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 6 of 51 · 1,013 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Freshen Up	SODIUM FLUORIDE, POTASSIUM NITRATE	MKJ BRANDS LLC	476f453b-9215-0a11-e063-6294a90a5cd4	2026-07-14	Warnings	Exact identifier application number: M021
Freshen Up Vanilla Mint	SODIUM FLUORIDE	MKJ BRANDS LLC	525662da-42be-eaa6-e063-6294a90af110	2026-07-14	Warnings	Exact identifier application number: M021
Freshen Up twisted peppermint	SODIUM FLUORIDE	MKJ BRANDS LLC	526acbdd-6531-692d-e063-6394a90ab9f1	2026-07-14	Warnings	Exact identifier application number: M021
Freshen Up chai latte mint	SODIUM FLUORIDE	MKJ BRANDS LLC	52e364f9-113a-df4e-e063-6294a90a263b	2026-07-14	Warnings	Exact identifier application number: M021
Freshen Up Holiday mint	SODIUM FLUORIDE	MKJ BRANDS LLC	5257c409-d379-8c48-e063-6294a90acda9	2026-07-14	Warnings	Exact identifier application number: M021
Freshen-up Matcha Mint	SODIUM FLUORIDE	MKJ BRANDS LLC	52bbc6d9-17ab-851a-e063-6394a90ab4bf	2026-07-14	Warnings	Exact identifier application number: M021
Freshen Up pepper mint	SODIUM FLUORIDE	MKJ BRANDS LLC	5259bc45-85da-b17b-e063-6294a90a7919	2026-07-14	Warnings	Exact identifier application number: M021
Colgate Optic White Advanced Icy Fresh	SODIUM MONOFLUOROPHOSPHATE	Colgate-Palmolive Company	f95496e3-11ec-4cd6-b3ee-cf6c657b790b	2026-07-13	Warnings	Exact identifier application number: M021
COLGATE MAX FRESH COCONUT PINEAPPLE	SODIUM FLUORIDE	Colgate-Palmolive Company	7f240d1d-ea3d-42b1-a4b0-106c58707452	2026-07-08	Warnings	Exact identifier application number: M021
Crest 3D White Deep Stain Remover Ultra White	SODIUM MONOFLUOROPHOSPHATE	The Procter & Gamble Manufacturing Company	2f24a9eb-7a89-30e1-e063-6394a90a032b	2026-07-08		Exact identifier application number: M021
Dr. Noah Kids Tooth	SODIUM MONOFLUOROPHOSPHATE	Project Noah Inc.	562311aa-9ac5-00c2-e063-6394a90a67a7	2026-07-08	Warnings	Exact identifier application number: M021
COLGATE BAKING SODA AND PEROXIDE WHITENING OXYGEN BUBBLES FROSTY MINT	SODIUM MONOFLUOROPHOSPHATE	Colgate-Palmolive Company	263fef13-347b-489b-987d-933a63dbc900	2026-07-08	Warnings	Exact identifier application number: M021
Colgate Triple Action	SODIUM FLUORIDE	Colgate-Palmolive Company	3082e9ba-66d9-4fc7-bbe6-b41b60939bd2	2026-07-08	Warnings	Exact identifier application number: M021
Colgate Junior Kids Batman Mild Bubble Fruit Fluoride	SODIUM FLUORIDE	Colgate-Palmolive Company	f464cecb-e876-4057-ab5c-94de747434db	2026-07-08	Warnings	Exact identifier application number: M021
Crest Premium Plus Scope Active Foam plus Whitening Minty Fresh	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	560815d6-018a-0c24-e063-6394a90a1071	2026-07-07	Warnings	Exact identifier application number: M021
Crest Plus Scope plus Whitening with Mouthwash	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	54ecfbed-ba99-11eb-e063-6294a90ae64d	2026-07-07	Warnings	Exact identifier application number: M021
Crest Plus Scope plus Whitening Minty Fresh with Mouthwash striped	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	56091601-74dd-0a3b-e063-6394a90af476	2026-07-07	Warnings	Exact identifier application number: M021
Crest Plus Scope plus Whitening Outlast Mint	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	55054217-f21b-1c41-e063-6394a90ae40b	2026-07-07	Warnings	Exact identifier application number: M021
Hello Dragon Dazzle Dragon Dazzle Fluoride	SODIUM FLUORIDE	Colgate-Palmolive Company	eaca1ad1-9e31-b904-4148-247ad2460661	2026-07-07	Warnings	Exact identifier application number: M021
Colgate Cavity Protection	SODIUM FLUORIDE	Colgate-Palmolive Company	cdd2ad04-8c65-40f2-b323-5ce11af52e4f	2026-07-06	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