FDA.reportPublic FDA data

A and H Plus Therabreath Breath Freshners

Product NDC
10237-676
11-digit product format
102370676
Labeler code
10237
Product ID
10237-676_501aaf53-e8df-0380-e063-6394a90aca25
Type
HUMAN OTC DRUG
Nonproprietary name
SODIUM FLUORIDE
Dosage form
PASTE, DENTIFRICE
Route
ORAL
Labeler
Church & Dwight Co., Inc.
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-01-01
Substance
SODIUM FLUORIDE
Active strength
.243 g/100g
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
A and H Plus Therabreath Breath Freshners
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE.243 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
18d6073e-b1ee-47d2-9758-2cf04f3cf3caAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10237-676-09A and H Plus Therabreath Breath Freshners1 in 1 CARTONPASTE, DENTIFRICE19
10237-676-09A and H Plus Therabreath Breath Freshners25.5 g in 1 TUBEPASTE, DENTIFRICE25.59
10237-676-45A and H Plus Therabreath Breath Freshners1 in 1 CARTONPASTE, DENTIFRICE19
10237-676-45A and H Plus Therabreath Breath Freshners4 in 1 PACKAGEPASTE, DENTIFRICE49
10237-676-51A and H Plus Therabreath Breath Freshners1 in 1 CARTONPASTE, DENTIFRICE19
10237-676-51A and H Plus Therabreath Breath Freshners5 in 1 CELLO PACKPASTE, DENTIFRICE59
10237-676-55A and H Plus Therabreath Breath Freshners1 in 1 CARTONPASTE, DENTIFRICE19
10237-676-55A and H Plus Therabreath Breath Freshners156 g in 1 TUBEPASTE, DENTIFRICE1569
10237-676-56A and H Plus Therabreath Breath Freshners2 in 1 CARTONPASTE, DENTIFRICE29
10237-676-56A and H Plus Therabreath Breath Freshners156 g in 1 TUBEPASTE, DENTIFRICE1569

