Lip Clear Lysine Plus

Product NDC: 70084-320
11-digit product format: 700840320
Labeler code: 70084
Product ID: 70084-320_419d00d6-7f99-7348-e063-6394a90a38cd
Type: HUMAN OTC DRUG
Nonproprietary name: Menthol, Unspecified Form
Dosage form: OINTMENT
Route: TOPICAL
Labeler: Quantum, Inc.
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 1984-10-01
Substance: MENTHOL, UNSPECIFIED FORM
Active strength: 1 mg/g
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 · 24 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
2025-08-27 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	70084-320-07	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
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	70084-320-07	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	70084-320-07	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	70084-320-07	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	70084-320-07	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	70084-320-07	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	70084-320-07	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	70084-320-07	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
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	70084-320-07	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	70084-320-07	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	70084-320-07	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	70084-320-07	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`

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: Lip Clear Lysine Plus
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MENTHOL, UNSPECIFIED FORM	1 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
L7T10EIP3A	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1812680	Internal RxNorm lookup
1812685	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
21a5b4fb-baed-4766-9820-5c6051c14720	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ebc62596-fc97-4d03-9483-7ba095d25db7	Product name	1	20151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
60c52429-fcef-eb54-2387-43bc9e4f296b	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2025-01-30	Lip Clear ® Lysine + ®
2025-01-30	Lip Clear ® Lysine + ®
2023-02-09	Lip Clear ® Lysine + ®
2023-02-09	Lip Clear ® Lysine + ®
2021-01-29	Lip Clear ® Lysine + ®
2021-01-29	Lip Clear ® Lysine + ®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70084-320-07	Lip Clear Lysine Plus	1 in 1 CARTON	OINTMENT	1		4
70084-320-07	Lip Clear Lysine Plus	7 g in 1 TUBE	OINTMENT	7		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70084-320	LIP CLEAR LYSINE PLUS (MENTHOL, UNSPECIFIED FORM) OINTMENT [QUANTUM, INC.]	3	Current NDC, Legacy NDC, 2 package rows	20230211_21a5b4fb-baed-4766-9820-5c6051c14720.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 69 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Topcare Cold and Hot Medicated	MENTHOL	Topco Associates LLC	8739aedd-165c-5ae0-e053-2a91aa0afcd0	2025-10-31	Warnings	Exact identifier application number: M017
CVS Medicated Heat 1 ct	CAPSAICIN	CVS Pharmacy, Inc.	d41dce5b-e698-4930-8869-040b2a973f25	2025-10-31	Warnings	Exact identifier application number: M017
Coralite Medicated Heat	CAPSAICIN	United Exchange Corp.	a0b89c7e-80bc-43c4-840c-5fd567f60b21	2025-10-31	Warnings	Exact identifier application number: M017
Dragon with Arnical Pain Relief	MENTHOL	Genomma Lab USA Inc.	b4cbb7b6-cb71-9721-e053-2995a90a2b2c	2025-10-31	Warnings	Exact identifier application number: M017
