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 32 of 51 · 1,013 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Listerine Total Care Kids Anticavity Fluoride Rinse - Berry Splash	SODIUM FLUORIDE	Kenvue Brands LLC	28986d7f-3e9a-8dfb-e063-6394a90a731e	2025-12-10	Warnings	Exact identifier application number: M021
Toms of Maine Tropical Island	ALUMINUM CHLOROHYDRATE	Colgate-Palmolive Company	0d6c51bc-5391-4533-b4fd-961dc4f36342	2025-12-10	Warnings	Exact identifier application number: M021
Business Class Kit	SODIUM MONOFLUOROPHOSPHATE	American Airlines, Inc.	483d7aec-34ac-49c5-ac0e-8fba5b4737ae	2025-12-09	Warnings	Exact identifier application number: M021
Colgate Anticavity Kit	SODIUM MONOFLUOROPHOSPHATE	Ming Fai Industrial (Shenzhen) Co. Ltd	121decce-c364-4060-87da-0c6a6cd48474	2025-12-08	Warnings	Exact identifier application number: M021
First Class Kit	SODIUM MONOFLUOROPHOSPHATE	American Airlines, Inc.	ba717de8-c3a2-41bf-85a1-aa75f9744d30	2025-12-08	Warnings	Exact identifier application number: M021
United Airlines Business Class Kit	SODIUM MONOFLUOROPHOSPHATE	United Airlines	94c5e9a4-19f3-4590-9da4-313c75261231	2025-12-08	Warnings	Exact identifier application number: M021
Dr. Jen SuperPaste Nano-Hydroxyapatite	SODIUM FLUORIDE	Dr Jen Natural, LLC	5f08d994-e458-42b2-aa39-e84fca3acf48	2025-12-05	Warnings	Exact identifier application number: M021
Colgate Anticavity Kit	SODIUM MONOFLUOROPHOSPHATE	Ming Fai Industrial (Shenzhen) Co. Ltd	86dfd09d-f3b6-4c4b-852d-7e04dc5c8fec	2025-12-05	Warnings	Exact identifier application number: M021
Dr. Jen SuperPaste Nano-Hydroxyapatite	SODIUM FLUORIDE	Dr Jen Natural, LLC	8b28b857-9162-4065-b0a0-571efffe9787	2025-12-05	Warnings	Exact identifier application number: M021
Dr. Jen SuperPaste Ortho	SODIUM FLUORIDE	Dr Jen Natural, LLC	9dd248bf-9488-43cd-a041-e8315a05ce5d	2025-12-04	Warnings	Exact identifier application number: M021
Dr. Jen SuperPaste Perio	SODIUM FLUORIDE	Dr Jen Natural, LLC	8c7e6d3a-49d9-4098-9d5e-e9792b373574	2025-12-04	Warnings	Exact identifier application number: M021
Colgate Total Plaque Cleanse	STANNOUS FLUORIDE	Colgate-Palmolive Company	b2980238-5bcb-467f-9e90-a307938632c2	2025-12-03	Warnings	Exact identifier application number: M021
Advance White Extreme Whitening Tartar Control	SODIUM FLUORIDE	Church & Dwight Co., Inc.	b539264f-e1ff-440b-af76-84266fe2c0a2	2025-12-02	Warnings	Exact identifier application number: M021
Sensodyne Pronamel Clinical Enamel Strength Fresh Breath	POTASSIUM NITRATE, SODIUM FLUORIDE	Haleon US Holdings LLC	34a1a32e-3017-f018-e063-6394a90a0230	2025-12-01	Warnings	Exact identifier application number: M021
Freshmint Anticavity Fluoride	SODIUM MONOFLUOROPHOSPHATE	New World Imports, Inc	77e51d6f-c1a2-4650-b3dd-5e4552379e77	2025-12-01	Warnings	Exact identifier application number: M021
Freshmint Sensitive	POTASSIUM NITRATE AND SODIUM FLUORIDE	New World Imports, Inc	aa2e0864-3325-4acf-a2c5-0eb27eb18baf	2025-12-01	Warnings	Exact identifier application number: m021
PRO-SYS	SODIUM FLUORIDE AND POTASSIUM NITRATE	Benco Dental	4e470ba4-60bb-1815-e063-6294a90abacc	2025-12-01	Warnings	Exact identifier application number: M021
PRO-SYS	SODIUM FLUORIDE	Benco Dental	4e539cb2-bcbd-95fc-e063-6294a90a2121	2025-12-01	Warnings	Exact identifier application number: M021
Cool sense Care Plus	SODIUM FLUORIDE	DONG IL PHARMS CO., LTD.	44763bf6-caf3-ec69-e063-6394a90a0ee1	2025-11-25	Warnings	Exact identifier application number: M021
DOCTRUST DOUBLEX Tooth	SODIUM FLUORIDE	DONG IL PHARMS CO.,LTD	44765e86-2eb2-6381-e063-6394a90a761f	2025-11-25	Warnings	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