OralLine Kids

Product NDC: 55873-003
11-digit product format: 558730003
Labeler code: 55873
Product ID: 55873-003_1076e667-505a-494a-865a-ee3767e3305e
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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 22 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	55873-003-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	55873-003-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	55873-003-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55873-003-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	55873-003-01	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	55873-003-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	55873-003-01	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	55873-003-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	55873-003-01	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	55873-003-01	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	55873-003-01	`1332a3947898…`	`d4bfe170f9cd…`

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 Kids
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
12c5bee5-e228-4f71-9bfd-c377ee2372a9	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
6084a4f4-5437-c9a5-caec-5361ee075a59	Product name	1	20140508
90c5639a-61b0-88d6-ddcf-21888e94869a	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
55873-003-01	2025-03-18	C162847	48780-1	f386c64a-3c1a-0266-e053-dadaa90a7c1a	12c5bee5-e228-4f71-9bfd-c377ee2372a9
55873-003-01	2023-01-30	C162847	48780-1	f386c64a-3c1a-0266-e053-dadaa90a7c1a	12c5bee5-e228-4f71-9bfd-c377ee2372a9

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55873-003-01	OralLine Kids	113.4 g in 1 TUBE	GEL, DENTIFRICE	113.4		6

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SODIUM FLUORIDE	ACTIVE INGREDIENT	8ZYQ1474W7	ORALLINE KIDS (SODIUM FLUORIDE) GEL, DENTIFRICE [J.M. MURRAY CENTER INC.]	1
SODIUM CATION	ACTIVE MOIETY	LYR4M0NH37	ORALLINE KIDS (SODIUM FLUORIDE) GEL, DENTIFRICE [J.M. MURRAY CENTER INC.]	1
CARBOXYMETHYLCELLULOSE SODIUM	INACTIVE INGREDIENT	K679OBS311	ORALLINE KIDS (SODIUM FLUORIDE) GEL, DENTIFRICE [J.M. MURRAY CENTER INC.]	1
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	ORALLINE KIDS (SODIUM FLUORIDE) GEL, DENTIFRICE [J.M. MURRAY CENTER INC.]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	ORALLINE KIDS (SODIUM FLUORIDE) GEL, DENTIFRICE [J.M. MURRAY CENTER INC.]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	ORALLINE KIDS (SODIUM FLUORIDE) GEL, DENTIFRICE [J.M. MURRAY CENTER INC.]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	ORALLINE KIDS (SODIUM FLUORIDE) GEL, DENTIFRICE [J.M. MURRAY CENTER INC.]	1
HYDRATED SILICA	INACTIVE INGREDIENT	Y6O7T4G8P9	ORALLINE KIDS (SODIUM FLUORIDE) GEL, DENTIFRICE [J.M. MURRAY CENTER INC.]	1
POLYETHYLENE GLYCOL 600	INACTIVE INGREDIENT	NL4J9F21N9	ORALLINE KIDS (SODIUM FLUORIDE) GEL, DENTIFRICE [J.M. MURRAY CENTER INC.]	1
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	ORALLINE KIDS (SODIUM FLUORIDE) GEL, DENTIFRICE [J.M. MURRAY CENTER INC.]	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	ORALLINE KIDS (SODIUM FLUORIDE) GEL, DENTIFRICE [J.M. MURRAY CENTER INC.]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	ORALLINE KIDS (SODIUM FLUORIDE) GEL, DENTIFRICE [J.M. MURRAY CENTER INC.]	1
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE	INACTIVE INGREDIENT	94255I6E2T	ORALLINE KIDS (SODIUM FLUORIDE) GEL, DENTIFRICE [J.M. MURRAY CENTER INC.]	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	ORALLINE KIDS (SODIUM FLUORIDE) GEL, DENTIFRICE [J.M. MURRAY CENTER INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	ORALLINE KIDS (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
