Crest 3D White Luxe

Product NDC: 37000-862
Requested package NDC: 37000-862-01
11-digit product format: 370000862
Labeler code: 37000
Product ID: 37000-862_48ea8786-3ce3-a637-e063-6294a90ab4a9
Type: HUMAN OTC DRUG
Nonproprietary name: Sodium Fluoride
Dosage form: RINSE
Route: ORAL
Labeler: The Procter & Gamble Manufacturing Company
Application: M021
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2015-02-19
Substance: SODIUM FLUORIDE
Active strength: .1 mg/mL
NDC exclude flag: No
Listing certified through: 2027-12-31
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: Crest 3D White Luxe
Brand name suffix: Diamond Strong
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SODIUM FLUORIDE	.1 mg/mL

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1090579	Internal RxNorm lookup
1486338	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
c1420129-5460-4900-ac9a-356d2d7c60a2	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
37000-862-01	2023-05-19	Crest ® 3D White Luxe™ Diamond Strong
37000-862-01	2023-05-19	Crest ® 3D White Luxe™ Diamond Strong
37000-862-01	2023-05-19	Crest ® 3D White Luxe™ Diamond Strong
37000-862-02	2023-05-19	Crest ® 3D White Luxe™ Diamond Strong
37000-862-02	2023-05-19	Crest ® 3D White Luxe™ Diamond Strong
37000-862-02	2023-05-19	Crest ® 3D White Luxe™ Diamond Strong
37000-862-01	2023-01-30	Crest ® 3D White Luxe™ Diamond Strong
37000-862-01	2023-01-30	Crest ® 3D White Luxe™ Diamond Strong
37000-862-01	2023-01-30	Crest ® 3D White Luxe™ Diamond Strong
37000-862-02	2023-01-30	Crest ® 3D White Luxe™ Diamond Strong
37000-862-02	2023-01-30	Crest ® 3D White Luxe™ Diamond Strong
37000-862-02	2023-01-30	Crest ® 3D White Luxe™ Diamond Strong
37000-862-01	2021-02-12	Crest ® 3D White Luxe™ Diamond Strong
37000-862-01	2021-02-12	Crest ® 3D White Luxe™ Diamond Strong
37000-862-01	2021-02-12	Crest ® 3D White Luxe™ Diamond Strong
37000-862-02	2021-02-12	Crest ® 3D White Luxe™ Diamond Strong
37000-862-02	2021-02-12	Crest ® 3D White Luxe™ Diamond Strong
37000-862-02	2021-02-12	Crest ® 3D White Luxe™ Diamond Strong
37000-862-01	2021-01-29	Crest ® 3D White Luxe™ Diamond Strong
37000-862-01	2021-01-29	Crest ® 3D White Luxe™ Diamond Strong
37000-862-01	2021-01-29	Crest ® 3D White Luxe™ Diamond Strong
37000-862-02	2021-01-29	Crest ® 3D White Luxe™ Diamond Strong
37000-862-02	2021-01-29	Crest ® 3D White Luxe™ Diamond Strong
37000-862-02	2021-01-29	Crest ® 3D White Luxe™ Diamond Strong

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
37000-862-01	Crest 3D White LuxeDiamond Strong	473 mL in 1 BOTTLE, PLASTIC	RINSE	473	11
37000-862-02	Crest 3D White LuxeDiamond Strong	946 mL in 1 BOTTLE, PLASTIC	RINSE	946	11
37000-862-03	Crest 3D White LuxeDiamond Strong	2 in 1 CELLO PACK	RINSE	2	11
37000-862-03	Crest 3D White LuxeDiamond Strong	946 mL in 1 BOTTLE	RINSE	946	11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Sodium Fluoride	ACTIVE INGREDIENT	8ZYQ1474W7	CREST 3D WHITE LUXE DIAMOND STRONG (SODIUM FLUORIDE) RINSE [PROCTER & GAMBLE MANUFACTURING COMPANY]	1
Fluoride Ion	ACTIVE MOIETY	Q80VPU408O	CREST 3D WHITE LUXE DIAMOND STRONG (SODIUM FLUORIDE) RINSE [PROCTER & GAMBLE MANUFACTURING COMPANY]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	CREST 3D WHITE LUXE DIAMOND STRONG (SODIUM FLUORIDE) RINSE [PROCTER & GAMBLE MANUFACTURING COMPANY]	1
