Perioe lucky fresh - cavity care

Product NDC: 53208-448
11-digit product format: 532080448
Labeler code: 53208
Product ID: 53208-448_953a9f75-39fb-4fa2-8ca0-81324ebbbfb9
Type: HUMAN OTC DRUG
Nonproprietary name: Sodium Monofluorophosphate, Pyridoxine Hydrochloride, Calcium Glycerophosphate
Dosage form: PASTE
Route: DENTAL
Labeler: LG Household and Healthcare, Inc.
Application: part355
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2010-04-26
Marketing end: 0000-00-00
Substance: SODIUM MONOFLUOROPHOSPHATE; PYRIDOXINE HYDROCHLORIDE; CALCIUM GLYCEROPHOSPHATE
Active strength: 1 g/100g; g/100g; g/100g
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	53208-448		I	Inactivated by FDA		2026-10-15
excluded package	package	53208-448	53208-448-02	I	Inactivated by FDA		2026-10-15

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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53208-448-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53208-448-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53208-448-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53208-448-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53208-448-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53208-448-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53208-448-02	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53208-448-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53208-448-02	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	53208-448-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	53208-448-02	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	53208-448-02	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	53208-448-02	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	53208-448-02	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	53208-448-02	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	53208-448-02	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	53208-448-02	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	53208-448-02	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	53208-448-02	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	53208-448-02	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	53208-448-02	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	53208-448-02	`110d247fa046…`	`a55b01930146…`

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
59361619-24d9-b610-eca6-5a7f25ed5e03	Product name	5	20240909
5e18e798-5614-cf5c-0185-38b1cb77a093	Product name	2	20160822

