Gelato Neutral PH

Manufacturer: Deepak Products, inc.
Effective date: 2011-08-11
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-05-31 20:12:43

Label at a glance#

ProductGelato Neutral PH

Active ingredientSODIUM FLUORIDE

Label structure5 sections

Storage and handling

Store at controlled room temperature 59-86 F (15-30 C) Protect from freezing

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

This is a prescription fluoride treatment foam used to help prevent dental decay.

WARNINGS SECTION

Do not swallow. Keep out of reach of children. Contents under pressure. Do not place in hot water or near radiators, stoves or other sources of heat. Do not puncture on incinerate container. Do not spray toward open flame. For professional use only.

INACTIVE INGREDIENT SECTION

Distilled water, Polaxamer, Triethanolamine, Phosphoric Acid, Sodium Saccharine, Sodium Laureth Sulfate, Hydrofluoric Acid, Xylitol, Potassium Hydroxide, Propellant A31.

STORAGE AND HANDLING SECTION

Store at controlled room temperature 59-86 F (15-30 C)
Protect from freezing

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1487267	Gelato 2 % Oral Foam	PSN	3
688393	sodium fluoride 2 % Oral Foam	PSN	3
1487267	sodium fluoride 20 MG/ML Oral Foam [Gelato sodium fluoride]	SBD	3
688393	sodium fluoride 20 MG/ML Oral Foam	SCD	3
1487267	Gelato 2 % Oral Foam	SY	3
1487267	Gelato 20 MG/ML Oral Foam	SY	3
1487267	Gelato Neutral pH 2 % Oral Foam	SY	3
688393	sodium fluoride 2 % Oral Foam	SY	3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68400-138-04	2020-01-31	C162847	48780-1	9d75b9d0-1ebb-f424-e053-dadaa90a57ce	ba5c415e-2a44-4b49-b85a-55984e3131b8

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68400-138-04	Gelato Neutral PH	125 g in 1 BOTTLE, SPRAY	AEROSOL, FOAM	125		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68400-138	GELATO NEUTRAL PH (SODIUM FLUORIDE) AEROSOL, FOAM [DEEPAK PRODUCTS, INC.]	3	Legacy NDC, 1 package rows	20110819_ba5c415e-2a44-4b49-b85a-55984e3131b8.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
SODIUM FLUORIDE	ACTIVE INGREDIENT	8ZYQ1474W7	3
FLUORIDE ION	ACTIVE MOIETY	Q80VPU408O	3
DECYL GLUCOSIDE	INACTIVE INGREDIENT	Z17H97EA6Y	3
DMDM HYDANTOIN	INACTIVE INGREDIENT	BYR0546TOW	3
HYDROFLUORIC ACID	INACTIVE INGREDIENT	RGL5YE86CZ	3
PHOSPHORIC ACID	INACTIVE INGREDIENT	E4GA8884NN	3
POLOXAMER 407	INACTIVE INGREDIENT	TUF2IVW3M2	3
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	3
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	3
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	3
SODIUM LAURETH SULFATE	INACTIVE INGREDIENT	BPV390UAP0	3
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	3
XYLITOL	INACTIVE INGREDIENT	VCQ006KQ1E	3

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

Gelato Neutral PH
Sodium Fluoride
FLUORIDE ION
WATER
POLOXAMER 407
DECYL GLUCOSIDE
SODIUM LAURETH SULFATE
TROLAMINE
PHOSPHORIC ACID
SACCHARIN SODIUM
SODIUM BENZOATE
XYLITOL
HYDROFLUORIC ACID
POTASSIUM HYDROXIDE
DMDM HYDANTOIN

