SHINGBASE Topical Analgesic

Product NDC: 80327-002
11-digit product format: 803270002
Labeler code: 80327
Product ID: 80327-002_efa7905b-7187-2251-e053-2a95a90a6673
Type: HUMAN OTC DRUG
Nonproprietary name: LIDOCAINE, MENTHOL
Dosage form: CREAM
Route: TOPICAL
Labeler: JOONEM LLC
Application: part348
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2020-09-01
Marketing end: 0000-00-00
Substance: LIDOCAINE; MENTHOL
Active strength: 40 mg/g; mg/g
Pharmacologic classes: Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC exclude flag: No
Listing certified through: 2023-12-31
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	80327-002		D	Discontinued by firm		2026-10-05
excluded package	package	80327-002	80327-002-01	D	Discontinued by firm		2026-10-05

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 · 4 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	80327-002-01	`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	80327-002-01	`f5e01cc5f278…`	`a2eaf40c39c3…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
80327-002-01	2024-01-30	C162847	48780-1	1030e365-21e4-111a-e063-dadaa90a10e2	SHINGBASE Topical Analgesic Cream

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80327-002	SHINGBASE TOPICAL ANALGESIC (LIDOCAINE, MENTHOL) CREAM [JOONEM LLC]	6	Legacy NDC	20240220_afebbc7a-ed03-9b3c-e053-2a95a90a3d95.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
98PI200987	LIDOCAINE	137-58-6	LIDOCAINE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
80327-002-01	80327000201	120 g in 1 BOTTLE (80327-002-01)	120 g	2020-09-01	0000-00-00	No	No	Current