FDA.reportPublic FDA data

Arm and Hammer

Product NDC
10237-680
11-digit product format
102370680
Labeler code
10237
Product ID
10237-680_545258fd-817a-fffc-e063-6394a90a467f
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
GEL, DENTIFRICE
Route
DENTAL
Labeler
Church & Dwight Co., Inc.
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-06-01
Substance
SODIUM FLUORIDE
Active strength
2.4 mg/g
NDC exclude flag
No
Listing certified through
2027-12-31
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
Arm and Hammer
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE2.4 mg/g

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
545258fd-8179-fffc-e063-6394a90a467fAvailable on FDA.report

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 42 of 51 · 1,013 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DOCTRUST DOUBLEX ToothSODIUM FLUORIDEDOCSMEDI Co., Ltd.aaf08481-a2ff-48f6-8611-73a469efe1db2025-01-22WarningsExact identifier
application number: M021
Double X CONCENTRATEDCETYLPYRIDINIUM CHLORIDEDOCSMEDI Co., Ltd.411be334-364c-4074-8d0b-8dda332f87de2025-01-22WarningsExact identifier
application number: M021
BIO SPECTRA ATTITUDESODIUM FLUORIDE9055-7588 Quebec Inc. DBA Attituded33e3778-ba1d-4560-bafa-74f7ab88c6b52025-01-20WarningsExact identifier
application number: M021
AMERFRESH FLUORIDE gelSODIUM FLUORIDEYangzhou ONE & ONLY Personal Care Products Co., LTD86279b4d-82e5-45b5-9ba7-94fe3620b8502025-01-16WarningsExact identifier
application number: M021
AMERFRESH FLUORIDESODIUM FLUORIDEYangzhou ONE & ONLY Personal Care Products Co., LTD827e45bb-84c0-48ee-a60b-2cc32b8f33e32025-01-16WarningsExact identifier
application number: M021
Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel ToothSODIUM FLUORIDEYangzhou ONE & ONLY Personal Care Products Co., LTDbb93fb1a-885a-4d2a-a1c2-3b37bc305d572025-01-16WarningsExact identifier
application number: M021
MedprideSODIUM MONOFLUOROPHOSPHATEShield Line LLC9c1b0420-6b57-4914-99fe-df6a494815c32025-01-16WarningsExact identifier
application number: M021
Freshmint Anticavity FluorideSODIUM FLUORIDENew World Imports, Inc2fa21cac-e71e-4bda-93ac-b5672d2d50952025-01-15WarningsExact identifier
application number: M021
Sodium FluorideSODIUM FLUORIDESafco Dental Supply LLC7a295974-c400-4442-9149-138a805ffb202025-01-09WarningsExact identifier
application number: M021
SaliveaFLUORIDE TOOTHPASTELaclede, Inc.6398ae96-dd38-44da-bc34-1d4d4c4a78ca2025-01-08WarningsExact identifier
application number: M021
EUTHYMOL Extraordinary Pink WhiteningSODIUM FLUORIDETai Guk Pharm. Co., Ltd.098a29d5-3836-d362-e063-6394a90a9fea2025-01-01WarningsExact identifier
application number: M021
PERIOE POP Sensitivity Care Prebiotic Clean MintSTANNOUS FLUORIDETai Guk Pharm. Co., Ltd.f4ef8ee7-7197-b3dc-e053-2a95a90a1c1b2025-01-01WarningsExact identifier
application number: M021
PERIOE Microbiome Sensitive Clean MintSTANNOUS FLUORIDETai Guk Pharm. Co., Ltd.dec29c9f-6ddb-0b4e-e053-2995a90a64b12025-01-01WarningsExact identifier
application number: M021
AVON Whitening Essentials Original Cool MintSODIUM FLUORIDETai Guk Pharm. Co., Ltd.8e5de76b-535a-9c95-e053-2995a90afcab2025-01-01WarningsExact identifier
application number: M021
AVON Whitening Essentials Blanc Charcoal Fresh MintSODIUM FLUORIDETai Guk Pharm. Co., Ltd.8f27c88a-7a70-e00a-e053-2a95a90a95a42025-01-01WarningsExact identifier
application number: M021
POP Feeling PeachySODIUM FLUORIDETAI GUK PHARM. CO., LTD0abb7a95-60b1-a1f3-e063-6294a90ace0c2025-01-01WarningsExact identifier
application number: M021
AVON Whitening Essentials Blanc Charcoal Fresh MintSODIUM FLUORIDETai Guk Pharm. Co., Ltd.99fff177-6300-220e-e053-2a95a90a06602025-01-01WarningsExact identifier
application number: M021
EUTHYMOL Extraordinary Pink WhiteningSODIUM FLUORIDETai Guk Pharm. Co., Ltd.05a9cee1-bd6e-6b93-e063-6294a90a5c102025-01-01WarningsExact identifier
application number: M021
PERIOE POP Advanced Whitening Prebiotic Cool MintSODIUM FLUORIDETai Guk Pharm. Co., Ltd.f546470a-7fae-4988-e053-2995a90ab61b2025-01-01WarningsExact identifier
application number: M021
PERIOE Microbiome Whitening Cool MintSODIUM FLUORIDETai Guk Pharm. Co., Ltd.de97dbea-dc8c-ebfa-e053-2995a90a22702025-01-01WarningsExact identifier
application number: M021

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
10237-680-06102370680061 TUBE in 1 CARTON (10237-680-06) / 170 g in 1 TUBE1 tube2026-06-01NoNoCurrent