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 28 of 52 · 1,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Potassium Citrate and Citric AcidPOTASSIUM CITRATE AND CITRIC ACIDChartwell RX, LLC978a5a9d-f0ca-4308-a84b-3b132263bbb82025-04-09Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
Bio Co Enzyme PhaseACONITICUM ACIDUM, CIS-, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ADRENALINUM, , ALPHA-KETOGLUTARICUM ACIDUM, ALPHA-LIPOICUM ACIDUM, ASCORBICUM ACIDUM, BARIUM OXALSUCCINICUM, BETA VULGARIS, CERIUM OXALICUM, CITRICUM ACIDUM, CYSTEINUM, FUMARICUM ACIDUM, HEPAR SULPHURIS CALCAREUM, MAGNESIUM OROTICUM DIHYDRICUM, MALICUM ACIDUM, MANGANUM PHOSPHORICUM, NADIDUM, NATRUM OXALACETICUM, NATRUM PYRUVICUM, NICOTINAMIDUM, PANTOTHENIC ACID, PROTEUS (MORGANI), PULSATILLA (PRATENSIS), PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM,Deseret Biologicals, Inc.6edee6eb-0ec9-4d2a-9dc9-dc2a6503a6db2025-04-08WarningsExact identifier
unii: 68Y4CF58BV
NiferexFERROUS ASPARTO GLYCINATE, IRON, ASCORBIC ACID, FOLIC ACID, CYANOCOBALAMIN, ZINC, AND SUCCINIC ACIDAvion Pharmaceuticals, LLCa38ff367-983b-42db-ae5e-c9f75f7ace132025-04-08Boxed warning, Adverse reactionsExact identifier
unii: 935E97BOY8
unii: P6YC3EG204
PMSANGELICA ARCHANGELICA, CIMICIFUGA RACEMOSA, FUCUS VESICULOSUS, HYPOTHALAMUS SUIS, MAGNESIUM GLUCONICUM DIHYDRICUM, OOPHORINUM (SUIS) PYRIDOXINUM HYDROCHLORICUM, BOVISTA, CUPRUM METALLICUM, SEPIA, ZINCUM METALLICUM, LACHESIS MUTUSBioActive Nutritional, Inc.85304d4f-78b9-499e-8e1d-9202d9cde33d2025-04-02WarningsExact identifier
unii: 68Y4CF58BV
GYNTIMA ProbioticaLACTIC ACID, FOLIC ACID, SAGEFytofontana LLC31b83e91-bdd1-bdd1-e063-6394a90a16d72025-04-01WarningsExact identifier
unii: 935E97BOY8
Alka-Seltzer Heartburn Relief Lemon LimeANHYDROUS CITRIC ACID, SODIUM BICARBONATE (HEAT-TREATED)Bayer Healthcare LLCcc21af24-9a5b-6831-e053-2a95a90a0af42025-04-01WarningsExact identifier
unii: 2968PHW8QP
JBA Collagen-Electrolyte MocktailVITAMIN C,THIAMIN,RIBOFLAVIN,NIACIN,VITAMIN B6,FOLATE,BIOTIN,PANTOTHENIC ACID,MAGNESIUM,ZINC,SODIUM,POTASSIUM,BOVINE COLLAGEN PEPTIDESAdvanced Pharmaceutical Services, Inc. Dba Affordable Quality Pharmaceuticalse0199be5-0c51-411a-a184-225c1e6e602f2025-03-31WarningsExact identifier
unii: 935E97BOY8
Bestmade Natural Products BM238SANTONINE, CINA, SILICEA, INDIGO, AMBROSIA, CUCCURBITA CIT, CUCCURBITA PEPBestmade Natural Products298fb9e2-3f98-01e6-e063-6294a90a7aaf2025-03-26WarningsExact identifier
unii: ETJ7Z6XBU4
Bestmade Natural Products BM60CIMICIFUGAD6, DROSERAD6, FORMICA RUFAD6, FULIGOD6, INULA HELD6, KALI MURD6, LAPIS ALBUSD6, SILICEAD6Bestmade Natural Products29912fb7-8712-18d9-e063-6394a90a82f72025-03-25WarningsExact identifier
unii: ETJ7Z6XBU4
Strovite One CapletsVITAMIN A, CALCIUM PANTOTHENATE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL SUCCINATE, D-, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, BIOTIN, CYANOCOBALAMIN, SELENIUM, MAGNESIUM OXIDE, ZINC OXIDE, CUPRIC SULFATE, MANGANESE, CHROMIUM, .ALPHA.-LIPOIC ACID, AND LUTEINExeltis USA, Inc.b9b71fa4-89c7-4f5b-8174-950649434ba52025-03-20Warnings, Adverse reactionsExact identifier
unii: 935E97BOY8
unii: P6YC3EG204
unii: 68Y4CF58BV
