DENBLAN

Manufacturer: DARPHIN DIST. | ELGC Kabushiki Kaisha | Estee Lauder Pennsylvania Distribution Center 2 (PADC 2) | ARAMIS, INC | ESTEE LAUDER COSMETICS DISTRIBUTION CENTER | ESTEE LAUDER COSMETICS, LTD | ESTEE LAUDER COSMETICS, LTD. | ESTEE LAUDER N.V. | LEN-RON MANUFACTURING DIVISION OF ARAMIS INC | NORTEC KEYSTONE | NORTHTEC BRISTOL | NORTHTEC KEYSTONE | WHITMAN LABORATORIES, LTD. | Aveda Corporation | CCI Productions Parfums & Cosmetiques
Effective date: 2011-12-01
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:30:47

Label at a glance#

ProductDENBLAN WHITENING FORMULA ANTI CAVITY FLUORIDE

Active ingredientSODIUM MONOFLUOROPHOSPHATE

Label structure9 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 doctor. Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as neccessary until capable of using without supervision. Children under 2 years of age: Consult a dentist or doctor.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium monofluorophosphate 0.76%

Purpose

OTC - PURPOSE SECTION

Fluoride toothpaste

Use

INDICATIONS & USAGE SECTION

Aids in the prevention of dental cavities.

Warnings

WARNINGS SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

OTC - WHEN USING 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 doctor.
Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing).
Supervise children as neccessary until capable of using without supervision.
Children under 2 years of age: Consult a dentist or doctor.

Ingredients

INACTIVE INGREDIENT SECTION

water, dicalcium phosphate, calcium carbonate, silica, glycerin, sorbitol, algin, carica papaya (papaya) fruit extract, ananas sativus (pineapple) fruit extract, mentha viridis (spearmint) leaf oil, mentha arvensis leaf oil, usnea barbata (lichen) extract, angelica archangelica root oil, carum petroselinum (parsley) seed oil, foeniculum vulgare (fennel) oil, sodium lauryl sulfate, propylene glycol, sodium saccharin, limonene, sodium benzoate, sodium propylparaben, sodium methylparaben <ILN36886>.

SPL UNCLASSIFIED SECTION

DARPHIN
LABORATORIES DARPHIN, Dist.

PRINCIPAL DISPLAY PANEL - 75mL Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

WHITENING FORMULA
DENBLAN
ANTICAVITY FLUORIDE TOOTHPASTE

REFRESHING MINT TASTE

e 75mL
POIDS NET WT. 2.6 OZ.

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
545626	sodium monofluorophosphate 0.76 % Toothpaste	PSN	1
545626	sodium monofluorophosphate 0.0076 MG/MG Toothpaste	SCD	1
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )Toothpaste	SY	1
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )Toothpaste	SY	1
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )Toothpaste	SY	1
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )Toothpaste	SY	1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
16555-996-01	2019-11-13	C162847	48780-1	97449f38-b672-f6ea-e053-dbdaa90aa703	WHITENING FORMULA DENBLAN ANTICAVITY FLUORIDE TOOTHPASTE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
16555-996-01	DENBLAN WHITENING FORMULA ANTI CAVITY FLUORIDE	1 in 1 CARTON	PASTE, DENTIFRICE	1		1
16555-996-01	DENBLAN WHITENING FORMULA ANTI CAVITY FLUORIDE	75 mL in 1 TUBE	PASTE, DENTIFRICE	75		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16555-996	DENBLAN WHITENING FORMULA ANTI CAVITY FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [DARPHIN DIST.]	1	Legacy NDC, 2 package rows	20120127_dbd98251-c137-4066-9645-f8b8ca71de16.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
SODIUM MONOFLUOROPHOSPHATE	ACTIVE INGREDIENT	C810JCZ56Q	1
FLUORIDE ION	ACTIVE MOIETY	Q80VPU408O	1
ANGELICA ROOT OIL	INACTIVE INGREDIENT	B25G881UOX	1
ANHYDROUS DIBASIC CALCIUM PHOSPHATE	INACTIVE INGREDIENT	L11K75P92J	1
FENNEL OIL	INACTIVE INGREDIENT	59AAO5F6HT	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	1
MENTHA ARVENSIS LEAF OIL	INACTIVE INGREDIENT	1AEY1M553N	1
METHYLPARABEN SODIUM	INACTIVE INGREDIENT	CR6K9C2NHK	1
PAPAYA	INACTIVE INGREDIENT	KU94FIY6JB	1
PARSLEY SEED OIL	INACTIVE INGREDIENT	XB8Q500O0Z	1
PINEAPPLE	INACTIVE INGREDIENT	2A88ZO081O	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	1
PROPYLPARABEN SODIUM	INACTIVE INGREDIENT	625NNB0G9N	1
SACCHARIN SODIUM DIHYDRATE	INACTIVE INGREDIENT	SB8ZUX40TY	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	1
SPEARMINT OIL	INACTIVE INGREDIENT	C3M81465G5	1
USNEA BARBATA	INACTIVE INGREDIENT	D6DVA9TCAP	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

