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 7 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
COLGATE ULTRA BRITE ADVANCED WHITENING ALL IN ONE CLEAN MINT	SODIUM FLUORIDE	Colgate-Palmolive Company	9aaa451d-8827-41b7-9661-bc1a7a69cfc3	2026-06-30	Warnings	Exact identifier application number: M021
CrestPlus Deep Clean plus Whitening Effervescent Mint	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	5579be77-97df-1000-e063-6294a90a4725	2026-06-30	Warnings	Exact identifier application number: M021
COLGATE OPTIC WHITE ADVANCED ENAMEL STRENGTH	SODIUM MONOFLUOROPHOSPHATE	Colgate-Palmolive Company	358842de-3e1d-4f66-8d08-fe8538441b34	2026-06-29	Warnings	Exact identifier application number: M021
Anticavity mouth rinse Low-foaming Spearmint	718 US VARIANT ANTICAVITY MOUTH RINSE LOW-FOAMING SPEARMINT	Dyson Technology Limited	5356d0a8-2db4-ce7f-e063-6394a90aa6d2	2026-06-26	Warnings	Exact identifier application number: M021
Colgate Optic White Renewal Brilliant Shine	SODIUM MONOFLUOROPHOSPHATE	Colgate-Palmolive Company	70734d67-fc3e-4515-b6e6-ab2c466578d6	2026-06-26	Warnings	Exact identifier application number: M021
Colgate Max Fresh Cool Mint	SODIUM FLUORIDE	Colgate-Palmolive Company	f87d6f04-507a-47ae-8a66-204cf59261c0	2026-06-26	Warnings	Exact identifier application number: M021
Crest Plus Scope plus Whitening Outlast Mint	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	5513ba92-cadc-2cf3-e063-6294a90ac3e5	2026-06-25	Warnings	Exact identifier application number: M021
Crest Plus Active Fresh Scope plus Whitening	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	5513e40f-b8e8-2d9a-e063-6394a90ab170	2026-06-25	Warnings	Exact identifier application number: M021
Crest 3D White Stain Eraser Mint Splash	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	4f6c690e-a1bb-4606-e063-6394a90ac4b6	2026-06-25		Exact identifier application number: M021
Crest 3D White Stain Eraser Daily Stain Prevention Polishing Mint	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	4f1bbc3d-a1f9-b278-e063-6294a90a62f7	2026-06-25		Exact identifier application number: M021
Crest 3D White Stain Eraser Daily Stain Prevention Icy Clean Mint	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	4f1bd56c-dac8-eb87-e063-6294a90a3cc1	2026-06-25		Exact identifier application number: M021
Crest 3D White Stain Eraser Daily Stain Prevention Icy Clean Mint	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	4f0b1d46-d52c-f409-e063-6394a90a5574	2026-06-25		Exact identifier application number: M021
Crest Plus Extra Whitening	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	5514e09e-0a7d-93e6-e063-6294a90ae3f0	2026-06-25	Warnings	Exact identifier application number: M021
Colgate Sparkling White Mint Zing	SODIUM MONOFLUOROPHOSPHATE	Colgate-Palmolive Company	0c2fe62b-4905-4213-a85b-e073d8eeb741	2026-06-24	Warnings	Exact identifier application number: M021
Colgate MaxFresh Charcoal	SODIUM FLUORIDE	Colgate-Palmolive Company	890c4c29-bba8-4775-a053-10c6292df930	2026-06-24	Warnings	Exact identifier application number: M021
Crest Premium Plus Active Foam Whitening scope	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	55004d9d-eda7-a285-e063-6294a90ad4ca	2026-06-24	Warnings	Exact identifier application number: M021
Euthymol Whitening Purple Corrector	SODIUM FLUORIDE	LG HOUSEHOLD & HEALTH CARE LTD.	5500686c-d417-c50a-e063-6294a90ac7fa	2026-06-24	Warnings	Exact identifier application number: M021
Crest Premium Plus Scope Active Foam plus Whitening Dualblast Mint	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	5500f9ab-b0c4-51d6-e063-6394a90acd38	2026-06-24	Warnings	Exact identifier application number: M021
Crest Premium Plus Deep Clean Active Foam plus Whitening Foaming Mint	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	5504ec96-aae1-f5f9-e063-6294a90ad8bb	2026-06-24	Warnings	Exact identifier application number: M021
COLGATE SPARKLING WHITE CINNAMINT	SODIUM FLUORIDE	Colgate-Palmolive Company	f2ff18d2-4ef0-454e-a6f1-6f3bf361c7d1	2026-06-24	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