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 · 1,024 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
COLGATE OPTIC WHITE CHARCOAL	SODIUM FLUORIDE	Colgate-Palmolive Company	70ed4a93-b68f-4198-b4b7-7cfeb17ba5d2	2026-07-30	Warnings	Exact identifier application number: M021
Colgate Optic White Charcoal	SODIUM FLUORIDE	Colgate-Palmolive Company	82ac5b9d-19e8-46ac-a195-c7d85f2967d5	2026-07-30	Warnings	Exact identifier application number: M021
Supersmile Professional Whitening TP Peppy Mint 1.4 oz	SODIUM MONOFLUOROPHOSPHATE	Robell Research, Inc	251264ea-20d2-be19-e063-6394a90aa5f6	2026-07-29	Warnings	Exact identifier application number: M021
Natural White Sensitive Enamel Guard Alpine Mint	SODIUM FLUORIDE	Lornamead Products	2e832204-ba2d-6dcb-e063-6394a90a5e6c	2026-07-29	Warnings	Exact identifier application number: M021
Natural White Radiant White	FLUORIDE	Lornamead Products	f0b62aaa-4983-4bd3-931e-f1a31b870f62	2026-07-29	Warnings	Exact identifier application number: M021
TP OW Pro Series Stain Prevention	SODIUM MONOFLUOROPHOSPHATE	Colgate-Palmolive Company	76df52a3-b24c-4009-8137-fe644dabebf6	2026-07-29	Warnings	Exact identifier application number: M021
Colgate Kids Cavity Protection	SODIUM FLUORIDE	Colgate-Palmolive Company	f0e68196-8566-443b-9cc8-b57d5c001558	2026-07-29	Warnings	Exact identifier application number: M021
TP OW Pro Series Vividly Fresh	SODIUM MONOFLUOROPHOSPHATE	Colgate-Palmolive Company	f0551acf-c4d6-4d49-ae9c-4aeaeb99a700	2026-07-29	Warnings	Exact identifier application number: M021
Colgate MaxFresh with Whitening KnockOut Fluoride	SODIUM FLUORIDE	Colgate-Palmolive Company	92079d13-3b66-42b7-9990-2727a489b6f6	2026-07-28	Warnings	Exact identifier application number: M021
BIO SPECTRA ATTITUDE	SODIUM FLUORIDE	9055-7588 Quebec Inc. DBA Attitude	7d04d050-b283-4fce-b1e9-e695b70363f9	2026-07-27	Warnings	Exact identifier application number: M021
COLGATE OPTIC WHITE ADVANCED OXYGENATING WHITE	SODIUM MONOFLUOROPHOSPHATE	Colgate-Palmolive Company	cd805999-86e4-4f6c-9889-fa9a2227d526	2026-07-24	Warnings	Exact identifier application number: M021
COLGATE Baking Soda and Peroxide Whitening Brisk Mint	SODIUM MONOFLUOROPHOSPHATE	Colgate-Palmolive Company	913a2cd6-b6a8-4069-979f-3c696a9bfdf0	2026-07-24	Warnings	Exact identifier application number: M021
COLGATE OPTIC WHITE PURPLE	SODIUM FLUORIDE	Colgate-Palmolive Company	16e9b303-fc2a-451a-adc7-dcb10fc0e6f8	2026-07-23	Warnings	Exact identifier application number: M021
Orajel Kids Superman	ANTICAVITY TOOTHPASTE	Church & Dwight Co., Inc.	2b47af33-32d4-7c06-e063-6394a90a2f33	2026-07-23	Warnings	Exact identifier application number: M021
Sensitive Teeth and Gums	POTASSIUM NITRATE, SODIUM FLUORIDE	Church & Dwight Co., Inc.	935172db-d78f-0c69-e053-2a95a90a0b69	2026-07-23	Warnings	Exact identifier application number: M021
Essentials Whiten and Strengthen	SODIUM FLUORIDE 0.24%	Church & Dwight Co., Inc.	96548550-2cd1-b757-e053-2995a90a15ea	2026-07-23	Warnings	Exact identifier application number: M021
TP COL OW Purple	SODIUM FLUORIDE	Colgate-Palmolive Company	ea0db59f-f9c0-49a8-9717-69cdf071f6e1	2026-07-23	Warnings	Exact identifier application number: M021
Colgate Max Fresh Cool Mint	SODIUM FLUORIDE	Colgate-Palmolive Company	00652bb2-090c-4eaa-8fc2-e0be6913a724	2026-07-22	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