PreviDent

Product NDC: 0126-0016
11-digit product format: 001260016
Labeler code: 0126
Product ID: 0126-0016_f4c2f476-bdd5-49d1-80f7-361be61e47e5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sodium fluoride
Dosage form: GEL, DENTIFRICE
Route: DENTAL
Labeler: Colgate Oral Pharmaceuticals, Inc.
Marketing category: UNAPPROVED DRUG OTHER
Marketing start: 2009-07-06
Substance: SODIUM FLUORIDE
Active strength: 6.1 mg/mL
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Additional Listing Data#

Finished product: Yes
Brand name base: PreviDent
Brand name suffix: 5000 Dry Mouth
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SODIUM FLUORIDE	6.1 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
8ZYQ1474W7	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
392038	Internal RxNorm lookup
630194	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
d93ee76f-454b-40bf-9357-39a2ae3b6ccb	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0126-0016-61	PreviDent 5000 Dry Mouth	100 mL in 1 BOTTLE	GEL, DENTIFRICE	100		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0126-0016-61	ML - Milliliter	0126-0016	6a1ff55d-412c-4784-8b0b-2c5512f701f2	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
Sodium fluoride	ACTIVE INGREDIENT	8ZYQ1474W7	PREVIDENT 5000 DRY MOUTH (SODIUM FLUORIDE) GEL, DENTIFRICE [COLGATE-PALMOLIVE COMPANY]	1
fluoride ion	ACTIVE MOIETY	Q80VPU408O	PREVIDENT 5000 DRY MOUTH (SODIUM FLUORIDE) GEL, DENTIFRICE [COLGATE-PALMOLIVE COMPANY]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0126-0016	PREVIDENT 5000 DRY MOUTH (SODIUM FLUORIDE) GEL, DENTIFRICE [COLGATE ORAL PHARMACEUTICALS, INC.]	5	Current NDC, Legacy NDC, 1 package rows	20221130_d93ee76f-454b-40bf-9357-39a2ae3b6ccb.zip

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
PreviDent 5000 Dry Mouth	SODIUM FLUORIDE	Colgate Oral Pharmaceuticals, Inc.	d93ee76f-454b-40bf-9357-39a2ae3b6ccb	2026-06-10	Warnings, Adverse reactions	Exact identifier ndc (product): 0126-0016

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
8ZYQ1474W7	SODIUM FLUORIDE	7681-49-4	SODIUM FLUORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
630194	PreviDent 5000 Plus 1.1 % Toothpaste	PSN	d93ee76f-454b-40bf-9357-39a2ae3b6ccb	5
392038	sodium fluoride 1.1 % Toothpaste	PSN	d93ee76f-454b-40bf-9357-39a2ae3b6ccb	5
630194	sodium fluoride 0.011 MG/MG Toothpaste [Prevident]	SBD	d93ee76f-454b-40bf-9357-39a2ae3b6ccb	5
392038	sodium fluoride 0.011 MG/MG Toothpaste	SCD	d93ee76f-454b-40bf-9357-39a2ae3b6ccb	5
630194	Prevident 0.011 MG/MG Toothpaste	SY	d93ee76f-454b-40bf-9357-39a2ae3b6ccb	5
630194	PreviDent 1.1 % Toothpaste	SY	d93ee76f-454b-40bf-9357-39a2ae3b6ccb	5
630194	PreviDent 5000 Booster 1.1 % Oral Gel	SY	d93ee76f-454b-40bf-9357-39a2ae3b6ccb	5
392038	sodium fluoride 1.1 % (fluoride ion 0.5 % ) Toothpaste	SY	d93ee76f-454b-40bf-9357-39a2ae3b6ccb	5
392038	sodium fluoride 1.1 % Dental Gel	SY	d93ee76f-454b-40bf-9357-39a2ae3b6ccb	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0126-0016-61	00126001661	100 mL in 1 BOTTLE (0126-0016-61)	100 ml	2009-07-06	0000-00-00	No	No	Current