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
Label	Manufacturer	Effective date	Type
TL Gard Rx - Trigen Laboratories, LLC	Trigen Laboratories, LLC	2019-11-07	DIETARY SUPPLEMENT

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
13811-527-01	EA - Each	13811-527	ab786c7c-9d48-4249-8b55-173c2b2ae04f	1	2013-06-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
cyanocobalamin	ACTIVE INGREDIENT	P6YC3EG204	TL GARD RX (FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, AND CYANOCOBALAMIN) TABLET, FILM COATED [TRIGEN LABORATORIES, INC.]	2
Folic Acid	ACTIVE INGREDIENT	935E97BOY8	TL GARD RX (FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, AND CYANOCOBALAMIN) TABLET, FILM COATED [TRIGEN LABORATORIES, INC.]	2
pyridoxine Hydrochloride	ACTIVE INGREDIENT	68Y4CF58BV	TL GARD RX (FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, AND CYANOCOBALAMIN) TABLET, FILM COATED [TRIGEN LABORATORIES, INC.]	2
cyanocobalamin	ACTIVE MOIETY	P6YC3EG204	TL GARD RX (FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, AND CYANOCOBALAMIN) TABLET, FILM COATED [TRIGEN LABORATORIES, INC.]	2
Folic Acid	ACTIVE MOIETY	935E97BOY8	TL GARD RX (FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, AND CYANOCOBALAMIN) TABLET, FILM COATED [TRIGEN LABORATORIES, INC.]	2
PYRIDOXINE	ACTIVE MOIETY	KV2JZ1BI6Z	TL GARD RX (FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, AND CYANOCOBALAMIN) TABLET, FILM COATED [TRIGEN LABORATORIES, INC.]	2
Calcium Phosphate, Dibasic, Anhydrous	INACTIVE INGREDIENT	L11K75P92J	TL GARD RX (FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, AND CYANOCOBALAMIN) TABLET, FILM COATED [TRIGEN LABORATORIES, INC.]	2
carboxymethylcellulose sodium	INACTIVE INGREDIENT	K679OBS311	TL GARD RX (FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, AND CYANOCOBALAMIN) TABLET, FILM COATED [TRIGEN LABORATORIES, INC.]	2
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	TL GARD RX (FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, AND CYANOCOBALAMIN) TABLET, FILM COATED [TRIGEN LABORATORIES, INC.]	2
citric acid monohydrate	INACTIVE INGREDIENT	2968PHW8QP	TL GARD RX (FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, AND CYANOCOBALAMIN) TABLET, FILM COATED [TRIGEN LABORATORIES, INC.]	2
dextrose	INACTIVE INGREDIENT	IY9XDZ35W2	TL GARD RX (FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, AND CYANOCOBALAMIN) TABLET, FILM COATED [TRIGEN LABORATORIES, INC.]	2
icodextrin	INACTIVE INGREDIENT	2NX48Z0A9G	TL GARD RX (FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, AND CYANOCOBALAMIN) TABLET, FILM COATED [TRIGEN LABORATORIES, INC.]	2
potassium citrate anhydrous	INACTIVE INGREDIENT	86R1NVR0HW	TL GARD RX (FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, AND CYANOCOBALAMIN) TABLET, FILM COATED [TRIGEN LABORATORIES, INC.]	2
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	TL GARD RX (FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, AND CYANOCOBALAMIN) TABLET, FILM COATED [TRIGEN LABORATORIES, INC.]	2
