLICUM, AURUM METALLICUM, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, HYDROFLUORICUM ACIDUM, IODIUM, MERCURIUS SOLUBILIS, NICCOLUM METALLICUM, SILICEA, ZINCUM METALLICUM, PLATINUM METALLICUMEnergique, Inc.12786efd-df42-4321-bfdf-88f542d387bb2026-05-06WarningsExact identifier
unii: ETJ7Z6XBU4
Folic AcidFOLIC ACIDCardinal Health 107, LLC6dd867fe-597e-4915-8baf-98a605bf93242026-05-06Warnings, Adverse reactionsExact identifier
unii: 935E97BOY8
Age Defiance Pro7-OXO-DEHYDROEPIANDROSTERONE-3B-ACETATE, CALCAREA CARBONICA, CONIUM MACULATUM, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, HYDROFLUORICUM ACIDUM, HYPOPHYSIS SUIS, LYCOPODIUM CLAVATUM, SELENIUM METALLICUM, SEPIA, SILICEA, HUMAN GROWTH HORMONEEnergique, Inc.d528bdbe-fb75-4b13-9cbc-efa2177d74d82026-05-06WarningsExact identifier
unii: ETJ7Z6XBU4
Pollen HayfeverADRENALINUM, ALLIUM CEPA, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM IODATUM, MUGWORT POLLEN (ARTEMISIA VULGARIS), BELLIS PERENNIS, BRASSICA SPP, CHENOPODIUM ALBUM, EUPHRASIA OFFICINALIS, HISTAMINUM HYDROCHLORICUM, ALFALFA POLLEN (MEDICAGO SATIVA), PHLEUM PRATENSE, YELLOW DOCK POLLEN (RUMEX CRISPUS), SABADILLA, SILICEA, GOLDENROD POLLEN (SOLIDAGO CANADENSIS), DANDELION POLLEN (TARAXACUM OFFICINALE), RED CLOVER POLLEN (TRIFOLIUM PRATENSE), XANTHIUM STRUMARIUMNaturalCare00665933-176e-4f16-b6ee-b55217b8abb32026-05-05WarningsExact identifier
unii: ETJ7Z6XBU4
Hydrate ICOFFEA TOSTA, GINKGO BILOBA, GERMANIUM SESQUIOXIDE, SILICEABioActive Nutritional, Inc.c0c8d350-0257-4484-acd8-f852350173db2026-04-30WarningsExact identifier
unii: ETJ7Z6XBU4
FolyraMULTIVITAMINOncora Pharma, LLCcb182e26-17c5-4d00-869f-08823afeeee82026-04-28Warnings, Adverse reactionsExact identifier
unii: 935E97BOY8
unii: P6YC3EG204
unii: 68Y4CF58BV
Norvexa MiniNORVEXA MINIFlorrax Pharmaceutical7c964ffd-4b14-43ef-9163-db21c6a1afc62026-04-27Warnings, Adverse reactionsExact identifier
unii: 935E97BOY8
unii: P6YC3EG204
REFRESH TEARS PFCARBOXYMETHYLCELLULOSE SODIUM, GLYCERINAllergan, Inc.9e1cba7b-84ed-47f3-b19a-1219928343502026-04-24WarningsExact identifier
unii: K679OBS311
Prenatal Plus VitaminsPRENATAL WITH FERROUS FUMARATE AND FOLIC ACIDREMEDYREPACK INC.1b8ef3ea-5563-48ef-ba5e-27e0b454efb92026-04-23Boxed warningExact identifier
unii: 935E97BOY8
unii: P6YC3EG204
unii: 68Y4CF58BV
Folic AcidFOLIC ACIDBryant Ranch Prepacka1b71c5d-c842-43fd-9557-2bb4e934b9142026-04-23Warnings, Adverse reactionsExact identifier
unii: 935E97BOY8
Folic AcidFOLIC ACIDPreferred Pharmaceuticals Inc.b4c3a754-64cd-499a-a32f-a6e935c413552026-04-22Warnings, Adverse reactionsExact identifier
unii: 935E97BOY8
ChromagenFERROUS ASPARTO GLYCINATE, FERROUS FUMARATE, ASCORBIC ACID, FOLIC ACID, LEVOMEFOLATE GLUCOSAMINE, CYANOCOBALAMIN, ZINC, AND INTRINSIC FACTORAvion Pharmaceuticals, LLC13c5ed58-6333-498f-9ace-1049d7ae35522026-04-17Boxed warning, Adverse reactionsExact identifier
unii: 935E97BOY8
unii: P6YC3EG204
PRENATE DHAASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, DL-, FOLIC ACID, LEVOMEFOLATE CALCIUM, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, CALCIUM FORMATE, FERROUS ASPARTO GLYCINATE, MAGNESIUM OXIDE AND DOCONEXENTAvion Pharmaceuticals, LLC8f2eca71-9a82-4a19-9206-36a04b865fe12026-04-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 935E97BOY8
unii: P6YC3EG204
unii: 68Y4CF58BV
Folic AcidFOLIC ACIDAmneal Pharmaceuticals of New York LLCfd85395e-6a0b-4072-a80b-36095c0c6dd62026-04-15Warnings, Adverse reactionsExact identifier
unii: 935E97BOY8

Reported adverse events (FAERS/openFDA)#

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