Colgate

Manufacturer: Mission Hills S.A de C.V | Mission Hills, S.A. de C.V.
Effective date: 2019-04-29
Label type: HUMAN OTC DRUG LABEL
Version: 10
Source: full-release
Hydrated at: 2026-06-01 00:57:23

Label at a glance#

ProductColgate Baking Soda and Peroxide Whitening Oxygen Bubbles Frosty Mint

Active ingredientSODIUM MONOFLUOROPHOSPHATE

Label structure10 sections

Dosage and administration

adults and children 2 years of age and older brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician children 2 to 6 years use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing) children under 2 years ask a dentist or physician

Contacts and useful links#

PhoneLabel contact1-800-468-6502

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium monofluorophosphate 0.76% (0.14% w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity

Use

INDICATIONS & USAGE SECTION

helps protect against cavities

Warnings

WARNINGS SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children under 6 years of age.

OTC - ASK DOCTOR SECTION

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 2 years of age and older	brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician
children 2 to 6 years	use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)
children under 2 years	ask a dentist or physician

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin, hydrated silica, water, sodium bicarbonate, PEG-12, sodium lauryl sulfate, flavor, sodium hydroxide, cellulose gum, carrageenan, sodium saccharin, calcium peroxide, titanium dioxide, FD&C blue no. 1, D&C yellow no. 10

Questions?

OTC - QUESTIONS SECTION

1-800-468-6502

SPL UNCLASSIFIED SECTION

Dist. by:
COLGATE-PALMOLIVE COMPANY
New York, NY 10022

PRINCIPAL DISPLAY PANEL - 232 g Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Colgate^®
Fluoride Toothpaste

NET WT 8.2 OZ (232 g)

Baking Soda
& Peroxide
Whitening

Cleans Deep and
Whitens Teeth

Frosty Mint^®Stripe Gel

PRINCIPAL DISPLAY PANEL - 232 g Tube Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
545626	sodium monofluorophosphate 0.76 % Toothpaste	PSN	10
545626	sodium monofluorophosphate 0.0076 MG/MG Toothpaste	SCD	10
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )Toothpaste	SY	10
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )Toothpaste	SY	10
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )Toothpaste	SY	10
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )Toothpaste	SY	10

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
65954-768-35	ColgateBaking Soda and Peroxide Whitening Oxygen Bubbles Frosty Mint	170 g in 1 TUBE	PASTE, DENTIFRICE	170	10
65954-768-35	ColgateBaking Soda and Peroxide Whitening Oxygen Bubbles Frosty Mint	3 in 1 CARTON	PASTE, DENTIFRICE	3	10
65954-768-60	ColgateBaking Soda and Peroxide Whitening Oxygen Bubbles Frosty Mint	1 in 1 CARTON	PASTE, DENTIFRICE	1	10
65954-768-60	ColgateBaking Soda and Peroxide Whitening Oxygen Bubbles Frosty Mint	170 g in 1 TUBE	PASTE, DENTIFRICE	170	10
65954-768-64	ColgateBaking Soda and Peroxide Whitening Oxygen Bubbles Frosty Mint	1 in 1 CARTON	PASTE, DENTIFRICE	1	10
65954-768-64	ColgateBaking Soda and Peroxide Whitening Oxygen Bubbles Frosty Mint	181 g in 1 TUBE	PASTE, DENTIFRICE	181	10
65954-768-69	ColgateBaking Soda and Peroxide Whitening Oxygen Bubbles Frosty Mint	113 g in 1 TUBE	PASTE, DENTIFRICE	113	10
65954-768-69	ColgateBaking Soda and Peroxide Whitening Oxygen Bubbles Frosty Mint	1 in 1 CARTON	PASTE, DENTIFRICE	1	10
65954-768-82	ColgateBaking Soda and Peroxide Whitening Oxygen Bubbles Frosty Mint	1 in 1 CARTON	PASTE, DENTIFRICE	1	10
65954-768-82	ColgateBaking Soda and Peroxide Whitening Oxygen Bubbles Frosty Mint	232 g in 1 TUBE	PASTE, DENTIFRICE	232	10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65954-768	COLGATE BAKING SODA AND PEROXIDE WHITENING OXYGEN BUBBLES FROSTY MINT (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MISSION HILLS S.A DE C.V]	10	Legacy NDC, 10 package rows	20250321_d8aad36d-5537-4eaf-b9a3-75a9919f4d6e.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
SODIUM MONOFLUOROPHOSPHATE	ACTIVE INGREDIENT	C810JCZ56Q	3
FLUORIDE ION	ACTIVE MOIETY	Q80VPU408O	3
CALCIUM PEROXIDE	INACTIVE INGREDIENT	7FRO2ENO91	3
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM	INACTIVE INGREDIENT	K679OBS311	3
CARRAGEENAN	INACTIVE INGREDIENT	5C69YCD2YJ	3
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	3
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	3
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	3
HYDRATED SILICA	INACTIVE INGREDIENT	Y6O7T4G8P9	3
POLYETHYLENE GLYCOL 600	INACTIVE INGREDIENT	NL4J9F21N9	3
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	3
SODIUM BICARBONATE	INACTIVE INGREDIENT	8MDF5V39QO	3
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	3
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	3