DENBLAN WHITENING FORMULA ANTI CAVITY FLUORIDE
SODIUM MONOFLUOROPHOSPHATE
FLUORIDE ION
WATER
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
SILICON DIOXIDE
GLYCERIN
SORBITOL
PAPAYA
PINEAPPLE
SPEARMINT OIL
MENTHA ARVENSIS LEAF OIL
USNEA BARBATA
ANGELICA ROOT OIL
PARSLEY SEED OIL
FENNEL OIL
SODIUM LAURYL SULFATE
PROPYLENE GLYCOL
SACCHARIN SODIUM DIHYDRATE
SODIUM BENZOATE
PROPYLPARABEN SODIUM
METHYLPARABEN SODIUM

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
16555-996	16555-996-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
SODIUM MONOFLUOROPHOSPHATE	C810JCZ56Q	ACTIB
WATER	059QF0KO0R	IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATE	L11K75P92J	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
GLYCERIN	PDC6A3C0OX	IACT
SORBITOL	506T60A25R	IACT
PAPAYA	KU94FIY6JB	IACT
PINEAPPLE	2A88ZO081O	IACT
SPEARMINT OIL	C3M81465G5	IACT
MENTHA ARVENSIS LEAF OIL	1AEY1M553N	IACT
USNEA BARBATA	D6DVA9TCAP	IACT
ANGELICA ROOT OIL	B25G881UOX	IACT
PARSLEY SEED OIL	XB8Q500O0Z	IACT
FENNEL OIL	59AAO5F6HT	IACT
SODIUM LAURYL SULFATE	368GB5141J	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
SACCHARIN SODIUM DIHYDRATE	SB8ZUX40TY	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
PROPYLPARABEN SODIUM	625NNB0G9N	IACT
METHYLPARABEN SODIUM	CR6K9C2NHK	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 7 · 396 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / ORAL		750 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	CREAM / VAGINAL		12 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	TABLET, FILM COATED / ORAL		240 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	INJECTION / INTRALESIONAL	45 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CLOTH / TOPICAL	0.05 mg/mg		Exact identifier — unii candidate 75 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SPONGE / TOPICAL	NA		Exact identifier — unii candidate 35 equally ranked IID candidates
ANHYDROUS DIBASIC CALCIUM PHOSPHATE	ANHYDROUS DIBASIC CALCIUM PHOSPHATE	L11K75P92J	POWDER / SUBLINGUAL		30 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SYRUP / ORAL		5700 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATE	SACCHARIN SODIUM	SB8ZUX40TY	TABLET, FILM COATED / ORAL	2 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SYRUP / ORAL		16734 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	LOTION, AUGMENTED / TOPICAL		2070 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / AURICULAR (OTIC)	56.55 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE, COATED / ORAL	25 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	PASTE / DENTAL	14.6 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SPRAY / NASAL	22.3 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION/ DROPS / AURICULAR (OTIC)		25 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / INTRAVENOUS	5 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SYSTEM / TOPICAL		2 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
SPEARMINT OIL	SPEARMINT OIL	C3M81465G5	SOLUTION / ORAL	NA		Exact identifier — unii candidate 7 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	POWDER / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 42 equally ranked IID candidates
ANHYDROUS DIBASIC CALCIUM PHOSPHATE	ANHYDROUS DIBASIC CALCIUM PHOSPHATE	L11K75P92J	PASTILLE / ORAL	NA		Exact identifier — unii candidate 15 equally ranked IID candidates
PROPYLPARABEN SODIUM	PROPYLPARABEN SODIUM	625NNB0G9N	SOLUTION / ORAL		30 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	INSERT / VAGINAL		15 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	GEL / DENTAL	1.47 %w/w		Exact identifier — unii candidate 42 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	OINTMENT / TOPICAL		5148 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
