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		2026-10-16
excluded package	package	82927-001	82927-001-01	I	Inactivated by FDA		2026-10-16

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 9 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CVS Hemorrhoidal Lidocaine 5 Rapid Pain Relief with 10 Finger Cots	LIDOCAINE	CVS PHARMACY, INC	caef51a8-76e9-42b3-a160-c54f62b47de1	2026-01-05	Warnings	Exact identifier application number: M015
CVS Maximum OTC Strength Hemorrhoidal with Aloe	GLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, WHITE PETROLATUM	CVS PHARMACY,INC	b55c63fb-5dfa-4567-8192-58f403868837	2026-01-02	Warnings	Exact identifier application number: M015
HemRid Anorectal Cream	LIDOCAINE	KKA & Associates LLC	dbeb4325-3e85-1147-e053-2995a90a2160	2025-12-31	Warnings	Exact identifier application number: M015
ElixirCurozole	CLOTRIMAZOLE	ELIXIR HEALTHCARE USA, LLC.	0c468a9e-d092-4704-b742-92ecd9918209	2025-12-26	Warnings	Exact identifier application number: M015
Hemorrhoidal	COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE	GRAXCELL PHARMACEUTICAL, LLC	5162baee-0d63-494e-8046-459437b85348	2025-12-25	Warnings	Exact identifier application number: M015
HEMORRHOIDAL	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE	Safeway	3e6728b6-26e3-4287-8ba6-e27f305cd93b	2025-12-20	Warnings	Exact identifier application number: M015
PREPARATION H	PHENYLEPHRINE HYDROCHLORIDE	Haleon US Holdings LLC	40fde50a-3cc0-4286-9b33-8f3912254c33	2025-12-18	Warnings	Exact identifier application number: M015
ElixirLidoFast Rapid Relief	GLYCERIN, LIDOCAINE, PETROLATUM, AND PHENYLEPHRINE HYDROCHLORIDE	ELIXIR HEALTHCARE USA, LLC.	45de9dfa-6c89-1eae-e063-6294a90a4dac	2025-12-13	Warnings	Exact identifier application number: M015
topcare hemorrhoidal	COCOA BUTTER, PHENYLEPHRINE HCL	Topco Associates LLC	81a3546b-5099-4b9a-b774-b3e79316b267	2025-12-13	Warnings	Exact identifier application number: M015
Kroger Hemorrhoid	GLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HCL	Kroger Company	45b2dd86-7fb0-07bf-e063-6394a90a1884	2025-12-11	Warnings	Exact identifier application number: M015
LMX5	LIDOCAINE	Ferndale Laboratories, Inc.	34f8ed6b-4a52-4a99-9c1b-254196dc29b0	2025-12-10	Warnings	Exact identifier application number: M015
PURA	WITCH HAZEL	Mypura.com Limited	1523f52f-6a5b-a12d-e063-6294a90a4496	2025-12-05	Warnings	Exact identifier application number: M015
Menthol and Zinc Oxide	MENTHOL AND ZINC OXIDE	Marlex Pharmaceuticals, Inc.	c24e2dab-cab4-38f4-e053-2995a90aabae	2025-12-04	Warnings	Exact identifier application number: M015
CAREALL Hemorrhoidal	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL	New World Imports, Inc	7913bd41-a606-4ca6-b69f-2717c2f54b07	2025-12-01	Warnings	Exact identifier application number: M015
Dr Butlers Hemorrhoid and Fissure PF	LIDOCAINE 4.00, PHENYLEPHRINE HYDROCHLORIDE 0.25	Beyond Health P.A.	f526199e-5c9e-7a3c-e053-2a95a90aa98e	2025-11-26	Warnings	Exact identifier application number: M015
Meicated Wipe	WITCH HAZEL	Diamond Wipes International, Inc	4458c80c-d013-55ba-e063-6394a90a6b39	2025-11-24	Warnings	Exact identifier application number: M015
Hemorrhoidal Cream	GLYCEROL, PHENYLEPHINE, PRAMOXINE, PETROLATUM	Trifecta Pharmaceuticals Usa Llc	804d7b1f-1be8-50c9-e053-2a91aa0a35d0	2025-11-18	Warnings	Exact identifier application number: M015
Launch Medical	LIDOCAINE HYDROCHLORIDE	Sambria Pharmaceuticals, LLC	293ef514-44c1-43ac-9a81-c30e34ad39e5	2025-11-12	Warnings	Exact identifier application number: M015
FARGELIN HEMORRHOIDAL	CALAMINE, PETROLATUM AND PHENYLEPHRINE HYDROCHLORIDE	MADISON ONE ACME INC	6844ad63-512d-496a-9458-011894185b0d	2025-11-10	Warnings	Exact identifier application number: M015
Hazel Perineal Healing Foam	WITCH HAZEL	Jiangsu Senwo Medical Technology Co., Ltd.	314b75cb-affe-a248-e063-6294a90a47b7	2025-11-07	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