Crayola ANTICAVITY BUBBLE GUM FLAVOR

Product NDC: 70108-076
11-digit product format: 701080076
Labeler code: 70108
Product ID: 70108-076_164bc453-ecba-490e-b10a-f9a4854735de
Type: HUMAN OTC DRUG
Nonproprietary name: Sodium fluoride
Dosage form: PASTE, DENTIFRICE
Route: DENTAL
Labeler: Ashtel Studios, Inc.
Application: M021
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2023-09-06
Substance: SODIUM FLUORIDE
Active strength: .243 g/100g
NDC exclude flag: No
Listing certified through: 2026-12-31
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 · 14 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70108-076-01	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70108-076-01	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70108-076-01	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70108-076-01	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70108-076-01	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70108-076-01	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70108-076-01	U	Excluded because listing certification expired	`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: Crayola ANTICAVITY BUBBLE GUM FLAVOR
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SODIUM FLUORIDE	.243 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
8ZYQ1474W7	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
891775	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
ec66246f-06e2-4da1-b9d5-ce2a7815ffd1	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70108-076-01	2025-03-21	C162847	48780-1	2cef2736-abe2-d83d-e063-dadaa90ab31f	Crayola ANTICAVITY FLUORIDE TOOTHPASTE - BUBBLE GUM FLAVOR
70108-076-01	2025-01-30	C162847	48780-1	2cef2736-abe2-d83d-e063-dadaa90ab31f	Crayola ANTICAVITY FLUORIDE TOOTHPASTE - BUBBLE GUM FLAVOR

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70108-076-01	Crayola ANTICAVITY BUBBLE GUM FLAVOR	113 g in 1 TUBE	PASTE, DENTIFRICE	113		2
70108-076-01	Crayola ANTICAVITY BUBBLE GUM FLAVOR	1 in 1 BOX	PASTE, DENTIFRICE	1		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70108-076	CRAYOLA ANTICAVITY BUBBLE GUM FLAVOR (SODIUM FLUORIDE) PASTE, DENTIFRICE [ASHTEL STUDIOS, INC.]	2	Current NDC, 2 package rows	20250323_ec66246f-06e2-4da1-b9d5-ce2a7815ffd1.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 16 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Toms of Maine Whiten Plus Deep Clean Peppermint	SODIUM FLUORIDE	Tom's of Maine	4c535776-3f80-4eeb-bb63-2d734c3c3a6b	2026-02-18	Warnings	Exact identifier application number: M021
Anticavity	SODIUM FLUORIDE	United Natural Foods, Inc. dba UNFI	dd6bf8df-1e28-4f61-b876-b9f1f8d5993a	2026-02-17	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity	SODIUM FLUORIDE	United Natural Foods, Inc. dba UNFI	8283cea0-7b62-4796-8763-6654039664cd	2026-02-17	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity	SODIUM FLUORIDE	United Natural Foods, Inc. dba UNFI	9d055fed-26d8-4827-a4cc-8c314514a6c3	2026-02-17	Warnings	Exact identifier application number: M021
Brush Buddies Crayola Color Changing ANTICAVITY FLUORIDE WATERMELON FLAVOR	SODIUM FLUORIDE	Ashtel Studios, Inc.	28d1b8c3-930f-4ac9-aa5a-b72b832bb77e	2026-02-17	Warnings	Exact identifier application number: M021
Anticavity Rinse	SODIUM FLUORIDE	Valu Merchandisers Company	088b95e6-30fd-4263-9fdc-57cd63385b71	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity Fluoride Rinse	SODIUM FLUORIDE	Valu Merchandisers Company	e31c1609-a1c3-4ed5-adfd-3cfa63205ec3	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity	SODIUM FLUORIDE	United Natural Foods, Inc. dba UNFI	3602c528-5f53-4d41-bf67-163149f52b35	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity Fluoride Rinse	SODIUM FLUORIDE	United Natural Foods, Inc. dba UNFI	e696038c-182e-4325-9b90-87fe498d9f67	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity Fluoride Rinse	SODIUM FLUORIDE	Topco Associates LLC	3b04142a-4a65-45ba-a5a2-e62b0c47ec55	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M021
Mouth Rinse	SODIUM FLUORIDE	Topco Associates LLC	c640adc0-e178-4b6a-af44-07d2f7da81d3	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity Fluoride Rinse	SODIUM FLUORIDE	Topco Associates LLC	f760f8f8-0c74-4a6e-b5c9-cc82b8758a45	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M021
Alcohol-Free Anticavity	SODIUM FLUORIDE	Topco Associates LLC	ade7dcb2-b4e2-4cef-b9a7-469867ead68a	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M021
Oral Antivavity	SODIUM FLUORIDE	Topco Associates LLC	84b30711-a7e5-4189-895a-a7989f05591c	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity fluoride rinse	SODIUM FLUORIDE	Topco Associates LLC	c3f2e952-a8d5-4e9d-a5c6-09e4f2544179	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity	SODIUM FLUORIDE	Topco Associates LLC	a9b8b2fe-0a60-4f65-b6f6-aae8509c919f	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M021
Salivea	FLUORIDE TOOTHPASTE	Laclede, Inc.	4abb0f80-d87d-730f-e063-6294a90a15f7	2026-02-13	Warnings	Exact identifier application number: M021
Anticavity	SODIUM FLUORIDE	Your Military Exchanges	581d5cdb-018a-42ad-899d-5331f0063376	2026-02-12	Warnings, Adverse reactions	Exact identifier application number: M021
Alcohol-Free Anticavity	SODIUM FLUORIDE	Your Military Exchanges	965911c3-7aa8-4830-8269-6aa5d526ee73	2026-02-12	Warnings, Adverse reactions	Exact identifier application number: M021
Mouth Rinse	SODIUM FLUORIDE	Walgreen Co.	eae87899-3eba-4d50-bc31-9eaf54ff9e00	2026-02-12	Warnings, Adverse reactions	Exact identifier application number: M021

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
8ZYQ1474W7	SODIUM FLUORIDE	7681-49-4	SODIUM FLUORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
891775	sodium fluoride 0.243 % Toothpaste	PSN	ec66246f-06e2-4da1-b9d5-ce2a7815ffd1	2
891775	sodium fluoride 0.00243 MG/MG Toothpaste	SCD	ec66246f-06e2-4da1-b9d5-ce2a7815ffd1	2
891775	sodium fluoride 0.243 % (fluoride ion 0.13 % ) Toothpaste	SY	ec66246f-06e2-4da1-b9d5-ce2a7815ffd1	2
891775	sodium fluoride 0.243 % (fluoride ion 0.14 % ) Toothpaste	SY	ec66246f-06e2-4da1-b9d5-ce2a7815ffd1	2
891775	sodium fluoride 0.243 % (fluoride ion 0.15 % ) Toothpaste	SY	ec66246f-06e2-4da1-b9d5-ce2a7815ffd1	2
891775	sodium fluoride 0.243 % (fluoride ion 0.16 % ) Toothpaste	SY	ec66246f-06e2-4da1-b9d5-ce2a7815ffd1	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70108-076-01	70108007601	1 TUBE in 1 BOX (70108-076-01) / 113 g in 1 TUBE	1 tube	2023-09-06	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Crayola ANTICAVITY FLUORIDE TOOTHPASTE - BUBBLE GUM FLAVOR	Ashtel Studios, Inc.	2025-03-19	HUMAN OTC DRUG LABEL	2