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 11 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Colgate Total SF Whitening	STANNOUS FLUORIDE	Colgate-Palmolive Company	3bba340e-2a62-3b04-41b5-0ed9c13adb13	2026-04-22	Warnings	Exact identifier application number: M021
EverSmile Squirt	SODIUM FLUORIDE 0.05%	Everbrands, Inc.	bc0ef174-2909-469a-b629-0eab4412bdfc	2026-04-20	Warnings	Exact identifier application number: M021
Gum Detoxify	STANNOUS FLUORIDE	Walmart	41d6cc7a-0b87-e474-e063-6294a90ae995	2026-04-20	Warnings	Exact identifier application number: M021
Eversmile Squirt	2.65% HYDROGEN PEROXIDE	Everbrands, Inc.	2c43dedf-eeb0-43ba-a352-3d56ffd9d6cf	2026-04-19	Warnings	Exact identifier application number: M021
Alcohol-Free Anticavity	SODIUM FLUORIDE	H E B	8d40f693-083c-4eb6-9da1-42675d757e0e	2026-04-16	Warnings, Adverse reactions	Exact identifier application number: M021
Eversmile OrthoFoam Anticavity	0.05% SODIUM FLUORIDE RINSE	Everbrands, Inc.	9c12e792-94c8-4e29-9a54-e7e70aadade6	2026-04-16	Warnings	Exact identifier application number: M021
Eversmile Squirt	2.65% HYDROGEN PEROXIDE	Everbrands, Inc.	6753b426-6d49-4438-a52f-c28e60a0e9d8	2026-04-16	Warnings	Exact identifier application number: M021
Osstem G Gum Health Care Tooth	SODIUM FLUORIDE	Osstem Pharma Co., Ltd	4f8b4fc0-4c98-5e52-e063-6394a90af710	2026-04-15	Warnings	Exact identifier application number: M021
Crest 3D White Deep Stain Remover Enamel Strength	SODIUM MONOFLUOROPHOSPHATE	The Procter & Gamble Manufacturing Company	4f6b8851-c778-8abd-e063-6294a90aef4f	2026-04-14		Exact identifier application number: M021
Crest 3D White Stain Eraser Luxe Mint	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	4f6beb3b-2521-bfb7-e063-6394a90ad9ea	2026-04-14		Exact identifier application number: M021
Kids Crest Strawberry Rush	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	6d96c5bb-d8d9-fbf6-e053-2a91aa0a5d13	2026-04-14	Warnings	Exact identifier application number: M021
Crest Pro-Health Mouthwash Multi-Protection Strong Mint	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	4f6d11b2-5aa2-ab34-e063-6294a90ac0bc	2026-04-14	Warnings	Exact identifier application number: M021
Anticavity Fluoride Rinse	SODIUM FLUORIDE	Publix Super Markets, Inc.	cb6850e9-ba3e-47ac-a3ca-5de4d57c01cb	2026-04-14	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity	SODIUM FLUORIDE	Publix Super Markets, Inc.	f0e84078-499f-4a5a-bcd2-23f57805de86	2026-04-14	Warnings, Adverse reactions	Exact identifier application number: M021
Crest Pro-Health Advanced Multi-Protection	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	1cfc5b61-c8e5-943d-e063-6394a90a890b	2026-04-14	Warnings	Exact identifier application number: M021
Crest Pro-Health Multi-Protection plus Extra Whitening	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	4f6f6299-f95f-2f0e-e063-6294a90a1641	2026-04-14	Warnings	Exact identifier application number: M021
Crest 3D White Strength Whitening Enamel Protection	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	4f7125aa-3aa2-ca64-e063-6394a90a4cf3	2026-04-14	Warnings	Exact identifier application number: M021
Eversmile TheraFoam	0.05% SODIUM FLUORIDE RINSE	Everbrands, Inc.	57da2479-923a-45ec-8149-57b469b11637	2026-04-13	Warnings	Exact identifier application number: M021
Crest Pro-Health Advanced Bacteria Protection	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	4f1ce508-fe6e-4045-e063-6294a90ab3e2	2026-04-10	Warnings	Exact identifier application number: M021
Crest Pro-Health Sensitivity Relief	SODIUM FLUORIDE AND POTASSIUM NITRATE	The Procter & Gamble Manufacturing Company	4f1d62ae-653e-3046-e063-6294a90abbf8	2026-04-10	Warnings	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