55873-003	ORALLINE KIDS (SODIUM FLUORIDE) GEL, DENTIFRICE [J.M. MURRAY CENTER INC.]	6	Current NDC, Legacy NDC, 1 package rows	20250323_12c5bee5-e228-4f71-9bfd-c377ee2372a9.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 50 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
United Airlines Therabody Polaris Kit	SODIUM MONOFLUOROPHOSPHATE	Wessco International	ab667740-55ab-470e-9514-163961502ceb	2023-10-26	Warnings	Exact identifier application number: M021
Cavity Protection Fresh Mint	SODIUM FLUORIDE	Oxyfresh Worldwide Inc	0ae98f28-7e78-4379-93b0-4f2657415c4d	2023-10-25	Warnings	Exact identifier application number: M021
Tanners Tasty Vanilla Bling	SODIUM FLUORIDE	Sheffield Pharmaceuticals LLC	521fe01e-7f2e-4d79-9126-e4880cdf4e71	2023-10-24	Warnings	Exact identifier application number: M021
Tanners Tasty Ooh La La Orange	SODIUM FLUORIDE	Sheffield Pharmaceuticals LLC	6027b961-314e-4f71-8b2f-646ce80214d8	2023-10-24	Warnings	Exact identifier application number: M021
Tanners Tasty Cha Cha Chocolate	SODIUM FLUORIDE	Sheffield Pharmaceuticals LLC	8609dbf3-7620-4a13-b40b-6bd705a78fb0	2023-10-24	Warnings	Exact identifier application number: M021
Glister Multi-Action	SODIUM FLUORIDE	Access Business Group LLC	e3f2c049-a0f5-4649-a4aa-11bdb252f951	2023-10-23	Warnings	Exact identifier application number: M021
UNITED Asutra TC Kit Colgate	SODIUM MONOFLUOROPHOSPHATE	MING FAI ENTERPRISE (CAMBODIA) CO., LTD	082a581a-c7e5-e614-e063-6394a90a87da	2023-10-20	Warnings	Exact identifier application number: M021
Plak Smacker Anti Cavity Fluoride	SODIUM FLUORIDE	YOUNG PS ACQUISITION, LLC	c6dee5fa-9cd4-4a94-9cbe-e977b2bd3dfe	2023-10-16	Warnings	Exact identifier application number: M021
Ionite H	STANNOUS FLUORIDE	Dharma Research, Inc.	152d84ee-d981-4032-bfb1-a559afe71d40	2023-10-11	Warnings	Exact identifier application number: M021
Sodium Fluoride	SODIUM FLUORIDE	Safco Dental Supply LLC	788080b3-fff8-4049-af98-f571824994c2	2023-10-11	Warnings	Exact identifier application number: M021
Ionite H	STANNOUS FLUORIDE	Dharma Research, Inc.	5c312b36-07f4-406e-b3d3-c6d1e964635d	2023-10-11	Warnings	Exact identifier application number: M021
Ionite H	STANNOUS FLUORIDE	Dharma Research, Inc.	042636cf-8b61-4022-b0a1-af09c06b145b	2023-10-11	Warnings	Exact identifier application number: M021
Ionite H	STANNOUS FLUORIDE	Dharma Research, Inc.	f4c3569b-7b6a-4566-9e87-492f291c5165	2023-10-11	Warnings	Exact identifier application number: M021
UNITED Asutra TC Kit Colgate	SODIUM MONOFLUOROPHOSPHATE	Procurall Solutions	042817f9-675f-056a-e063-6394a90a2d97	2023-08-30	Warnings	Exact identifier application number: M021
Colgate Max Fresh Cool Mint	SODIUM FLUORIDE	Mission Hills S.A de C.V	d142e43f-415a-41c5-a7db-8b18a039a323	2019-04-09	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	12c5bee5-e228-4f71-9bfd-c377ee2372a9	6
416783	sodium fluoride 0.0024 MG/MG Toothpaste	SCD	12c5bee5-e228-4f71-9bfd-c377ee2372a9	6
416783	sodium fluoride 0.24 % (fluoride ion 0.13 % ) Toothpaste	SY	12c5bee5-e228-4f71-9bfd-c377ee2372a9	6
416783	sodium fluoride 0.24 % (fluoride ion 0.14 % ) Toothpaste	SY	12c5bee5-e228-4f71-9bfd-c377ee2372a9	6
416783	sodium fluoride 0.24 % (fluoride ion 0.15 % ) Toothpaste	SY	12c5bee5-e228-4f71-9bfd-c377ee2372a9	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55873-003-01	55873000301	113.4 g in 1 TUBE (55873-003-01)	113.4 g	2025-03-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
OralLine Kids - J.M. Murray Center Inc.	J.M. Murray Center Inc.	2025-03-21	HUMAN OTC DRUG LABEL	6