FDA.reportPublic FDA data

HEB

Product NDC
37808-167
Requested package NDC
37808-167-72
11-digit product format
378080167
Labeler code
37808
Product ID
37808-167_47e5198e-7bfa-72a8-e063-6294a90a7ec5
Type
HUMAN OTC DRUG
Nonproprietary name
Fluoride
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
HEB
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-12-01
Substance
SODIUM FLUORIDE
Active strength
.15 g/100g
NDC exclude flag
No
Listing certified through
2027-12-31
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 · 5 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2022-08-30 03:57 UTC · source 2022-08-29fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-0886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-278dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17e2bbac7714bc…27bdfed8d636…

Additional Listing Data#

Finished product
Yes
Brand name base
HEB
Brand name suffix
HEBuddy
Listing expiration
2027-12-31

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
2c972c65-34aa-4348-b997-c5e65a884575Available 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, Related label table
NDCEffectiveRelated label
37808-167-702024-02-235820035 HEB Cavity Protection Bubblegum (8015167)
37808-167-702024-02-235820035 HEB Cavity Protection Bubblegum (8015167)
37808-167-722024-02-235820035 HEB Cavity Protection Bubblegum (8015167)
37808-167-722024-02-235820035 HEB Cavity Protection Bubblegum (8015167)
37808-167-702020-09-275820035 HEB Cavity Protection Bubblegum (8015167)
37808-167-702020-09-275820035 HEB Cavity Protection Bubblegum (8015167)
37808-167-722020-09-275820035 HEB Cavity Protection Bubblegum (8015167)
37808-167-722020-09-275820035 HEB Cavity Protection Bubblegum (8015167)
37808-167-702020-09-255820035 HEB Cavity Protection Bubblegum (8015167)
37808-167-702020-09-255820035 HEB Cavity Protection Bubblegum (8015167)
37808-167-722020-09-255820035 HEB Cavity Protection Bubblegum (8015167)
37808-167-722020-09-255820035 HEB Cavity Protection Bubblegum (8015167)
37808-167-702020-07-225820035 HEB Cavity Protection Bubblegum (8015167)
37808-167-702020-07-225820035 HEB Cavity Protection Bubblegum (8015167)
37808-167-722020-07-225820035 HEB Cavity Protection Bubblegum (8015167)
37808-167-722020-07-225820035 HEB Cavity Protection Bubblegum (8015167)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37808-167-70HEBHEBuddy12 in 1 CASEPASTE, DENTIFRICE127
37808-167-70HEBHEBuddy119 g in 1 TUBEPASTE, DENTIFRICE1197
37808-167-72HEBHEBuddy119 g in 1 TUBEPASTE, DENTIFRICE1197