Products#

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

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

Colgate Baking Soda and Peroxide Whitening Oxygen Bubbles Frosty Mint
SODIUM MONOFLUOROPHOSPHATE
FLUORIDE ION
GLYCERIN
HYDRATED SILICA
WATER
SODIUM BICARBONATE
POLYETHYLENE GLYCOL 600
SODIUM LAURYL SULFATE
SODIUM HYDROXIDE
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED
CARRAGEENAN
SACCHARIN SODIUM
CALCIUM PEROXIDE
D&C YELLOW NO. 10
FD&C BLUE NO. 1
TITANIUM DIOXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
65954-768	65954-768-69, 65954-768-64, 65954-768-82, 65954-768-60, 65954-768-35

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 MONOFLUOROPHOSPHATE	C810JCZ56Q	ACTIM
GLYCERIN	PDC6A3C0OX	IACT
HYDRATED SILICA	Y6O7T4G8P9	IACT
WATER	059QF0KO0R	IACT
SODIUM BICARBONATE	8MDF5V39QO	IACT
POLYETHYLENE GLYCOL 600	NL4J9F21N9	IACT
SODIUM LAURYL SULFATE	368GB5141J	IACT
SODIUM HYDROXIDE	55X04QC32I	IACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED	K679OBS311	IACT
CARRAGEENAN	5C69YCD2YJ	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT
CALCIUM PEROXIDE	7FRO2ENO91	IACT
D&C YELLOW NO. 10	35SW5USQ3G	IACT
FD&C BLUE NO. 1	H3R47K3TBD	IACT
TITANIUM DIOXIDE	15FIX9V2JP	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 9 · 530 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	OINTMENT / TOPICAL	NA		Exact identifier — unii candidate 34 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	CAPSULE, COATED PELLETS / ORAL	0.01 mg		Exact identifier — unii candidate 31 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	SOLUTION / ORAL		8 mg	Exact identifier — unii candidate 31 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	POWDER, FOR SUSPENSION / ORAL	1 mg/5ml		Exact identifier — unii candidate 37 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	CAPSULE / ORAL	60 mg		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 42 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	CONCENTRATE / ORAL	10 mg/5ml		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	POWDER, FOR SUSPENSION / ORAL		9 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET / PERIODONTAL	0.53 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	GEL / VAGINAL	0.2 %w/w		Exact identifier — unii candidate 42 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	GUM, CHEWING / ORAL		2 mg	Exact identifier — unii candidate 31 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SUSPENSION/ DROPS / OPHTHALMIC	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		27 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	1000 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	EMULSION / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 174 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, EXTENDED RELEASE / ORAL		67 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
CARRAGEENAN	CARRAGEENAN	5C69YCD2YJ	CAPSULE, DELAYED RELEASE / ORAL		1 mg	Exact identifier — unii candidate 10 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET, FILM COATED / ORAL	1.55 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CLOTH / TOPICAL	0.05 mg/mg		Exact identifier — unii candidate 75 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	GEL / DENTAL	NA		Exact identifier — unii candidate 31 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	EMULSION / OPHTHALMIC		3 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	INJECTION / INTRATHECAL	0.05 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	GRANULE, EFFERVESCENT / ORAL	267 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	SOLUTION/ DROPS / OPHTHALMIC		2 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	GEL / OPHTHALMIC		6 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, POWDER, FOR SOLUTION / INTRATHECAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE, DELAYED RELEASE / ORAL		2 mg	Exact identifier — unii candidate 37 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION / INTRAVENOUS		33750 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	PASTE / DENTAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	ELIXIR / ORAL		5621 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	FILM, EXTENDED RELEASE / TRANSDERMAL	0.85 mg		Exact identifier — unii candidate 174 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, LIQUID FILLED / ORAL		12 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	CAPSULE, EXTENDED RELEASE / ORAL		4 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS		3219 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRADERMAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	CREAM / TOPICAL		69 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	INSERT / VAGINAL		129 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	PASTE, DENTIFRICE / DENTAL	0.4 %w/w		Exact identifier — unii candidate 40 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	CAPSULE, EXTENDED RELEASE / ORAL		3 mg	Exact identifier — unii candidate 31 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	TABLET / BUCCAL		42 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SOLUTION / INTRAVESICAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	PASTE / DENTAL	0.3 %w/w		Exact identifier — unii candidate 34 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	INJECTION / INTRAVENOUS	812 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	POWDER, FOR SUSPENSION / ENDOTRACHEAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	DOUCHE / VAGINAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	CREAM / VAGINAL	0.19 %w/w		Exact identifier — unii candidate 174 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	INJECTION / INTRAMUSCULAR		22 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SUSPENSION / INTRASYNOVIAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	TABLET / BUCCAL	5.18 mg		Exact identifier — unii candidate 42 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET, COATED / ORAL	1 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	POWDER, FOR SUSPENSION / ORAL		560 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	CAPSULE / ORAL	160 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	SOLUTION / OPHTHALMIC		1 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	FILM, SOLUBLE / ORAL		2 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
CARRAGEENAN	CARRAGEENAN	5C69YCD2YJ	CAPSULE / ORAL		3 mg	Exact identifier — unii candidate 10 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	TABLET, FILM COATED / ORAL	50 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	SHAMPOO / TOPICAL	0.75 %w/w		Exact identifier — unii candidate 37 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	SUSPENSION / ORAL	705 mg		Exact identifier — unii candidate 42 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
3a8ad951-91ec-44d2-8be8-f8da4c26a975			d8aad36d-5537-4eaf-b9a3-75a9919f4d6e	2019-04-29	Warnings	Exact identifier spl id: 3a8ad951-91ec-44d2-8be8-f8da4c26a975 spl set id: d8aad36d-5537-4eaf-b9a3-75a9919f4d6e

Reported adverse events (FAERS/openFDA)#

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