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…`

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 1 of 52 · 1,037 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BIO SPECTRA ATTITUDE	SODIUM FLUORIDE	9055-7588 Qubec Inc. DBA Attitude	54bd43c9-489d-4e6b-9031-90ec0e3c4516	2026-09-01	Warnings	Exact identifier application number: M021
BIO SPECTRA ATTITUDE	SODIUM FLUORIDE	9055-7588 Qubec Inc. DBA Attitude	53c344e9-49f5-48aa-8309-1e15f80b80a0	2026-09-01	Warnings	Exact identifier application number: M021
Anticavity Fluoride Rinse	SODIUM FLUORIDE	Nice-Pak Products, LLC	c71d4064-f938-477b-9346-eb38be65390d	2026-08-25	Warnings, Adverse reactions	Exact identifier application number: M021
AIM Whitening with Baking Soda	SODIUM FLUORIDE	Church & Dwight Co., Inc.	1d0fd0b4-33ba-5764-e054-00144ff88e88	2026-08-25	Warnings	Exact identifier application number: M021
OPTIC WHITE PRO SERIES VIBRANT CLEAN	SODIUM MONOFLUOROPHOSPHATE	Colgate-Palmolive Company	b1ada157-a9a0-4eec-83a2-6e448d7f12dc	2026-08-21	Warnings	Exact identifier application number: M021
Colgate Max Fresh Clean Mint	SODIUM FLUORIDE	Colgate-Palmolive Company	7cb85fc4-573b-45d7-a430-f2fd17320c43	2026-08-21	Warnings	Exact identifier application number: M021
Therabreath Whitening	SODIUM FLUORIDE	Church & Dwight Co., Inc.	3ba04b55-38f9-76f3-e063-6394a90a3c03	2026-08-21	Warnings	Exact identifier application number: M021
Therabreath Deep Clean	STANNOUS FLUORIDE	Church & Dwight Co., Inc.	3c372f26-e0c4-0659-e063-6294a90ae9f9	2026-08-21	Warnings	Exact identifier application number: M021
TheraBreath	POTASSIUM NITRATE, SODIUM FLUORIDE	Church & Dwight Co., Inc.	4b812a38-f7cb-51c8-e063-6394a90ab82c	2026-08-21	Warnings	Exact identifier application number: M021
Anticavity	SODIUM FLUORIDE	Your Military Exchanges	eb95e0ca-a94c-41cb-9f54-6c64ed9a9733	2026-08-21	Warnings, Adverse reactions	Exact identifier application number: M021
Pop On Toothpaste.	POP ON TOOTHPASTE.	POPONSMILES,LLC	4a0edab5-ae36-91b5-e063-6294a90aa685	2026-08-21	Warnings	Exact identifier application number: M021
COLGATE OPTIC WHITE PRO SERIES EXPRESS WHITE	SODIUM MONOFLUOROPHOSPHATE	Colgate-Palmolive Company	188dc3ac-64c9-438e-858b-846f725c6ea0	2026-08-21	Warnings	Exact identifier application number: M021
freshSTART Anticavity fluoride toothpaste.	ANTICAVITY FLUORIDE TOOTHPASTE	Guangzhou Xinuo Technology Co., Ltd.	596432d5-3541-6dff-e063-6294a90a9d42	2026-08-19	Warnings	Exact identifier application number: M021
COLGATE 2IN1 WHITENING STAIN LIFTERS	SODIUM FLUORIDE	Colgate-Palmolive Company	26f1f873-06b2-45ef-a4b9-32f997642bc7	2026-08-17	Warnings	Exact identifier application number: M021
COLGATE OPTIC WHITE PRO SERIES HI WHITE	SODIUM MONOFLUOROPHOSPHATE	Colgate-Palmolive Company	8b210b6c-b712-4f14-906c-306922573a26	2026-08-17	Warnings	Exact identifier application number: M021
SprinJene Natural	SODIUM MONOFLUOROPHOSPHATE	Health and Natural Beauty USA Corp	e64cecc3-0845-4bdf-a449-d78248791ccf	2026-08-17	Warnings	Exact identifier application number: M021
ATOMY ANTICAVITY TOOTH	SODIUM MONOFLUOROPHOSPHATE	ATOMY CO., LTD.	592caccc-e3a9-9c66-e063-6394a90a26e3	2026-08-16	Warnings	Exact identifier application number: M021
SprinJene Health Boost	SODIUM MONOFLUOROPHOSPHATE	Health and Natural Beauty USA Corp	9be87bcd-403a-4d7e-8ded-9833249565d1	2026-08-14	Warnings	Exact identifier application number: M021
SprinJene Fresh Boost	SODIUM FLUORIDE	Health and Natural Beauty USA Corp	919f6f51-6c43-4f1c-9bc7-029bf76c0e68	2026-08-14	Warnings	Exact identifier application number: M021
SprinJene Natural Sensitivity Relief	SODIUM MONOFLUOROPHOSPHATE AND POTASSIUM NITRATE	Health and Natural Beauty USA Corp	32cc5bc2-60c9-4cb4-acde-485ae494aba2	2026-08-14	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