MedActive Oral Relief

Manufacturer: Integrate Oral Care, LLC.
Effective date: 2021-12-30
Label type: HUMAN OTC DRUG LABEL
Version: 12
Source: full-release
Hydrated at: 2026-05-31 23:46:05

Label at a glance#

ProductMedActive Oral Relief

Active ingredientGLYCERIN

Label structure10 sections

Contacts and useful links#

PhoneLabel contact1-866-887-4867

Websitewww.integrateoralcare.com

www.integrateoralcare.com

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Glycerin 6% (prediluted)

OTC - PURPOSE SECTION

Purpose

Oral Demulcent

INDICATIONS & USAGE SECTION

Uses

For temporary relief of minor discomfort and protection of irritated areas in sore mouth and sore throat.

WARNINGS SECTION

Warnings

Sore Throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, see your dentist or doctor promptly.

If an excessive amount of spray is accidentally swallowed, get medical help or contact a Poison Control Center right away. Avoid contact with eyes.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children.

DOSAGE & ADMINISTRATION SECTION

Directions

Use as needed or as directed by a dentist or doctor.

Adults and children 2 years of age and older: Hold bottle upright. Gently press down on spray and apply directly to affected areas in the mouth, approximately 3-4 times per application. Do not rinse out.
Children under 12 years of age: Should be supervised in the use of this product.
Children under 2 years of age: Consult a dentist or doctor.

OTHER SAFETY INFORMATION

Other Information

Store at room temperature. Safe to swallow.
Do not use if safety sleeve or label is damaged prior to first use. Do not push down on spray rapidly or excessively, as it may cause blockage.
You may experience a slight, temporary tingle sensation upon initial use; this is normal and causes no harm.

INACTIVE INGREDIENT SECTION

Inactive Ingredients

dimethicone, EDTA, flavor (includes Spilanthes Extract), poloxamer 407, potassium sorbate, sodium saccharin, sucralose, water, xanthan gum, xylitol

OTC - QUESTIONS SECTION

Questions or comments?

Call toll-free 1-866-887-4867 or visit www.integrateoralcare.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Oral Relief Spray

NEW Natural Spring Flavor

MedActive® Oral Relief Spray

with ULTRAMULSION® & Spilanthes Extract

For Relief of Oral Discomfort

Oral Demulcent

Glycerin 6%

NDC 49741-1016-1

1 FL.OZ. (29.5 mL)

Spray Natural Spring

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
GLYCERIN Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
777d68c6-a5ab-e06c-d314-677b0b9af0c8	Product name	2	20240508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
49741-1016-1	2023-01-30	C162847	48780-1	ab0e2407-2d5d-f274-e053-dbdaa90a6471	205c42c1-6849-4e70-e054-00144ff88e88
49741-1016-1	2020-12-31	C162847	48780-1	ab0e2407-2d5d-f274-e053-dbdaa90a6471	205c42c1-6849-4e70-e054-00144ff88e88
49741-1016-1	2020-09-27	C162847	48780-1	ab0e2407-2d5d-f274-e053-dbdaa90a6471	205c42c1-6849-4e70-e054-00144ff88e88
49741-1016-1	2020-09-25	C162847	48780-1	ab0e2407-2d5d-f274-e053-dbdaa90a6471	205c42c1-6849-4e70-e054-00144ff88e88
49741-1016-1	2020-07-22	C162847	48780-1	ab0e2407-2d5d-f274-e053-dbdaa90a6471	205c42c1-6849-4e70-e054-00144ff88e88

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
49741-1016-1	MedActive Oral Relief	29.5 mL in 1 BOTTLE, SPRAY	SPRAY	29.5		12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49741-1016	MEDACTIVE ORAL RELIEF (SPRAY) SPRAY [INTEGRATE ORAL CARE, LLC.]	12	Legacy NDC, 1 package rows	20211231_205c42c1-6849-4e70-e054-00144ff88e88.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
GLYCERIN	ACTIVE INGREDIENT	PDC6A3C0OX	1
GLYCERIN	ACTIVE MOIETY	PDC6A3C0OX	1
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	1
EDETIC ACID	INACTIVE INGREDIENT	9G34HU7RV0	1
POLOXAMER 407	INACTIVE INGREDIENT	TUF2IVW3M2	1
POTASSIUM SORBATE	INACTIVE INGREDIENT	1VPU26JZZ4	1
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	1
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	1
XYLITOL	INACTIVE INGREDIENT	VCQ006KQ1E	1

