OralLine

Product NDC: 55873-002
11-digit product format: 558730002
Labeler code: 55873
Product ID: 55873-002_816c3b07-a6fd-4837-8260-2b6417f24fb2
Type: HUMAN OTC DRUG
Nonproprietary name: SODIUM FLUORIDE
Dosage form: GEL, DENTIFRICE
Route: ORAL
Labeler: J.M. Murray Center Inc.
Application: M021
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2025-03-01
Substance: SODIUM FLUORIDE
Active strength: .15 g/100g
NDC exclude flag: No
Listing certified through: 2026-12-31
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: OralLine
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SODIUM FLUORIDE	.15 g/100g

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
416783	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
4c0970e9-7417-4234-89e3-3b602a609af5	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55873-002-01	OralLine	85 g in 1 TUBE	GEL, DENTIFRICE	85		4

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SODIUM FLUORIDE	ACTIVE INGREDIENT	8ZYQ1474W7	ORALLINE SECURE (SODIUM FLUORIDE) PASTE, DENTIFRICE ORALLINE (SODIUM FLUORIDE) GEL, DENTIFRICE [J.M. MURRAY CENTER INC.]	1
SODIUM CATION	ACTIVE MOIETY	LYR4M0NH37	ORALLINE SECURE (SODIUM FLUORIDE) PASTE, DENTIFRICE ORALLINE (SODIUM FLUORIDE) GEL, DENTIFRICE [J.M. MURRAY CENTER INC.]	1
CARBOXYMETHYLCELLULOSE SODIUM	INACTIVE INGREDIENT	K679OBS311	ORALLINE SECURE (SODIUM FLUORIDE) PASTE, DENTIFRICE ORALLINE (SODIUM FLUORIDE) GEL, DENTIFRICE [J.M. MURRAY CENTER INC.]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	ORALLINE SECURE (SODIUM FLUORIDE) PASTE, DENTIFRICE ORALLINE (SODIUM FLUORIDE) GEL, DENTIFRICE [J.M. MURRAY CENTER INC.]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	ORALLINE SECURE (SODIUM FLUORIDE) PASTE, DENTIFRICE ORALLINE (SODIUM FLUORIDE) GEL, DENTIFRICE [J.M. MURRAY CENTER INC.]	1
HYDRATED SILICA	INACTIVE INGREDIENT	Y6O7T4G8P9	ORALLINE SECURE (SODIUM FLUORIDE) PASTE, DENTIFRICE ORALLINE (SODIUM FLUORIDE) GEL, DENTIFRICE [J.M. MURRAY CENTER INC.]	1
POLYETHYLENE GLYCOL 600	INACTIVE INGREDIENT	NL4J9F21N9	ORALLINE SECURE (SODIUM FLUORIDE) PASTE, DENTIFRICE ORALLINE (SODIUM FLUORIDE) GEL, DENTIFRICE [J.M. MURRAY CENTER INC.]	1
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	ORALLINE SECURE (SODIUM FLUORIDE) PASTE, DENTIFRICE ORALLINE (SODIUM FLUORIDE) GEL, DENTIFRICE [J.M. MURRAY CENTER INC.]	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	ORALLINE SECURE (SODIUM FLUORIDE) PASTE, DENTIFRICE ORALLINE (SODIUM FLUORIDE) GEL, DENTIFRICE [J.M. MURRAY CENTER INC.]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	ORALLINE SECURE (SODIUM FLUORIDE) PASTE, DENTIFRICE ORALLINE (SODIUM FLUORIDE) GEL, DENTIFRICE [J.M. MURRAY CENTER INC.]	1
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE	INACTIVE INGREDIENT	94255I6E2T	ORALLINE SECURE (SODIUM FLUORIDE) PASTE, DENTIFRICE ORALLINE (SODIUM FLUORIDE) GEL, DENTIFRICE [J.M. MURRAY CENTER INC.]	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	ORALLINE SECURE (SODIUM FLUORIDE) PASTE, DENTIFRICE ORALLINE (SODIUM FLUORIDE) GEL, DENTIFRICE [J.M. MURRAY CENTER INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ORALLINE SECURE (SODIUM FLUORIDE) PASTE, DENTIFRICE ORALLINE (SODIUM FLUORIDE) GEL, DENTIFRICE [J.M. MURRAY CENTER INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	ORALLINE SECURE (SODIUM FLUORIDE) PASTE, DENTIFRICE ORALLINE (SODIUM FLUORIDE) GEL, DENTIFRICE [J.M. MURRAY CENTER INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55873-002	ORALLINE SECURE (SODIUM FLUORIDE) PASTE, DENTIFRICE ORALLINE (SODIUM FLUORIDE) GEL, DENTIFRICE [J.M. MURRAY CENTER INC.]	4	Current NDC, Legacy NDC, 1 package rows	20250322_4c0970e9-7417-4234-89e3-3b602a609af5.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 39 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Listerine Clinical Solutions Enamel Strength Alpine Mint	SODIUM FLUORIDE	Kenvue Brands LLC	11e1c1d0-465b-9e14-e063-6394a90a8cdd	2025-04-22	Warnings	Exact identifier application number: M021
Hello Mighty Multi tasker	STANNOUS FLUORIDE	Colgate-Palmolive Company	48e36e06-3666-9032-b9c8-4be035e751f2	2025-04-15	Warnings	Exact identifier application number: M021
