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 5 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sensitive Teeth and Gums	POTASSIUM NITRATE, SODIUM FLUORIDE	Church & Dwight Co., Inc.	935172db-d78f-0c69-e053-2a95a90a0b69	2026-07-23	Warnings	Exact identifier application number: M021
Essentials Whiten and Strengthen	SODIUM FLUORIDE 0.24%	Church & Dwight Co., Inc.	96548550-2cd1-b757-e053-2995a90a15ea	2026-07-23	Warnings	Exact identifier application number: M021
TP COL OW Purple	SODIUM FLUORIDE	Colgate-Palmolive Company	ea0db59f-f9c0-49a8-9717-69cdf071f6e1	2026-07-23	Warnings	Exact identifier application number: M021
Colgate Max Fresh Cool Mint	SODIUM FLUORIDE	Colgate-Palmolive Company	00652bb2-090c-4eaa-8fc2-e0be6913a724	2026-07-22	Warnings	Exact identifier application number: M021
Colgate Ultra White Charcoal	SODIUM FLUORIDE	Colgate-Palmolive Company	95d06fcc-f56d-43f1-924a-3f91fda59bdf	2026-07-22	Warnings	Exact identifier application number: M021
COLGATE Great Regular Flavor	SODIUM MONOFLUOROPHOSPHATE	Colgate-Palmolive Company	730f40f6-6ac6-49bd-888b-c0b5818a03c8	2026-07-20	Warnings	Exact identifier application number: M021
COLGATE KPOP DEMON HUNTERS BUBBLE POP	SODIUM FLUORIDE	Colgate-Palmolive Company	bf465181-01e9-44ca-91f8-03110a606774	2026-07-16	Warnings	Exact identifier application number: M021
Colgate Minions Mild Bubble Fruit Fluoride	SODIUM FLUORIDE	Colgate-Palmolive Company	16634b99-f305-48bf-ac54-a9f53797a9e5	2026-07-16	Warnings	Exact identifier application number: M021
Freshen Up Holiday mint	SODIUM FLUORIDE	Dabur India Limited	56aaa9f5-7eac-11d9-e063-6294a90af3a8	2026-07-15	Warnings	Exact identifier application number: M021
Freshen Up pepper mint	SODIUM FLUORIDE	Dabur India Limited	56aaba60-523e-6ac7-e063-6394a90a2756	2026-07-15	Warnings	Exact identifier application number: M021
Freshen-up Matcha Mint	SODIUM FLUORIDE	Dabur India Limited	56aac050-73e7-298c-e063-6294a90a26eb	2026-07-15	Warnings	Exact identifier application number: M021
Freshen Up twisted peppermint	SODIUM FLUORIDE	Dabur India Limited	56aac7a7-c086-2fa5-e063-6294a90aa959	2026-07-15	Warnings	Exact identifier application number: M021
Freshen Up Vanilla Mint	SODIUM FLUORIDE	Dabur India Limited	56aad223-db88-7cf6-e063-6394a90a6b72	2026-07-15	Warnings	Exact identifier application number: M021
Freshen Up	SODIUM FLUORIDE	MKJ BRANDS LLC	2dcd4816-caa5-c006-e063-6394a90ac487	2026-07-15	Warnings	Exact identifier application number: M021
Freshen Up	SODIUM FLUORIDE	DABUR INDIA LIMITED	56acecd2-6966-2ee4-e063-6394a90a356f	2026-07-15	Warnings	Exact identifier application number: M021
Colgate Max Fresh Advanced Whitening	SODIUM FLUORIDE	Colgate-Palmolive Company	01c07c25-2748-4d90-9505-094e2c977c9c	2026-07-15	Warnings	Exact identifier application number: M021
Crest Strawberry	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	7d51c67b-7409-e5a7-e053-2a91aa0a81fa	2026-07-14	Warnings	Exact identifier application number: M021
Freshen Up	SODIUM FLUORIDE, POTASSIUM NITRATE	MKJ BRANDS LLC	476f453b-9215-0a11-e063-6294a90a5cd4	2026-07-14	Warnings	Exact identifier application number: M021
Freshen Up Vanilla Mint	SODIUM FLUORIDE	MKJ BRANDS LLC	525662da-42be-eaa6-e063-6294a90af110	2026-07-14	Warnings	Exact identifier application number: M021
Freshen Up twisted peppermint	SODIUM FLUORIDE	MKJ BRANDS LLC	526acbdd-6531-692d-e063-6394a90ab9f1	2026-07-14	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