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10237-676A AND H PLUS THERABREATH BREATH FRESHNERS (SODIUM FLUORIDE) PASTE, DENTIFRICE [CHURCH & DWIGHT CO., INC.]7Current NDC, 10 package rows20250223_18d6073e-b1ee-47d2-9758-2cf04f3cf3ca.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 21 of 51 · 1,013 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HismileSTRAWBERRY FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTEHismile Pty Ltd0ef766ae-754a-f185-e063-6294a90a32992026-01-15WarningsExact identifier
application number: M021
HismileBANANA FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTEHismile Pty Ltd0ef7be5b-df8f-9f32-e063-6394a90a47242026-01-15WarningsExact identifier
application number: M021
HismileVANILLA FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTEHismile Pty Ltd0ef8d0ef-a051-f610-e063-6394a90a85372026-01-15WarningsExact identifier
application number: M021
HISMILESODIUM FLUORIDEHISMILE PTY LTD1d40b98b-2e9a-d84a-e063-6294a90a20962026-01-15WarningsExact identifier
application number: M021
HISMILESODIUM FLUORIDEHISMILE PTY LTD1d44863e-93be-2b80-e063-6294a90a4a9d2026-01-15WarningsExact identifier
application number: M021
HISMILESODIUM FLUORIDEHISMILE PTY LTD1d458ccc-8f1e-f9c8-e063-6294a90a8da42026-01-15WarningsExact identifier
application number: M021
HISMILESODIUM FLUORIDEHISMILE PTY LTD1d447939-fbf6-42f6-e063-6294a90af6d92026-01-15WarningsExact identifier
application number: M021
HISMILESODIUM FLUORIDEHISMILE PTY LTD1de591d9-9cab-e63d-e063-6394a90ac8eb2026-01-15WarningsExact identifier
application number: M021
Ice Pop Flavor Sodium Fluoride Anticavity ToothpastSODIUM FLUORIDEHISMILE PTY LTD20e1603e-bcd1-6a5e-e063-6294a90ad1db2026-01-15WarningsExact identifier
application number: M021
HismileCANDY CANE FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTEHISMILE PTY LTD1e725b7e-accc-f51c-e063-6394a90a455c2026-01-15WarningsExact identifier
application number: M021
Enamelon Preventive TreatmentSTANNOUS FLUORIDEPremier Dental Products Company04c3f178-7905-404d-9ac2-67c453287ddf2026-01-13WarningsExact identifier
application number: M021
EnamelonSTANNOUS FLUORIDEPremier Dental Products Company1626375a-f78b-4192-b7f3-ca932acab7fb2026-01-13WarningsExact identifier
application number: M021
ARU CAVITY PROTECTIONSODIUM FLUORIDEAshtel Studios, Inc.97bd2934-4bff-4fdb-9199-fcdc0f77fada2026-01-13WarningsExact identifier
application number: M021
ACT Anticavity Fluoride CinnamonSODIUM FLUORIDEChattem, Inc.f2952ca5-c1c3-42fc-82a4-08662286be442026-01-12WarningsExact identifier
application number: M021
ACT Anticavity Fluoride Kids Wild WatermelonSODIUM FLUORIDE 0.24 (0.14 W/V FLUORIDE ION)Chattem, Inc.bc578c6e-0186-4ac7-ad3a-e8d1e0dcb8a82026-01-12WarningsExact identifier
application number: M021
ACT Kids Anticavity Fluoride Pineapple PunchSODIUM FLUORIDEChattem, Inc.2bb69826-12e5-4a4e-8d4a-23a9da6b4b9b2026-01-12WarningsExact identifier
application number: M021
Botao Kids Strawberry Flavored with FluorideBOTAO KIDS STRAWBERRY FLAVORED TOOTHPASTE WITH FLUORIDEPeer Pharm Ltd.48b8d884-5e15-4145-8521-ae9ee482e3922026-01-12WarningsExact identifier
application number: M021
ACT Total Care Anticavity Fluoride Fresh MintSODIUM FLUORIDEChattem, Inc.4ee6a478-afcf-4540-b427-ba08c942ccb32026-01-12WarningsExact identifier
application number: M021
ACT Anticavity Fluoride MintSODIUM FLUORIDEChattem, Inc.e81c83a2-363a-442f-8731-2598a4f4c21e2026-01-12WarningsExact identifier
application number: M021
ACT Total Care Anticavity Fluoride Icy Clean MintSODIUM FLUORIDEChattem, Inc.258b78b4-55e7-410c-90f8-a3e456c025792026-01-12WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416783sodium fluoride 0.24 % ToothpastePSN18d6073e-b1ee-47d2-9758-2cf04f3cf3ca9
416783sodium fluoride 0.0024 MG/MG ToothpasteSCD18d6073e-b1ee-47d2-9758-2cf04f3cf3ca9
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSY18d6073e-b1ee-47d2-9758-2cf04f3cf3ca9
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY18d6073e-b1ee-47d2-9758-2cf04f3cf3ca9
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY18d6073e-b1ee-47d2-9758-2cf04f3cf3ca9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
10237-676-09102370676091 TUBE in 1 CARTON (10237-676-09) / 25.5 g in 1 TUBE1 tube2024-01-01NoNoCurrent
10237-676-45102370676454 CARTON in 1 PACKAGE (10237-676-45) / 1 TUBE in 1 CARTON / 156 g in 1 TUBE4 carton2026-04-06NoNoCurrent
10237-676-51102370676515 CARTON in 1 CELLO PACK (10237-676-51) / 1 TUBE in 1 CARTON / 156 g in 1 TUBE5 carton2025-02-01NoNoCurrent
10237-676-55102370676551 TUBE in 1 CARTON (10237-676-55) / 156 g in 1 TUBE1 tube2024-01-01NoNoCurrent
10237-676-56102370676562 TUBE in 1 CARTON (10237-676-56) / 156 g in 1 TUBE2 tube2024-01-01NoNoCurrent