LIDOCAINE

Product NDC: 82927-001
11-digit product format: 829270001
Labeler code: 82927
Product ID: 82927-001_e32f1a47-9a5c-73de-e053-2995a90a28a4
Type: HUMAN OTC DRUG
Nonproprietary name: LIDOCAINE
Dosage form: CREAM
Route: TOPICAL
Labeler: CHENGDU DISCOUNT TRADING CO.LTD
Application: M015
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2022-08-08
Marketing end: 0000-00-00
Substance: LIDOCAINE
Active strength: 5 g/100g
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	82927-001		I	Inactivated by FDA		2026-10-21
excluded package	package	82927-001	82927-001-01	I	Inactivated by FDA		2026-10-21

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 · 30 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	82927-001-01	`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	82927-001-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	82927-001-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	82927-001-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	82927-001-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	82927-001-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	82927-001-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	82927-001-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	82927-001-01	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	82927-001-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	82927-001-01	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	82927-001-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	82927-001-01	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	82927-001-01	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	82927-001-01	`1332a3947898…`	`d4bfe170f9cd…`

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
82927-001-01	2023-07-28	C162847	48780-1	0191ceaa-6516-198a-e063-dbdaa90aec3e	001

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
82927-001-01	LIDOCAINE	56 g in 1 BOX	CREAM	56		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
82927-001	LIDOCAINE CREAM [CHENGDU DISCOUNT TRADING CO.LTD]	1	Legacy NDC, 1 package rows	20220813_e32f1a47-9a5b-73de-e053-2995a90a28a4.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 17 of 22 · 436 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Revivol Hemorrhoid and Fissure	GLYCERIN 14.4%, LIDOCAINE 5%, PETROLATUM 15%, PHENYLEPHRINE HCL 0.25%	Derma Care Research Labs, LLC	0140cf68-b6a0-4378-e063-6394a90afee8	2024-12-19	Warnings	Exact identifier application number: M015
Hemorroidal Cooling gel	PHENYLEPHRINE, WITCH HAZEL	Trifecta Pharmaceuticals Usa Llc	651c0143-384c-3649-e053-2991aa0a0f28	2024-12-18	Warnings	Exact identifier application number: M015
HemorrhoidalOintment	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCI	Trifecta Pharmaceuticals USA LLC	c50cc6ad-e8a0-47c1-e053-2a95a90a4de6	2024-12-18	Warnings	Exact identifier application number: M015
HemorrhoidalOintment	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCI	Trifecta Pharmaceuticals USA LLC	fe18fa61-83f9-8bf9-e053-6294a90a7585	2024-12-18	Warnings	Exact identifier application number: M015
HemorrhoidalOintment	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCI	Trifecta Pharmaceuticals USA LLC	c59dcb2a-392b-670b-e053-2995a90a9682	2024-12-18	Warnings	Exact identifier application number: M015
TheraCare Hemorrhoidal	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL	Veridian Healthcare	fab95657-d257-e671-e053-6294a90a59e0	2024-12-18	Warnings	Exact identifier application number: M015
TN Dickinsons Witch Hazel Hemorrhoidal Pads	WITCH HAZEL	Dickinson Brands Inc.	1b50f4dc-c26a-431a-ae18-c43513871b39	2024-12-18	Warnings	Exact identifier application number: M015
RECTICARE	LIDOCAINE	Ferndale Laboratories, Inc.	49cb48cf-7a26-4d7a-887f-2e98261d269d	2024-12-17	Warnings	Exact identifier application number: M015
Recticare Advanced	LIDOCAINE AND MINERAL OIL AND PHENYLEPHRINE HCL AND WHITE PETROLATUM	Ferndale Laboratories, Inc.	209212a7-7b6e-4b26-9f31-0eeb76f026bf	2024-12-17	Warnings	Exact identifier application number: M015
RECTICARE	LIDOCAINE AND GLYCERIN	Ferndale Laboratories, Inc.	2b94136a-4975-2925-e054-00144ff88e88	2024-12-17	Warnings	Exact identifier application number: M015
PRAX	PRAMOXINE HYDROCHLORIDE	Ferndale Laboratories, Inc.	674f0d8b-3d50-42b1-8401-d2967bcdf5cf	2024-12-17	Warnings	Exact identifier application number: M015
Hemorrhoidal	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCI	Rugby	a5b5e0a9-eee9-2a1e-e053-2a95a90a464e	2024-12-17	Warnings	Exact identifier application number: M015
Warrior Rectal Care	LIDOCAINE 4%, PHENYLEPHRINE HYDROCHLORIDE 0.25%	Derma Care Research Labs	fc10cbc3-fc1b-ae09-e053-6394a90ac8f3	2024-12-15	Warnings	Exact identifier application number: M015
Tucks Multi-Care Relief Kit (Tucks Hemorrhoidal and Tucks Medicated Cooling 40 Count)	GLYCERIN, LIDOCAINE, AND WITCH HAZEL	Blistex Inc	a7cb6d78-3048-43b3-afe7-4d862fdcfd3f	2024-12-13	Warnings	Exact identifier application number: M015
Tucks Medicated Cooling Pads	WITCH HAZEL	Blistex Inc	b3e68008-3d0d-4124-9579-b503e9fb95c9	2024-12-13	Warnings	Exact identifier application number: M015
T.N. Dickinsons Witch Hazel Medicated Cooling Pads Hemorrhoidal Relief	WITCH HAZEL	Dickinson Brands Inc.	2a4273a4-3bda-4653-a065-cd4578053f3c	2024-12-12	Warnings	Exact identifier application number: M015
Witch Hazel	WITCH HAZEL	Medical Products Laboratories, Inc.	b815792f-2f8f-7ac8-e053-2995a90ade18	2024-12-11	Warnings	Exact identifier application number: M015
Zensa	LIDOCAINE	Alera Skin Care Products Inc.	f56146b6-3c11-4608-a6ab-6142f27e9ac3	2024-11-24	Warnings	Exact identifier application number: M015
Hemorrhoid Pain Relief	LIDOCAINE	Telebrands Corp	04164425-ca3b-ef24-e063-6294a90a59d8	2024-11-20	Warnings	Exact identifier application number: M015
Hempvana Maximum Strength Pain Relief Topical Anesthetic	LIDOCAINE	Telebrands Corp	f525075a-d7ee-dad0-e053-2a95a90a6f3f	2024-11-20	Warnings	Exact identifier application number: M015

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1534792	lidocaine 5 % Topical Cream	PSN	e32f1a47-9a5b-73de-e053-2995a90a28a4	1
1534792	lidocaine 50 MG/ML Topical Cream	SCD	e32f1a47-9a5b-73de-e053-2995a90a28a4	1
1534792	lidocaine 5 % Topical Cream	SY	e32f1a47-9a5b-73de-e053-2995a90a28a4	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
82927-001-01	82927000101	56 g in 1 BOX (82927-001-01)	56 g	2022-08-08	0000-00-00	No	No	Current