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
68400-138	68400-138-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
SODIUM FLUORIDE	8ZYQ1474W7	ACTIB
WATER	059QF0KO0R	IACT
POLOXAMER 407	TUF2IVW3M2	IACT
DECYL GLUCOSIDE	Z17H97EA6Y	IACT
SODIUM LAURETH SULFATE	BPV390UAP0	IACT
TROLAMINE	9O3K93S3TK	IACT
PHOSPHORIC ACID	E4GA8884NN	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
XYLITOL	VCQ006KQ1E	IACT
HYDROFLUORIC ACID	RGL5YE86CZ	IACT
POTASSIUM HYDROXIDE	WZH3C48M4T	IACT
DMDM HYDANTOIN	BYR0546TOW	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 · 165 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	GEL / DENTAL	0.08 %w/w		Exact identifier — unii candidate 35 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	FILM, SOLUBLE / BUCCAL		2 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
POTASSIUM HYDROXIDE	POTASSIUM HYDROXIDE	WZH3C48M4T	SOLUTION / TOPICAL	14.02 %w/w		Exact identifier — unii candidate 13 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	FILM, SOLUBLE / BUCCAL		3 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	FILM / BUCCAL		3 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	LIQUID / ORAL		3 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	PASTE, DENTIFRICE / DENTAL	0.5 %w/w		Exact identifier — unii candidate 35 equally ranked IID candidates
SODIUM LAURETH SULFATE	SODIUM LAURETH-3 SULFATE	BPV390UAP0	CAPSULE / ORAL	3.5 mg		Exact identifier — unii candidate 5 equally ranked IID candidates
PHOSPHORIC ACID	PHOSPHORIC ACID	E4GA8884NN	AEROSOL, FOAM / VAGINAL	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
PHOSPHORIC ACID	PHOSPHORIC ACID	E4GA8884NN	SPONGE / TOPICAL	ADJ PH		Exact identifier — unii candidate 28 equally ranked IID candidates
POTASSIUM HYDROXIDE	POTASSIUM HYDROXIDE	WZH3C48M4T	CAPSULE, EXTENDED RELEASE / ORAL	0.07 mg		Exact identifier — unii candidate 13 equally ranked IID candidates
PHOSPHORIC ACID	PHOSPHORIC ACID	E4GA8884NN	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	ADJ PH		Exact identifier — unii candidate 28 equally ranked IID candidates
POLOXAMER 407	POLOXAMER 407	TUF2IVW3M2	CREAM / TOPICAL		13 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	TABLET, ORALLY DISINTEGRATING / ORAL		10 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	TABLET / ORAL	15.04 mg		Exact identifier — unii candidate 12 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	GEL, METERED / TOPICAL		20 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
POTASSIUM HYDROXIDE	POTASSIUM HYDROXIDE	WZH3C48M4T	CAPSULE / ORAL		172 mg	Exact identifier — unii candidate 13 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	SOLUTION / RECTAL		665 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	GEL / DENTAL	0.3 %w/w		Exact identifier — unii candidate 34 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	GEL / TOPICAL		6 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
POTASSIUM HYDROXIDE	POTASSIUM HYDROXIDE	WZH3C48M4T	CAPSULE, DELAYED RELEASE / ORAL		5 mg	Exact identifier — unii candidate 13 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	OINTMENT / DENTAL	NA		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
PHOSPHORIC ACID	PHOSPHORIC ACID	E4GA8884NN	GEL / TOPICAL	ADJ PH		Exact identifier — unii candidate 28 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	GRANULE / ORAL	NA		Exact identifier — unii candidate 35 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	TABLET / BUCCAL	0.4 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	CREAM, AUGMENTED / TOPICAL		20 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SPONGE / TOPICAL	NA		Exact identifier — unii candidate 35 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	POWDER, FOR SOLUTION / ORAL		98 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	OINTMENT / TOPICAL	NA		Exact identifier — unii candidate 34 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	SUSPENSION / ORAL	5000 mg/5ml		Exact identifier — unii candidate 34 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	INJECTION / INTRAVENOUS		864 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SOLUTION / ORAL		660 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	TABLET, COATED / ORAL	0.2 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	TABLET, FILM COATED / ORAL	2 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
POLOXAMER 407	POLOXAMER 407	TUF2IVW3M2	SOLUTION / ORAL	50 mg/5ml		Exact identifier — unii candidate 15 equally ranked IID candidates
POLOXAMER 407	POLOXAMER 407	TUF2IVW3M2	CAPSULE, DELAYED RELEASE / ORAL		5 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
PHOSPHORIC ACID	PHOSPHORIC ACID	E4GA8884NN	INJECTION / INTRAVENOUS		1294 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
PHOSPHORIC ACID	PHOSPHORIC ACID	E4GA8884NN	INJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS	ADJ PH		Exact identifier — unii candidate 28 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS	0.02 %w/v		Exact identifier — unii candidate 22 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	CAPSULE / ORAL		24 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SODIUM LAURETH SULFATE	SODIUM LAURETH-3 SULFATE	BPV390UAP0	TABLET / ORAL	0.91 mg		Exact identifier — unii candidate 5 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	EMULSION / TOPICAL	0.5 %w/w		Exact identifier — unii candidate 22 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SOLUTION / TOPICAL	0.1 %w/v		Exact identifier — unii candidate 35 equally ranked IID candidates
POLOXAMER 407	POLOXAMER 407	TUF2IVW3M2	TABLET / ORAL		495 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
POLOXAMER 407	POLOXAMER 407	TUF2IVW3M2	GEL / TOPICAL		28 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	AEROSOL, METERED / RECTAL	ADJ PH		Exact identifier — unii candidate 22 equally ranked IID candidates
POTASSIUM HYDROXIDE	POTASSIUM HYDROXIDE	WZH3C48M4T	PASTILLE / ORAL	ADJ PH		Exact identifier — unii candidate 13 equally ranked IID candidates
DMDM HYDANTOIN	DMDM HYDANTOIN	BYR0546TOW	LOTION / TOPICAL		3 mg	Exact identifier — unii candidate
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	SOLUTION / ORAL		665 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
POTASSIUM HYDROXIDE	POTASSIUM HYDROXIDE	WZH3C48M4T	SOLUTION / INTRAVASCULAR	NA		Exact identifier — unii candidate 13 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	SPONGE / TOPICAL	11 %w/w		Exact identifier — unii candidate 22 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	SHAMPOO / TOPICAL	3.7 %w/w		Exact identifier — unii candidate 22 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	TABLET / ORAL		43 mg	Exact identifier — unii candidate 34 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	GRANULE, FOR SOLUTION / ORAL	5.5 mg/120ml		Exact identifier — unii candidate 34 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	INJECTION, EMULSION / INTRAVENOUS	0.1 %w/v		Exact identifier — unii candidate 35 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	SOLUTION / ORAL		21600 mg	Exact identifier — unii candidate 12 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	AEROSOL, FOAM / VAGINAL	2 %w/w		Exact identifier — unii candidate 22 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	PASTE, DENTIFRICE / DENTAL	0.2 %w/w		Exact identifier — unii candidate 34 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
202c46b4-9136-4bce-8cee-82718ebb3818			ba5c415e-2a44-4b49-b85a-55984e3131b8	2011-08-11	Warnings	Exact identifier spl id: 202c46b4-9136-4bce-8cee-82718ebb3818 spl set id: ba5c415e-2a44-4b49-b85a-55984e3131b8

Reported adverse events (FAERS/openFDA)#

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