Opalescence Whitening

Product NDC: 51206-302
11-digit product format: 512060302
Labeler code: 51206
Product ID: 51206-302_5b14d90f-23ec-372b-e063-6294a90a2066
Type: HUMAN OTC DRUG
Nonproprietary name: Sodium Fluoride
Dosage form: GEL, DENTIFRICE
Route: DENTAL
Labeler: Ultradent Products, Inc
Application: M021
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 1994-07-01
Marketing end: 2030-09-30
Substance: SODIUM FLUORIDE
Active strength: 1.1 mg/g
NDC exclude flag: No
Current FDA listing: Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Opalescence Whitening

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SODIUM FLUORIDE	1.1 mg/g

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1044547	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
d07f842e-b6f1-4ae1-b576-f542ecd02dd4	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
51206-302-06	Opalescence™ whitening toothpaste
51206-302-06	Opalescence™ whitening toothpaste
51206-302-07	Opalescence™ whitening toothpaste
51206-302-07	Opalescence™ whitening toothpaste
51206-302-08	Opalescence™ whitening toothpaste
51206-302-08	Opalescence™ whitening toothpaste
51206-302-09	Opalescence™ whitening toothpaste
51206-302-09	Opalescence™ whitening toothpaste
51206-302-10	Opalescence™ whitening toothpaste
51206-302-10	Opalescence™ whitening toothpaste
51206-302-11	Opalescence™ whitening toothpaste
51206-302-11	Opalescence™ whitening toothpaste

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
51206-302-06	Opalescence Whitening	133 g in 1 TUBE	GEL, DENTIFRICE	133	9
51206-302-06	Opalescence Whitening	1 in 1 BOX	GEL, DENTIFRICE	1	9
51206-302-07	Opalescence Whitening	1 in 1 BOX	GEL, DENTIFRICE	1	9
51206-302-07	Opalescence Whitening	28.35 g in 1 TUBE	GEL, DENTIFRICE	28.35	9
51206-302-08	Opalescence Whitening	1 in 1 BOX	GEL, DENTIFRICE	1	9
51206-302-08	Opalescence Whitening	3 in 1 PACKAGE, COMBINATION	GEL, DENTIFRICE	3	9
51206-302-09	Opalescence Whitening	1 in 1 BOX	GEL, DENTIFRICE	1	9
51206-302-09	Opalescence Whitening	12 in 1 PACKAGE, COMBINATION	GEL, DENTIFRICE	12	9
51206-302-10	Opalescence Whitening	24 in 1 PACKAGE, COMBINATION	GEL, DENTIFRICE	24	9
51206-302-10	Opalescence Whitening	1 in 1 BOX	GEL, DENTIFRICE	1	9
51206-302-11	Opalescence Whitening	1 in 1 BOX	GEL, DENTIFRICE	1	9
51206-302-11	Opalescence Whitening	6 in 1 PACKAGE, COMBINATION	GEL, DENTIFRICE	6	9

