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 30 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MIPasteOne Kids Blue Raspberry	MI PASTE ONE KIDS BLUE RASPBERRY	GC America Inc.	bf7d668c-752a-2eee-e053-2a95a90add16	2025-12-19	Warnings	Exact identifier application number: M021
MIPaste Plus Tutti Frutti	MIPASTE PLUS TUTTI FRUTTI	GC America Inc.	d724bd2a-2a8e-faeb-e053-2995a90aca19	2025-12-19	Warnings	Exact identifier application number: M021
MIPaste Plus Vanilla	MIPASTE PLUS VANILLA	GC America Inc.	d7244125-1ca5-78ba-e053-2995a90ab764	2025-12-19	Warnings	Exact identifier application number: M021
MIPaste Plus Melon	MIPASTE PLUS MELON	GC America Inc.	d724fe9f-c9ef-d9ad-e053-2995a90a7ecf	2025-12-19	Warnings	Exact identifier application number: M021
MIPaste Plus Mint	MIPASTE PLUS MINT	GC America Inc.	d72415b3-c501-141f-e053-2995a90aaaa3	2025-12-19	Warnings	Exact identifier application number: M021
MIPaste One Perio	MIPASTE ONE PERIO	GC America Inc.	d656b72d-48f8-4425-e053-2995a90ab1f2	2025-12-19	Warnings	Exact identifier application number: M021
MIPaste One Kids Blue Raspberry	MIPASTE ONE KIDS BLUE RASPBERRY	GC America Inc.	c07e1058-903b-fd47-e053-2995a90afdab	2025-12-19	Warnings	Exact identifier application number: M021
MIPaste Plus Strawberry	MIPASTE PLUS STRAWBERRY	GC America Inc.	d7235ad7-83d7-12e5-e053-2a95a90aaeaf	2025-12-19	Warnings	Exact identifier application number: M021
MIPaste One Kids Cotton Candy	MIPASTE ONE KIDS COTTON CANDY	GC America Inc.	c07d6b50-1d67-ea7f-e053-2a95a90afbe4	2025-12-19	Warnings	Exact identifier application number: M021
MIPaste One Kids Bubble Gum	MIPASTE ONE KIDS BUBBLE GUM	GC America Inc.	c07c7853-763b-4383-e053-2995a90ab725	2025-12-19	Warnings	Exact identifier application number: M021
MIPaste One	MIPASTE ONE	GC America Inc.	d71f8e6e-7005-4b3e-e053-2995a90a6789	2025-12-19	Warnings	Exact identifier application number: M021
TheraBreath AM-PM Twin Pack	SODIUM FLUORIDE	Church & Dwight Co., Inc.	4618e390-9039-a1d0-e063-6294a90ab294	2025-12-16	Warnings	Exact identifier application number: M021
Parodontax Gum Strengthen and Protect	STANNOUS FLUORIDE	Haleon US Holdings LLC	3bb40ceb-841b-4a25-e063-6294a90ab897	2025-12-15	Warnings	Exact identifier application number: M021
Sensodyne Pronamel Kids Bubble Mint	SODIUM FLUORIDE	Haleon US Holdings LLC	41b1e626-e79b-d638-e063-6394a90a1f5b	2025-12-15	Warnings	Exact identifier application number: M021
Simple Truth Kids Flouride	SODIUM MONOFLUOROPHOSPHATE	Kroger Company	82b9db89-d108-3f64-e053-2991aa0aee74	2025-12-15	Warnings	Exact identifier application number: M021
Natural Adult Fluoride	SODIUM MONOFLUOROPHOSPHATE	Kroger	a71c537e-39d9-1c3b-e053-2a95a90ac3ec	2025-12-15	Warnings	Exact identifier application number: M021
Therabreath Overnight Chamomile Mint	SODIUM FLUORIDE	Church & Dwight Co., Inc.	cc0c533c-145e-4877-b421-1baf3a3a572e	2025-12-11	Warnings	Exact identifier application number: M021
BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE BUBBLEGUM	SODIUM FLUORIDE	Kingkey MBC Life Technology Group co., LTD.	188d28f9-a814-0f98-e063-6294a90a106b	2025-12-11	Warnings	Exact identifier application number: M021
BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE WATERMELON	SODIUM FLUORIDE	Kingkey MBC Life Technology Group Co.,Ltd	1b4cf935-38a6-f4fb-e063-6394a90a4bc0	2025-12-11		Exact identifier application number: M021
BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE WATERMELON	SODIUM FLUORIDE	Kingkey MBC Life Technology Group co., LTD.	188cddb2-c799-0897-e063-6294a90a5d96	2025-12-11	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