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53208-448-02	2019-10-21	C162847	48780-1	956f9ecf-c0ae-621f-e053-dbdaa90a74ad	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53208-448-01	Perioe lucky fresh - cavity care	130 g in 1 TUBE	PASTE	130		1
53208-448-02	Perioe lucky fresh - cavity care	1 in 1 CARTON	PASTE	1		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Calcium Glycerophosphate	ACTIVE INGREDIENT	XWV9Z12C1C	PERIOE LUCKY FRESH - CAVITY CARE (SODIUM MONOFLUOROPHOSPHATE, PYRIDOXINE HYDROCHLORIDE, CALCIUM GLYCEROPHOSPHATE) PASTE [LG HOUSEHOLD AND HEALTHCARE, INC.]	1
Pyridoxine hydrochloride	ACTIVE INGREDIENT	68Y4CF58BV	PERIOE LUCKY FRESH - CAVITY CARE (SODIUM MONOFLUOROPHOSPHATE, PYRIDOXINE HYDROCHLORIDE, CALCIUM GLYCEROPHOSPHATE) PASTE [LG HOUSEHOLD AND HEALTHCARE, INC.]	1
Sodium Monofluorophosphate	ACTIVE INGREDIENT	C810JCZ56Q	PERIOE LUCKY FRESH - CAVITY CARE (SODIUM MONOFLUOROPHOSPHATE, PYRIDOXINE HYDROCHLORIDE, CALCIUM GLYCEROPHOSPHATE) PASTE [LG HOUSEHOLD AND HEALTHCARE, INC.]	1
Calcium Glycerophosphate	ACTIVE MOIETY	XWV9Z12C1C	PERIOE LUCKY FRESH - CAVITY CARE (SODIUM MONOFLUOROPHOSPHATE, PYRIDOXINE HYDROCHLORIDE, CALCIUM GLYCEROPHOSPHATE) PASTE [LG HOUSEHOLD AND HEALTHCARE, INC.]	1
FLUORIDE ION	ACTIVE MOIETY	Q80VPU408O	PERIOE LUCKY FRESH - CAVITY CARE (SODIUM MONOFLUOROPHOSPHATE, PYRIDOXINE HYDROCHLORIDE, CALCIUM GLYCEROPHOSPHATE) PASTE [LG HOUSEHOLD AND HEALTHCARE, INC.]	1
Pyridoxine	ACTIVE MOIETY	KV2JZ1BI6Z	PERIOE LUCKY FRESH - CAVITY CARE (SODIUM MONOFLUOROPHOSPHATE, PYRIDOXINE HYDROCHLORIDE, CALCIUM GLYCEROPHOSPHATE) PASTE [LG HOUSEHOLD AND HEALTHCARE, INC.]	1
Calcium Carbonate	INACTIVE INGREDIENT	H0G9379FGK	PERIOE LUCKY FRESH - CAVITY CARE (SODIUM MONOFLUOROPHOSPHATE, PYRIDOXINE HYDROCHLORIDE, CALCIUM GLYCEROPHOSPHATE) PASTE [LG HOUSEHOLD AND HEALTHCARE, INC.]	1
CARBOXYMETHYLCELLULOSE SODIUM	INACTIVE INGREDIENT	K679OBS311	PERIOE LUCKY FRESH - CAVITY CARE (SODIUM MONOFLUOROPHOSPHATE, PYRIDOXINE HYDROCHLORIDE, CALCIUM GLYCEROPHOSPHATE) PASTE [LG HOUSEHOLD AND HEALTHCARE, INC.]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	PERIOE LUCKY FRESH - CAVITY CARE (SODIUM MONOFLUOROPHOSPHATE, PYRIDOXINE HYDROCHLORIDE, CALCIUM GLYCEROPHOSPHATE) PASTE [LG HOUSEHOLD AND HEALTHCARE, INC.]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	PERIOE LUCKY FRESH - CAVITY CARE (SODIUM MONOFLUOROPHOSPHATE, PYRIDOXINE HYDROCHLORIDE, CALCIUM GLYCEROPHOSPHATE) PASTE [LG HOUSEHOLD AND HEALTHCARE, INC.]	1
Methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	PERIOE LUCKY FRESH - CAVITY CARE (SODIUM MONOFLUOROPHOSPHATE, PYRIDOXINE HYDROCHLORIDE, CALCIUM GLYCEROPHOSPHATE) PASTE [LG HOUSEHOLD AND HEALTHCARE, INC.]	1
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	PERIOE LUCKY FRESH - CAVITY CARE (SODIUM MONOFLUOROPHOSPHATE, PYRIDOXINE HYDROCHLORIDE, CALCIUM GLYCEROPHOSPHATE) PASTE [LG HOUSEHOLD AND HEALTHCARE, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	PERIOE LUCKY FRESH - CAVITY CARE (SODIUM MONOFLUOROPHOSPHATE, PYRIDOXINE HYDROCHLORIDE, CALCIUM GLYCEROPHOSPHATE) PASTE [LG HOUSEHOLD AND HEALTHCARE, INC.]	1
Sodium Lauryl Sulfate	INACTIVE INGREDIENT	368GB5141J	PERIOE LUCKY FRESH - CAVITY CARE (SODIUM MONOFLUOROPHOSPHATE, PYRIDOXINE HYDROCHLORIDE, CALCIUM GLYCEROPHOSPHATE) PASTE [LG HOUSEHOLD AND HEALTHCARE, INC.]	1
Sorbitan Monooleate	INACTIVE INGREDIENT	06XEA2VD56	PERIOE LUCKY FRESH - CAVITY CARE (SODIUM MONOFLUOROPHOSPHATE, PYRIDOXINE HYDROCHLORIDE, CALCIUM GLYCEROPHOSPHATE) PASTE [LG HOUSEHOLD AND HEALTHCARE, INC.]	1
Sorbitol	INACTIVE INGREDIENT	506T60A25R	PERIOE LUCKY FRESH - CAVITY CARE (SODIUM MONOFLUOROPHOSPHATE, PYRIDOXINE HYDROCHLORIDE, CALCIUM GLYCEROPHOSPHATE) PASTE [LG HOUSEHOLD AND HEALTHCARE, INC.]	1
Water	INACTIVE INGREDIENT	059QF0KO0R	PERIOE LUCKY FRESH - CAVITY CARE (SODIUM MONOFLUOROPHOSPHATE, PYRIDOXINE HYDROCHLORIDE, CALCIUM GLYCEROPHOSPHATE) PASTE [LG HOUSEHOLD AND HEALTHCARE, INC.]	1
Xanthan Gum	INACTIVE INGREDIENT	TTV12P4NEE	PERIOE LUCKY FRESH - CAVITY CARE (SODIUM MONOFLUOROPHOSPHATE, PYRIDOXINE HYDROCHLORIDE, CALCIUM GLYCEROPHOSPHATE) PASTE [LG HOUSEHOLD AND HEALTHCARE, INC.]	1
Xylitol	INACTIVE INGREDIENT	VCQ006KQ1E	PERIOE LUCKY FRESH - CAVITY CARE (SODIUM MONOFLUOROPHOSPHATE, PYRIDOXINE HYDROCHLORIDE, CALCIUM GLYCEROPHOSPHATE) PASTE [LG HOUSEHOLD AND HEALTHCARE, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53208-448	PERIOE LUCKY FRESH - CAVITY CARE (SODIUM MONOFLUOROPHOSPHATE, PYRIDOXINE HYDROCHLORIDE, CALCIUM GLYCEROPHOSPHATE) PASTE [LG HOUSEHOLD AND HEALTHCARE, INC.]	1	Legacy NDC, 2 package rows	20100507_abdd24ae-3dee-4a47-8c43-0bdeaf04e7f4.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
C810JCZ56Q	SODIUM MONOFLUOROPHOSPHATE	10163-15-2	SODIUM MONOFLUOROPHOSPHATE
68Y4CF58BV	PYRIDOXINE HYDROCHLORIDE	58-56-0	PYRIDOXINE HYDROCHLORIDE
XWV9Z12C1C	CALCIUM GLYCEROPHOSPHATE	27214-00-2	CALCIUM GLYCEROPHOSPHATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1046423	calcium glycerophosphate 0.13 % / vitamin B6 HCl 0.03 % / sodium monofluorophosphate 0.76 % Toothpaste	PSN	abdd24ae-3dee-4a47-8c43-0bdeaf04e7f4	1
1046423	calcium glycerophosphate 1.3 MG/ML / pyridoxine hydrochloride 0.3 MG/ML / sodium monofluorophosphate 7.6 MG/ML Toothpaste	SCD	abdd24ae-3dee-4a47-8c43-0bdeaf04e7f4	1
1046423	calcium glycerophosphate 0.13 % / vitamin B6 HCl 0.03 % / sodium monofluorophosphate 0.76 % Toothpaste	SY	abdd24ae-3dee-4a47-8c43-0bdeaf04e7f4	1
1046423	Calcium Glycerophosphate 1.3 MG/ML / vit-B6 Hydrochloride 0.3 MG/ML / Sodium monofluorophosphate 7.6 MG/ML Toothpaste	SY	abdd24ae-3dee-4a47-8c43-0bdeaf04e7f4	1
1046423	Calcium Glycerophosphate 1.3 MG/ML / vitamin B6 Hydrochloride 0.3 MG/ML / Sodium monofluorophosphate 7.6 MG/ML Toothpaste	SY	abdd24ae-3dee-4a47-8c43-0bdeaf04e7f4	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
53208-448-01	53208044801	130 g in 1 TUBE	130 g	Historical
53208-448-02	53208044802	1 in 1 CARTON		Historical