Colgate Total Whitening Charcoal

Product NDC: 35000-571
11-digit product format: 350000571
Labeler code: 35000
Product ID: 35000-571_a95051eb-ef65-4886-b899-5fae8e271aaf
Type: HUMAN OTC DRUG
Nonproprietary name: Stannous Fluoride
Dosage form: PASTE, DENTIFRICE
Route: DENTAL
Labeler: Colgate-Palmolive Company
Application: M021
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2020-12-10
Marketing end: 2026-12-31
Substance: STANNOUS FLUORIDE
Active strength: 1.1 mg/g
NDC exclude flag: No
Current FDA listing: Yes

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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	35000-571	35000-571-48	D	Discontinued by firm		2026-10-12
excluded package	package	35000-571	35000-571-96	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 · 18 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source date	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	35000-571-96	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	35000-571-48	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	35000-571-96	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	35000-571-48	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	35000-571-96	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	35000-571-48	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	35000-571-96	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	35000-571-48	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	35000-571-96	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	35000-571-48	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	35000-571-96	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	35000-571-48	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	35000-571-96	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	35000-571-48	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	35000-571-96	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	35000-571-48	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	35000-571-96	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	35000-571-48	`0efc9e666f02…`	`f202fb6c5f17…`

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: Colgate Total Whitening Charcoal

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
STANNOUS 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
3FTR44B32Q	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
416784	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
56434e3d-ba0a-8b42-6c97-0d0055606793	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
35000-571-32	Colgate Total Whitening Charcoal	1 in 1 CARTON	PASTE, DENTIFRICE	1	10
35000-571-32	Colgate Total Whitening Charcoal	93 g in 1 TUBE	PASTE, DENTIFRICE	93	10
35000-571-48	Colgate Total Whitening Charcoal	136 g in 1 TUBE	PASTE, DENTIFRICE	136	10
35000-571-48	Colgate Total Whitening Charcoal	1 in 1 CARTON	PASTE, DENTIFRICE	1	10
35000-571-65	Colgate Total Whitening Charcoal	144 g in 1 TUBE	PASTE, DENTIFRICE	144	10
35000-571-65	Colgate Total Whitening Charcoal	2 in 1 CARTON	PASTE, DENTIFRICE	2	10
35000-571-66	Colgate Total Whitening Charcoal	144 g in 1 TUBE	PASTE, DENTIFRICE	144	10
35000-571-66	Colgate Total Whitening Charcoal	1 in 1 CARTON	PASTE, DENTIFRICE	1	10
35000-571-96	Colgate Total Whitening Charcoal	136 g in 1 TUBE	PASTE, DENTIFRICE	136	10
35000-571-96	Colgate Total Whitening Charcoal	2 in 1 CARTON	PASTE, DENTIFRICE	2	10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
35000-571	COLGATE TOTAL WHITENING CHARCOAL (STANNOUS FLUORIDE) PASTE, DENTIFRICE [COLGATE-PALMOLIVE COMPANY]	10	Current NDC, Legacy NDC, 10 package rows	20241003_56434e3d-ba0a-8b42-6c97-0d0055606793.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 9 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Walgreens Restore and Defend	STANNOUS FLUORIDE	Walgreens	e808ea4b-9081-085b-e053-2a95a90a4f9b	2026-06-02	Warnings	Exact identifier application number: M021
Hello Unicorn Splash unicorn splash anticavity fluoride rinse	SODIUM FLUORIDE	Colgate-Palmolive Company	a1014431-7d23-aaff-6dc7-ab58683d0338	2026-06-02	Warnings	Exact identifier application number: M021
Therabreath Anticavity	SODIUM FLUORIDE	Church & Dwight Co., Inc.	feab3d45-ff95-4b32-8258-7d932a7380c9	2026-06-01	Warnings	Exact identifier application number: M021
Orajel Toy Story 5 Anticavity	SODIUM FLUORIDE	Church & Dwight Co., Inc.	4b80947d-f389-2f80-e063-6294a90abd55	2026-06-01	Warnings	Exact identifier application number: M021
Arm and Hammer	SODIUM FLUORIDE	Church & Dwight Co., Inc.	54113245-0c1e-739e-e063-6294a90aea42	2026-06-01	Warnings	Exact identifier application number: M021
Arm and Hammer	SODIUM FLUORIDE	Church & Dwight Co., Inc.	545258fd-8179-fffc-e063-6394a90a467f	2026-06-01	Warnings	Exact identifier application number: M021
Orajel Paw Patrol	SODIUM FLUORIDE	Church & Dwight Co., Inc.	99d87bea-3e99-5d04-e053-2a95a90aaf54	2026-06-01	Warnings	Exact identifier application number: M021
Orajel SuperMario	ANTICAVITY TOOTHPASTE	Church & Dwight Co., Inc.	27d2f6cb-8661-da9c-e063-6394a90a5bde	2026-06-01	Warnings	Exact identifier application number: M021
Orajel KidsToothpaste	SODIUM FLUORIDE	Church & Dwight Co., Inc.	99d62125-c2c5-5926-e053-2995a90aaa29	2026-06-01	Warnings	Exact identifier application number: M021
AIM CAVITY PROTECTION Multi Benefit	SODIUM FLUORIDE	Church & Dwight Co., Inc.	1d0f8a33-0b01-40e2-e054-00144ff88e88	2026-06-01	Warnings	Exact identifier application number: M021
Crest plus Tartar Protection Whitening	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	560980ea-749f-593d-e063-6394a90a1b9e	2026-06-01	Warnings	Exact identifier application number: M021
Colgate Revitalizing White	SODIUM MONOFLUOROPHOSPHATE	Colgate-Palmolive Company	c67223ae-b068-41c5-a15b-7ae9840b93ef	2026-05-27	Warnings	Exact identifier application number: M021
Colgate Kids Harry Potter	SODIUM FLUORIDE	Colgate-Palmolive Company	61c06da4-9f02-4fbc-b80f-1c443e298496	2026-05-26	Warnings	Exact identifier application number: M021
sodium fluoride rinse	SODIUM FLUORIDE RINSE	Rockland Cosmetics, Inc.	52430b12-4d5f-d1e1-e063-6394a90abd64	2026-05-20	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity	SODIUM FLUORIDE	H E B	d0a52519-3339-40ea-93e5-78f76d348a4d	2026-05-14	Warnings, Adverse reactions	Exact identifier application number: M021
Burts Bees Extra White	SODIUM FLUORIDE	Procter & Gamble Manufacturing Company	c92524fd-8b93-592d-e053-2a95a90a88c6	2026-05-13	Warnings	Exact identifier application number: M021
MIPaste Plus Strawberry	SODIUM FLUORIDE	GC America Inc.	1b68bd67-65d3-4c64-e054-00144ff8d46c	2026-05-12	Warnings	Exact identifier application number: M021
White Glo Purple Color Corrector Fluoride Anticavity	SODIUM MONOFLUOROPHOSPHATE	White Glo USA Inc	6f8b77c3-9833-4c75-b41c-a2bc12616157	2026-05-12	Warnings	Exact identifier application number: M021
botalab HERBAL COMPLETE TOOTH	SODIUM FLUORIDE	KMPHARMACEUTICAL CO., LTD.	51365ef7-ed94-2650-e063-6394a90ab89e	2026-05-07	Warnings	Exact identifier application number: M021
Morning Fresh Mint Toothpaste, with Fluoride	MORNING FRESH MINT TOOTHPASTE, WITH FLUORIDE	Dynarex Corporation	2a42d8ce-e7f2-caa5-e063-6294a90ac01f	2026-05-07	Warnings	Exact identifier application number: M021

