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 9 of 51 · 1,013 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Optimax Anticavity Fluoride Raspberry	SODIUM MONOFLUOROPHOSPHATE	White Glo USA Inc	57e1d1cb-da58-4cd2-b960-4056e0b0d214	2026-06-05	Warnings	Exact identifier application number: M021
3ECARE Dual FormulaWhiteningToothpaste	SODIUM FLUORIDE	Hangzhou Namei Zhikang Technology Co., Ltd.	533fb7dd-7f84-59c5-e063-6394a90accad	2026-06-02	Warnings	Exact identifier application number: M021
3ECARE Dual FormulaToothpastefor sensitiveteeth	POTASSIUM NITRATE SODIUM MONOFLUOROPHOSPHATE	Hangzhou Namei Zhikang Technology Co., Ltd.	533fc83e-a8cf-15c1-e063-6294a90a7b74	2026-06-02	Warnings	Exact identifier application number: M021
Walgreens Restore and Defend	STANNOUS FLUORIDE	Walgreens	e808ea4b-9081-085b-e053-2a95a90a4f9b	2026-06-02	Warnings	Exact identifier application number: M021
Hello Unicorn Splash unicorn splash anticavity fluoride rinse	SODIUM FLUORIDE	Colgate-Palmolive Company	a1014431-7d23-aaff-6dc7-ab58683d0338	2026-06-02	Warnings	Exact identifier application number: M021
Therabreath Anticavity	SODIUM FLUORIDE	Church & Dwight Co., Inc.	feab3d45-ff95-4b32-8258-7d932a7380c9	2026-06-01	Warnings	Exact identifier application number: M021
Orajel Toy Story 5 Anticavity	SODIUM FLUORIDE	Church & Dwight Co., Inc.	4b80947d-f389-2f80-e063-6294a90abd55	2026-06-01	Warnings	Exact identifier application number: M021
Arm and Hammer	SODIUM FLUORIDE	Church & Dwight Co., Inc.	54113245-0c1e-739e-e063-6294a90aea42	2026-06-01	Warnings	Exact identifier application number: M021
Arm and Hammer	SODIUM FLUORIDE	Church & Dwight Co., Inc.	545258fd-8179-fffc-e063-6394a90a467f	2026-06-01	Warnings	Exact identifier application number: M021
Orajel Paw Patrol	SODIUM FLUORIDE	Church & Dwight Co., Inc.	99d87bea-3e99-5d04-e053-2a95a90aaf54	2026-06-01	Warnings	Exact identifier application number: M021
Orajel SuperMario	ANTICAVITY TOOTHPASTE	Church & Dwight Co., Inc.	27d2f6cb-8661-da9c-e063-6394a90a5bde	2026-06-01	Warnings	Exact identifier application number: M021
Orajel KidsToothpaste	SODIUM FLUORIDE	Church & Dwight Co., Inc.	99d62125-c2c5-5926-e053-2995a90aaa29	2026-06-01	Warnings	Exact identifier application number: M021
AIM CAVITY PROTECTION Multi Benefit	SODIUM FLUORIDE	Church & Dwight Co., Inc.	1d0f8a33-0b01-40e2-e054-00144ff88e88	2026-06-01	Warnings	Exact identifier application number: M021
Crest plus Tartar Protection Whitening	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	560980ea-749f-593d-e063-6394a90a1b9e	2026-06-01	Warnings	Exact identifier application number: M021
Colgate Revitalizing White	SODIUM MONOFLUOROPHOSPHATE	Colgate-Palmolive Company	c67223ae-b068-41c5-a15b-7ae9840b93ef	2026-05-27	Warnings	Exact identifier application number: M021
Colgate Kids Harry Potter	SODIUM FLUORIDE	Colgate-Palmolive Company	61c06da4-9f02-4fbc-b80f-1c443e298496	2026-05-26	Warnings	Exact identifier application number: M021
sodium fluoride rinse	SODIUM FLUORIDE RINSE	Rockland Cosmetics, Inc.	52430b12-4d5f-d1e1-e063-6394a90abd64	2026-05-20	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity	SODIUM FLUORIDE	H E B	d0a52519-3339-40ea-93e5-78f76d348a4d	2026-05-14	Warnings, Adverse reactions	Exact identifier application number: M021
Burts Bees Extra White	SODIUM FLUORIDE	Procter & Gamble Manufacturing Company	c92524fd-8b93-592d-e053-2a95a90a88c6	2026-05-13	Warnings	Exact identifier application number: M021
MIPaste Plus Strawberry	SODIUM FLUORIDE	GC America Inc.	1b68bd67-65d3-4c64-e054-00144ff8d46c	2026-05-12	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