Hello Unicorn Splash

Product NDC: 35000-687
11-digit product format: 350000687
Labeler code: 35000
Product ID: 35000-687_5ad12666-22b6-4760-894f-8d9e96f41714
Type: HUMAN OTC DRUG
Nonproprietary name: sodium fluoride
Dosage form: MOUTHWASH
Route: DENTAL
Labeler: Colgate-Palmolive Company
Application: M021
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2023-07-01
Substance: SODIUM FLUORIDE
Active strength: .02 g/100mL
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: Hello Unicorn Splash
Brand name suffix: unicorn splash anticavity fluoride rinse
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SODIUM FLUORIDE	.02 g/100mL

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
240698	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
a1014431-7d23-aaff-6dc7-ab58683d0338	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
35000-687-10	Hello Unicorn Splashunicorn splash anticavity fluoride rinse	473 mL in 1 BOTTLE	MOUTHWASH	473		8
35000-687-12	Hello Unicorn Splashunicorn splash anticavity fluoride rinse	520 mL in 1 BOTTLE	MOUTHWASH	520		8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
35000-687	HELLO UNICORN SPLASH UNICORN SPLASH ANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [COLGATE-PALMOLIVE COMPANY]	7	Current NDC, 2 package rows	20250418_a1014431-7d23-aaff-6dc7-ab58683d0338.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 22 of 49 · 972 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Prime Tooth Care Strawberries	SODIUM FLUORIDE	Prime Tooth Care LLC	7b4328bd-5d2d-40ca-8322-5e818e1babf9	2026-01-09	Warnings	Exact identifier application number: M021
Prime Tooth Care Summer Watermelon	SODIUM FLUORIDE	Prime Tooth Care LLC	b7c731a1-80e7-4571-a568-db0290a720c1	2026-01-09	Warnings	Exact identifier application number: M021
Kids Prime Pediatric Dental Group Anticavity for Kids	SODIUM FLUORIDE	Prime Tooth Care LLC	93259174-447d-4f7a-8e55-990eb8da5151	2026-01-09	Warnings	Exact identifier application number: M021
Crest 3D White Brilliance Pro Enamel Protect	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	f32d5708-8cb1-6499-e053-2995a90ac632	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro-Health Advanced Complete Care Anticavity Fluoride	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	f3a644c0-da04-276d-e053-2a95a90abf27	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro-Health Densify Active Repair	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	f4487d78-1da8-3f33-e053-2a95a90a6d92	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro-Health Densify Sensitive Care	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	f435c1fe-7fbb-1b25-e053-2995a90aca11	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro-Health Densify Pro Intensive Repair	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	f45c9c89-f294-deca-e053-2a95a90ae557	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro-health Gum Detoxify Deep Clean	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	f49a00de-b16a-66e6-e053-2995a90aedc6	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro-Health Gum Detoxify Gentle Whitening	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	f49a7dc7-77f3-3911-e053-2a95a90ad55c	2026-01-08	Warnings	Exact identifier application number: M021
Crest Complete Multi-Benefit Whitening plus Cinnamon Expressions	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	961295a6-79ae-44b1-e053-2995a90a6130	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro Health Enamel Repair and Gum Intensive Clean	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	f4c2118d-1216-d0d0-e053-2995a90a7088	2026-01-08	Warnings	Exact identifier application number: M021
Crest 3D White Charcoal	SODIUM FLUORIDE	Procter & Gamble Manfuacturing Company	96247083-39e9-7ca7-e053-2995a90a75d0	2026-01-08	Warnings	Exact identifier application number: M021
Crest 3D White Advanced Express White	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	f4c2d5aa-b0e6-7068-e053-2995a90ae90c	2026-01-08	Warnings	Exact identifier application number: M021
Crest complete plus Whitening Deep Clean	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	973ce138-c64e-c059-e053-2a95a90a3148	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro Health Gum Detoxify and Restore Pro Deep Clean	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	f4c3ad36-72d8-16e8-e053-2a95a90a8702	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro Health Gum Detoxify and Restore Pro Whitening	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	f4d65b58-9818-820d-e053-2995a90a9f00	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro-Health Sensitive and Gum All Day Protection	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	f4d775a1-a4f6-cd69-e053-2995a90a5f64	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro Health Enamel Repair and Gum Advanced Whitening	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	f4ead762-17b2-22a0-e053-2a95a90ac866	2026-01-08	Warnings	Exact identifier application number: M021
Crest 3D White Advanced Luminous Mint	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	f5c82742-fb27-62a2-e053-2a95a90aa7c4	2026-01-08	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
240698	sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral Rinse	PSN	a1014431-7d23-aaff-6dc7-ab58683d0338	8
240698	sodium fluoride 0.5 MG/ML Mouthwash	SCD	a1014431-7d23-aaff-6dc7-ab58683d0338	8
240698	sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral Rinse	SY	a1014431-7d23-aaff-6dc7-ab58683d0338	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
35000-687-10	35000068710	473 mL in 1 BOTTLE (35000-687-10)	473 ml	2023-07-01	No	No	Current
35000-687-12	35000068712	520 mL in 1 BOTTLE (35000-687-12)	520 ml	2026-01-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hello ® Unicorn Splash unicorn splash anticavity fluoride rinse	Colgate-Palmolive Company \| Accupac	2026-06-02	HUMAN OTC DRUG LABEL	10