Lip Clear Lysine Plus

Product NDC: 70084-320
Requested package NDC: 70084-320-07
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 · 12 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2022-08-30 03:57 UTC · source 2022-08-29	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	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 102 of 151 · 3,010 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
K19 RELIEF	MENTHOL	K19 LLC	e2e1ca96-1ae8-4c99-b8de-ce26754292f9	2025-01-15	Warnings	Exact identifier application number: M017
Anecream	LIDOCAINE 4%	Focus Health Group	2d7706e2-7363-4047-96cb-85b718277e8c	2025-01-15	Warnings	Exact identifier application number: M017
Boroleum	CAMPHOR, MENTHOL, WHITE PETROLATUM	Reliable 1 Laboratories	846568af-0fdd-a80e-e053-2a91aa0a9c9e	2025-01-15	Warnings	Exact identifier application number: M017
LidoPro Pain Relief	CAPSAICIN AND LIDOCAINE	Advanced Rx of Tennessee, LLC	27d5997b-1cc2-41c2-e063-6394a90ac74a	2025-01-15	Warnings	Exact identifier application number: M017
Pain Relief Patch 4% Lidocaine	LIDOCAINE	Reliable 1 Laboratories LLC	2b624763-c310-63d9-e063-6394a90a1928	2025-01-15	Warnings	Exact identifier application number: M017
Cannarelief 1000mg	MENTHOL	Carolina Cannabis Creations LLC	01e2ae1a-c969-6dd2-e063-6394a90a9d9e	2025-01-15	Warnings	Exact identifier application number: M017
Healing Hand Cream 2000mg	MENTHOL	Carolina Cannabis Creations LLC	01f8795b-9f95-c793-e063-6394a90a8330	2025-01-15	Warnings	Exact identifier application number: M017
CBD Clinic Deep-Rub Pain Relief - Level 5	CAMPHOR, MENTHOL	ABACUS HEALTH PRODUCTS, INC.	31e2e5cd-d33e-f058-e063-6394a90af7d2	2025-01-14	Warnings	Exact identifier application number: M017
Meijer Odor Free Analgesic Pain Relieving Topical Analgesic	LIDOCAINE HYDROCHLORIDE	Meijer Distribution, Inc	6288efea-f636-4eea-bb9f-78aa2f9af54a	2025-01-14	Warnings	Exact identifier application number: M017
IKONIK TONIK	LIDOCAINE HYDROCHLORIDE	IKONIK CARE, LLC	122fdfe8-b5fa-46d1-9fd9-3df9887ed320	2025-01-14	Warnings	Exact identifier application number: M017
elp essential MANTECA DE UBRE	METHYL SALICYLATE, CAMPHOR	Miramar Cosmetics, Inc DBA Miramar Lab	c3964dfe-17fe-4d89-a4c4-cf500f982259	2025-01-13	Warnings	Exact identifier application number: M017
Methylten	METHYL SALICYLATE 10%	Puretek Corporation	28f4093f-803f-0e70-e063-6294a90a98a4	2025-01-13	Warnings	Exact identifier application number: M017
Refill Bundle 7 Large Office	BENZALKONIUM CHLORIDE	CMC Group, Inc.	6620a8f3-098d-d045-e053-2a91aa0a0d94	2025-01-13	Warnings	Exact identifier application number: M017
Jakwork Numbing Cream	NUMBING CREAM	Guangzhou Zanming Trading Co., Ltd.	2ba1de83-494a-6c54-e063-6294a90a9b2d	2025-01-13	Warnings	Exact identifier application number: M017
Arthritis Hot	MENTHOL AND METHYL SALICYLATE	Chattem, Inc.	cc57b9b6-8ba5-4ff3-a5df-97d8f5b1bebd	2025-01-13	Warnings	Exact identifier application number: M017
Re-Lieved Lidocaine Patch	LIDOCAINE PATCH 4%	Transfer Technology	00b40dda-53ad-0458-e063-6394a90aa835	2025-01-11	Warnings	Exact identifier application number: M017
Re-Lieved Lidocaine Patch	LIDOCAINE PATCH 4%	Transfer Technology	00b47eb7-6b43-d9e2-e063-6294a90a9a38	2025-01-11	Warnings	Exact identifier application number: M017
Re-Lieved 4% Lidocaine Fabric Tape	LIDOCAINE 4% FABRIC TAPE	Transfer Technology	e9a894b0-54f2-707e-e053-2a95a90a0f0d	2025-01-11	Warnings	Exact identifier application number: M017
Re-Lieved 3 in 1 Patch	MENTHOL, CAMPHOR, METHYL SALICYLATE PATCH	Transfer Technology	e9ab9a03-b9e3-7317-e053-2995a90a9950	2025-01-11	Warnings	Exact identifier application number: M017
ASTRAPHARM CHILLI BRAND	CAPSAICIN	Dersan Pharmaceutical Co., Ltd	b4c2d4fd-7d5d-4156-ac27-e72ebc9671ec	2025-01-10	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