HEB

Product NDC: 37808-167
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	37808-167	37808-167-70	D	Discontinued by firm		2026-10-05

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	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	37808-167-70	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	37808-167-70	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	37808-167-70	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	37808-167-70	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	37808-167-70	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	37808-167-70	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	37808-167-70	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	37808-167-70	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	37808-167-70	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	37808-167-70	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	37808-167-70	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	37808-167-70	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	37808-167-72	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	37808-167-72	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	37808-167-72	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	37808-167-72	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	37808-167-72	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`

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: HEB
Brand name suffix: HEBuddy
Listing expiration: 2027-12-31

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
2c972c65-34aa-4348-b997-c5e65a884575	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, Related label table
NDC	Effective	Related label
37808-167-70	2024-02-23	5820035 HEB Cavity Protection Bubblegum (8015167)
37808-167-70	2024-02-23	5820035 HEB Cavity Protection Bubblegum (8015167)
37808-167-72	2024-02-23	5820035 HEB Cavity Protection Bubblegum (8015167)
37808-167-72	2024-02-23	5820035 HEB Cavity Protection Bubblegum (8015167)
37808-167-70	2020-09-27	5820035 HEB Cavity Protection Bubblegum (8015167)
37808-167-70	2020-09-27	5820035 HEB Cavity Protection Bubblegum (8015167)
37808-167-72	2020-09-27	5820035 HEB Cavity Protection Bubblegum (8015167)
37808-167-72	2020-09-27	5820035 HEB Cavity Protection Bubblegum (8015167)
37808-167-70	2020-09-25	5820035 HEB Cavity Protection Bubblegum (8015167)
37808-167-70	2020-09-25	5820035 HEB Cavity Protection Bubblegum (8015167)
37808-167-72	2020-09-25	5820035 HEB Cavity Protection Bubblegum (8015167)
37808-167-72	2020-09-25	5820035 HEB Cavity Protection Bubblegum (8015167)
37808-167-70	2020-07-22	5820035 HEB Cavity Protection Bubblegum (8015167)
37808-167-70	2020-07-22	5820035 HEB Cavity Protection Bubblegum (8015167)
37808-167-72	2020-07-22	5820035 HEB Cavity Protection Bubblegum (8015167)
37808-167-72	2020-07-22	5820035 HEB Cavity Protection Bubblegum (8015167)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
37808-167-70	HEBHEBuddy	12 in 1 CASE	PASTE, DENTIFRICE	12	7
37808-167-70	HEBHEBuddy	119 g in 1 TUBE	PASTE, DENTIFRICE	119	7
37808-167-72	HEBHEBuddy	119 g in 1 TUBE	PASTE, DENTIFRICE	119	7

