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 dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55873-003-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55873-003-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55873-003-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55873-003-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55873-003-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55873-003-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage55873-003-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage55873-003-01557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage55873-003-018af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage55873-003-01834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage55873-003-011332a3947898…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
IngredientStrength
SODIUM FLUORIDE.15 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8ZYQ1474W7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
416783Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
12c5bee5-e228-4f71-9bfd-c377ee2372a9Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55873-003-012025-03-18C16284748780-1f386c64a-3c1a-0266-e053-dadaa90a7c1a12c5bee5-e228-4f71-9bfd-c377ee2372a9
55873-003-012023-01-30C16284748780-1f386c64a-3c1a-0266-e053-dadaa90a7c1a12c5bee5-e228-4f71-9bfd-c377ee2372a9

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55873-003-01OralLine Kids113.4 g in 1 TUBEGEL, DENTIFRICE113.46

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W7ORALLINE KIDS (SODIUM FLUORIDE) GEL, DENTIFRICE [J.M. MURRAY CENTER INC.]1
SODIUM CATIONACTIVE MOIETYLYR4M0NH37ORALLINE KIDS (SODIUM FLUORIDE) GEL, DENTIFRICE [J.M. MURRAY CENTER INC.]1
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311ORALLINE KIDS (SODIUM FLUORIDE) GEL, DENTIFRICE [J.M. MURRAY CENTER INC.]1
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LORALLINE KIDS (SODIUM FLUORIDE) GEL, DENTIFRICE [J.M. MURRAY CENTER INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDORALLINE KIDS (SODIUM FLUORIDE) GEL, DENTIFRICE [J.M. MURRAY CENTER INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAORALLINE KIDS (SODIUM FLUORIDE) GEL, DENTIFRICE [J.M. MURRAY CENTER INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXORALLINE KIDS (SODIUM FLUORIDE) GEL, DENTIFRICE [J.M. MURRAY CENTER INC.]1
HYDRATED SILICAINACTIVE INGREDIENTY6O7T4G8P9ORALLINE KIDS (SODIUM FLUORIDE) GEL, DENTIFRICE [J.M. MURRAY CENTER INC.]1
POLYETHYLENE GLYCOL 600INACTIVE INGREDIENTNL4J9F21N9ORALLINE KIDS (SODIUM FLUORIDE) GEL, DENTIFRICE [J.M. MURRAY CENTER INC.]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYORALLINE KIDS (SODIUM FLUORIDE) GEL, DENTIFRICE [J.M. MURRAY CENTER INC.]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUORALLINE KIDS (SODIUM FLUORIDE) GEL, DENTIFRICE [J.M. MURRAY CENTER INC.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JORALLINE KIDS (SODIUM FLUORIDE) GEL, DENTIFRICE [J.M. MURRAY CENTER INC.]1
SODIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENT94255I6E2TORALLINE KIDS (SODIUM FLUORIDE) GEL, DENTIFRICE [J.M. MURRAY CENTER INC.]1
SORBITOLINACTIVE INGREDIENT506T60A25RORALLINE KIDS (SODIUM FLUORIDE) GEL, DENTIFRICE [J.M. MURRAY CENTER INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RORALLINE KIDS (SODIUM FLUORIDE) GEL, DENTIFRICE [J.M. MURRAY CENTER INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55873-003ORALLINE KIDS (SODIUM FLUORIDE) GEL, DENTIFRICE [J.M. MURRAY CENTER INC.]6Current NDC, Legacy NDC, 1 package rows20250323_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 32 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Colgate Anticavity KitSODIUM MONOFLUOROPHOSPHATEMing Fai Industrial (Shenzhen) Co. Ltd86dfd09d-f3b6-4c4b-852d-7e04dc5c8fec2025-12-05WarningsExact identifier