sodium citrate	INACTIVE INGREDIENT	1Q73Q2JULR	TL GARD RX (FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, AND CYANOCOBALAMIN) TABLET, FILM COATED [TRIGEN LABORATORIES, INC.]	2
stearic acid	INACTIVE INGREDIENT	4ELV7Z65AP	TL 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 47 of 51 · 1,018 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
REFRESH PLUS	CARBOXYMETHYLCELLULOSE SODIUM	Allergan, Inc.	0f6a4b4b-cde6-4518-84b5-ce997f1154a7	2022-06-28	Warnings	Exact identifier unii: K679OBS311
Addiclenz	BETA VULGARIS, BOLDO, CHELIDONIUM MAJUS, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, ARSENICUM ALBUM, BISPHENOL A, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, ZINCUM METALLICUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYL PARABEN, PROPYL PARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM	Deseret Biologicals, Inc.	e39235ea-2a2f-44a7-92d6-fb1d428ebabd	2022-05-12	Warnings	Exact identifier unii: 1Q73Q2JULR
Cyanocobalamin	CYANOCOBALAMIN	Meitheal Pharmaceuticals Inc.	ccf5b124-083d-4465-a666-c1bc6e84d630	2022-04-29	Warnings, Adverse reactions	Exact identifier unii: P6YC3EG204
cyanocobalamin	CYANOCOBALAMIN	Zydus Pharmaceuticals USA Inc.	e6712877-ace0-441c-99a9-adf567c0b9a2	2022-04-25	Warnings, Adverse reactions	Exact identifier unii: P6YC3EG204
cyanocobalamin	CYANOCOBALAMIN	Zydus Lifesciences Limited	ef300a08-8212-40a9-847a-1b62348896dd	2022-04-19		Exact identifier unii: P6YC3EG204
FOLIC ACID	FOLIC ACID	Proficient Rx LP	607d23e8-21ef-4d73-88f1-990cf267d22e	2022-04-01	Warnings, Adverse reactions	Exact identifier unii: 935E97BOY8
ALPHA SH	SANGUINARIA CANADENSIS ROOT, GOLDENSEAL, SILICON DIOXIDE, POTASSIUM CHLORIDE, PULSATILLA VULGARIS	Schwabe Mexico, S.A. de C.V.	3e2e5f52-db54-4635-83a8-a67a683c093c	2022-03-22	Warnings	Exact identifier unii: ETJ7Z6XBU4
ALPHA SH	SANGUINARIA CANADENSIS ROOT, GOLDENSEAL, SILICON DIOXIDE, POTASSIUM CHLORIDE, PULSATILLA VULGARIS	Schwabe North America, Inc.	94de9ce3-6ee9-4322-bda2-0b4391f09d87	2022-03-22	Warnings	Exact identifier unii: ETJ7Z6XBU4
Ear Care	ECHINACEA, HYDRASTIS CANADENSIS, APIS MELLIFICA, ARSENICUM ALBUM, BELLADONNA, BRYONIA, CAPSICUM ANNUUM, CAUSTICUM, CINCHONA OFFICINALIS, CONIUM MACULATUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI SULPHURICUM, LYCOPODIUM CLAVATUM, MERCURIUS VIVUS, MEZEREUM, PHOSPHORUS, PLANTAGO MAJOR, PULSATILLA, SILICEA, VERBASCUM THAPSUS, TELLURIUM METALLICUM, INFLUENZINUM	Newton Laboratories, Inc.	da807eb3-34a3-61b9-e053-2995a90a0e21	2022-03-18	Warnings	Exact identifier unii: ETJ7Z6XBU4
Ear Care	INFLUENZINUM, TELLURIUM METALLICUM, APIS MEL., ARSENICUM ALB., BELLADONNA, BRYONIA, CAPSICUM, CAUSTICUM, CINCHONA, CONIUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPH. CALC.,KALI SULPH., LYCOPODIUM, MERC. VIV., MEZEREUM, PHOSPHORUS, PLANTAGO, PULSATILLA, SILICEA, VERBASCUM, ECHINACEA, HYDRASTIS	Newton Laboratories, Inc.	da80a5ea-f603-719e-e053-2995a90a9710	2022-03-18	Warnings	Exact identifier unii: ETJ7Z6XBU4
