Colgate Sensitive plus Whitening

Product NDC: 35000-023
11-digit product format: 350000023
Labeler code: 35000
Product ID: 35000-023_a0bc4e50-643e-47cb-a47f-b3978c197387
Type: HUMAN OTC DRUG
Nonproprietary name: POTASSIUM NITRATE and SODIUM FLUORIDE
Dosage form: PASTE, DENTIFRICE
Route: DENTAL
Labeler: Colgate-Palmolive Company
Application: M022
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2019-02-25
Marketing end: 2027-12-31
Substance: POTASSIUM NITRATE; SODIUM FLUORIDE
Active strength: 50; 1.1 mg/g; 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: Colgate Sensitive plus Whitening

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
POTASSIUM NITRATE	50 mg/g
SODIUM FLUORIDE	1.1 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
RU45X2JN0Z	Internal UNII lookup
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
1038929	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
2092c747-e025-47a9-9e54-731631d3c831	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6084a4f4-5437-c9a5-caec-5361ee075a59	Product name	1	20140508
90c5639a-61b0-88d6-ddcf-21888e94869a	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
35000-023-34	Colgate Sensitive plus Whitening	2 in 1 CARTON	PASTE, DENTIFRICE	2	8
35000-023-34	Colgate Sensitive plus Whitening	170 g in 1 TUBE	PASTE, DENTIFRICE	170	8
35000-023-46	Colgate Sensitive plus Whitening	130 g in 1 TUBE	PASTE, DENTIFRICE	130	8
35000-023-46	Colgate Sensitive plus Whitening	1 in 1 CARTON	PASTE, DENTIFRICE	1	8
35000-023-60	Colgate Sensitive plus Whitening	1 in 1 CARTON	PASTE, DENTIFRICE	1	8
35000-023-60	Colgate Sensitive plus Whitening	170 g in 1 TUBE	PASTE, DENTIFRICE	170	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
35000-023	COLGATE SENSITIVE PLUS WHITENING (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE, DENTIFRICE [COLGATE-PALMOLIVE COMPANY]	7	Current NDC, Legacy NDC, 6 package rows	20240113_2092c747-e025-47a9-9e54-731631d3c831.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 34 of 40 · 782 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Orajel 2X Medicated Gel	ORAL PAIN RELIEVER	Church & Dwight Co., Inc.	262be295-4eaf-3136-e063-6294a90a7dcc	2024-11-05	Warnings	Exact identifier application number: M022
BIOTENE Fresh Mint Original	SODIUM FLUORIDE	Haleon US Holdings LLC	1101c17f-c848-4cd5-a7cd-679b59dbe1bf	2024-11-05	Warnings	Exact identifier application number: M022
biotene	SODIUM MONOFLUOROPHOSPHATE	Haleon US Holdings LLC	a47a6502-efb2-4072-9562-cbe293531c2b	2024-11-04	Warnings	Exact identifier application number: M022
Amosan Oral Wound Cleanser Cherry	SODIUM PERBORATE MONOHYDRATE	Vintage Brands Limited	a0e145c8-6b08-40be-ae4f-5678c4a78b1e	2024-10-30	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	043bfbc3-c33b-78b7-e063-6294a90a1a5a	2024-10-29	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	043bfbc3-c33a-78b7-e063-6294a90a1a5a	2024-10-29	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	043a3cb4-f560-0ffd-e063-6394a90a2ff6	2024-10-29	Warnings	Exact identifier application number: M022
Amosan Oral Wound Cleanser Mint	SODIUM PERBORATE MONOHYDRATE	Vintage Brands Limited	be57ca56-834f-4170-a407-f193484d8b0a	2024-10-29	Warnings	Exact identifier application number: M022
SENSODYNE PRONAMEL Intensive Enamel Repair Clean Mint	SODIUM FLUORIDE	Haleon US Holdings LLC	817c0dad-d109-428e-adb5-3354604acc94	2024-10-28	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	1f3d68f6-afd6-42e7-b3e5-210228c8e7de	2024-10-28	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals LLC	0dd15227-6603-42ac-9a5f-f2dc49e0382a	2024-10-28	Warnings, Adverse reactions	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	0605d5d6-82bd-415e-b5cb-e273f934a4a7	2024-10-28	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic Liquid	BENZOCAINE	Beutlich Pharmaceuticals, LLC	f70fa3fc-cd65-4a80-9efd-129e98fd3998	2024-10-28	Warnings	Exact identifier application number: M022
Sore Throat Relief Menthol	PHENOL	Chain Drug Consortium	af661ef0-cdc3-4146-8ae5-59795aa49650	2024-10-28	Warnings	Exact identifier application number: M022
Sore Throat Relief Cherry Flavor	PHENOL	Chain Drug Consortium	a9cf9829-4b70-44fa-9719-240b65c06724	2024-10-28	Warnings	Exact identifier application number: M022
Ear Wax Removal Aid Drops	CARBAMIDE PEROXIDE	PHARMACY VALUE ALLIANCE, LLC	85ae80c1-2bc2-4c90-9559-63510d03e739	2024-10-28	Warnings	Exact identifier application number: M022
Chloraspetic	MENTHOL AND BENZOCAINE	Prestige Brands Holdings, Inc.	2b1808b2-2574-4ab8-a762-5733251848ce	2024-10-25	Warnings	Exact identifier application number: M022
Chloraseptic Warming Sore Throat	PHENOL	Prestige Brands Holdings, Inc.	a197fab2-70ce-4a6c-9add-29d7368a75c5	2024-10-25	Warnings	Exact identifier application number: M022
Gly-Oxide	CARBAMIDE PEROXIDE	Medtech Products Inc.	086a0b82-e947-41c9-89e7-ba06483960c9	2024-10-25	Warnings	Exact identifier application number: M022
CHLORASEPTIC	MENTHOL AND BENZOCAINE	Prestige Brands Holdings, Inc.	d500f423-b9f2-4d98-8f2a-8bab7c05737c	2024-10-25	Warnings	Exact identifier application number: M022

