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 75 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Kalaya Extra Strength Pain Relief Cream with Hemp Seed Oil	METHYL SALICYLATE, MENTHOL, CAMPHOR	Avaria Health & Beauty Corp	2eccf23c-fae2-423c-9cae-549bc4194104	2025-10-08	Warnings	Exact identifier application number: M017
KALAYA BACK AND NECK PAIN RELIEF	METHYL SALICYLATE, MENTHOL, CAMPHOR	Avaria Health & Beauty Corp	48fd73e7-1443-4ac7-bf7c-d99bf2449f51	2025-10-08	Warnings	Exact identifier application number: M017
Lidocaine Pain Relieving Patch	LIDOCAINE 4%	BluePoint Laboratories	3117273d-e006-2726-e063-6294a90a9c33	2025-10-08	Warnings	Exact identifier application number: M017
EQUATE PAIN RELIEVING PATCHES	LIDOCAINE 4%	WALMART, INC	01e1cc0e-e1c9-d274-e063-6294a90a409e	2025-10-08	Warnings	Exact identifier application number: M017
Equate Pain Relief Balm	MENTHOL 11%, CAMPHOR 11% OINTMENT	WALMART, INC	d8ddf835-f008-ce1f-e053-2a95a90aa9b3	2025-10-08	Warnings	Exact identifier application number: M017
TheraCare Pain Relieving Menthol Gel	MENTHOL 2%	Veridian Healthcare	9d2ccb02-746c-4cb9-905d-280987778f4d	2025-10-08	Warnings	Exact identifier application number: M017
COOLING PAIN RELIEF	MENTHOL, CAMPHOR	SUNSET NOVELTIES, INC	3a9019b1-8798-1ef9-e063-6394a90a09a4	2025-10-08	Warnings	Exact identifier application number: M017
Coralite Capsaicin Heat Patch 2ct	CAPSAICIN	United Exchange Corp.	4128b1ac-f540-2611-e063-6294a90ac98b	2025-10-08	Warnings	Exact identifier application number: M017
Ombre Men overtime wipes	BENZOCAINE	Sambria Pharmaceuticals, LLC	405f23ca-99c1-4db4-aba1-2fd7f93f55ee	2025-10-07	Warnings	Exact identifier application number: M017
Pain free IV	LIDOCAINE	Sambria Pharmaceuticals, LLC	7aa4cb20-d452-417f-afdb-307df754ed75	2025-10-07	Warnings	Exact identifier application number: M017
HYDROCORTISONE	HYDROCORTISONE	CVS PHARMACY, INC	b3bdff5e-37fe-442a-a370-7b19799ea781	2025-10-07	Warnings	Exact identifier application number: M017
HealthWise Pain Relief Patch	MENTHOL, METHYL SALICYLATE	Veridian Healthcare	b65932fd-ee9f-4fa2-b842-01e0f54133c9	2025-10-07	Warnings	Exact identifier application number: M017
AREX SINSIN PAS	CAMPHOR, MENTHA OIL, MENTHOL, METHYL SALICYLATE, ZINC OXIDE	Sinsin Pharmaceutical Co., Ltd.	2013ea44-e2ea-4b36-bddb-7f64163284b6	2025-10-07	Warnings	Exact identifier application number: M017
SINSINPAS LIDOCAINE PAIN RELIEVING	LIDOCAINE	Sinsin Pharmaceutical Co., Ltd.	82c0a036-8750-5b3d-e053-2a91aa0a1815	2025-10-07	Warnings	Exact identifier application number: M017
SINSIN MULPAS	L-MENTHOL, METHYL SALICYLATE, DL-CAMPHOR, CHLORPHENIRAMINE MALEATE, THYMOL	Sinsin Pharmaceutical Co., Ltd.	81baffcb-c08e-4616-e053-2a91aa0aaf15	2025-10-07	Warnings	Exact identifier application number: M017
Arex Sinsin Pas	CAMPHOR, MENTHA OIL, MENTHOL, METHYL SALICYLATE, ZINC OXIDE	Sinsin Pharmaceutical Co., Ltd.	a851854a-5dfe-4bd5-95f6-67c3f13f1187	2025-10-07	Warnings	Exact identifier application number: M017
Sinsinpas Arex Flex Gel Pain Relieving Patch	L-MENTHOL	Sinsin Pharmaceutical Co., Ltd.	1758ef9b-4fac-4066-e063-6394a90a8cc3	2025-10-07	Warnings	Exact identifier application number: M017
SINSINPAS CORN REMOVER	SALICYLIC ACID	Sinsin Pharmaceutical Co., Ltd.	e2771dfc-ee57-553f-e053-2a95a90af281	2025-10-07	Warnings	Exact identifier application number: M017
Capsaicin	CAPSAICIN	PHARMACURE LLC	05a09ee5-e7a4-4758-8b16-f60b945a7d82	2025-10-06	Warnings	Exact identifier application number: M017
Lidocanna	LIDOCAINE	PHARMACURE LLC	b28ebbb6-1112-4750-a2bb-f96b03fabe6e	2025-10-06	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