Hello Kids Wild Strawberry Wild Strawberry	SODIUM FLUORIDE	Colgate-Palmolive Company	39dddf11-45a0-b883-e12f-d80c582e8c89	2025-04-15	Warnings	Exact identifier application number: M021
Hello Magical Mermaid	SODIUM FLUORIDE	Colgate-Palmolive Company	bdabf74f-8d1e-0f11-159a-0025bcd0ca3e	2025-04-15	Warnings	Exact identifier application number: M021
Euthymol Whitening Purple Corrector	SODIUM FLUORIDE	LG HOUSEHOLD & HEALTH CARE LTD.	300303e7-ef8b-7449-e063-6294a90ac811	2025-04-09	Warnings	Exact identifier application number: M021
Euthymol Whitening	SODIUM FLUORIDE	LG HOUSEHOLD & HEALTH CARE LTD.	303d4ad0-5a2b-347a-e063-6394a90aa0ba	2025-04-07	Warnings	Exact identifier application number: M021
OralLine Kids	SODIUM FLUORIDE	J.M. Murray Center Inc.	12c5bee5-e228-4f71-9bfd-c377ee2372a9	2025-03-21	Warnings	Exact identifier application number: M021
AdoptaPlatoon	SODIUM FLUORIDE	Yangzhou ONE & ONLY Personal Care Products Co., LTD	c1592b56-cf3d-4a4d-be84-e40eb3f1456e	2025-03-21	Warnings	Exact identifier application number: M021
OralLine Secure	SODIUM FLUORIDE	J.M. Murray Center Inc.	4c0970e9-7417-4234-89e3-3b602a609af5	2025-03-20	Warnings	Exact identifier application number: M021 ndc (product): 55873-002
Crayola ANTICAVITY BUBBLE GUM FLAVOR	SODIUM FLUORIDE	Ashtel Studios, Inc.	ec66246f-06e2-4da1-b9d5-ce2a7815ffd1	2025-03-19	Warnings	Exact identifier application number: M021
smart way MINT cavity protection	SODIUM MONOFLUOROPHOSPHATE	The Kroger Co.	45cc7a60-b4a7-4263-a114-f0d1f98a87fc	2025-03-19	Warnings	Exact identifier application number: M021
Crayola ANTICAVITY WATERMELON FLAVOR	SODIUM FLUORIDE	Ashtel Studios, Inc.	720f6344-ac48-414c-a1c2-f56c3206343c	2025-03-19	Warnings	Exact identifier application number: M021
Crayola ANTICAVITY STRAWBERRY FLAVOR	SODIUM FLUORIDE	Ashtel Studios, Inc.	17bd65a8-0a33-4421-8b9a-a7f9b94fe987	2025-03-19	Warnings	Exact identifier application number: M021
Hismile	MAGICALLY DELICIOUS FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTE	Hismile Pty Ltd	309366f8-6a52-fe9f-e063-6394a90a5de3	2025-03-18	Warnings	Exact identifier application number: M021
Hismile Grape Bubblegum Flavor Sodium Fluoride Anticavity Toothpast	SODIUM FLUORIDE	Hismile Pty Ltd	2b3e72ca-2bbb-adf1-e063-6394a90a2c7a	2025-03-13	Warnings	Exact identifier application number: M021
Hismile Pink Lemonade Sodium Fluoride Anticavity Toothpast	SODIUM FLUORIDE	Hismile Pty Ltd	2b92ff92-3722-3702-e063-6394a90a38b0	2025-03-13	Warnings	Exact identifier application number: M021
Hismile Miffy Sweet Apple Flavor Sodium Fluoride Anticavity Toothpast	SODIUM FLUORIDE	Hismile Pty Ltd	2ba2318e-7a58-7b68-e063-6394a90ae784	2025-03-13	Warnings	Exact identifier application number: M021
Listerine Total Care Fresh Mint Anticavity Fluoride	SODIUM FLUORIDE	Kenvue Brands LLC	ed15e0b9-00c9-0df1-e053-2a95a90a42c0	2025-02-28	Warnings	Exact identifier application number: M021
WHITE GLO BIO-ENZYME	SODIUM MONOFLUOROPHOSPHATE	WHITE GLO USA INC	f894a841-0df7-470d-8fc2-c9d6ba0edf99	2025-02-26	Warnings	Exact identifier application number: M021
WHITE GLO MICELLAR	SODIUM MONOFLUOROPHOSPHATE	WHITE GLO USA INC	16be06ba-330d-46b8-ba4e-5d732642ee26	2025-02-26	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
416783	sodium fluoride 0.24 % Toothpaste	PSN	4c0970e9-7417-4234-89e3-3b602a609af5	4
416783	sodium fluoride 0.0024 MG/MG Toothpaste	SCD	4c0970e9-7417-4234-89e3-3b602a609af5	4
416783	sodium fluoride 0.24 % (fluoride ion 0.13 % ) Toothpaste	SY	4c0970e9-7417-4234-89e3-3b602a609af5	4
416783	sodium fluoride 0.24 % (fluoride ion 0.14 % ) Toothpaste	SY	4c0970e9-7417-4234-89e3-3b602a609af5	4
416783	sodium fluoride 0.24 % (fluoride ion 0.15 % ) Toothpaste	SY	4c0970e9-7417-4234-89e3-3b602a609af5	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55873-002-01	55873000201	85 g in 1 TUBE (55873-002-01)	85 g	2025-03-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
OralLine Secure - J.M. Murray Center Inc.	J.M. Murray Center Inc.	2025-03-20	HUMAN OTC DRUG LABEL	4