H E B

Product NDC: 37808-230
11-digit product format: 378080230
Labeler code: 37808
Product ID: 37808-230_47e52621-fd2a-850a-e063-6294a90affff
Type: HUMAN OTC DRUG
Nonproprietary name: Fluoride
Dosage form: PASTE, DENTIFRICE
Route: DENTAL
Labeler: HEB
Application: M021
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2014-07-01
Substance: STANNOUS FLUORIDE
Active strength: .15 g/100g
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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 · 3 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product	37808-230		U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	37808-230	37808-230-09	U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	37808-230	37808-230-92	U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`

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: H E B
Brand name suffix: Restore and Defend
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
STANNOUS 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
3FTR44B32Q	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
416784	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
56080493-9ab8-4b4f-be5f-7df22dee133f	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
37808-230-09	H E BRestore and Defend	1 in 1 CARTON	PASTE, DENTIFRICE	1	15
37808-230-09	H E BRestore and Defend	96.4 g in 1 TUBE	PASTE, DENTIFRICE	96.4	15
37808-230-92	H E BRestore and Defend	2 in 1 CARTON	PASTE, DENTIFRICE	2	15
37808-230-92	H E BRestore and Defend	96.4 g in 1 TUBE	PASTE, DENTIFRICE	96.4	15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
STANNOUS FLUORIDE	ACTIVE INGREDIENT	3FTR44B32Q	H E B RESTORE AND DEFEND (FLUORIDE) PASTE, DENTIFRICE [HEB]	1
FLUORIDE ION	ACTIVE MOIETY	Q80VPU408O	H E B RESTORE AND DEFEND (FLUORIDE) PASTE, DENTIFRICE [HEB]	1
CARBOXYMETHYLCELLULOSE SODIUM	INACTIVE INGREDIENT	K679OBS311	H E B RESTORE AND DEFEND (FLUORIDE) PASTE, DENTIFRICE [HEB]	1
COCAMIDOPROPYL BETAINE	INACTIVE INGREDIENT	5OCF3O11KX	H E B RESTORE AND DEFEND (FLUORIDE) PASTE, DENTIFRICE [HEB]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	H E B RESTORE AND DEFEND (FLUORIDE) PASTE, DENTIFRICE [HEB]	1
HYDRATED SILICA	INACTIVE INGREDIENT	Y6O7T4G8P9	H E B RESTORE AND DEFEND (FLUORIDE) PASTE, DENTIFRICE [HEB]	1
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	H E B RESTORE AND DEFEND (FLUORIDE) PASTE, DENTIFRICE [HEB]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	H E B RESTORE AND DEFEND (FLUORIDE) PASTE, DENTIFRICE [HEB]	1
SODIUM TRIPOLYPHOSPHATE ANHYDROUS	INACTIVE INGREDIENT	9SW4PFD2FZ	H E B RESTORE AND DEFEND (FLUORIDE) PASTE, DENTIFRICE [HEB]	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	H E B RESTORE AND DEFEND (FLUORIDE) PASTE, DENTIFRICE [HEB]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	H E B RESTORE AND DEFEND (FLUORIDE) PASTE, DENTIFRICE [HEB]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	H E B RESTORE AND DEFEND (FLUORIDE) PASTE, DENTIFRICE [HEB]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
37808-230	H E B RESTORE AND DEFEND (FLUORIDE) PASTE, DENTIFRICE [HEB]	13	Current NDC, Legacy NDC, 4 package rows	20250316_56080493-9ab8-4b4f-be5f-7df22dee133f.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
3FTR44B32Q	STANNOUS FLUORIDE	7783-47-3	STANNOUS FLUORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
416784	stannous fluoride 0.454 % (fluoride ion 0.16 % ) Toothpaste	PSN	56080493-9ab8-4b4f-be5f-7df22dee133f	15
416784	stannous fluoride 0.00454 MG/MG Toothpaste	SCD	56080493-9ab8-4b4f-be5f-7df22dee133f	15
416784	stannous fluoride 0.454 % (fluoride ion 0.14 % ) Toothpaste	SY	56080493-9ab8-4b4f-be5f-7df22dee133f	15
416784	stannous fluoride 0.454 % (fluoride ion 0.15 % ) Toothpaste	SY	56080493-9ab8-4b4f-be5f-7df22dee133f	15
416784	stannous fluoride 0.454 % (fluoride ion 0.16 % ) Toothpaste	SY	56080493-9ab8-4b4f-be5f-7df22dee133f	15

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
37808-230-09	37808023009	1 TUBE in 1 CARTON (37808-230-09) / 96.4 g in 1 TUBE	1 tube	2014-07-01	0000-00-00	No	No	Current
37808-230-92	37808023092	2 TUBE in 1 CARTON (37808-230-92) / 96.4 g in 1 TUBE	2 tube	2019-02-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
5820230, 5820273 HEB Sensitive Restore and Defend	HEB \| Lornamead Products	2026-01-08	HUMAN OTC DRUG LABEL	15