Salivea

Product NDC: 54897-701
11-digit product format: 548970701
Labeler code: 54897
Product ID: 54897-701_2b37e5f3-ae54-4993-e063-6394a90aff97
Type: HUMAN OTC DRUG
Nonproprietary name: Fluoride Toothpaste
Dosage form: PASTE, DENTIFRICE
Route: DENTAL
Labeler: Laclede, Inc.
Application: M021
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2018-02-19
Substance: SODIUM MONOFLUOROPHOSPHATE
Active strength: 1.4 mg/g
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: Salivea
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SODIUM MONOFLUOROPHOSPHATE	1.4 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
C810JCZ56Q	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
851054	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
6398ae96-dd38-44da-bc34-1d4d4c4a78ca	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
54897-701-13	Salivea	121.9 g in 1 TUBE	PASTE, DENTIFRICE	121.9		3
54897-701-14	Salivea	21 g in 1 TUBE	PASTE, DENTIFRICE	21		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54897-701	SALIVEA (FLUORIDE TOOTHPASTE) PASTE, DENTIFRICE [LACLEDE, INC.]	3	Current NDC, 1 package rows	20250110_6398ae96-dd38-44da-bc34-1d4d4c4a78ca.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 31 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE BUBBLEGUM	SODIUM FLUORIDE	Kingkey MBC Life Technology Group co., LTD	1ba491f4-2ad2-6e7b-e063-6394a90a9fb7	2025-12-11	Warnings	Exact identifier application number: M021
BRUSH BUDDIES HOTWHEEL ANTICAVITY FLUORIDE STRAWBERRY	SODIUM FLUORIDE	Kingkey MBC Life Technology Group co., LTD.	188ac743-3ba8-4da4-e063-6294a90a8f87	2025-12-11	Warnings	Exact identifier application number: M021
BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE STRAWBERRY	SODIUM FLUORIDE	Kingkey MBC Life Technology Group Co.,Ltd	1b682604-c563-01f1-e063-6294a90ab0bd	2025-12-11		Exact identifier application number: M021
BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE STRAWBERRY	SODIUM FLUORIDE	Kingkey MBC Life Technology Group Co.,Ltd	1b110db1-fcc0-377f-e063-6394a90a4d44	2025-12-11		Exact identifier application number: M021
BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE WATERMELON	SODIUM FLUORIDE	Kingkey MBC Life Technology Group co., LTD	1b74ecc4-a1e6-348f-e063-6294a90a5894	2025-12-11		Exact identifier application number: M021
BRUSH BUDDIES BRBIE ANTICAVITY FLUORIDE BUBBLEGUM	SODIUM FLUORIDE	Kingkey MBC Life Technology Group co., LTD.	1b68315c-6afa-3f37-e063-6294a90a14e8	2025-12-11	Warnings	Exact identifier application number: M021
ANTICAVITY FLUORIDE	SODIUM FLUORIDE	Kingkey MBC Life Technology Group co., LTD	295b88e8-c4b5-c0b0-e063-6394a90aca01	2025-12-11	Warnings	Exact identifier application number: M021
BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE BUBBLEGUM	SODIUM FLUORIDE	Kingkey MBC Life Technology Group co., LTD	1b74f072-c33b-c6e2-e063-6394a90ab1e6	2025-12-11	Warnings	Exact identifier application number: M021
BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE STRAWBERRY	SODIUM FLUORIDE	Kingkey MBC Life Technology Group co., LTD	1ba4a807-d6d5-04a0-e063-6294a90ae04d	2025-12-11		Exact identifier application number: M021
BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE STRAWBERRY	SODIUM FLUORIDE	Kingkey MBC Life Technology Group Co.,Ltd	1b617f4a-b56c-9f75-e063-6294a90a7abe	2025-12-11		Exact identifier application number: M021