Ear Care	INFLUENZINUM, TELLURIUM METALLICUM, APIS MEL., ARSENICUM ALB., BELLADONNA, BRYONIA, CAPSICUM, CAUSTICUM, CINCHONA, CONIUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPH. CALC.,KALI SULPH., LYCOPODIUM, MERC. VIV., MEZEREUM, PHOSPHORUS, PLANTAGO, PULSATILLA, SILICEA, VERBASCUM, ECHINACEA, HYDRASTIS	Newton Laboratories, Inc.	da81b21a-090a-dabf-e053-2995a90aa05e	2022-03-18	Warnings	Exact identifier unii: ETJ7Z6XBU4
Ear Care	INFLUENZINUM, TELLURIUM METALLICUM, APIS MEL., ARSENICUM ALB., BELLADONNA, BRYONIA, CAPSICUM, CAUSTICUM, CINCHONA, CONIUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPH. CALC.,KALI SULPH., LYCOPODIUM, MERC. VIV., MEZEREUM, PHOSPHORUS, PLANTAGO, PULSATILLA, SILICEA, VERBASCUM, ECHINACEA, HYDRASTIS	Newton Laboratories, Inc.	da821d05-b2f0-3582-e053-2a95a90afe59	2022-03-18	Warnings	Exact identifier unii: ETJ7Z6XBU4
Ear Care	ECHINACEA, HYDRASTIS CANADENSIS, APIS MELLIFICA, ARSENICUM ALBUM, BELLADONNA, BRYONIA, CAPSICUM ANNUUM, CAUSTICUM, CINCHONA OFFICINALIS, CONIUM MACULATUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI SULPHURICUM, LYCOPODIUM CLAVATUM, MERCURIUS VIVUS, MEZEREUM, PHOSPHORUS, PLANTAGO MAJOR, PULSATILLA, SILICEA, VERBASCUM THAPSUS, TELLURIUM METALLICUM, INFLUENZINUM	Newton Laboratories, Inc.	da717cf0-54af-c4e2-e053-2995a90ac97c	2022-03-17	Warnings	Exact identifier unii: ETJ7Z6XBU4
Cyanocobalamin	CYANOCOBALAMIN	AuroMedics Pharma LLC	db84d0ea-5c15-47f5-bbe2-8d455e75695e	2022-03-10	Warnings, Adverse reactions	Exact identifier unii: P6YC3EG204
ACNE HP	CARBO ANIMALIS, ACTIVATED CHARCOAL, POTASSIUM DICHROMATE, SODIUM CHLORIDE, PULSATILLA VULGARIS, SEPIA OFFICINALIS JUICE, SILICON DIOXIDE, SULFUR, ZINC	Natural Creations, Inc.	b2368ab6-e233-4473-99fa-86e1fbc2a879	2022-02-14	Warnings	Exact identifier unii: ETJ7Z6XBU4
ACD-A	ANTICOAGULANT CITRATE DEXTROSE SOLUTION FORMULA A	Fenwal, Inc.	22805f0d-ba58-41ea-b245-19980abcda22	2022-02-11		Exact identifier unii: 1Q73Q2JULR
Dotremin	FOLIC ACID, VITAMIN D3	PureTek Corporation	cd132db2-7ff7-a9eb-e053-2995a90a02c5	2022-01-14	Warnings, Adverse reactions	Exact identifier unii: 935E97BOY8
Prenatal Plus Vitamins	PRENATAL WITH FERROUS FUMARATE AND FOLIC ACID	Patrin Pharma, Inc.	59c5c1a4-3f42-441a-b842-903f9bab346f	2022-01-13	Boxed warning	Exact identifier unii: 935E97BOY8 unii: P6YC3EG204 unii: 68Y4CF58BV
EAR RX	ACONITUM NAP, BARYTA CARB, BELLADONNA, CALC CARB, CAPSICUM, CARBO VEG, CAUSTICUM, CHAMOMILLA, FERRUM PHOS, HEPAR SULPH CALC, KALI MUR, LACHESIS, LYCOPODIUM, MERCURIUS SOL, NATRUM MUR, PLANTAGO, PULSATILLA, SILICEA, SULPHUR, VERBASCUM	Miami Beach Pediatrics pa	a8753f88-4b8a-472f-a4bd-f2e9cec83610	2021-12-29	Warnings	Exact identifier unii: ETJ7Z6XBU4
Lyme Disease Support 2	ARGENTUM NITRICUM, ASTRAGALUS MENZIESII, CALCAREA SULPHURICA, CUPRUM ARSENICOSUM, DNA, FERRUM PHOSPHORICUM, KALI MURIATICUM, KALI SULPHURICUM, LEDUM PALUSTRE, MAGNESIA PHOSPHORICA, RNA, SILICEA.	OHM PHARMA INC.	13b4b78b-f9f7-4cf6-8f43-61679160086b	2021-12-29	Warnings	Exact identifier unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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