Opal by Opalescence Original

Product NDC: 51206-312
11-digit product format: 512060312
Labeler code: 51206
Product ID: 51206-312_5b14e96f-d015-5738-e063-6294a90ac014
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: 2023-11-19
Marketing end: 2029-02-21
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: Opal by Opalescence Original

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
5c3bf8fc-2e8f-4a58-bcbf-e47540072a49	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
51206-312-02	2024-01-30	C162847	48780-1	1030e365-4aaa-111a-e063-dadaa90a10e2	Opal™ by Opalescence ® Original
51206-312-02	2024-01-30	C162847	48780-1	1030e365-4aaa-111a-e063-dadaa90a10e2	Opal™ by Opalescence ® Original

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
51206-312-01	Opal by Opalescence Original	1 in 1 CARTON	GEL, DENTIFRICE	1	5
51206-312-01	Opal by Opalescence Original	133 g in 1 TUBE	GEL, DENTIFRICE	133	5
51206-312-02	Opal by Opalescence Original	1 in 1 CARTON	GEL, DENTIFRICE	1	5
51206-312-02	Opal by Opalescence Original	3 in 1 PACKAGE, COMBINATION	GEL, DENTIFRICE	3	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51206-312	OPAL BY OPALESCENCE ORIGINAL (SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.]	4	Current NDC, 4 package rows	20250402_5c3bf8fc-2e8f-4a58-bcbf-e47540072a49.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 12 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Crest Clean Breath Peppermint	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	4f1ef07b-ee68-e6ae-e063-6394a90af5e5	2026-04-10	Warnings	Exact identifier application number: M021
Crest Clean Breath Spearmint	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	4f20343e-6c03-48e8-e063-6294a90a8cdf	2026-04-10	Warnings	Exact identifier application number: M021
Crest Clean Breath Smooth Mint	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	4f2042b4-8eae-5c2c-e063-6394a90a640c	2026-04-10	Warnings	Exact identifier application number: M021
Crest 3D White Advanced Arctic Fresh with Stain-Blasting Foam	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	4ef4146d-6281-fe66-e063-6394a90a32c3	2026-04-09	Warnings	Exact identifier application number: M021
Crest 3D White Advanced Glamorous White with Stain-Blasting Foam	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	4ef5261e-9d2f-ae05-e063-6294a90a489a	2026-04-09	Warnings	Exact identifier application number: M021
Crest 3D White Advanced Luminous Mint Daily Whitening Upkeep	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	4f0876d9-41c9-d891-e063-6394a90a1cbd	2026-04-09	Warnings	Exact identifier application number: M021
Crest 3D White Advanced Charcoal with Stain-Blasting Foam	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	4ef57a05-b9f5-42f7-e063-6294a90a5d89	2026-04-09	Warnings	Exact identifier application number: M021
Crest 3D White Advanced Radiant Mint with Stain Blasting Foam	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	4ee26a82-16fd-f0fb-e063-6394a90a91d1	2026-04-09	Warnings	Exact identifier application number: M021
Crest 3D White Whitening Therapy Deep Clean Charcoal	SODIUM FLUORIDE	Procter & Gamble Manfuacturing Company	812c1519-1a4b-2495-e053-2a91aa0a914a	2026-04-09	Warnings	Exact identifier application number: M021
Crest 3D White Advanced Deep Clean with Stain-Blasting Foam	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	4ef4e7c2-1f58-59fc-e063-6294a90ad43b	2026-04-08	Warnings	Exact identifier application number: M021
Anticavity mouth rinse Low-foaming Spearmint	779 US VARIANT ANTICAVITY MOUTH RINSE LOW-FOAMING SPEARMINT	Dyson Technology Limited	4ef669b9-defe-8965-e063-6394a90ab335	2026-04-08	Warnings	Exact identifier application number: M021
Crest 3D White Advanced Radiant Mint	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	f5c89efc-5fa0-2a05-e053-2a95a90a7b9c	2026-04-07	Warnings	Exact identifier application number: M021
Crest 3D White Advanced Charcoal	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	f4eb8111-53da-17ae-e053-2a95a90a1127	2026-04-07	Warnings	Exact identifier application number: M021
Anticavity	SODIUM FLUORIDE	ADUSA Distribution, LLC	35385ada-bd8d-4d38-9587-0256885f749f	2026-04-07	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity	SODIUM FLUORIDE	ADUSA Distribution, LLC	cf0c8b48-0d1c-406a-a67d-7d16187d38d8	2026-04-07	Warnings, Adverse reactions	Exact identifier application number: M021
Crest 3D White Arctic Fresh	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	fa08a877-b9e5-4eba-b832-3a28f4f3f83c	2026-04-07	Warnings	Exact identifier application number: M021
Anticavity Fluoride	SODIUM FLUORIDE	Family Dollar (FAMILY WELLNESS)	63c4c0e9-84b1-4076-bdf4-7e9543b2cf46	2026-04-01	Warnings	Exact identifier application number: M021
CloSYS Silver Sensitive Mouth Rinse Fluoride Rinse	SODIUM FLUORIDE	Rowpar Pharmaceuticals, Inc.	98a8cee8-9f3c-4a4a-89f8-72e1f1b06796	2026-04-01	Warnings	Exact identifier application number: M021
CloSYS	SODIUM FLUORIDE	Rowpar Pharmaceuticals, Inc.	5f87abb7-0e9d-6369-e053-2a91aa0a2411	2026-03-31	Warnings	Exact identifier application number: M021
Crest Clean Breath Spearmint	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	4e544d09-0cf3-f0c7-e063-6394a90a2369	2026-03-31	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	5c3bf8fc-2e8f-4a58-bcbf-e47540072a49	5
1044547	sodium fluoride 0.0025 MG/MG Toothpaste	SCD	5c3bf8fc-2e8f-4a58-bcbf-e47540072a49	5
1044547	sodium fluoride 0.25 % (fluoride ion 0.15 % ) Toothpaste	SY	5c3bf8fc-2e8f-4a58-bcbf-e47540072a49	5
1044547	sodium fluoride 0.25 % Toothpaste	SY	5c3bf8fc-2e8f-4a58-bcbf-e47540072a49	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51206-312-01	51206031201	1 TUBE in 1 CARTON (51206-312-01) / 133 g in 1 TUBE	1 tube	2023-11-19	2029-02-21	No	No	Historical
51206-312-02	51206031202	3 CARTON in 1 PACKAGE, COMBINATION (51206-312-02) / 1 TUBE in 1 CARTON / 133 g in 1 TUBE	3 carton	2023-11-19	2029-02-21	No	No	Historical