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 11 of 54 · 1,067 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AfloraMULTIVITAMINOncora Pharma, LLC38e463d1-f608-7cb5-e063-6294a90a4abb2026-02-12Warnings, Adverse reactionsExact identifier
unii: 935E97BOY8
unii: P6YC3EG204
unii: 68Y4CF58BV
FolixiaMULTIVITAMINOncora Pharma, LLC413945b5-116b-d8b6-e063-6394a90a55e82026-02-12Warnings, Adverse reactionsExact identifier
unii: 935E97BOY8
unii: P6YC3EG204
unii: 68Y4CF58BV
NutralynMULTIVITAMINOncora Pharma, LLC33da017b-1e8c-d41c-e063-6394a90aab8c2026-02-12Warnings, Adverse reactionsExact identifier
unii: 935E97BOY8
unii: P6YC3EG204
unii: 68Y4CF58BV
FolatenMULTIVITAMINOncora Pharma, LLC93086235-2c33-424d-b0c3-2130319885812026-02-12Warnings, Adverse reactionsExact identifier
unii: 935E97BOY8
unii: P6YC3EG204
unii: 68Y4CF58BV
Floravita MiniFLORAVITA MINIFlorrax Pharmaceutical682bda57-21e0-47df-9596-78846d4d97c02026-02-12Warnings, Adverse reactionsExact identifier
unii: 935E97BOY8
unii: P6YC3EG204
Mold, Yeast and DustADRENALINUM, ARSENICUM IODATUM, ASPERGILLUS FLAVUS, ASPERGILLUS FUMIGATUS, ASPERGILLUS GLAUCUS, ASPERGILLUS NIDULANS, ASPERGILLUS NIGER, CANDIDA ALBICANS, DERMATOPHAGOIDES FARINAE, HISTAMINUM HYDROCHLORICUM, LYCOPODIUM CLAVATUM, MUCOR PLUMBEUS, NATRUM SULPHURICUM, PENICILLIUM DIGITATUM, PENICILLIUM ROQUEFORTII, SACCHAROMYCES CEREVISIAE, SILICEANaturalCare32afa0f0-bca5-4246-bc2e-decd757fcf9d2026-02-09WarningsExact identifier
unii: ETJ7Z6XBU4
cyanocobalaminCYANOCOBALAMINSportpharm LLC647842f4-b211-4f52-8b73-975fae7670232026-02-05Warnings, Adverse reactionsExact identifier
unii: P6YC3EG204
DPT-TOXDROSERA, ECHINACEA, HYPERICUM, KALI MUR, MEZEREUM, SILICEA, THUJANutrition Center Inc dba Nutri-West dba Micro-West5e39f4e6-939f-4b71-9cc5-6d4b8711ea322026-02-04WarningsExact identifier
unii: ETJ7Z6XBU4
Meteoric Iron PrunusMETEORIC IRON PRUNUSUriel Pharmacy Inc.e9020757-2393-4a22-9665-25da0a0993d02026-02-03WarningsExact identifier
unii: ETJ7Z6XBU4
Mold, Yeast and DustACREMONIUM STRICTUM, ADRENALINUM, ALLIUM CEPA, ALTERNARIA ALTERNATA, ARSENICUM IODATUM, ASPERGILLUS FUMIGATUS, ASPERGILLUS NIGER, AUREOBASIDIUM PULLULANS, CANDIDA ALBICANS, CLADOSPORIUM HERBARUM, COCKROACH, DERMATOPHAGOIDES FARINAE, EPICOCCUM PURPURASCENS, FUSARIUM SOLANI, HISTAMINUM HYDROCHLORICUM, LYCOPODIUM CLAVATUM, MUCOR CIRCINELLOIDES, NATRUM SULPHURICUM, RHIZOPUS STOLONIFER, SACCHAROMYCES CEREVISIAE, SILICEANaturalCaree0f53f47-acd9-43e2-a7a2-2a500bc9dc1b2026-02-03WarningsExact identifier
unii: ETJ7Z6XBU4
Additive Formula 3DEXTROSE MONOHYDRATE, TRISODIUM CITRATE DIHYDRATE, SODIUM CHLORIDE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, CITRIC ACID MONOHYDRATE, AND ADENINETerumo BCT, Ltd9a5247a1-cc05-442d-b2d0-950f887f03c22026-01-30Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACID MONOHYDRATEAtlantic Biologicals Corp.42d837ae-2578-46df-92d2-24774964aaad2026-01-28Adverse reactionsExact identifier
unii: 1Q73Q2JULR
Carboxymethylcellulose Sodium Eye Drops 0.5%CARBOXYMETHYLCELLULOSE SODIUM EYE DROPS 0.5%Aurolabe8b4df3b-3d81-b3ca-e053-2a95a90af2ec2026-01-27WarningsExact identifier
unii: K679OBS311
AURO-CMCCARBOXYMETHYLCELLULOSE EYE DROPS 0.5%Aurolabe90b397f-fe64-8674-e053-2995a90a223f2026-01-27WarningsExact identifier
unii: K679OBS311
Dialyvite 5000ASCORBIC ACID, TOCOPHERYL ACID SUCCINATE, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, FOLIC ACID, COBALAMIN, BIOTIN, PANTOTHENIC ACID, ZINC, SELENIUMHillestad Pharmaceuticals USA97791f73-e0c5-45a6-8aed-f456a5466eaf2026-01-27Adverse reactionsExact identifier
unii: 935E97BOY8
unii: 68Y4CF58BV
DialyviteASCORBIC ACID, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, FOLIC ACID, COBALAMIN, BIOTIN, PANTOTHENIC ACIDHillestad Pharmaceuticals USA7a5e6dd6-5687-44bb-8964-841961c0e64a2026-01-27Adverse reactionsExact identifier
unii: 935E97BOY8
unii: 68Y4CF58BV
Dialyvite Supreme DASCORBIC ACID, CHOLECALCIFEROL, ALPHA-TOCOPHEROL, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, FOLIC ACID, COBALAMIN, BIOTIN, PANTOTHENIC ACID, ZINC, SELENIUMHillestad Pharmaceuticals USA46fc3acf-1e6d-4830-ae9a-abd9c1132fca2026-01-27Adverse reactionsExact identifier
unii: 935E97BOY8
unii: 68Y4CF58BV
BioMicroneedle PDRN CreamSILICON DIOXIDEGuangzhou Shengyanghui Industrial Trading Co., Ltd48e2edae-94ea-c42e-e063-6394a90a907b2026-01-21WarningsExact identifier
unii: ETJ7Z6XBU4
Folic AcidFOLIC ACIDXGen Pharmaceuticals DJB, Inc.c5b2b84d-9f5e-4b81-ba10-9f2854e5dce92026-01-21Warnings, Adverse reactionsExact identifier
unii: 935E97BOY8
Inflammation IECHINACEA (ANGUSTIFOLIA), NASTURTIUM AQUATICUM, PHYTOLACCA DECANDRA, HYDRASTIS CANADENSIS, APIS MELLIFICA, BELLADONNA, FERRUM PHOSPHORICUM, NITRICUM ACIDUM, OLEANDER, SILICEABioActive Nutritional, Inc.3cb12181-ae7e-45c7-a1b1-e1952f36f8c32026-01-21WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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