Crest 3D White

Product NDC: 37000-853
11-digit product format: 370000853
Labeler code: 37000
Product ID: 37000-853_bb26208c-64c1-f440-e053-2995a90ad557
Type: HUMAN OTC DRUG
Nonproprietary name: Sodium Fluoride
Dosage form: PASTE, DENTIFRICE
Route: DENTAL
Labeler: The Procter & Gamble Manufacturing Company
Application: part355
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2014-02-04
Marketing end: 0000-00-00
Substance: SODIUM FLUORIDE
Active strength: 2 mg/g
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	37000-853		D	Discontinued by firm	2026-10-12
excluded package	package	37000-853	37000-853-04	D	Discontinued by firm	2026-10-12
excluded package	package	37000-853	37000-853-08	D	Discontinued by firm	2026-10-12
excluded package	package	37000-853	37000-853-83	D	Discontinued by firm	2026-10-12
excluded package	package	37000-853	37000-853-85	D	Discontinued by firm	2026-10-12

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 16 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	37000-853-85	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	37000-853-08	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	37000-853-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	37000-853-83	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	37000-853-83	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	37000-853-83	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	37000-853-83	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	37000-853-83	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	37000-853-83	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	37000-853-83	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	37000-853-83	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	37000-853-83	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	37000-853-83	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	37000-853-83	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	37000-853-83	`557ba5c1ecfa…`	`9c80585c8c6e…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
37000-853-04	2023-03-30	Crest ® 3D White ®
37000-853-08	2023-03-30	Crest ® 3D White ®
37000-853-83	2023-03-30	Crest ® 3D White ®
37000-853-85	2023-03-30	Crest ® 3D White ®
37000-853-04	2023-01-30	Crest ® 3D White ®
37000-853-08	2023-01-30	Crest ® 3D White ®
37000-853-83	2023-01-30	Crest ® 3D White ®
37000-853-85	2023-01-30	Crest ® 3D White ®
37000-853-04	2021-02-12	Crest ® 3D White ®
37000-853-08	2021-02-12	Crest ® 3D White ®
37000-853-83	2021-02-12	Crest ® 3D White ®
37000-853-85	2021-02-12	Crest ® 3D White ®
37000-853-04	2021-01-29	Crest ® 3D White ®
37000-853-08	2021-01-29	Crest ® 3D White ®
37000-853-83	2021-01-29	Crest ® 3D White ®
37000-853-85	2021-01-29	Crest ® 3D White ®

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Sodium Fluoride	ACTIVE INGREDIENT	8ZYQ1474W7	CREST 3D WHITE (SODIUM FLUORIDE) PASTE, DENTIFRICE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]	1
Fluoride Ion	ACTIVE MOIETY	Q80VPU408O	CREST 3D WHITE (SODIUM FLUORIDE) PASTE, DENTIFRICE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]	1
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	CREST 3D WHITE (SODIUM FLUORIDE) PASTE, DENTIFRICE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]	1
CARBOXYMETHYLCELLULOSE SODIUM	INACTIVE INGREDIENT	K679OBS311	CREST 3D WHITE (SODIUM FLUORIDE) PASTE, DENTIFRICE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]	1
COCAMIDOPROPYL BETAINE	INACTIVE INGREDIENT	5OCF3O11KX	CREST 3D WHITE (SODIUM FLUORIDE) PASTE, DENTIFRICE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	CREST 3D WHITE (SODIUM FLUORIDE) PASTE, DENTIFRICE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	CREST 3D WHITE (SODIUM FLUORIDE) PASTE, DENTIFRICE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	CREST 3D WHITE (SODIUM FLUORIDE) PASTE, DENTIFRICE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]	1
HIGH DENSITY POLYETHYLENE	INACTIVE INGREDIENT	UG00KM4WR7	CREST 3D WHITE (SODIUM FLUORIDE) PASTE, DENTIFRICE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]	1
HYDRATED SILICA	INACTIVE INGREDIENT	Y6O7T4G8P9	CREST 3D WHITE (SODIUM FLUORIDE) PASTE, DENTIFRICE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]	1
MICA	INACTIVE INGREDIENT	V8A1AW0880	CREST 3D WHITE (SODIUM FLUORIDE) PASTE, DENTIFRICE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]	1
POLYETHYLENE GLYCOL 1000000	INACTIVE INGREDIENT	HZ58M6D839	CREST 3D WHITE (SODIUM FLUORIDE) PASTE, DENTIFRICE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]	1
POLYETHYLENE GLYCOL 900000	INACTIVE INGREDIENT	16P9295IIL	CREST 3D WHITE (SODIUM FLUORIDE) PASTE, DENTIFRICE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]	1
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	CREST 3D WHITE (SODIUM FLUORIDE) PASTE, DENTIFRICE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]	1
SODIUM ACID PYROPHOSPHATE	INACTIVE INGREDIENT	H5WVD9LZUD	CREST 3D WHITE (SODIUM FLUORIDE) PASTE, DENTIFRICE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	CREST 3D WHITE (SODIUM FLUORIDE) PASTE, DENTIFRICE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]	1
SODIUM LAURETH-2 PHOSPHATE	INACTIVE INGREDIENT	1IO8CC3XDG	CREST 3D WHITE (SODIUM FLUORIDE) PASTE, DENTIFRICE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	CREST 3D WHITE (SODIUM FLUORIDE) PASTE, DENTIFRICE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]	1
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	CREST 3D WHITE (SODIUM FLUORIDE) PASTE, DENTIFRICE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CREST 3D WHITE (SODIUM FLUORIDE) PASTE, DENTIFRICE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	CREST 3D WHITE (SODIUM FLUORIDE) PASTE, DENTIFRICE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]	1
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	CREST 3D WHITE (SODIUM FLUORIDE) PASTE, DENTIFRICE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]	1
XYLITOL	INACTIVE INGREDIENT	VCQ006KQ1E	CREST 3D WHITE (SODIUM FLUORIDE) PASTE, DENTIFRICE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
37000-853	CREST 3D WHITE (SODIUM FLUORIDE) PASTE, DENTIFRICE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]	8	Legacy NDC	20250110_ecc528b2-167e-4213-a03a-b2d45c76e168.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
8ZYQ1474W7	SODIUM FLUORIDE	7681-49-4	SODIUM FLUORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
37000-853-04	37000085304	1 TUBE in 1 CARTON (37000-853-04) > 116 g in 1 TUBE	1 tube	2014-02-04	0000-00-00	No	No	Current
37000-853-08	37000085308	2 CARTON in 1 CELLO PACK (37000-853-08) > 1 TUBE in 1 CARTON > 116 g in 1 TUBE	2 carton	2014-02-04	0000-00-00	No	No	Current
37000-853-85	37000085385	1 TUBE in 1 CARTON (37000-853-85) > 24 g in 1 TUBE	1 tube	2014-02-04	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Crest ® 3D White ®	The Procter & Gamble Manufacturing Company	2025-01-08	HUMAN OTC DRUG LABEL	8