HEB

Product NDC: 37808-192
11-digit product format: 378080192
Labeler code: 37808
Product ID: 37808-192_437f93d5-d593-6b3a-e063-6294a90ac268
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: 2026-12-31
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	37808-192	37808-192-00	D	Discontinued by firm		2026-10-15

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	37808-192-00	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	37808-192-00	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	37808-192-00	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	37808-192-00	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	37808-192-00	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	37808-192-00	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	37808-192-00	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	37808-192-00	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	37808-192-00	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	37808-192-00	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	37808-192-00	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	37808-192-00	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	37808-192-02	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	37808-192-02	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	37808-192-02	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	37808-192-02	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	37808-192-02	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: 2026-12-31

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
891775	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
a6af1baf-17bf-428c-8744-1490359b0cfb	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
37808-192-00	2024-02-23	5820034 HEB Cavity Protection Watermelon Mint (8015188)
37808-192-02	2024-02-23	5820034 HEB Cavity Protection Watermelon Mint (8015188)
37808-192-00	2020-09-27	5820034 HEB Cavity Protection Watermelon Mint (8015188)
37808-192-02	2020-09-27	5820034 HEB Cavity Protection Watermelon Mint (8015188)
37808-192-00	2020-09-25	5820034 HEB Cavity Protection Watermelon Mint (8015188)
37808-192-02	2020-09-25	5820034 HEB Cavity Protection Watermelon Mint (8015188)
37808-192-00	2020-07-22	5820034 HEB Cavity Protection Watermelon Mint (8015188)
37808-192-02	2020-07-22	5820034 HEB Cavity Protection Watermelon Mint (8015188)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
37808-192-00	HEBHEBuddy	12 in 1 CASE	PASTE, DENTIFRICE	12	9
37808-192-00	HEBHEBuddy	120 g in 1 TUBE	PASTE, DENTIFRICE	120	9
37808-192-02	HEBHEBuddy	120 g in 1 TUBE	PASTE, DENTIFRICE	120	9

