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 18 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Anticavity Fluoride Rinse	SODIUM FLUORIDE	Lidl US, LLC	c47475aa-3125-410f-aa31-0add6e4ce125	2026-02-04	Warnings, Adverse reactions	Exact identifier application number: M021
Crest 3D White Brilliance Pro Ultra White	SODIUM MONOFLUOROPHOSPHATE	The Procter & Gamble Manufacturing Company	f4c02924-95ee-09d2-e053-2995a90a8121	2026-02-03		Exact identifier application number: M021
Crest 3D White Stain Eraser Icy Clean Mint	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	f5d97011-7be3-3b1c-e053-2a95a90ade86	2026-02-03		Exact identifier application number: M021
Anticavity	SODIUM FLUORIDE	Demoulas Super Markets, Inc.	c28c3475-efbb-4099-83ab-ab91bac9dfc3	2026-02-03	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity Fluoride Rinse	SODIUM FLUORIDE	Demoulas Super Markets, Inc	65abfb4d-3a1e-42df-b343-f270ce60a3bf	2026-02-03	Warnings, Adverse reactions	Exact identifier application number: M021
Crest Cavity Protection Cool Mint Gel	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	102e4d9c-0fae-d48a-e063-6294a90aac94	2026-02-03	Warnings	Exact identifier application number: M021
Crest Plus Tartar Protection	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	08767b0f-ed6e-8d32-e063-6294a90a10cd	2026-02-03	Warnings	Exact identifier application number: M021
Crest Braces Care Anticavity Fluoride Rinse	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	d8398cfd-9af6-690d-e053-2995a90a9b7c	2026-02-03	Warnings	Exact identifier application number: M021
AutoBrush bubblegum	SODIUM FLUORIDE	Lander Enterprises, LLC	2e85d6f7-2df8-4eb9-bc97-d7b7af7fb460	2026-02-03	Warnings	Exact identifier application number: M021
AutoBrush Mint	SODIUM FLUORIDE	Lander Enterprises, LLC	d859d02d-a036-4d90-bed4-9a5c31e9e1ef	2026-02-03	Warnings	Exact identifier application number: M021
Glowing White	SODIUM FLUORIDE	Demoulas Super Markets, Inc	32faf47d-b64f-4454-9f14-51503504c6b5	2026-02-03	Warnings, Adverse reactions	Exact identifier application number: M021
Sodium fluoride	SODIUM FLUORIDE	Demoulas Super Markets, Inc	2f5d3c75-1a11-47e1-b297-e2302177efe7	2026-02-03	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity	SODIUM FLUORIDE	Demoulas Super Markets, Inc	096e6a1d-316b-432a-bf27-70e8a13337cc	2026-02-03	Warnings, Adverse reactions	Exact identifier application number: M021
Listerine Total Care Extra Mild Alcohol Free Anticavity Fluoride Mouthwash	SODIUM FLUORIDE	Kenvue Brands LLC	49d1932f-a85c-7b8f-e063-6394a90a6aca	2026-02-02	Warnings	Exact identifier application number: M021
Listerine Total Care Mild Alcohol Free Anticavity Fluoride Mouthwash	SODIUM FLUORIDE	Kenvue Brands LLC	49d4f96f-e61f-e6e6-e063-6294a90ab0a0	2026-02-02	Warnings	Exact identifier application number: M021
Brush Buddies Mouthwash Toy Story Wild West Watermelon	SODIUM FLUORIDE	Kingkey MBC Life Technology Group co., LTD.	49d69901-0b07-b07d-e063-6394a90a3c34	2026-02-02	Warnings	Exact identifier application number: M021
Brush Buddies Mouthwash Frozen Blizzard Berry	SODIUM FLUORIDE	Kingkey MBC Life Technology Group co., LTD.	49d6c1c9-cd21-cac6-e063-6294a90a81d6	2026-02-02	Warnings	Exact identifier application number: M021
Brush Buddies Mouthwash Disney Princesses Grand Grape	SODIUM FLUORIDE	Kingkey MBC Life Technology Group co., LTD.	49d6f926-da4e-26df-e063-6294a90a1c0c	2026-02-02	Warnings	Exact identifier application number: M021
Brush Buddies Mouthwash Spidey and Hist Amazing Friends Peter Parker Punch	SODIUM FLUORIDE	Kingkey MBC Life Technology Group co., LTD.	49d70b88-d57c-37cd-e063-6294a90a4a59	2026-02-02	Warnings	Exact identifier application number: M021
Anticavity	SODIUM FLUORIDE	Rite Aid Corporation	54a8b884-969a-4a41-ac2a-bc1f1fe9f7fe	2026-02-02	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