application number: M021
Dr. Jen SuperPaste Nano-HydroxyapatiteSODIUM FLUORIDEDr Jen Natural, LLC8b28b857-9162-4065-b0a0-571efffe97872025-12-05WarningsExact identifier
application number: M021
Dr. Jen SuperPaste OrthoSODIUM FLUORIDEDr Jen Natural, LLC9dd248bf-9488-43cd-a041-e8315a05ce5d2025-12-04WarningsExact identifier
application number: M021
Dr. Jen SuperPaste PerioSODIUM FLUORIDEDr Jen Natural, LLC8c7e6d3a-49d9-4098-9d5e-e9792b3735742025-12-04WarningsExact identifier
application number: M021
Colgate Total Plaque CleanseSTANNOUS FLUORIDEColgate-Palmolive Companyb2980238-5bcb-467f-9e90-a307938632c22025-12-03WarningsExact identifier
application number: M021
Advance White Extreme Whitening Tartar ControlSODIUM FLUORIDEChurch & Dwight Co., Inc.b539264f-e1ff-440b-af76-84266fe2c0a22025-12-02WarningsExact identifier
application number: M021
Sensodyne Pronamel Clinical Enamel Strength Fresh BreathPOTASSIUM NITRATE, SODIUM FLUORIDEHaleon US Holdings LLC34a1a32e-3017-f018-e063-6394a90a02302025-12-01WarningsExact identifier
application number: M021
PRO-SYSSODIUM FLUORIDE AND POTASSIUM NITRATEBenco Dental4e470ba4-60bb-1815-e063-6294a90abacc2025-12-01WarningsExact identifier
application number: M021
PRO-SYSSODIUM FLUORIDEBenco Dental4e539cb2-bcbd-95fc-e063-6294a90a21212025-12-01WarningsExact identifier
application number: M021
Cool sense Care PlusSODIUM FLUORIDEDONG IL PHARMS CO., LTD.44763bf6-caf3-ec69-e063-6394a90a0ee12025-11-25WarningsExact identifier
application number: M021
DOCTRUST DOUBLEX ToothSODIUM FLUORIDEDONG IL PHARMS CO.,LTD44765e86-2eb2-6381-e063-6394a90a761f2025-11-25WarningsExact identifier
application number: M021
TheraBreath for Kids Anticavity Wacky WatermelonSODIUM FLUORIDEChurch & Dwight Co., Inc.578f8010-6b1c-4c6b-91d3-e483ace40f662025-11-25WarningsExact identifier
application number: M021
Sensodyne Cavity and SensitivityPOTASSIUM NITRATE, SODIUM FLUORIDEHaleon US Holdings LLCd002074b-0580-4247-b3c7-121b8c0986972025-11-24WarningsExact identifier
application number: M021
CVS Pharmacy Enamel GuardFLUORIDECVS Pharmacy18295a1c-c2a6-489b-be34-9252b9e1e2b82025-11-21WarningsExact identifier
application number: M021
365 Everyday Value Cavity Fighting and WhiteningSODIUM MONOFLOUROPHOSPHATEWhole Foods Market, Inc.83704717-19bc-2634-e053-2991aa0a29792025-11-21WarningsExact identifier
application number: M021
WhiteningMONOFLUOROPHOSPHATETarget0074630f-9d8d-9209-e063-6294a90a4f012025-11-21WarningsExact identifier
application number: M021
Rite Aid Enamel GuardFLUORIDERite Aid67c1fc04-0f21-4944-8b9d-0d8ffd0518742025-11-21WarningsExact identifier
application number: M021
ME MOTHER EARTHZERO WASTE TOOTHPASTE TABLETS PEPPERMINTA PLUS MERCHANDISE LLC43d30abc-889a-5377-e063-6294a90ab8042025-11-17WarningsExact identifier
application number: M021
Natural White Sensitivity and GumSTANNOUS FLUORIDELornamead Products2e83bda8-4d4b-640f-e063-6294a90abc602025-11-14WarningsExact identifier
application number: M021
CVS Pharmacy Restore and DefendFLUORIDECVS Pharmacy99f86135-05b7-42b1-aef5-df4513259b8f2025-11-14WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416783sodium fluoride 0.24 % ToothpastePSN12c5bee5-e228-4f71-9bfd-c377ee2372a96
416783sodium fluoride 0.0024 MG/MG ToothpasteSCD12c5bee5-e228-4f71-9bfd-c377ee2372a96
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSY12c5bee5-e228-4f71-9bfd-c377ee2372a96
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY12c5bee5-e228-4f71-9bfd-c377ee2372a96
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY12c5bee5-e228-4f71-9bfd-c377ee2372a96

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55873-003-0155873000301113.4 g in 1 TUBE (55873-003-01) 113.4 g2025-03-010000-00-00NoNoCurrent