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
RU45X2JN0Z	POTASSIUM NITRATE	7757-79-1	POTASSIUM NITRATE
8ZYQ1474W7	SODIUM FLUORIDE	7681-49-4	SODIUM FLUORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1038929	potassium nitrate 5 % / sodium fluoride 0.24 % Toothpaste	PSN	2092c747-e025-47a9-9e54-731631d3c831	8
1038929	potassium nitrate 0.05 MG/MG / sodium fluoride 0.0024 MG/MG Toothpaste	SCD	2092c747-e025-47a9-9e54-731631d3c831	8
1038929	K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG Toothpaste	SY	2092c747-e025-47a9-9e54-731631d3c831	8
1038929	Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG Toothpaste	SY	2092c747-e025-47a9-9e54-731631d3c831	8
1038929	potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.14 % ) Toothpaste	SY	2092c747-e025-47a9-9e54-731631d3c831	8
1038929	potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.15 % ) Toothpaste	SY	2092c747-e025-47a9-9e54-731631d3c831	8
1038929	potassium nitrate 5 % / sodium fluoride 0.24 % Toothpaste	SY	2092c747-e025-47a9-9e54-731631d3c831	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
35000-023-34	35000002334	2 TUBE in 1 CARTON (35000-023-34) / 170 g in 1 TUBE	2 tube	2019-02-25	2027-12-31	No	No	Current
35000-023-46	35000002346	1 TUBE in 1 CARTON (35000-023-46) / 130 g in 1 TUBE	1 tube	2020-06-15	2027-12-31	No	No	Current
35000-023-60	35000002360	1 TUBE in 1 CARTON (35000-023-60) / 170 g in 1 TUBE	1 tube	2019-02-25	2027-12-31	No	No	Current