SPEARMINT OIL	SPEARMINT OIL	C3M81465G5	SYRUP / ORAL	NA		Exact identifier — unii candidate 7 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	OINTMENT, AUGMENTED / TOPICAL		714 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / BUCCAL		3 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
PROPYLPARABEN SODIUM	PROPYLPARABEN SODIUM	625NNB0G9N	TABLET / ORAL	0.06 mg		Exact identifier — unii candidate 6 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		69 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE, DELAYED RELEASE / ORAL	1.7 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CREAM / TOPICAL		76000 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	ENEMA / RECTAL		60 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	LOTION / TOPICAL		3392 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TAMPON / VAGINAL	62.1 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / RECTAL		90400 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATE	SACCHARIN SODIUM	SB8ZUX40TY	INJECTION / INTRAMUSCULAR		22 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOAP / TOPICAL	0.76 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
ANHYDROUS DIBASIC CALCIUM PHOSPHATE	ANHYDROUS DIBASIC CALCIUM PHOSPHATE	L11K75P92J	CREAM / TOPICAL	36 %w/w		Exact identifier — unii candidate 15 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SYRUP / ORAL	4370 mg/5ml		Exact identifier — unii candidate 44 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION / SUBCUTANEOUS	1.4 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATE	SACCHARIN SODIUM	SB8ZUX40TY	POWDER, FOR SOLUTION / ORAL		199 mg	Exact identifier — unii candidate 34 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
SACCHARIN SODIUM DIHYDRATE	SACCHARIN SODIUM	SB8ZUX40TY	TABLET / ORAL		43 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SPEARMINT OIL	SPEARMINT OIL	C3M81465G5	PASTE, DENTIFRICE / DENTAL	27.6 %w/w		Exact identifier — unii candidate 7 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATE	SACCHARIN SODIUM	SB8ZUX40TY	LIQUID / ORAL		3 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	OINTMENT / RECTAL		27 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	LIQUID / ORAL		2400 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUPPOSITORY / VAGINAL	227.9 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	INJECTION / INTRAVENOUS		864 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION / INTRAMUSCULAR		450 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SPRAY, METERED / NASAL		240 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, EXTENDED RELEASE / ORAL	9 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CREAM / VAGINAL		60 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	TABLET, EFFERVESCENT / ORAL	1.5 mg		Exact identifier — unii candidate 42 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL / OPHTHALMIC	0.44 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	POWDER / VAGINAL	3 mg		Exact identifier — unii candidate 42 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATE	SACCHARIN SODIUM	SB8ZUX40TY	SOLUTION / ORAL		665 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / NASAL		20 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	CREAM / TOPICAL	36.8 %w/w		Exact identifier — unii candidate 44 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
3771b213-03f0-45e5-9423-bff016c95c56			dbd98251-c137-4066-9645-f8b8ca71de16	2011-12-01	Warnings	Exact identifier spl id: 3771b213-03f0-45e5-9423-bff016c95c56 spl set id: dbd98251-c137-4066-9645-f8b8ca71de16

Reported adverse events (FAERS/openFDA)#

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