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 85 of 151 · 3,010 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Shopko Hydrocortisone	HYDROCORTISONE	Shopko Stores Operating Co., LLC	92bcbde3-401a-4301-854e-c352852317d6	2025-07-15	Warnings	Exact identifier application number: M017
TopCare Hydrocortisone	HYDROCORTISONE	Topco Associates LLC	bd3585fa-3b48-49b7-8ad1-749bf1e31ed5	2025-07-15	Warnings	Exact identifier application number: M017
Methyl Salicylate 25% Pain Relieving	METHYL SALICYLATE	Puretek Corporation	376797ff-cf13-a3c6-e063-6394a90a9de1	2025-07-15	Warnings	Exact identifier application number: M017
TIGER BALM PAIN RELIEVING	CAMPHOR (SYNTHETIC), LEVOMENTHOL, AND CAPSICUM	Haw Par Healthcare Ltd.	440e97bc-bd97-4733-9955-643b18e7fb18	2025-07-15	Warnings	Exact identifier application number: M017
Tiger Balm Pain Relieving Hydrogel Large	CAMPHOR (SYNTHETIC), LEVOMENTHOL, AND CAPSICUM	Haw Par Healthcare Ltd.	064d04ca-184d-492b-867c-beaa165ab3e0	2025-07-14	Warnings	Exact identifier application number: M017
Methyl Salicylate 25% Cream	METHYL SALICYLATE	Medcore LLC	143f76bf-2de4-466a-8a6b-d6ab6314a2c3	2025-07-14	Warnings	Exact identifier application number: M017
BLUESPRING Doctors Pain Formula Pain Relief	MENTHOL	ACA MANAGEMENT LLC	98f3f719-792f-4a93-95b1-90072e0f8bf4	2025-07-14	Warnings	Exact identifier application number: M017
Shopko Anti-Itch	DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE	Shopko Stores Operating Co., LLC	130119eb-b87e-4a07-8d2a-317369bfa541	2025-07-14	Warnings	Exact identifier application number: M017
Equate Hydrocortisone Intensive Healing Formula	HYDROCORTISONE	Wal-Mart Stores Inc.	635b49c4-54d2-4b6d-bee8-851fc2c7ca9c	2025-07-14	Warnings	Exact identifier application number: M017
ULTRA STRENGTH ZHENG GU SHUI	MENTHOL AND CAMPHOR	GUANGXI YULIN PHARMACEUTICAL GROUP CO LTD	53397663-044d-4e48-989b-2c6257af5f84	2025-07-14	Warnings, Adverse reactions	Exact identifier application number: M017
TIGER BALM PAIN RELIEVING HYDROGEL	CAMPHOR (SYNTHETIC), LEVOMENTHOL, AND CAPSICUM	Haw Par Healthcare Ltd.	cb60037f-bceb-4090-a5e4-bdda0cbf9f5c	2025-07-14	Warnings	Exact identifier application number: M017
Avedana Hydrocortisone Cream with Aloe	HYDROCORTISONE	Unipack LLC	2a55c426-39b4-4d94-b6b4-6c548c9685e9	2025-07-13	Warnings	Exact identifier application number: M017
Hydrocortisone	HYDROCORTISONE ACETATE	Rite Aid Corporation	cb6e0bed-2ea1-49d2-89e7-2554e7565b74	2025-07-11	Warnings	Exact identifier application number: M017
QUALITY CHOICE Maximum Strength Lidocaine Pain Relief Roll On	LIDOCAINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION	7b3ff4c1-0b60-4f7a-8aa4-c84b7c7137c4	2025-07-11	Warnings	Exact identifier application number: M017
Antibiotic Plus Pain Relief	NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE	TARGET Corporation	6fba5890-f48f-4302-a8ac-5087a6e03bd5	2025-07-11	Warnings	Exact identifier application number: M017
TopCare Antibiotic Plus Pain Relief	NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE	Topco Associates LLC	55dc4025-f07f-41b2-8b18-6a11ee04b5cc	2025-07-11	Warnings	Exact identifier application number: M017
Benadryl Extra Strength Itch Relief	DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE	Kenvue Brands LLC	309d9be0-e367-429a-a1fa-ab7855477c8a	2025-07-10	Warnings	Exact identifier application number: M017
Bengay Vanishing Scent	MENTHOL, UNSPECIFIED FORM	Kenvue Brands LLC	6cc3294b-3b0f-44d0-af71-61db1022d269	2025-07-10	Warnings	Exact identifier application number: M017
Cold Hot Medicated Patch 5% Menthol	MENTHOL	Quality Choice	ce544a7c-8dc6-4e63-b499-d8a4e0ec48c3	2025-07-10	Warnings	Exact identifier application number: M017
Hydrocortisone	HYDROCORTISONE ACETATE	Walgreen Company	bff322f1-59c3-41e0-8685-fcfe52bf4b42	2025-07-10	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