HYDROGEN PEROXIDE	INACTIVE INGREDIENT	BBX060AN9V	CREST 3D WHITE LUXE DIAMOND STRONG (SODIUM FLUORIDE) RINSE [PROCTER & GAMBLE MANUFACTURING COMPANY]	1
PHOSPHORIC ACID	INACTIVE INGREDIENT	E4GA8884NN	CREST 3D WHITE LUXE DIAMOND STRONG (SODIUM FLUORIDE) RINSE [PROCTER & GAMBLE MANUFACTURING COMPANY]	1
POLOXAMER 407	INACTIVE INGREDIENT	TUF2IVW3M2	CREST 3D WHITE LUXE DIAMOND STRONG (SODIUM FLUORIDE) RINSE [PROCTER & GAMBLE MANUFACTURING COMPANY]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	CREST 3D WHITE LUXE DIAMOND STRONG (SODIUM FLUORIDE) RINSE [PROCTER & GAMBLE MANUFACTURING COMPANY]	1
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	CREST 3D WHITE LUXE DIAMOND STRONG (SODIUM FLUORIDE) RINSE [PROCTER & GAMBLE MANUFACTURING COMPANY]	1
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	22ADO53M6F	CREST 3D WHITE LUXE DIAMOND STRONG (SODIUM FLUORIDE) RINSE [PROCTER & GAMBLE MANUFACTURING COMPANY]	1
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	CREST 3D WHITE LUXE DIAMOND STRONG (SODIUM FLUORIDE) RINSE [PROCTER & GAMBLE MANUFACTURING COMPANY]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	CREST 3D WHITE LUXE DIAMOND STRONG (SODIUM FLUORIDE) RINSE [PROCTER & GAMBLE MANUFACTURING COMPANY]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
37000-862	CREST 3D WHITE LUXE DIAMOND STRONG (SODIUM FLUORIDE) RINSE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]	9	Current NDC, Legacy NDC, 4 package rows	20250309_c1420129-5460-4900-ac9a-356d2d7c60a2.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 32 of 49 · 974 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Advance White Extreme Whitening Tartar Control	SODIUM FLUORIDE	Church & Dwight Co., Inc.	b539264f-e1ff-440b-af76-84266fe2c0a2	2025-12-02	Warnings	Exact identifier application number: M021
Sensodyne Pronamel Clinical Enamel Strength Fresh Breath	POTASSIUM NITRATE, SODIUM FLUORIDE	Haleon US Holdings LLC	34a1a32e-3017-f018-e063-6394a90a0230	2025-12-01	Warnings	Exact identifier application number: M021
PRO-SYS	SODIUM FLUORIDE AND POTASSIUM NITRATE	Benco Dental	4e470ba4-60bb-1815-e063-6294a90abacc	2025-12-01	Warnings	Exact identifier application number: M021
PRO-SYS	SODIUM FLUORIDE	Benco Dental	4e539cb2-bcbd-95fc-e063-6294a90a2121	2025-12-01	Warnings	Exact identifier application number: M021
Cool sense Care Plus	SODIUM FLUORIDE	DONG IL PHARMS CO., LTD.	44763bf6-caf3-ec69-e063-6394a90a0ee1	2025-11-25	Warnings	Exact identifier application number: M021
DOCTRUST DOUBLEX Tooth	SODIUM FLUORIDE	DONG IL PHARMS CO.,LTD	44765e86-2eb2-6381-e063-6394a90a761f	2025-11-25	Warnings	Exact identifier application number: M021
TheraBreath for Kids Anticavity Wacky Watermelon	SODIUM FLUORIDE	Church & Dwight Co., Inc.	578f8010-6b1c-4c6b-91d3-e483ace40f66	2025-11-25	Warnings	Exact identifier application number: M021
Sensodyne Cavity and Sensitivity	POTASSIUM NITRATE, SODIUM FLUORIDE	Haleon US Holdings LLC	d002074b-0580-4247-b3c7-121b8c098697	2025-11-24	Warnings	Exact identifier application number: M021
