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 32 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Colgate Anticavity Kit	SODIUM MONOFLUOROPHOSPHATE	Ming Fai Industrial (Shenzhen) Co. Ltd	86dfd09d-f3b6-4c4b-852d-7e04dc5c8fec	2025-12-05	Warnings	Exact identifier application number: M021
Dr. Jen SuperPaste Nano-Hydroxyapatite	SODIUM FLUORIDE	Dr Jen Natural, LLC	8b28b857-9162-4065-b0a0-571efffe9787	2025-12-05	Warnings	Exact identifier application number: M021
Dr. Jen SuperPaste Ortho	SODIUM FLUORIDE	Dr Jen Natural, LLC	9dd248bf-9488-43cd-a041-e8315a05ce5d	2025-12-04	Warnings	Exact identifier application number: M021
Dr. Jen SuperPaste Perio	SODIUM FLUORIDE	Dr Jen Natural, LLC	8c7e6d3a-49d9-4098-9d5e-e9792b373574	2025-12-04	Warnings	Exact identifier application number: M021
Colgate Total Plaque Cleanse	STANNOUS FLUORIDE	Colgate-Palmolive Company	b2980238-5bcb-467f-9e90-a307938632c2	2025-12-03	Warnings	Exact identifier application number: M021
Advance White Extreme Whitening Tartar Control	SODIUM FLUORIDE	Church & Dwight Co., Inc.	b539264f-e1ff-440b-af76-84266fe2c0a2	2025-12-02	Warnings	Exact identifier application number: M021
Sensodyne Pronamel Clinical Enamel Strength Fresh Breath	POTASSIUM NITRATE, SODIUM FLUORIDE	Haleon US Holdings LLC	34a1a32e-3017-f018-e063-6394a90a0230	2025-12-01	Warnings	Exact identifier application number: M021
PRO-SYS	SODIUM FLUORIDE AND POTASSIUM NITRATE	Benco Dental	4e470ba4-60bb-1815-e063-6294a90abacc	2025-12-01	Warnings	Exact identifier application number: M021
PRO-SYS	SODIUM FLUORIDE	Benco Dental	4e539cb2-bcbd-95fc-e063-6294a90a2121	2025-12-01	Warnings	Exact identifier application number: M021
Cool sense Care Plus	SODIUM FLUORIDE	DONG IL PHARMS CO., LTD.	44763bf6-caf3-ec69-e063-6394a90a0ee1	2025-11-25	Warnings	Exact identifier application number: M021
DOCTRUST DOUBLEX Tooth	SODIUM FLUORIDE	DONG IL PHARMS CO.,LTD	44765e86-2eb2-6381-e063-6394a90a761f	2025-11-25	Warnings	Exact identifier application number: M021
TheraBreath for Kids Anticavity Wacky Watermelon	SODIUM FLUORIDE	Church & Dwight Co., Inc.	578f8010-6b1c-4c6b-91d3-e483ace40f66	2025-11-25	Warnings	Exact identifier application number: M021
Sensodyne Cavity and Sensitivity	POTASSIUM NITRATE, SODIUM FLUORIDE	Haleon US Holdings LLC	d002074b-0580-4247-b3c7-121b8c098697	2025-11-24	Warnings	Exact identifier application number: M021
CVS Pharmacy Enamel Guard	FLUORIDE	CVS Pharmacy	18295a1c-c2a6-489b-be34-9252b9e1e2b8	2025-11-21	Warnings	Exact identifier application number: M021
365 Everyday Value Cavity Fighting and Whitening	SODIUM MONOFLOUROPHOSPHATE	Whole Foods Market, Inc.	83704717-19bc-2634-e053-2991aa0a2979	2025-11-21	Warnings	Exact identifier application number: M021
Whitening	MONOFLUOROPHOSPHATE	Target	0074630f-9d8d-9209-e063-6294a90a4f01	2025-11-21	Warnings	Exact identifier application number: M021
Rite Aid Enamel Guard	FLUORIDE	Rite Aid	67c1fc04-0f21-4944-8b9d-0d8ffd051874	2025-11-21	Warnings	Exact identifier application number: M021
ME MOTHER EARTH	ZERO WASTE TOOTHPASTE TABLETS PEPPERMINT	A PLUS MERCHANDISE LLC	43d30abc-889a-5377-e063-6294a90ab804	2025-11-17	Warnings	Exact identifier application number: M021
Natural White Sensitivity and Gum	STANNOUS FLUORIDE	Lornamead Products	2e83bda8-4d4b-640f-e063-6294a90abc60	2025-11-14	Warnings	Exact identifier application number: M021
CVS Pharmacy Restore and Defend	FLUORIDE	CVS Pharmacy	99f86135-05b7-42b1-aef5-df4513259b8f	2025-11-14	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