Hydrocortisone Anti-Itch	HYDROCORTISONE	Universal Distribution Center LLC	186afb11-06b6-4bfa-e063-6294a90aefc6	2025-10-30	Warnings	Exact identifier application number: M017
Gemachlich ZuHause NEUROPATHY SOLID Ointment.	GEMACHLICH ZUHAUSE NEUROPATHY SOLID OINTMENT.	Guangdong Quadrant Ecological Technology Co., Ltd.	425b1b9d-c33a-05e9-e063-6394a90a97a6	2025-10-30	Warnings	Exact identifier application number: M017
Gemachlich ZuHause NEUROPATHY Spray.	GEMACHLICH ZUHAUSE NEUROPATHY SPRAY.	Guangdong Quadrant Ecological Technology Co., Ltd.	425b8259-af38-8d68-e063-6394a90a1120	2025-10-30	Warnings	Exact identifier application number: M017
Family Care Muscle and Joint	MENTHOL	United Exchange Corp.	959af9f4-7188-91a1-e053-2995a90a4665	2025-10-30	Warnings	Exact identifier application number: M017
CVS Maximum Strength Boil Relief	BENZOCAINE	CVS Pharmacy, Inc.	0761b866-af34-42bd-adc9-3d229170d01c	2025-10-30	Warnings	Exact identifier application number: M017
CVS Cold and Hot	MENTHOL	CVS Pharmacy	a44ca52d-fec8-0e8c-e053-2995a90a2e60	2025-10-30	Warnings	Exact identifier application number: M017
CVS CAPSAICIN	CAPSAICIN	CVS PHARMACY	9b551fe3-3842-482a-9042-63de5ad39884	2025-10-30	Warnings	Exact identifier application number: M017
TopCare Health Pain Relief	MENTHOL, CAMPHOR, AND METHYL SALICYLATE	Topco Associates LLC	dac364ef-6dcd-3fc6-e053-2a95a90a9bb2	2025-10-30	Warnings	Exact identifier application number: M017
Calamine Plus	CALAMINE PLUS PRAMOXINE HCL	AmerisourceBergen Drug Corporation	f161e151-4fab-2fbc-e053-2a95a90a5437	2025-10-30	Warnings	Exact identifier application number: M017
Lidocaine	BURN RELIEF	Perrigo Direct	c7b50f14-3481-9ebd-e053-2995a90afe1c	2025-10-30	Warnings	Exact identifier application number: M017
Lipoflavonoid Ear Pain Kids Relief Drops	LIPOFLAVONOID EAR PAIN KIDS RELIEF DROPS	Clarion Brands LLC	4265361b-5526-c3e0-e063-6394a90a1777	2025-10-30	Warnings	Exact identifier application number: M017
Diphenhydramine HCl and Zinc Acetate	EXTRA STRENGTH ITCH RELIEF	HEB	2aedbf1d-c8b7-4d5d-83ee-e38872c37d4f	2025-10-30	Warnings	Exact identifier application number: M017
Hydrocortisone	HYDROCORTISONE SPRAY	Meijer Distribution Inc.	28daaf97-b0b3-7a54-e063-6294a90a23f1	2025-10-30	Warnings	Exact identifier application number: M017
Calamine Plus	CALAMINE PLUS PRAMOXINE HCL	Meijer Distribution Inc.	03c46823-0b1f-4101-e063-6294a90aaf94	2025-10-30	Warnings	Exact identifier application number: M017
Extra Strength Itch Relief	DIPHENHYDRAMINE HCL AND ZINC ACETATE	Meijer Distribution Inc	02f9e270-6047-83b6-e063-6394a90afc27	2025-10-30	Warnings	Exact identifier application number: M017
Muscle Rub Pain Reliever Gel	MENTHOL, UNSPECIFIED FORM	Universal Distribution Centre LLC	18536e21-afc3-8447-e063-6394a90aabae	2025-10-30	Warnings	Exact identifier application number: M017

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
L7T10EIP3A	MENTHOL, UNSPECIFIED FORM	1490-04-6	MENTHOL, UNSPECIFIED FORM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1812685	Lysine Plus 0.1 % Topical Ointment	PSN	21a5b4fb-baed-4766-9820-5c6051c14720	4
1812680	menthol 0.1 % Topical Ointment	PSN	21a5b4fb-baed-4766-9820-5c6051c14720	4
1812685	menthol 0.001 MG/MG Topical Ointment [Lysine Plus]	SBD	21a5b4fb-baed-4766-9820-5c6051c14720	4
1812680	menthol 0.001 MG/MG Topical Ointment	SCD	21a5b4fb-baed-4766-9820-5c6051c14720	4
1812685	Lysine Plus 0.1 % Topical Ointment	SY	21a5b4fb-baed-4766-9820-5c6051c14720	4
1812680	menthol 0.1 % Topical Ointment	SY	21a5b4fb-baed-4766-9820-5c6051c14720	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70084-320-07	70084032007	1 TUBE in 1 CARTON (70084-320-07) / 7 g in 1 TUBE	1 tube	1984-10-01	No	No	Current