gelo-X

Manufacturer: Dharma Research, Inc.
Effective date: 2021-07-02
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 20:37:17

Label at a glance#

Productgelo-X

Active ingredientSODIUM FLUORIDE

Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GeloXOrange

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53045-212-17	gelo-X	490 g in 1 BOTTLE	GEL, DENTIFRICE	490		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53045-212	GELO-X (SODIUM FLUORIDE) GEL, DENTIFRICE [DHARMA RESEARCH, INC.]	1	1 package rows	20210703_2ac13564-6076-476a-baf8-8a95747eca1f.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 17 matching rows.

gelo-X
Sodium Fluoride
FLUORIDE ION
CITRIC ACID MONOHYDRATE
FD&C RED NO. 40
FD&C YELLOW NO. 5
HYDROFLUORIC ACID
MAGNESIUM ALUMINUM SILICATE
PHOSPHORIC ACID
POLYSORBATE 20
WATER
SODIUM BENZOATE
SACCHARIN SODIUM
TITANIUM DIOXIDE
.ALPHA.-TOCOPHEROL ACETATE
XANTHAN GUM
XYLITOL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
53045-212	53045-212-17

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
SODIUM FLUORIDE	8ZYQ1474W7	ACTIM
CITRIC ACID MONOHYDRATE	2968PHW8QP	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
FD&C YELLOW NO. 5	I753WB2F1M	IACT
HYDROFLUORIC ACID	RGL5YE86CZ	IACT
MAGNESIUM ALUMINUM SILICATE	6M3P64V0NC	IACT
PHOSPHORIC ACID	E4GA8884NN	IACT
POLYSORBATE 20	7T1F30V5YH	IACT
WATER	059QF0KO0R	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	IACT
XANTHAN GUM	TTV12P4NEE	IACT
XYLITOL	VCQ006KQ1E	IACT

Source Document#

Source XML

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
10503e47-108e-4c8e-9ec9-b2f9ef7ae165			2ac13564-6076-476a-baf8-8a95747eca1f	2021-07-02		Exact identifier spl id: 10503e47-108e-4c8e-9ec9-b2f9ef7ae165 spl set id: 2ac13564-6076-476a-baf8-8a95747eca1f

Reported adverse events (FAERS/openFDA)#

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