Crayola ANTICAVITY WATERMELON FLAVOR

Product NDC: 70108-081
Requested package NDC: 70108-081-01
11-digit product format: 701080081
Labeler code: 70108
Product ID: 70108-081_a951bbf4-c554-457f-86da-6de0eb2ec4be
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
Marketing end: 2028-03-31
Substance: SODIUM FLUORIDE
Active strength: .243 g/100g
NDC exclude flag: No
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 · 7 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	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 WATERMELON FLAVOR

Active Ingredients#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70108-081-01	2025-03-21	C162847	48780-1	2cef2736-afff-d83d-e063-dadaa90ab31f	Crayola ANTICAVITY FLUORIDE TOOTHPASTE - WATERMELON FLAVOR
70108-081-01	2025-01-30	C162847	48780-1	2cef2736-afff-d83d-e063-dadaa90ab31f	Crayola ANTICAVITY FLUORIDE TOOTHPASTE - WATERMELON FLAVOR

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70108-081-01	Crayola ANTICAVITY WATERMELON FLAVOR	1 in 1 BOX	PASTE, DENTIFRICE	1		2
70108-081-01	Crayola ANTICAVITY WATERMELON FLAVOR	113 g in 1 TUBE	PASTE, DENTIFRICE	113		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70108-081	CRAYOLA ANTICAVITY WATERMELON FLAVOR (SODIUM FLUORIDE) PASTE, DENTIFRICE [ASHTEL STUDIOS, INC.]	2	Current NDC, 2 package rows	20250323_720f6344-ac48-414c-a1c2-f56c3206343c.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 4 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TOMS OF MAINE ACTIVATED CHARCOAL PEPPERMINT	SODIUM FLUORIDE	Tom's of Maine, Inc.	b9e6e455-8444-4805-89f1-ee9142f98e36	2026-08-10	Warnings	Exact identifier application number: M021
TOMS OF MAINE WHOLE CARE SPEARMINT	SODIUM MONOFLUOROPHOSPHATE	Tom's of Maine, Inc.	7db8e49d-1073-4a81-a3a4-f3a19ebce921	2026-08-10	Warnings	Exact identifier application number: M021
TOMS OF MAINE WHITEN PLUS DEEP CLEAN SPEARMINT	SODIUM FLUORIDE	Tom's of Maine, Inc.	1fe50b49-bc62-4137-866c-e87bb878a96d	2026-08-10	Warnings	Exact identifier application number: M021
Colgate Optic White Stain Fighter With Baking Soda	SODIUM FLUORIDE	Colgate-Palmolive Company	8e6113e2-101b-4bde-90e9-6ab32c6ebf5c	2026-08-05	Warnings	Exact identifier application number: M021
COLGATE MAX FRESH WATERMELON BLAST	SODIUM FLUORIDE	Colgate-Palmolive Company	6c391ef3-d625-403c-a4dc-6e2212682ed1	2026-08-04	Warnings	Exact identifier application number: M021
Rorobell WaWa Tooth	SODIUM MONOFLUOROPHOSPHATE	ROROBELL	93113481-ad9d-4be0-a7b7-a72c8726127d	2026-08-03	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

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	720f6344-ac48-414c-a1c2-f56c3206343c	2
891775	sodium fluoride 0.00243 MG/MG Toothpaste	SCD	720f6344-ac48-414c-a1c2-f56c3206343c	2
891775	sodium fluoride 0.243 % (fluoride ion 0.13 % ) Toothpaste	SY	720f6344-ac48-414c-a1c2-f56c3206343c	2
891775	sodium fluoride 0.243 % (fluoride ion 0.14 % ) Toothpaste	SY	720f6344-ac48-414c-a1c2-f56c3206343c	2
891775	sodium fluoride 0.243 % (fluoride ion 0.15 % ) Toothpaste	SY	720f6344-ac48-414c-a1c2-f56c3206343c	2
891775	sodium fluoride 0.243 % (fluoride ion 0.16 % ) Toothpaste	SY	720f6344-ac48-414c-a1c2-f56c3206343c	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70108-081-01	70108008101	1 TUBE in 1 BOX (70108-081-01) / 113 g in 1 TUBE	1 tube	2023-09-06	2028-03-31	No	No	Historical

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