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		2026-10-12

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 49 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Murchison Hume Dental Kit	SODIUM MONOFLUOROPHOSPHATE	Buzz Products Inc.	b1a442e1-86cf-cba6-e053-2995a90a593a	2023-12-20	Warnings	Exact identifier application number: M021
United Airlines Polaris Kit with Colgate	SODIUM MONOFLUOROPHOSPHATE	Buzz Export Services Pty Ltd (Buzz Products)	de4564a4-1012-baad-e053-2a95a90a11b7	2023-12-20	Warnings	Exact identifier application number: M021
Orajel Complete Protection	SODIUM FLUORIDE	Church & Dwight Co., Inc.	daebd16f-d278-446d-8b7a-33add5a74fdd	2023-12-19	Warnings	Exact identifier application number: M021
Orajel Sensitivity Relief	SODIUM FLUORIDE AND POTASSIUM NITRATE	Church & Dwight Co., Inc.	7b9d9e7d-3844-4d18-ab03-bd0e9dcfccdb	2023-12-19	Warnings	Exact identifier application number: M021
ORTHO GUARD	SODIUM FLUORIDE	Massco Dental A Division of Dunagin Pharmaceuticals	8d3e0dd0-b584-413b-adf3-5c2d05ab72dd	2023-12-17	Warnings	Exact identifier application number: M021
Beyond Activated Coconut Charcoal and Sea Salt	SODIUM FLUORIDE	Beyond International Inc	d075fa15-7309-0c10-e053-2995a90a7c95	2023-11-28	Warnings	Exact identifier application number: M021
Pro-Den Rx	STANNOUS FLUORIDE	Den-mat Holdings, Llc	9036aa8a-59b1-41b0-b3cb-529d3303a1c0	2023-11-20	Warnings	Exact identifier application number: M021
Fluoridex	STANNOUS FLUORIDE RINSE	DEN-MAT HOLDINGS, LLC	5e81f073-c0ca-aa38-e053-2a91aa0ab37b	2023-11-20	Warnings	Exact identifier application number: M021
Hello Vitamin C Whitening	SODIUM FLUORIDE	Colgate-Palmolive Company	38a0276e-910c-527d-1736-65928b9d4ca4	2023-11-20	Warnings	Exact identifier application number: M021
POP Feeling Peachy	SODIUM FLUORIDE	LG H&H CO., LTD.	0abaf99b-9547-46ae-e063-6394a90a6c15	2023-11-17	Warnings	Exact identifier application number: M021
UNIVERSAL ANTI-CAVITY FLUORIDE	SODIUM MONOFLUOROPHOSPHATE	Universal Distribution Center LLC	e3356374-befa-41b0-ab0f-edfd5a062601	2023-11-16	Warnings	Exact identifier application number: M021
ANTI CAVITY FLUORIDE	SODIUM MONOFLUOROPHOSPHATE	Universal Distribution Center LLC	421fc2f0-b118-4e7a-a399-ba4780028c54	2023-11-16	Warnings	Exact identifier application number: M021
UNIVERSAL CHARCOAL WITH ALOE VERA ANTI-CAVITY FLUORIDE	SODIUM FLUORIDE	Universal Distribution Center LLC	3411924d-1002-460c-83e8-c0c7fbff9ad1	2023-11-16	Warnings	Exact identifier application number: M021
ADVANCED WHITENING ANTI CAVITY FLUORIDE	SODIUM MONOFLUOROPHOSPHATE	Universal Distribution Center LLC	8ea8a8d9-b7e4-468f-9a09-4ec634cbd80e	2023-11-16	Warnings	Exact identifier application number: M021
UNIVERSAL ADVANCED WHITENING ANTI-CAVITY FLUORIDE	SODIUM MONOFLUOROPHOSPHATE	Universal Distribution Center LLC	879dfaf0-27c8-41a3-8d01-a1c3eec9edfc	2023-11-15	Warnings	Exact identifier application number: M021
EUTHYMOL Extraordinary Pink Whitening	SODIUM FLUORIDE	LG H&H CO., LTD.	0989936c-237d-dc63-e063-6294a90a885f	2023-11-07	Warnings	Exact identifier application number: M021
Eurofresh Whitening	SODIUM FLUORIDE	Farmasi US LLC	b56b2b55-e3a4-785a-e053-2a95a90a7abf	2023-11-05	Warnings	Exact identifier application number: M021
Farmasi Whitening	SODIUM FLUORIDE	Farmasi US LLC	25b3608e-abed-41ca-9971-21981b8a4610	2023-11-05	Warnings	Exact identifier application number: M021
United Airlines Therabody UPP Kit	SODIUM MONOFLUOROPHOSPHATE	Wessco International	fb6c355b-a67d-c4b4-e053-6394a90a0e66	2023-10-26	Warnings	Exact identifier application number: M021
United Dental Kit	SODIUM MONOFLUOROPHOSPHATE	Wessco International	7f348fe7-9918-4934-bed0-f0a77c09d046	2023-10-26	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