ROOTSALLO TOOTHPASTE

Product NDC: 82450-050
Requested package NDC: 82450-050-02
11-digit product format: 824500050
Labeler code: 82450
Product ID: 82450-050_d2472689-fc65-4b47-9f19-dc476af733ab
Type: HUMAN OTC DRUG
Nonproprietary name: CALCIUM CARBONATE, ALCLOXA, Aminocaproic Acid, DIBASIC CALCIUM PHOSPHATE DIHYDRATE
Dosage form: GEL, DENTIFRICE
Route: ORAL
Labeler: rootsallo Qwell
Marketing category: UNAPPROVED DRUG OTHER
Marketing start: 2021-12-01
Marketing end: 0000-00-00
Substance: CALCIUM CARBONATE; ALCLOXA; AMINOCAPROIC ACID; DIBASIC CALCIUM PHOSPHATE DIHYDRATE
Active strength: 10 g/100g; g/100g; g/100g; g/100g
NDC exclude flag: No
Listing certified through: 2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	82450-050	82450-050-02	I	Inactivated by FDA		2026-10-16

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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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
bee4fa8d-8d82-423a-a0b5-40a89dd13a99	Product name	1	20250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767	Product name	4	20250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2	Product name	5	20250304
83904ae6-37b6-4aa3-b6c9-663bc8d6ab8d	Product name	9	20250103
334fe8d2-68fb-4331-a576-420e302ec069	Product name	7	20240320
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
e92765c1-be81-432a-b909-1b10777ec378	Product name	1	20190208
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
0441a8f5-3835-497c-aedd-bc78cba56b2a	Product name	1	20150317
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
e89c33e6-9224-49b0-4d80-05239f586f24	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
82450-050-02	2023-01-30	C162847	48780-1	f386c64a-3b81-0266-e053-dadaa90a7c1a	7daf7905-f045-450a-a672-20f17f54b6e0

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
82450-050-01	ROOTSALLO TOOTHPASTE	120 g in 1 TUBE	GEL, DENTIFRICE	120		1
82450-050-02	ROOTSALLO TOOTHPASTE	1 in 1 CARTON	GEL, DENTIFRICE	1		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
82450-050	ROOTSALLO TOOTHPASTE (CALCIUM CARBONATE, ALCLOXA, AMINOCAPROIC ACID, DIBASIC CALCIUM PHOSPHATE DIHYDRATE) GEL, DENTIFRICE [ROOTSALLO QWELL]	1	Legacy NDC, 2 package rows	20220104_7daf7905-f045-450a-a672-20f17f54b6e0.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
H0G9379FGK	CALCIUM CARBONATE	471-34-1	CALCIUM CARBONATE
18B8O9DQA2	ALCLOXA	1317-25-5	ALCLOXA
U6F3787206	AMINOCAPROIC ACID	60-32-2	AMINOCAPROIC ACID
O7TSZ97GEP	DIBASIC CALCIUM PHOSPHATE DIHYDRATE	7789-77-7	DIBASIC CALCIUM PHOSPHATE DIHYDRATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
82450-050-02	82450005002	1 TUBE in 1 CARTON (82450-050-02) > 120 g in 1 TUBE (82450-050-01)	1 tube	2021-12-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ROOTSALLO TOOTHPASTE - rootsallo Qwell \| Woorilife&Health	rootsallo Qwell \| Woorilife&Health	2021-12-30	HUMAN OTC DRUG LABEL	1