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W7HEB HEBUDDY (FLUORIDE) PASTE, DENTIFRICE [HEB]1
FLUORIDE IONACTIVE MOIETYQ80VPU408OHEB HEBUDDY (FLUORIDE) PASTE, DENTIFRICE [HEB]1
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311HEB HEBUDDY (FLUORIDE) PASTE, DENTIFRICE [HEB]1
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KXHEB HEBUDDY (FLUORIDE) PASTE, DENTIFRICE [HEB]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAHEB HEBUDDY (FLUORIDE) PASTE, DENTIFRICE [HEB]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXHEB HEBUDDY (FLUORIDE) PASTE, DENTIFRICE [HEB]1
HYDRATED SILICAINACTIVE INGREDIENTY6O7T4G8P9HEB HEBUDDY (FLUORIDE) PASTE, DENTIFRICE [HEB]1
POLYETHYLENE GLYCOL 600INACTIVE INGREDIENTNL4J9F21N9HEB HEBUDDY (FLUORIDE) PASTE, DENTIFRICE [HEB]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYHEB HEBUDDY (FLUORIDE) PASTE, DENTIFRICE [HEB]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUHEB HEBUDDY (FLUORIDE) PASTE, DENTIFRICE [HEB]1
SORBITOLINACTIVE INGREDIENT506T60A25RHEB HEBUDDY (FLUORIDE) PASTE, DENTIFRICE [HEB]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHEB HEBUDDY (FLUORIDE) PASTE, DENTIFRICE [HEB]1
WATERINACTIVE INGREDIENT059QF0KO0RHEB HEBUDDY (FLUORIDE) PASTE, DENTIFRICE [HEB]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-167HEB HEBUDDY (FLUORIDE) PASTE, DENTIFRICE [HEB]5Current NDC, Legacy NDC, 3 package rows20250309_2c972c65-34aa-4348-b997-c5e65a884575.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 1 of 52 · 1,024 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BIO SPECTRA ATTITUDESODIUM FLUORIDE9055-7588 Qubec Inc. DBA Attitude54bd43c9-489d-4e6b-9031-90ec0e3c45162026-09-01WarningsExact identifier
application number: M021
BIO SPECTRA ATTITUDESODIUM FLUORIDE9055-7588 Qubec Inc. DBA Attitude53c344e9-49f5-48aa-8309-1e15f80b80a02026-09-01WarningsExact identifier
application number: M021
COLGATE OPTIC WHITE CHARCOALSODIUM FLUORIDEColgate-Palmolive Company70ed4a93-b68f-4198-b4b7-7cfeb17ba5d22026-07-30WarningsExact identifier
application number: M021
Colgate Optic White CharcoalSODIUM FLUORIDEColgate-Palmolive Company82ac5b9d-19e8-46ac-a195-c7d85f2967d52026-07-30WarningsExact identifier
application number: M021
Supersmile Professional Whitening TP Peppy Mint 1.4 ozSODIUM MONOFLUOROPHOSPHATERobell Research, Inc251264ea-20d2-be19-e063-6394a90aa5f62026-07-29WarningsExact identifier
application number: M021
Natural White Sensitive Enamel Guard Alpine MintSODIUM FLUORIDELornamead Products2e832204-ba2d-6dcb-e063-6394a90a5e6c2026-07-29WarningsExact identifier
application number: M021
Natural White Radiant WhiteFLUORIDELornamead Productsf0b62aaa-4983-4bd3-931e-f1a31b870f622026-07-29WarningsExact identifier
application number: M021
TP OW Pro Series Stain PreventionSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Company76df52a3-b24c-4009-8137-fe644dabebf62026-07-29WarningsExact identifier
application number: M021
Colgate Kids Cavity ProtectionSODIUM FLUORIDEColgate-Palmolive Companyf0e68196-8566-443b-9cc8-b57d5c0015582026-07-29WarningsExact identifier
application number: M021
TP OW Pro Series Vividly FreshSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Companyf0551acf-c4d6-4d49-ae9c-4aeaeb99a7002026-07-29WarningsExact identifier
application number: M021
Colgate MaxFresh with Whitening KnockOut FluorideSODIUM FLUORIDEColgate-Palmolive Company92079d13-3b66-42b7-9990-2727a489b6f62026-07-28WarningsExact identifier
application number: M021
BIO SPECTRA ATTITUDESODIUM FLUORIDE9055-7588 Quebec Inc. DBA Attitude7d04d050-b283-4fce-b1e9-e695b70363f92026-07-27WarningsExact identifier
application number: M021
COLGATE OPTIC WHITE ADVANCED OXYGENATING WHITESODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Companycd805999-86e4-4f6c-9889-fa9a2227d5262026-07-24WarningsExact identifier
application number: M021
COLGATE Baking Soda and Peroxide Whitening Brisk MintSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Company913a2cd6-b6a8-4069-979f-3c696a9bfdf02026-07-24WarningsExact identifier
application number: M021
COLGATE OPTIC WHITE PURPLESODIUM FLUORIDEColgate-Palmolive Company16e9b303-fc2a-451a-adc7-dcb10fc0e6f82026-07-23WarningsExact identifier
application number: M021
Orajel Kids SupermanANTICAVITY TOOTHPASTEChurch & Dwight Co., Inc.2b47af33-32d4-7c06-e063-6394a90a2f332026-07-23WarningsExact identifier
application number: M021
Sensitive Teeth and GumsPOTASSIUM NITRATE, SODIUM FLUORIDEChurch & Dwight Co., Inc.935172db-d78f-0c69-e053-2a95a90a0b692026-07-23WarningsExact identifier
application number: M021
Essentials Whiten and StrengthenSODIUM FLUORIDE 0.24%Church & Dwight Co., Inc.96548550-2cd1-b757-e053-2995a90a15ea2026-07-23WarningsExact identifier
application number: M021
TP COL OW PurpleSODIUM FLUORIDEColgate-Palmolive Companyea0db59f-f9c0-49a8-9717-69cdf071f6e12026-07-23WarningsExact identifier
application number: M021
Colgate Max Fresh Cool MintSODIUM FLUORIDEColgate-Palmolive Company00652bb2-090c-4eaa-8fc2-e0be6913a7242026-07-22WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416783sodium fluoride 0.24 % ToothpastePSN2c972c65-34aa-4348-b997-c5e65a8845757
416783sodium fluoride 0.0024 MG/MG ToothpasteSCD2c972c65-34aa-4348-b997-c5e65a8845757
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSY2c972c65-34aa-4348-b997-c5e65a8845757
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY2c972c65-34aa-4348-b997-c5e65a8845757
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY2c972c65-34aa-4348-b997-c5e65a8845757

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
37808-167-7237808016772119 g in 1 TUBE (37808-167-72) 119 g2012-12-01NoNoCurrent