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

MedActive Oral Relief
Spray
POLOXAMER 407
SUCRALOSE
GLYCERIN
DIMETHICONE
EDETIC ACID
SACCHARIN SODIUM
WATER
XYLITOL
XANTHAN GUM
POTASSIUM SORBATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
49741-1016	49741-1016-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
POLOXAMER 407	TUF2IVW3M2	IACT
SUCRALOSE	96K6UQ3ZD4	IACT
GLYCERIN	PDC6A3C0OX	ACTIB
DIMETHICONE	92RU3N3Y1O	IACT
EDETIC ACID	9G34HU7RV0	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT
WATER	059QF0KO0R	IACT
XYLITOL	VCQ006KQ1E	IACT
XANTHAN GUM	TTV12P4NEE	IACT
POTASSIUM SORBATE	1VPU26JZZ4	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 3 · 144 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	GRANULE, FOR SUSPENSION / ORAL		80 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	TABLET, COATED / ORAL	NA		Exact identifier — unii candidate 19 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SUSPENSION / TOPICAL	0.11 %w/v		Exact identifier — unii candidate 29 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	OINTMENT / DENTAL	NA		Exact identifier — unii candidate 34 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	EMULSION / OPHTHALMIC	0.47 %w/v		Exact identifier — unii candidate 19 equally ranked IID candidates
EDETIC ACID	EDETIC ACID	9G34HU7RV0	GEL / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 13 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	TABLET, ORALLY DISINTEGRATING / ORAL	0.15 mg		Exact identifier — unii candidate 29 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SUSPENSION / OPHTHALMIC		2 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	SOLUTION / ORAL		665 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
EDETIC ACID	EDETIC ACID	9G34HU7RV0	SHAMPOO / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 13 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	SUSPENSION, EXTENDED RELEASE / ORAL		9000 mg	Exact identifier — unii candidate 12 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	GRANULE, FOR SUSPENSION / ORAL		450 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	TABLET, EFFERVESCENT / ORAL		1080 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SUSPENSION / ORAL		360 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	TABLET / BUCCAL	0.4 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	GRANULE, FOR SOLUTION / ORAL	5.5 mg/120ml		Exact identifier — unii candidate 34 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	CAPSULE / ORAL		24 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	AEROSOL, METERED / RESPIRATORY (INHALATION)	0.05 %w/w		Exact identifier — unii candidate 34 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	FILM, SOLUBLE / ORAL		33 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	SUSPENSION / RECTAL		290 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	INJECTION / INTRAVENOUS		22 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	ELIXIR / ORAL	15 mg/5ml		Exact identifier — unii candidate 34 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	TABLET / RECTAL	0.6 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	TROCHE / ORAL		60 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	FILM / BUCCAL		3 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SOLUTION / OPHTHALMIC	0.6 %w/v		Exact identifier — unii candidate 29 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	TABLET, EXTENDED RELEASE / ORAL		1 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	SOLUTION / DENTAL	0.05 %w/v		Exact identifier — unii candidate 34 equally ranked IID candidates
EDETIC ACID	EDETIC ACID	9G34HU7RV0	INJECTION, SOLUTION / INTRAMUSCULAR		2 mg	Exact identifier — unii candidate 13 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	LIQUID / ORAL		3 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
POLOXAMER 407	POLOXAMER 407	TUF2IVW3M2	CAPSULE / ORAL		468 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
EDETIC ACID	EDETIC ACID	9G34HU7RV0	INJECTION, SOLUTION / SUBCUTANEOUS		2 mg	Exact identifier — unii candidate 13 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	SOLUTION/ DROPS / OPHTHALMIC	0.47 %w/v		Exact identifier — unii candidate 19 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	SYRUP / ORAL		80 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL		2350 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	LOTION / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 19 equally ranked IID candidates
POLOXAMER 407	POLOXAMER 407	TUF2IVW3M2	SUSPENSION / INTRATYMPANIC		63 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	LOTION / TOPICAL	0.3 %w/v		Exact identifier — unii candidate 29 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	POWDER, FOR SUSPENSION / ORAL	4223 mg		Exact identifier — unii candidate 12 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SUSPENSION / RECTAL		452 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	CREAM / TOPICAL		46 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	SOLUTION / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 34 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	TABLET, FOR SUSPENSION / ORAL		6 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	SOLUTION / RECTAL		665 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	POWDER, FOR SOLUTION / ORAL	10 mg/5ml		Exact identifier — unii candidate 29 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	TABLET / ORAL		56 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
POLOXAMER 407	POLOXAMER 407	TUF2IVW3M2	SOLUTION / ORAL	50 mg/5ml		Exact identifier — unii candidate 15 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	FILM, SOLUBLE / ORAL		29 mg	Exact identifier — unii candidate 12 equally ranked IID candidates
EDETIC ACID	EDETIC ACID	9G34HU7RV0	TABLET / ORAL	4 mg		Exact identifier — unii candidate 13 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	INJECTION / INTRAMUSCULAR		22 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	TABLET / SUBLINGUAL		7 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SUSPENSION/ DROPS / ORAL		22 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	FILM, SOLUBLE / ORAL		1 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
POLOXAMER 407	POLOXAMER 407	TUF2IVW3M2	GEL / PERIODONTAL	155 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	0.2 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	TROCHE / ORAL		948 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	SUSPENSION, EXTENDED RELEASE / ORAL		16 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	SOLUTION / ORAL		800 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	SYRUP / ORAL	2 mg/1ml		Exact identifier — unii candidate 19 equally ranked IID candidates
EDETIC ACID	EDETIC ACID	9G34HU7RV0	INJECTION, SOLUTION / SUBMUCOSAL	0.03 %w/v		Exact identifier — unii candidate 13 equally ranked IID candidates

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
d464492d-63c3-d956-e053-2995a90ae010			205c42c1-6849-4e70-e054-00144ff88e88	2021-12-30	Warnings	Exact identifier spl id: d464492d-63c3-d956-e053-2995a90ae010 spl set id: 205c42c1-6849-4e70-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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