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 44 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Colgate Kids Space Jam Mild Bubble Fruit Flavor	SODIUM FLUORIDE	Colgate-Palmolive Company	54cbfb09-8fd7-ef08-99fd-14fc019c81ff	2024-11-14	Warnings	Exact identifier application number: M021
Colgate Kids Llama Mild Bubble Fruit Flavor	SODIUM FLUORIDE	Colgate-Palmolive	a7b02cb2-cfb3-7b35-42da-7924d156dcc3	2024-11-14	Warnings	Exact identifier application number: M021
Colgate MaxFresh with Mini Breath Clean Mint	SODIUM FLUORIDE	Colgate-Palmolive Company	82bc1101-84d7-4e21-be9c-870ad88a4b7c	2024-11-14	Warnings	Exact identifier application number: M021
Colgate MaxFresh Knockout	SODIUM FLUORIDE	COLGATE PALMOLIVE COMPANY	b6ca4ec7-5087-4693-82b7-199b44d7f931	2024-11-13	Warnings	Exact identifier application number: M021
Listerine Smart Rinse Berry Splash	SODIUM FLUORIDE	Kenvue Brands LLC	5c9d763b-7fa2-4b6f-9247-fd28eeda7f0b	2024-11-11	Warnings	Exact identifier application number: M021
Listerine Clinical Solutions Teeth Strength Alpine Mint	SODIUM FLUORIDE	Kenvue Brands LLC	06e2de03-4a58-3de0-e063-6294a90a5857	2024-11-11	Warnings	Exact identifier application number: M021
Listerine Smart Rinse Anticavity Fluoride Rinse - Berry Splash	SODIUM FLUORIDE	Kenvue Brands LLC	ee9a962d-83c7-4b13-bff6-140e48785e8a	2024-11-11	Warnings	Exact identifier application number: M021
Listerine Smart Rinse Anticavity Fluoride Rinse - Mint Shield	SODIUM FLUORIDE	Kenvue Brands LLC	d69d2e0d-a3e3-4d95-992d-c0c59172b3a5	2024-11-11	Warnings	Exact identifier application number: M021
Listerine Smart Rinse Anticavity Fluoride Rinse - Bubble Blast	SODIUM FLUORIDE	Kenvue Brands LLC	f09f334b-709c-473e-b91e-3f31480ceb90	2024-11-11	Warnings	Exact identifier application number: M021
HIMALAYA PINK SALT Purple Color Corrector plus Intensive Whitening Vanilla Mint	SODIUM FLUORIDE	LG H&H Co.,Ltd.	2697fa68-b991-ab09-e063-6394a90aec4c	2024-11-01	Warnings	Exact identifier application number: M021
HIMALAYA PINK SALT Purple Color Corrector plus Intensive Whitening Vanilla Mint	SODIUM FLUORIDE	Tai Guk Pharma. Co., Ltd.	2698d6d8-051b-6c10-e063-6394a90a9418	2024-11-01	Warnings	Exact identifier application number: M021
Made by Dentist for Kids Chew Toy (Bubblegum)	SODIUM FLUORIDE	MADE BY DENTISTS INC	263c448b-728f-4370-bcdb-148d614d9b34	2024-10-30	Warnings	Exact identifier application number: M021
OCEAN FRIENDS ANTICAVITY FLUORIDE BUBBLEGUM FLAVOR	SODIUM FLUORIDE	CVS Pharmacy, Inc.	17f589e9-f4ba-46d3-a345-db38f9a9067d	2024-10-17	Warnings	Exact identifier application number: M021
ACT Kids Anticavity Fluoride Wild Watermelon	SODIUM FLUORIDE	Chattem, Inc.	8d7faeab-ac70-472a-acbb-de67493718ce	2024-10-16	Warnings	Exact identifier application number: M021
Rexall Restore and Defend Sensitive Whitening	STANNOUS FLUORIDE	Old East Main CO.	691c9638-75d2-4e53-bec4-2eafacd7216c	2024-10-14	Warnings	Exact identifier application number: M021
Rexall Travel Toothbrush and Tooth-paste	SODIUM MONOFLUOROPHOSPHATE	Old East Main CO.	1bfba18b-1418-4c39-b666-96fa0674cc70	2024-10-14	Warnings	Exact identifier application number: M021
Crest Cavity Protection Regular	SODIUM FLUORIDE	Navajo Manufacturing Company Inc.	23851360-e30e-dd97-e063-6394a90a5474	2024-10-02	Warnings	Exact identifier application number: M021
Colgate Total SF Clean Mint	STANNOUS FLUORIDE	Colgate-Palmolive Company	8e79e33c-88d3-afc2-e5a2-c6ad55db0dc0	2024-10-02	Warnings	Exact identifier application number: M021
Colgate Total SF Whitening Charcoal	STANNOUS FLUORIDE	Colgate-Palmolive Company	36cd9cfc-7390-4400-8ede-b9d172d83953	2024-10-02	Warnings	Exact identifier application number: M021
Colgate Total SF Deep Clean	STANNOUS FLUORIDE	Colgate-Palmolive Company	85e83b72-2d09-aec0-db7e-6b5715c5a86c	2024-10-01	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