Vitafol Fe PlusDOCONEXENT, NIACINAMIDE, .ALPHA.-TOCOPHEROL ACETATE, DL-, CHOLECALCIFEROL, BETA CAROTENE, ASCORBIC ACID, THIAMINE MONONITRATE, RIBOFLAVIN, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, IRON, ZINC OXIDE, CUPRIC OXIDE, POTASSIUM IODIDE, MAGNESIUM OXIDE, FOLIC ACID, AND LEVOMEFOLATE CALCIUMExeltis USA, Inc.3927b074-d72a-4d8c-9f7e-15c42a8309452025-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 935E97BOY8
unii: P6YC3EG204
unii: 68Y4CF58BV
Vitafol OnePRENATAL SUPPLEMENT WITH DHAExeltis USA, Inc.42a5cafd-a2c0-4ac2-99c9-708642f007162025-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 935E97BOY8
unii: P6YC3EG204
unii: 68Y4CF58BV
HypothaltemEUPATORIUM PERFOLIATUM, BERBERIS VULGARIS, MENTHA PULEGIUM, MOSCHUS, BENZINUM, SEPIA, BARYTA CARBONICA, GLANDULA SUPRARENALIS SUIS, HYPOPHYSIS SUIS, HYPOTHALAMUS SUIS, THYROIDINUM (SUIS), PYRIDOXINUM HYDROCHLORICUM, GELSEMIUM SEMPERVIRENS, NATRUM CARBONICUM, NUX VOMICA, STAPHYSAGRIANucleic Products, LLCb95050f2-f40d-4e84-8752-4d7ad75390c92025-03-20WarningsExact identifier
unii: 68Y4CF58BV
Natural Eyes Stye Relief Fast Dissolving TablesAPIS MELLIFICA, CARBONEUM SULPHURATUM, PULSATILLA, SEPIA, SILICEATRP Company30a5435b-32b0-807d-e063-6294a90a84da2025-03-18WarningsExact identifier
unii: ETJ7Z6XBU4
EMF Protect and BalanceALFALFA, CADMIUM SULPHURATUM, CALCAREA CARBONICA, CUPRUM METALLICUM, FERRUM METALLICUM, FUCUS VESICULOSUS, HYPERICUM PERFORATUM, KALI PHOSPHORICUM, MAGNESIA PHOSPHORICA, MANGANUM METALLICUM, MERCURIUS VIVUS, PLUMBUM METALLICUM, SILICEA, SYMPHYTUM OFFICINALE, TARENTULA HISPANA, X-RAY, YTTERBIUM OXIDEDeseret Biologicals, Inc.00a2c1c7-2c04-4c71-9276-24ba87288d612025-03-17WarningsExact identifier
unii: ETJ7Z6XBU4
FOLIC ACIDFOLIC ACIDPD-Rx Pharmaceuticals, Inc.726bb436-69e3-452f-9f28-153b58bf3ca52025-03-13Warnings, Adverse reactionsExact identifier
unii: 935E97BOY8
Vitafol UltraDOCONEXENT, NIACINAMIDE, .ALPHA.-TOCOPHEROL ACETATE, DL-, CHOLECALCIFEROL, .BETA.-CAROTENE, ASCORBIC ACID, THIAMINE MONONITRATE, RIBOFLAVIN, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, IRON, ZINC OXIDE, CUPRIC OXIDE, POTASSIUM IODIDE, MAGNESIUM OXIDE, FOLIC ACID, AND LEVOMEFOLATE CALCIUMExeltis USA, Inc.40fa2c3a-f41f-434c-91de-5150a18d3e4b2025-03-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 935E97BOY8
unii: P6YC3EG204
unii: 68Y4CF58BV
Se-Natal 19 ChewableVITAMINS AND MINERALSSeton Pharmaceuticalsa54dd642-8884-415a-a082-cd9fb544e4002025-03-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 935E97BOY8
unii: P6YC3EG204
unii: 68Y4CF58BV
Alka-Seltzer Heartburn Relief Extra StrengthANHYDROUS CITRIC ACID, SODIUM BICARBONATE (HEAT-TREATED)Bayer Healthcare LLCdc1641f8-54c2-0d86-e053-2995a90a1dce2025-03-11WarningsExact identifier
unii: 2968PHW8QP
AddiclenzASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM, ARSENICUM ALBUM, BETA VULGARIS, BISPHENOL A, BOLDO, CHELIDONIUM MAJUS, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PETROSELINUM SATIVUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, TARAXACUM OFFICINALE, ZINCUM METALLICUMDeseret Biologicals, Inc.25036c26-1c21-4e5a-b4db-b8e1774583412025-03-11WarningsExact identifier
unii: 1Q73Q2JULR

Reported adverse events (FAERS/openFDA)#

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