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 41 of 52 · 1,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Equate Lubricant Eye Drops Preservative-FreeCARBOXYMETHYLCELLULOSE SODIUMWal-Mart Stores, Inc.9228a39b-38d2-1dfc-e053-2a95a90a3c902023-12-23WarningsExact identifier
unii: K679OBS311
Equate Restore Plus Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMWalmart, Inc.9e665ca2-4fa6-fdb4-e053-2a95a90abcca2023-12-23WarningsExact identifier
unii: K679OBS311
Leader Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMCardinal Health8d9a4eec-bf0e-6c3b-e053-2995a90ae9aa2023-12-23WarningsExact identifier
unii: K679OBS311
Good Neighbor Pharmacy Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMAmerisource Bergen Drug Corp.fd2dc23f-6ccc-2644-e053-6294a90a889e2023-12-23WarningsExact identifier
unii: K679OBS311
Folic AcidFOLIC ACIDCadila Pharmaceuticals Limited103c2cdd-5822-48ba-b62a-e2b11aa444ef2023-12-23Warnings, Adverse reactionsExact identifier
unii: 935E97BOY8
Walgreens Lubricant Eye Drops Preservative FreeCARBOXYMETHYLCELLULOSE SODIUMWalgreen Company9912b773-e7a5-3a82-e053-2995a90a5b2c2023-12-20WarningsExact identifier
unii: K679OBS311
Lubricant Eye Drops Preservative FreeCARBOXYMETHYLCELLULOSE SODIUMTarget Corporation454ce049-49e5-48b1-8499-048e5e7d72d32023-12-20WarningsExact identifier
unii: K679OBS311
Rugby Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMRugby Laboratoriesf9292d5d-e0a3-9287-e053-6294a90a43e92023-12-20WarningsExact identifier
unii: K679OBS311
Signature Care Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMBetter Living Brands LLCea358e01-f03e-454b-bae1-6c83da44c3692023-12-20WarningsExact identifier
unii: K679OBS311
Kroger Lubricant EyeCARBOXYMETHYLCELLULOSE SODIUMThe Kroger Co.046f4ebc-d8f9-4755-b6ba-790fe86f31282023-12-20WarningsExact identifier
unii: K679OBS311
HEB Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMHEB5d522e4d-d647-486f-a947-25c14b1417fa2023-12-20WarningsExact identifier
unii: K679OBS311
MenatrolFOLATE, MULTIVITAMINPureTek Corporation0a100e7d-3a8d-2d8b-e063-6394a90a32032023-12-18Boxed warning, Adverse reactionsExact identifier
unii: 68Y4CF58BV
BSSBALANCED SALT SOLUTIONAlcon Laboratories, Inc.28488c7b-cf6a-4a03-916f-cc66b3afdc572023-12-14Warnings, Adverse reactionsExact identifier
unii: 1Q73Q2JULR
OracitCITRIC ACID AND SODIUM CITRATECMP Pharma, Inc.bc26abed-8e6e-475d-8ab3-abf7d03770032023-12-07Adverse reactionsExact identifier
unii: 2968PHW8QP
FOLIC ACIDFOLIC ACIDBryant Ranch Prepack0b263a1e-260b-4775-a76e-766add336f122023-12-04Warnings, Adverse reactionsExact identifier
unii: 935E97BOY8
Doxylamine Succinate and Pyridoxine HydrochlorideDOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE, DELAYED RELEASE TABLETS 10 MG/10 MGBryant Ranch Prepackc283720d-f9a5-471f-9616-853a70f2b31d2023-12-04Warnings, Adverse reactionsExact identifier
unii: 68Y4CF58BV
CyanocobalaminCYANOCOBALAMINHikma Pharmaceuticals USA Inc.a66eb3c4-3e1d-4d49-b963-4fa2334cc9b62023-12-01Warnings, Adverse reactionsExact identifier
unii: P6YC3EG204
Davimet-MMULTIVITAMINPureTek Corporation0b67e8de-d81e-0fda-e063-6394a90ac2292023-11-30Warnings, Adverse reactionsExact identifier
unii: 68Y4CF58BV
PhexxiLACTIC ACID, L-, CITRIC ACID MONOHYDRATE, AND POTASSIUM BITARTRATEEvofem, Inc.173ff411-7227-47b0-94dc-844e1ebaf14e2023-11-21Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
Cellular OxygenatorCACTUS GRANDIFLORUS, ASCORBICUM ACIDUM, NICOTINAMIDUM, PYRIDOXINUM HYDROCHLORICUM, THIAMINUM HYDROCHLORICUM, MAGNESIUM GLUCONICUM DIHYDRICUM, RIBOFLAVINUM, MAGNESIA PHOSPHORICA, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-LIPOICUM ACIDUM, ANTHRACHINONUM, COENZYME A, NADIDUM, NAJA TRIPUDIANS, UBIDECARENONUM (COQ10)Nutritional Specialties, Inc.e5869f25-276f-456a-ab05-2a1899845afb2023-11-21WarningsExact identifier
unii: 68Y4CF58BV

Reported adverse events (FAERS/openFDA)#

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