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]	4
FLUORIDE ION	ACTIVE MOIETY	Q80VPU408O	HEB HEBUDDY (FLUORIDE) PASTE, DENTIFRICE [HEB]	4
CARBOXYMETHYLCELLULOSE SODIUM	INACTIVE INGREDIENT	K679OBS311	HEB HEBUDDY (FLUORIDE) PASTE, DENTIFRICE [HEB]	4
COCAMIDOPROPYL BETAINE	INACTIVE INGREDIENT	5OCF3O11KX	HEB HEBUDDY (FLUORIDE) PASTE, DENTIFRICE [HEB]	4
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	HEB HEBUDDY (FLUORIDE) PASTE, DENTIFRICE [HEB]	4
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	HEB HEBUDDY (FLUORIDE) PASTE, DENTIFRICE [HEB]	4
HYDRATED SILICA	INACTIVE INGREDIENT	Y6O7T4G8P9	HEB HEBUDDY (FLUORIDE) PASTE, DENTIFRICE [HEB]	4
POLYETHYLENE GLYCOL 600	INACTIVE INGREDIENT	NL4J9F21N9	HEB HEBUDDY (FLUORIDE) PASTE, DENTIFRICE [HEB]	4
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	HEB HEBUDDY (FLUORIDE) PASTE, DENTIFRICE [HEB]	4
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	HEB HEBUDDY (FLUORIDE) PASTE, DENTIFRICE [HEB]	4
SORBITOL	INACTIVE INGREDIENT	506T60A25R	HEB HEBUDDY (FLUORIDE) PASTE, DENTIFRICE [HEB]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	HEB HEBUDDY (FLUORIDE) PASTE, DENTIFRICE [HEB]	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	HEB HEBUDDY (FLUORIDE) PASTE, DENTIFRICE [HEB]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
37808-192	HEB HEBUDDY (FLUORIDE) PASTE, DENTIFRICE [HEB]	7	Current NDC, Legacy NDC, 3 package rows	20250119_a6af1baf-17bf-428c-8744-1490359b0cfb.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 13 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CloSYS	SODIUM FLUORIDE	Rowpar Pharmaceuticals, Inc.	ed617c7a-805c-4788-9bce-9b7fead4312d	2026-03-31	Warnings	Exact identifier application number: M021
Colgate Total Enamel Strength	STANNOUS FLUORIDE	Colgate-Palmolive Company	1f29c893-e7c5-4a0e-941b-c2634d821147	2026-03-25	Warnings	Exact identifier application number: M021
AP-24 Whitening	SODIUM MONOFLUOROPHOSPHATE	NSE Products, Inc.	57e9e68c-41dd-470b-80db-dfaedc0e2a0a	2026-03-24	Warnings	Exact identifier application number: M021
Euthymol Whitening	SODIUM FLUORIDE	LG HOUSEHOLD & HEALTH CARE LTD.	369c0d44-6375-dcae-e063-6394a90a74d0	2026-03-24	Warnings	Exact identifier application number: M021
Euthymol Whitening Purple Corrector	SODIUM FLUORIDE	LG HOUSEHOLD & HEALTH CARE LTD.	369bc785-fb77-a56d-e063-6394a90a2e6b	2026-03-24	Warnings	Exact identifier application number: M021
SensitiveToothpaste	ANTI SENSITIVETOOTHPASTE	Huain Best Trade Co., Ltd.	4db239f3-2ad7-3a5b-e063-6294a90a11a7	2026-03-23	Warnings	Exact identifier application number: M021
Crest Bubblegum	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	7d6268c7-b273-1bbf-e053-2a91aa0a5d32	2026-03-17	Warnings	Exact identifier application number: M021
Natures Promise Childrens Fluoride Strawberry	SODIUM MONOFLUOROPHOSPHATE	Foodhold U.S.A.	81a4e196-8b2d-0745-e053-2991aa0a7de6	2026-03-16	Warnings	Exact identifier application number: M021
Stance	0.63% STANNOUS FLUORIDE CONCENTRATE RINSE	Elevate Oral Care	3ae8badf-f960-62fd-e054-00144ff8d46c	2026-03-11	Warnings	Exact identifier application number: M021
Stance	0.63% STANNOUS FLUORIDE CONCENTRATE RINSE	Elevate Oral Care	3ae71258-a8c2-6eb5-e054-00144ff88e88	2026-03-11	Warnings	Exact identifier application number: M021
Delta Travel Kit Comfort plus	SODIUM MONOFLUOROPHOSPHATE	Buzz Products Inc.	d31e0920-4317-1e0c-e053-2a95a90aebeb	2026-03-11	Warnings	Exact identifier application number: M021
Anticavity Fluoride Rinse	SODIUM FLUORIDE	CVS Pharmacy, Inc.	eac346d9-d9c1-4417-8193-390c7a0dcc2a	2026-03-10	Warnings, Adverse reactions	Exact identifier application number: M021
Crest Cavity Protection Regular	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	6caf3f2e-70a2-4530-99fa-f5af7e4c511a	2026-03-10	Warnings	Exact identifier application number: M021
Amerfresh Toothpowder	SODIUM FLUORIDE	Yangzhou ONE & ONLY Personal Care Products Co., LTD	1cacf93e-aa60-4717-87ab-0568a701a4f3	2026-03-10	Warnings	Exact identifier application number: M021
Anticavity	SODIUM FLUORIDE	CVS Pharmacy, Inc.	a51357df-6d55-4030-a5db-42da7ba54a37	2026-03-09	Warnings, Adverse reactions	Exact identifier application number: M021
Fluoride	FLUORIDE TOOTHPASTE	McKesson	4c482e45-0502-a93a-e063-6394a90aa961	2026-03-05	Warnings	Exact identifier application number: M021
Colgate Maximum Cavity Protection Bubble Fruit Flavor	SODIUM FLUORIDE	Colgate-Palmolive Company	0a1389f6-cac9-3d58-0744-c488abb0bbcc	2026-03-03	Warnings	Exact identifier application number: M021
Alcohol-Free Anticavity	SODIUM FLUORIDE	Amazon.com Services LLC	349eca80-2e0c-409b-af29-3235fdc0695b	2026-03-03	Warnings, Adverse reactions	Exact identifier application number: M021
Oral Antivavity	SODIUM FLUORIDE	Amazon.com Services LLC	03735abc-d1be-4ca0-a497-0a5c5f289402	2026-03-03	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity	SODIUM FLUORIDE	Old East Main Co.	f8036e2e-7541-4922-92b9-0d8319f7b64c	2026-03-02	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
891775	sodium fluoride 0.243 % Toothpaste	PSN	a6af1baf-17bf-428c-8744-1490359b0cfb	9
891775	sodium fluoride 0.00243 MG/MG Toothpaste	SCD	a6af1baf-17bf-428c-8744-1490359b0cfb	9
891775	sodium fluoride 0.243 % (fluoride ion 0.13 % ) Toothpaste	SY	a6af1baf-17bf-428c-8744-1490359b0cfb	9
891775	sodium fluoride 0.243 % (fluoride ion 0.14 % ) Toothpaste	SY	a6af1baf-17bf-428c-8744-1490359b0cfb	9
891775	sodium fluoride 0.243 % (fluoride ion 0.15 % ) Toothpaste	SY	a6af1baf-17bf-428c-8744-1490359b0cfb	9
891775	sodium fluoride 0.243 % (fluoride ion 0.16 % ) Toothpaste	SY	a6af1baf-17bf-428c-8744-1490359b0cfb	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
37808-192-00	37808019200	12 in 1 CASE					Historical
37808-192-02	37808019202	120 g in 1 TUBE (37808-192-02)	120 g	2012-12-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
5820034 HEB Cavity Protection Watermelon Mint (8015188)	HEB \| Lornamead Products	2025-11-13	HUMAN OTC DRUG LABEL	9

HEB