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Sodium Fluoride	ACTIVE INGREDIENT	8ZYQ1474W7	OPALESCENCE WHITENING TOOTHPASTE (SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.]	1
Fluoride Ion	ACTIVE MOIETY	Q80VPU408O	OPALESCENCE WHITENING TOOTHPASTE (SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.]	1
FD&C Blue No. 1	INACTIVE INGREDIENT	H3R47K3TBD	OPALESCENCE WHITENING TOOTHPASTE (SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.]	1
FD&C Yellow No. 5	INACTIVE INGREDIENT	I753WB2F1M	OPALESCENCE WHITENING TOOTHPASTE (SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.]	1
Glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	OPALESCENCE WHITENING TOOTHPASTE (SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.]	1
Methyl Salicylate	INACTIVE INGREDIENT	LAV5U5022Y	OPALESCENCE WHITENING TOOTHPASTE (SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.]	1
Saccharin Sodium	INACTIVE INGREDIENT	SB8ZUX40TY	OPALESCENCE WHITENING TOOTHPASTE (SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.]	1
Silicon Dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	OPALESCENCE WHITENING TOOTHPASTE (SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.]	1
Sodium Benzoate	INACTIVE INGREDIENT	OJ245FE5EU	OPALESCENCE WHITENING TOOTHPASTE (SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.]	1
Sodium Lauryl Sulfate	INACTIVE INGREDIENT	368GB5141J	OPALESCENCE WHITENING TOOTHPASTE (SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.]	1
Sorbitol	INACTIVE INGREDIENT	506T60A25R	OPALESCENCE WHITENING TOOTHPASTE (SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.]	1
Water	INACTIVE INGREDIENT	059QF0KO0R	OPALESCENCE WHITENING TOOTHPASTE (SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.]	1
Xanthan Gum	INACTIVE INGREDIENT	TTV12P4NEE	OPALESCENCE WHITENING TOOTHPASTE (SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.]	1
Xylitol	INACTIVE INGREDIENT	VCQ006KQ1E	OPALESCENCE WHITENING TOOTHPASTE (SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51206-302	OPALESCENCE WHITENING (SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC]	7	Current NDC, Legacy NDC, 12 package rows	20240224_d07f842e-b6f1-4ae1-b576-f542ecd02dd4.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 22 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ACT Restoring Anticavity Fluoride Cool Mint	SODIUM FLUORIDE	Chattem, Inc.	ef63e193-5804-4b35-bae7-cad29cf4e8bc	2026-01-12	Warnings	Exact identifier application number: M021
Prime Tooth Care Blueberry	SODIUM FLUORIDE	Prime Tooth Care LLC	86642110-4572-4b8b-88f1-8d25fe05701e	2026-01-09	Warnings	Exact identifier application number: M021
Prime Tooth Care Juicy Peach	SODIUM FLUORIDE	Prime Tooth Care LLC	142f1610-3494-459f-a956-760e82169b87	2026-01-09	Warnings	Exact identifier application number: M021
Prime Tooth Care Coconut Whip	SODIUM FLUORIDE	Prime Tooth Care LLC	55e95657-9415-4d9c-ac9b-d021aa14e64d	2026-01-09	Warnings	Exact identifier application number: M021
Prime Tooth Care Hami Melon	SODIUM FLUORIDE	Prime Tooth Care LLC	0028f88d-a9fe-4cfa-a6c6-168f9689b5f6	2026-01-09	Warnings	Exact identifier application number: M021
Prime Tooth Care Mango Smoothie	SODIUM FLUORIDE	Prime Tooth Care LLC	2f2cf851-2edc-4aaf-9083-c37bc58547de	2026-01-09	Warnings	Exact identifier application number: M021
Prime Tooth Care Strawberries	SODIUM FLUORIDE	Prime Tooth Care LLC	7b4328bd-5d2d-40ca-8322-5e818e1babf9	2026-01-09	Warnings	Exact identifier application number: M021
Prime Tooth Care Summer Watermelon	SODIUM FLUORIDE	Prime Tooth Care LLC	b7c731a1-80e7-4571-a568-db0290a720c1	2026-01-09	Warnings	Exact identifier application number: M021
Kids Prime Pediatric Dental Group Anticavity for Kids	SODIUM FLUORIDE	Prime Tooth Care LLC	93259174-447d-4f7a-8e55-990eb8da5151	2026-01-09	Warnings	Exact identifier application number: M021
Crest 3D White Brilliance Pro Enamel Protect	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	f32d5708-8cb1-6499-e053-2995a90ac632	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro-Health Advanced Complete Care Anticavity Fluoride	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	f3a644c0-da04-276d-e053-2a95a90abf27	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro-Health Densify Active Repair	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	f4487d78-1da8-3f33-e053-2a95a90a6d92	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro-Health Densify Sensitive Care	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	f435c1fe-7fbb-1b25-e053-2995a90aca11	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro-Health Densify Pro Intensive Repair	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	f45c9c89-f294-deca-e053-2a95a90ae557	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro-health Gum Detoxify Deep Clean	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	f49a00de-b16a-66e6-e053-2995a90aedc6	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro-Health Gum Detoxify Gentle Whitening	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	f49a7dc7-77f3-3911-e053-2a95a90ad55c	2026-01-08	Warnings	Exact identifier application number: M021
Crest Complete Multi-Benefit Whitening plus Cinnamon Expressions	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	961295a6-79ae-44b1-e053-2995a90a6130	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro Health Enamel Repair and Gum Intensive Clean	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	f4c2118d-1216-d0d0-e053-2995a90a7088	2026-01-08	Warnings	Exact identifier application number: M021
Crest 3D White Charcoal	SODIUM FLUORIDE	Procter & Gamble Manfuacturing Company	96247083-39e9-7ca7-e053-2995a90a75d0	2026-01-08	Warnings	Exact identifier application number: M021
Crest 3D White Advanced Express White	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	f4c2d5aa-b0e6-7068-e053-2995a90ae90c	2026-01-08	Warnings	Exact identifier application number: M021

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
1044547	sodium fluoride 0.25 % Toothpaste	PSN	d07f842e-b6f1-4ae1-b576-f542ecd02dd4	9
1044547	sodium fluoride 0.0025 MG/MG Toothpaste	SCD	d07f842e-b6f1-4ae1-b576-f542ecd02dd4	9
1044547	sodium fluoride 0.25 % (fluoride ion 0.15 % ) Toothpaste	SY	d07f842e-b6f1-4ae1-b576-f542ecd02dd4	9
1044547	sodium fluoride 0.25 % Toothpaste	SY	d07f842e-b6f1-4ae1-b576-f542ecd02dd4	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51206-302-06	51206030206	1 TUBE in 1 BOX (51206-302-06) / 133 g in 1 TUBE	1 tube	1994-07-01	2030-09-30	No	No	Current
51206-302-07	51206030207	1 TUBE in 1 BOX (51206-302-07) / 28.35 g in 1 TUBE	1 tube	1994-07-01	2030-09-30	No	No	Current
51206-302-08	51206030208	3 BOX in 1 PACKAGE, COMBINATION (51206-302-08) / 1 TUBE in 1 BOX / 133 g in 1 TUBE	3 box	2016-06-01	2030-09-30	No	No	Current
51206-302-09	51206030209	12 BOX in 1 PACKAGE, COMBINATION (51206-302-09) / 1 TUBE in 1 BOX / 133 g in 1 TUBE	12 box	2016-06-01	2030-09-30	No	No	Current
51206-302-10	51206030210	24 BOX in 1 PACKAGE, COMBINATION (51206-302-10) / 1 TUBE in 1 BOX / 28.35 g in 1 TUBE	24 box	2016-06-01	2030-09-03	No	No	Current
51206-302-11	51206030211	6 BOX in 1 PACKAGE, COMBINATION (51206-302-11) / 1 TUBE in 1 BOX / 133 g in 1 TUBE	6 box	2020-08-24	2030-09-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Opalescence™ whitening toothpaste	Ultradent Products, Inc \| Ultradent Products, Inc.	2026-09-09	HUMAN OTC DRUG LABEL	10