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
3FTR44B32Q	STANNOUS FLUORIDE	7783-47-3	STANNOUS FLUORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
416784	stannous fluoride 0.454 % (fluoride ion 0.16 % ) Toothpaste	PSN	56434e3d-ba0a-8b42-6c97-0d0055606793	10
416784	stannous fluoride 0.00454 MG/MG Toothpaste	SCD	56434e3d-ba0a-8b42-6c97-0d0055606793	10
416784	stannous fluoride 0.454 % (fluoride ion 0.14 % ) Toothpaste	SY	56434e3d-ba0a-8b42-6c97-0d0055606793	10
416784	stannous fluoride 0.454 % (fluoride ion 0.15 % ) Toothpaste	SY	56434e3d-ba0a-8b42-6c97-0d0055606793	10
416784	stannous fluoride 0.454 % (fluoride ion 0.16 % ) Toothpaste	SY	56434e3d-ba0a-8b42-6c97-0d0055606793	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
35000-571-32	35000057132	1 TUBE in 1 CARTON (35000-571-32) / 93 g in 1 TUBE	1 tube	2021-01-20	2026-12-31	No	No	Current
35000-571-48	35000057148	1 TUBE in 1 CARTON (35000-571-48) > 136 g in 1 TUBE	1 tube	2020-12-10	0000-00-00	No	No	Current
35000-571-65	35000057165	2 TUBE in 1 CARTON (35000-571-65) / 144 g in 1 TUBE	2 tube	2021-12-08	2026-12-31	No	No	Current
35000-571-66	35000057166	1 TUBE in 1 CARTON (35000-571-66) / 144 g in 1 TUBE	1 tube	2021-12-27	2026-12-31	No	No	Current
35000-571-96	35000057196	2 TUBE in 1 CARTON (35000-571-96) > 136 g in 1 TUBE	2 tube	2020-12-11	0000-00-00	No	No	Current