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 49 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Murchison Hume Dental Kit	SODIUM MONOFLUOROPHOSPHATE	Buzz Products Inc.	b1a442e1-86cf-cba6-e053-2995a90a593a	2023-12-20	Warnings	Exact identifier application number: M021
United Airlines Polaris Kit with Colgate	SODIUM MONOFLUOROPHOSPHATE	Buzz Export Services Pty Ltd (Buzz Products)	de4564a4-1012-baad-e053-2a95a90a11b7	2023-12-20	Warnings	Exact identifier application number: M021
Orajel Complete Protection	SODIUM FLUORIDE	Church & Dwight Co., Inc.	daebd16f-d278-446d-8b7a-33add5a74fdd	2023-12-19	Warnings	Exact identifier application number: M021
Orajel Sensitivity Relief	SODIUM FLUORIDE AND POTASSIUM NITRATE	Church & Dwight Co., Inc.	7b9d9e7d-3844-4d18-ab03-bd0e9dcfccdb	2023-12-19	Warnings	Exact identifier application number: M021
ORTHO GUARD	SODIUM FLUORIDE	Massco Dental A Division of Dunagin Pharmaceuticals	8d3e0dd0-b584-413b-adf3-5c2d05ab72dd	2023-12-17	Warnings	Exact identifier application number: M021
Beyond Activated Coconut Charcoal and Sea Salt	SODIUM FLUORIDE	Beyond International Inc	d075fa15-7309-0c10-e053-2995a90a7c95	2023-11-28	Warnings	Exact identifier application number: M021
Pro-Den Rx	STANNOUS FLUORIDE	Den-mat Holdings, Llc	9036aa8a-59b1-41b0-b3cb-529d3303a1c0	2023-11-20	Warnings	Exact identifier application number: M021
Fluoridex	STANNOUS FLUORIDE RINSE	DEN-MAT HOLDINGS, LLC	5e81f073-c0ca-aa38-e053-2a91aa0ab37b	2023-11-20	Warnings	Exact identifier application number: M021
Hello Vitamin C Whitening	SODIUM FLUORIDE	Colgate-Palmolive Company	38a0276e-910c-527d-1736-65928b9d4ca4	2023-11-20	Warnings	Exact identifier application number: M021
POP Feeling Peachy	SODIUM FLUORIDE	LG H&H CO., LTD.	0abaf99b-9547-46ae-e063-6394a90a6c15	2023-11-17	Warnings	Exact identifier application number: M021
UNIVERSAL ANTI-CAVITY FLUORIDE	SODIUM MONOFLUOROPHOSPHATE	Universal Distribution Center LLC	e3356374-befa-41b0-ab0f-edfd5a062601	2023-11-16	Warnings	Exact identifier application number: M021
ANTI CAVITY FLUORIDE	SODIUM MONOFLUOROPHOSPHATE	Universal Distribution Center LLC	421fc2f0-b118-4e7a-a399-ba4780028c54	2023-11-16	Warnings	Exact identifier application number: M021
UNIVERSAL CHARCOAL WITH ALOE VERA ANTI-CAVITY FLUORIDE	SODIUM FLUORIDE	Universal Distribution Center LLC	3411924d-1002-460c-83e8-c0c7fbff9ad1	2023-11-16	Warnings	Exact identifier application number: M021
ADVANCED WHITENING ANTI CAVITY FLUORIDE	SODIUM MONOFLUOROPHOSPHATE	Universal Distribution Center LLC	8ea8a8d9-b7e4-468f-9a09-4ec634cbd80e	2023-11-16	Warnings	Exact identifier application number: M021
UNIVERSAL ADVANCED WHITENING ANTI-CAVITY FLUORIDE	SODIUM MONOFLUOROPHOSPHATE	Universal Distribution Center LLC	879dfaf0-27c8-41a3-8d01-a1c3eec9edfc	2023-11-15	Warnings	Exact identifier application number: M021
EUTHYMOL Extraordinary Pink Whitening	SODIUM FLUORIDE	LG H&H CO., LTD.	0989936c-237d-dc63-e063-6294a90a885f	2023-11-07	Warnings	Exact identifier application number: M021
Eurofresh Whitening	SODIUM FLUORIDE	Farmasi US LLC	b56b2b55-e3a4-785a-e053-2a95a90a7abf	2023-11-05	Warnings	Exact identifier application number: M021
Farmasi Whitening	SODIUM FLUORIDE	Farmasi US LLC	25b3608e-abed-41ca-9971-21981b8a4610	2023-11-05	Warnings	Exact identifier application number: M021
United Airlines Therabody UPP Kit	SODIUM MONOFLUOROPHOSPHATE	Wessco International	fb6c355b-a67d-c4b4-e053-6394a90a0e66	2023-10-26	Warnings	Exact identifier application number: M021
United Dental Kit	SODIUM MONOFLUOROPHOSPHATE	Wessco International	7f348fe7-9918-4934-bed0-f0a77c09d046	2023-10-26	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