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SODIUM FLUORIDE	ACTIVE INGREDIENT	8ZYQ1474W7	HEB HEBUDDY (FLUORIDE) PASTE, DENTIFRICE [HEB]	1
FLUORIDE ION	ACTIVE MOIETY	Q80VPU408O	HEB HEBUDDY (FLUORIDE) PASTE, DENTIFRICE [HEB]	1
CARBOXYMETHYLCELLULOSE SODIUM	INACTIVE INGREDIENT	K679OBS311	HEB HEBUDDY (FLUORIDE) PASTE, DENTIFRICE [HEB]	1
COCAMIDOPROPYL BETAINE	INACTIVE INGREDIENT	5OCF3O11KX	HEB HEBUDDY (FLUORIDE) PASTE, DENTIFRICE [HEB]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	HEB HEBUDDY (FLUORIDE) PASTE, DENTIFRICE [HEB]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	HEB HEBUDDY (FLUORIDE) PASTE, DENTIFRICE [HEB]	1
HYDRATED SILICA	INACTIVE INGREDIENT	Y6O7T4G8P9	HEB HEBUDDY (FLUORIDE) PASTE, DENTIFRICE [HEB]	1
POLYETHYLENE GLYCOL 600	INACTIVE INGREDIENT	NL4J9F21N9	HEB HEBUDDY (FLUORIDE) PASTE, DENTIFRICE [HEB]	1
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	HEB HEBUDDY (FLUORIDE) PASTE, DENTIFRICE [HEB]	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	HEB HEBUDDY (FLUORIDE) PASTE, DENTIFRICE [HEB]	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	HEB HEBUDDY (FLUORIDE) PASTE, DENTIFRICE [HEB]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	HEB HEBUDDY (FLUORIDE) PASTE, DENTIFRICE [HEB]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	HEB HEBUDDY (FLUORIDE) PASTE, DENTIFRICE [HEB]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
37808-167	HEB HEBUDDY (FLUORIDE) PASTE, DENTIFRICE [HEB]	5	Current NDC, Legacy NDC, 3 package rows	20250309_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 18 of 51 · 1,013 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TheraBreath Kids Anticavity Oral Rinse Bubblegum	ANTICAVITY ORAL RINSE	Church & Dwight Co., Inc.	2770424d-7416-66d4-e063-6394a90ad4b1	2026-02-06	Warnings	Exact identifier application number: M021
Crest Pro-Health Sensitivity Whitening Plus Scope	SODIUM FLUORIDE AND POTASSIUM NITRATE	The Procter & Gamble Manufacturing Company	463b7820-a5ce-f8b5-e063-6394a90aa018	2026-02-05	Warnings	Exact identifier application number: M021
Anticavity	SODIUM FLUORIDE	Publix Super Markets, Inc.	14494238-872b-49e2-8bf7-df3844a0a6c8	2026-02-05	Warnings, Adverse reactions	Exact identifier application number: M021
HAPEE EXPLOSIVE MENTHOL RED 150	SODIUM MONOFLUOROPHOSPHATE	LAMOIYAN CORPORATION	14c14694-6149-40a8-aff2-660d39f7e0c1	2026-02-05	Warnings	Exact identifier application number: M021
Anticavity Fluoride Rinse	SODIUM FLUORIDE	HARRIS TEETER	f759e9e4-6de2-4b80-903b-e67c06e36295	2026-02-04	Warnings, Adverse reactions	Exact identifier application number: M021
Oral Antivavity	SODIUM FLUORIDE	HARRIS TEETER	571f7628-fd59-462f-96dd-67aeaa98cff1	2026-02-04	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity Fluoride Rinse	SODIUM FLUORIDE	Lidl US, LLC	c47475aa-3125-410f-aa31-0add6e4ce125	2026-02-04	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity Rinse	SODIUM FLUORIDE	Demoulas Super Markets, Inc	6391ca2e-10e8-429d-a873-238a515f9c60	2026-02-03	Warnings, Adverse reactions	Exact identifier application number: M021
Crest 3D White Brilliance Pro Ultra White	SODIUM MONOFLUOROPHOSPHATE	The Procter & Gamble Manufacturing Company	f4c02924-95ee-09d2-e053-2995a90a8121	2026-02-03		Exact identifier application number: M021
Crest 3D White Stain Eraser Icy Clean Mint	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	f5d97011-7be3-3b1c-e053-2a95a90ade86	2026-02-03		Exact identifier application number: M021
Anticavity	SODIUM FLUORIDE	Demoulas Super Markets, Inc.	c28c3475-efbb-4099-83ab-ab91bac9dfc3	2026-02-03	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity Fluoride Rinse	SODIUM FLUORIDE	Demoulas Super Markets, Inc	65abfb4d-3a1e-42df-b343-f270ce60a3bf	2026-02-03	Warnings, Adverse reactions	Exact identifier application number: M021
Crest Cavity Protection Cool Mint Gel	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	102e4d9c-0fae-d48a-e063-6294a90aac94	2026-02-03	Warnings	Exact identifier application number: M021
Crest Plus Tartar Protection	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	08767b0f-ed6e-8d32-e063-6294a90a10cd	2026-02-03	Warnings	Exact identifier application number: M021
Crest Braces Care Anticavity Fluoride Rinse	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	d8398cfd-9af6-690d-e053-2995a90a9b7c	2026-02-03	Warnings	Exact identifier application number: M021
AutoBrush bubblegum	SODIUM FLUORIDE	Lander Enterprises, LLC	2e85d6f7-2df8-4eb9-bc97-d7b7af7fb460	2026-02-03	Warnings	Exact identifier application number: M021
AutoBrush Mint	SODIUM FLUORIDE	Lander Enterprises, LLC	d859d02d-a036-4d90-bed4-9a5c31e9e1ef	2026-02-03	Warnings	Exact identifier application number: M021
Glowing White	SODIUM FLUORIDE	Demoulas Super Markets, Inc	32faf47d-b64f-4454-9f14-51503504c6b5	2026-02-03	Warnings, Adverse reactions	Exact identifier application number: M021
Sodium fluoride	SODIUM FLUORIDE	Demoulas Super Markets, Inc	2f5d3c75-1a11-47e1-b297-e2302177efe7	2026-02-03	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity	SODIUM FLUORIDE	Demoulas Super Markets, Inc	096e6a1d-316b-432a-bf27-70e8a13337cc	2026-02-03	Warnings, Adverse reactions	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	2c972c65-34aa-4348-b997-c5e65a884575	7
416783	sodium fluoride 0.0024 MG/MG Toothpaste	SCD	2c972c65-34aa-4348-b997-c5e65a884575	7
416783	sodium fluoride 0.24 % (fluoride ion 0.13 % ) Toothpaste	SY	2c972c65-34aa-4348-b997-c5e65a884575	7
416783	sodium fluoride 0.24 % (fluoride ion 0.14 % ) Toothpaste	SY	2c972c65-34aa-4348-b997-c5e65a884575	7
416783	sodium fluoride 0.24 % (fluoride ion 0.15 % ) Toothpaste	SY	2c972c65-34aa-4348-b997-c5e65a884575	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
37808-167-70	37808016770	12 in 1 CASE					Historical
37808-167-72	37808016772	119 g in 1 TUBE (37808-167-72)	119 g	2012-12-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
5820035 HEB Cavity Protection Bubblegum (8015167)	HEB \| Lornamead Products	2026-01-08	HUMAN OTC DRUG LABEL	7

HEB