CVS Pharmacy Enamel Guard	FLUORIDE	CVS Pharmacy	18295a1c-c2a6-489b-be34-9252b9e1e2b8	2025-11-21	Warnings	Exact identifier application number: M021
365 Everyday Value Cavity Fighting and Whitening	SODIUM MONOFLOUROPHOSPHATE	Whole Foods Market, Inc.	83704717-19bc-2634-e053-2991aa0a2979	2025-11-21	Warnings	Exact identifier application number: M021
Whitening	MONOFLUOROPHOSPHATE	Target	0074630f-9d8d-9209-e063-6294a90a4f01	2025-11-21	Warnings	Exact identifier application number: M021
Rite Aid Enamel Guard	FLUORIDE	Rite Aid	67c1fc04-0f21-4944-8b9d-0d8ffd051874	2025-11-21	Warnings	Exact identifier application number: M021
ME MOTHER EARTH	ZERO WASTE TOOTHPASTE TABLETS PEPPERMINT	A PLUS MERCHANDISE LLC	43d30abc-889a-5377-e063-6294a90ab804	2025-11-17	Warnings	Exact identifier application number: M021
Natural White Sensitivity and Gum	STANNOUS FLUORIDE	Lornamead Products	2e83bda8-4d4b-640f-e063-6294a90abc60	2025-11-14	Warnings	Exact identifier application number: M021
CVS Pharmacy Restore and Defend	FLUORIDE	CVS Pharmacy	99f86135-05b7-42b1-aef5-df4513259b8f	2025-11-14	Warnings	Exact identifier application number: M021
HEB HEBuddy	FLUORIDE	HEB	a6af1baf-17bf-428c-8744-1490359b0cfb	2025-11-13	Warnings	Exact identifier application number: M021
Spearmint Whitening with Hemp Oil	SODIUM MONOFLUOROPHOSPHATE	Whole Foods	a4714db7-abc4-1eff-e053-2995a90a7740	2025-11-13	Warnings	Exact identifier application number: M021
Complete Protection TP	STANNOUS FLUORIDE	Rite Aid	ccad28b5-254e-679f-e053-2a95a90abdd5	2025-11-13	Warnings	Exact identifier application number: M021
Rite Aid Sensitivity and Gum	STANNOUS FLUORIDE	Rite Aid	ed362e9c-2dab-1102-e053-2a95a90a76f3	2025-11-13	Warnings	Exact identifier application number: M021
Gum Detoxify	STANNOUS FLUORIDE	Meijer, Inc.	0338495b-08a5-047f-e063-6394a90aa124	2025-11-13	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
1486338	Crest 0.022 % (fluoride ion 0.01 % ) Mouthwash	PSN	c1420129-5460-4900-ac9a-356d2d7c60a2	11
1090579	sodium fluoride 0.0219 % (fluoride ion 0.01 % ) Mouthwash	PSN	c1420129-5460-4900-ac9a-356d2d7c60a2	11
1486338	sodium fluoride 0.22 MG/ML Mouthwash [Crest]	SBD	c1420129-5460-4900-ac9a-356d2d7c60a2	11
1090579	sodium fluoride 0.22 MG/ML Mouthwash	SCD	c1420129-5460-4900-ac9a-356d2d7c60a2	11
1486338	Crest 0.022 % (fluoride ion 0.01 % ) Mouthwash	SY	c1420129-5460-4900-ac9a-356d2d7c60a2	11
1486338	Crest 0.22 MG/ML Mouthwash	SY	c1420129-5460-4900-ac9a-356d2d7c60a2	11
1486338	Crest Pro-Health For Me 0.022 % (fluoride ion 0.01 % ) Oral Rinse	SY	c1420129-5460-4900-ac9a-356d2d7c60a2	11
1486338	Crest Pro-Health For Me 0.22 MG/ML Mouthwash	SY	c1420129-5460-4900-ac9a-356d2d7c60a2	11
1486338	Crest Sensi-Care Mouthwash	SY	c1420129-5460-4900-ac9a-356d2d7c60a2	11
1486338	Kids Crest Cavity Protection 0.22 MG/ML Mouthwash	SY	c1420129-5460-4900-ac9a-356d2d7c60a2	11
1090579	sodium fluoride 0.0219 % (fluoride ion 0.01 % ) Mouthwash	SY	c1420129-5460-4900-ac9a-356d2d7c60a2	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
37000-862-01	37000086201	473 mL in 1 BOTTLE, PLASTIC (37000-862-01)	473 ml	2015-02-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Crest ® 3D White Luxe™ Diamond Strong	The Procter & Gamble Manufacturing Company	2026-01-21	HUMAN OTC DRUG LABEL	11