BRUSH BUDDIES BRBIE ANTICAVITY FLUORIDE BUBBLEGUM	SODIUM FLUORIDE	Kingkey MBC Life Technology Group co., LTD.	1b9ec370-eadf-92c4-e063-6294a90a9055	2025-12-11	Warnings	Exact identifier application number: M021
BRUSH BUDDIES SQUISHMALLOWS ANTICAVITY FLUORIDE MINT FALVOR	SODIUM FLUORIDE	Kingkey MBC Life Technology Group co., LTD	1eb04296-ecb1-3ccc-e063-6294a90a9bda	2025-12-11	Warnings	Exact identifier application number: M021
BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE STRAWBERRY	SODIUM FLUORIDE	Kingkey MBC Life Technology Group Co.,Ltd	1b9e7b21-0d34-74ec-e063-6294a90a1f59	2025-12-11		Exact identifier application number: M021
Listerine Total Care Kids Anticavity Fluoride Rinse - Berry Splash	SODIUM FLUORIDE	Kenvue Brands LLC	28986d7f-3e9a-8dfb-e063-6394a90a731e	2025-12-10	Warnings	Exact identifier application number: M021
Toms of Maine Tropical Island	ALUMINUM CHLOROHYDRATE	Colgate-Palmolive Company	0d6c51bc-5391-4533-b4fd-961dc4f36342	2025-12-10	Warnings	Exact identifier application number: M021
Business Class Kit	SODIUM MONOFLUOROPHOSPHATE	American Airlines, Inc.	483d7aec-34ac-49c5-ac0e-8fba5b4737ae	2025-12-09	Warnings	Exact identifier application number: M021
Colgate Anticavity Kit	SODIUM MONOFLUOROPHOSPHATE	Ming Fai Industrial (Shenzhen) Co. Ltd	121decce-c364-4060-87da-0c6a6cd48474	2025-12-08	Warnings	Exact identifier application number: M021
First Class Kit	SODIUM MONOFLUOROPHOSPHATE	American Airlines, Inc.	ba717de8-c3a2-41bf-85a1-aa75f9744d30	2025-12-08	Warnings	Exact identifier application number: M021
United Airlines Business Class Kit	SODIUM MONOFLUOROPHOSPHATE	United Airlines	94c5e9a4-19f3-4590-9da4-313c75261231	2025-12-08	Warnings	Exact identifier application number: M021
Dr. Jen SuperPaste Nano-Hydroxyapatite	SODIUM FLUORIDE	Dr Jen Natural, LLC	5f08d994-e458-42b2-aa39-e84fca3acf48	2025-12-05	Warnings	Exact identifier application number: M021

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
C810JCZ56Q	SODIUM MONOFLUOROPHOSPHATE	10163-15-2	SODIUM MONOFLUOROPHOSPHATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
851054	sodium monofluorophosphate 0.14 % Toothpaste	PSN	6398ae96-dd38-44da-bc34-1d4d4c4a78ca	3
851054	sodium monofluorophosphate 0.0014 MG/MG Toothpaste	SCD	6398ae96-dd38-44da-bc34-1d4d4c4a78ca	3
851054	sodium monofluorophosphate 0.14 % Dental Gel	SY	6398ae96-dd38-44da-bc34-1d4d4c4a78ca	3
851054	sodium monofluorophosphate 0.14 % Toothpaste	SY	6398ae96-dd38-44da-bc34-1d4d4c4a78ca	3
851054	sodium monofluorophosphate 0.14 % Toothpaste	PSN	4abb0f80-d87d-730f-e063-6294a90a15f7	1
851054	sodium monofluorophosphate 0.0014 MG/MG Toothpaste	SCD	4abb0f80-d87d-730f-e063-6294a90a15f7	1
851054	sodium monofluorophosphate 0.14 % Dental Gel	SY	4abb0f80-d87d-730f-e063-6294a90a15f7	1
851054	sodium monofluorophosphate 0.14 % Toothpaste	SY	4abb0f80-d87d-730f-e063-6294a90a15f7	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
54897-701-13	54897070113	121.9 g in 1 TUBE (54897-701-13)	121.9 g	2018-02-19	No	No	Current
54897-701-14	54897070114	21 g in 1 TUBE (54897-701-14)	21 g	2025-01-01	Yes	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Salivea - Laclede, Inc.	Laclede, Inc.	2026-02-13	HUMAN OTC DRUG LABEL	1
Salivea - Laclede, Inc.	Laclede, Inc.	2025-01-08	HUMAN OTC DRUG LABEL	3