DenTek Looney Tunes Kids

Product NDC: 60630-498
11-digit product format: 606300498
Labeler code: 60630
Product ID: 60630-498_2b437c41-f6db-1da3-e054-00144ff88e88
Type: HUMAN OTC DRUG
Nonproprietary name: Fluoride Toothpaste
Dosage form: PASTE, DENTIFRICE
Route: DENTAL
Labeler: DenTek Oral Care, Inc.
Application: part355
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2014-02-28
Marketing end: 0000-00-00
Substance: SODIUM FLUORIDE
Active strength: 0 g/76.5g
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	60630-498		I	Inactivated by FDA	2026-10-02
excluded product	product	60630-498		D	Discontinued by firm	2026-10-02
excluded package	package	60630-498	60630-498-01	I	Inactivated by FDA	2026-10-02
excluded package	package	60630-498	60630-498-01	D	Discontinued by firm	2026-10-02

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 2 · 68 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
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	60630-498-01	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	60630-498-01	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	60630-498-01	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	60630-498-01	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
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	60630-498-01	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	60630-498-01	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
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	60630-498-01	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	60630-498-01	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
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	60630-498-01	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	60630-498-01	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
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	60630-498-01	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	60630-498-01	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	60630-498-01	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	60630-498-01	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	60630-498-01	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	60630-498-01	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	60630-498-01	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	60630-498-01	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	60630-498-01	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	60630-498-01	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	60630-498-01	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	60630-498-01	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	60630-498-01	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	60630-498-01	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	60630-498-01	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	60630-498-01	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	60630-498-01	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	60630-498-01	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	60630-498-01	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	60630-498-01	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6084a4f4-5437-c9a5-caec-5361ee075a59	Product name	1	20140508
90c5639a-61b0-88d6-ddcf-21888e94869a	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
60630-498-01	2020-01-31	C162847	48780-1	9d75b9d0-06b2-f424-e053-dadaa90a57ce	DenTek Looney Tunes Kids Anticavity Fluoride Toothpaste

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
60630-498-01	DenTek Looney Tunes KidsBubblegum Blast	76.5 g in 1 TUBE	PASTE, DENTIFRICE	76.5		3
60630-498-01	DenTek Kids Anticavity FluorideLooney Tunes Bubblegum Blast	76.5 g in 1 TUBE	PASTE, DENTIFRICE	76.5		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SODIUM FLUORIDE	ACTIVE INGREDIENT	8ZYQ1474W7	DENTEK KIDS ANTICAVITY FLUORIDE LOONEY TUNES BUBBLEGUM BLAST (SODIUM FLUORIDE) PASTE, DENTIFRICE [DENTEK ORAL CARE, INC.]	1
FLUORIDE ION	ACTIVE MOIETY	Q80VPU408O	DENTEK KIDS ANTICAVITY FLUORIDE LOONEY TUNES BUBBLEGUM BLAST (SODIUM FLUORIDE) PASTE, DENTIFRICE [DENTEK ORAL CARE, INC.]	1
CARBOXYMETHYLCELLULOSE SODIUM	INACTIVE INGREDIENT	K679OBS311	DENTEK KIDS ANTICAVITY FLUORIDE LOONEY TUNES BUBBLEGUM BLAST (SODIUM FLUORIDE) PASTE, DENTIFRICE [DENTEK ORAL CARE, INC.]	1
HYDRATED SILICA	INACTIVE INGREDIENT	Y6O7T4G8P9	DENTEK KIDS ANTICAVITY FLUORIDE LOONEY TUNES BUBBLEGUM BLAST (SODIUM FLUORIDE) PASTE, DENTIFRICE [DENTEK ORAL CARE, INC.]	1
SACCHARIN SODIUM DIHYDRATE	INACTIVE INGREDIENT	SB8ZUX40TY	DENTEK KIDS ANTICAVITY FLUORIDE LOONEY TUNES BUBBLEGUM BLAST (SODIUM FLUORIDE) PASTE, DENTIFRICE [DENTEK ORAL CARE, INC.]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	DENTEK KIDS ANTICAVITY FLUORIDE LOONEY TUNES BUBBLEGUM BLAST (SODIUM FLUORIDE) PASTE, DENTIFRICE [DENTEK ORAL CARE, INC.]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	DENTEK KIDS ANTICAVITY FLUORIDE LOONEY TUNES BUBBLEGUM BLAST (SODIUM FLUORIDE) PASTE, DENTIFRICE [DENTEK ORAL CARE, INC.]	1
SODIUM PHOSPHATE	INACTIVE INGREDIENT	SE337SVY37	DENTEK KIDS ANTICAVITY FLUORIDE LOONEY TUNES BUBBLEGUM BLAST (SODIUM FLUORIDE) PASTE, DENTIFRICE [DENTEK ORAL CARE, INC.]	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	DENTEK KIDS ANTICAVITY FLUORIDE LOONEY TUNES BUBBLEGUM BLAST (SODIUM FLUORIDE) PASTE, DENTIFRICE [DENTEK ORAL CARE, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	DENTEK KIDS ANTICAVITY FLUORIDE LOONEY TUNES BUBBLEGUM BLAST (SODIUM FLUORIDE) PASTE, DENTIFRICE [DENTEK ORAL CARE, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60630-498	DENTEK LOONEY TUNES KIDS BUBBLEGUM BLAST (FLUORIDE TOOTHPASTE) PASTE, DENTIFRICE [DENTEK ORAL CARE, INC.]	3	Legacy NDC, 1 package rows	20160208_2b437c41-f6da-1da3-e054-00144ff88e88.zip
60630-498	DENTEK KIDS ANTICAVITY FLUORIDE LOONEY TUNES BUBBLEGUM BLAST (SODIUM FLUORIDE) PASTE, DENTIFRICE [DENTEK ORAL CARE, INC.]	1	Legacy NDC, 1 package rows	20140201_5cab16d1-7d22-4d66-b31f-0d62beecb059.zip

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
245598	sodium fluoride 0.22 % Toothpaste	PSN	2b437c41-f6da-1da3-e054-00144ff88e88	3
245598	sodium fluoride 0.0022 MG/MG Toothpaste	SCD	2b437c41-f6da-1da3-e054-00144ff88e88	3
245598	sodium fluoride 0.22 % (fluoride 0.1 % ) Toothpaste	SY	2b437c41-f6da-1da3-e054-00144ff88e88	3
245598	sodium fluoride 0.22 % Toothpaste	PSN	5cab16d1-7d22-4d66-b31f-0d62beecb059	1
245598	sodium fluoride 0.0022 MG/MG Toothpaste	SCD	5cab16d1-7d22-4d66-b31f-0d62beecb059	1
245598	sodium fluoride 0.22 % (fluoride 0.1 % ) Toothpaste	SY	5cab16d1-7d22-4d66-b31f-0d62beecb059	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
60630-498-01	60630049801	76.5 g in 1 TUBE	76.5 g	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DenTek Looney Tunes Kids Anticavity Fluoride Toothpaste	DenTek Oral Care, Inc. \| Goran Pharma Pvt. Ltd.	2016-02-08	HUMAN OTC DRUG LABEL	3
Kids Toothpaste with sodium fluoride	DenTek Oral Care, Inc.	2013-10-01	HUMAN OTC DRUG LABEL	1