MAXOCAINE Topical Anesthetic Anorectal

Product NDC: 72188-076
11-digit product format: 721880076
Labeler code: 72188
Product ID: 72188-076_361dcf5a-5697-6935-e063-6294a90aaee1
Type: HUMAN OTC DRUG
Nonproprietary name: LIDOCAINE
Dosage form: CREAM
Route: TOPICAL
Labeler: PRIME COMMERCE, LLC
Application: M015
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2025-05-15
Substance: LIDOCAINE
Active strength: 50 mg/mL
Pharmacologic classes: Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
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 · 20 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
2025-04-01 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	72188-076-59	`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	72188-076-59	`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	72188-076-59	`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	72188-076-59	`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	72188-076-59	`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	72188-076-59	`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	72188-076-59	`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	72188-076-59	`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	72188-076-59	`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	72188-076-59	`557ba5c1ecfa…`	`9c80585c8c6e…`

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: MAXOCAINE Topical Anesthetic Anorectal
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LIDOCAINE	50 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
98PI200987	Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
26e8c867-8cb8-4a25-91b1-da45a1edd09a	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
070fbed5-7088-434a-a7ce-f2a64d8d40ac	Product name	2	20260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80f	Product name	5	20250819
860a93dc-4863-49cc-b284-6bbe8191bc48	Product name	4	20250214
eaba870a-6a9d-442e-8643-87b3f558a451	Product name	1	20250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86	Product name	1	20230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57	Product name	3	20210602
aed701d5-9c75-dfaf-7154-cde46179faea	Product name	9	20200313
fa8b5901-e681-426f-82fe-54f6d81ec698	Product name	4	20180619
332d03e4-aa24-4b11-841a-02bf41081920	Product name	1	20171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070	Product name	1	20171221
68ed98f8-24c2-44a0-944a-6d36e82ce25a	Product name	1	20141222
1cd42bc2-a430-c72b-636d-991b235fbf80	Product name	1	20140508
49fa150c-f0de-cce7-3d9c-993ed81c5698	Product name	1	20140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ff	Product name	1	20140508
9137811f-f279-8640-5aeb-99fa2145d64d	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72188-076-59	MAXOCAINE Topical Anesthetic Anorectal	59 mL in 1 JAR	CREAM	59		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72188-076	MAXOCAINE TOPICAL ANESTHETIC ANORECTAL (LIDOCAINE) CREAM [PRIME COMMERCE, LLC]	4	Current NDC, Legacy NDC, 1 package rows	20250529_26e8c867-8cb8-4a25-91b1-da45a1edd09a.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 8 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hemorrhoid, Fissure, ProctalgiaSuppositories	CARBON, MIRABILITE, PEPPERMINT OIL, BORNEOL	WU XI ZHONG ZHI WEI NA TECHNOLOGY CO., Ltd.	1d40d16a-ee52-463a-e063-6394a90a6077	2026-01-14	Warnings	Exact identifier application number: M015
Hemorrhoid, Fissure, Proctalgia Relief Wash	CARBON, PANTHENOL, SODIUM HYALURONATE	WU XI ZHONG ZHI WEI NA TECHNOLOGY CO., Ltd.	1e20de39-45b0-54ec-e063-6294a90a04ed	2026-01-14	Warnings	Exact identifier application number: M015
Hemorrhoid, Fissure, Proctalgia Ointments	CARBON, MIRABILITE, PEPPERMINT OIL, BORNEOL, GLYCERIN	WU XI ZHONG ZHI WEI NA TECHNOLOGY CO., Ltd.	1efe43d5-a29b-5cb2-e063-6394a90aca66	2026-01-14	Warnings	Exact identifier application number: M015
LONAZEM	MENTHOL,PETROLATUM	PEER PHARM LTD.	91f7a741-4178-4639-9cd5-746a4b9a21bf	2026-01-12	Warnings	Exact identifier application number: M015
Hemorrhoidal Hygiene pads	WITCH HAZEL	Akron Pharma Inc.	936a0cca-5049-4ddf-9581-75c2da6d9cfa	2026-01-12	Warnings	Exact identifier application number: M015
Signature numbing cream	5% LIDOCAINE	Shengnan (Guangzhou) Cosmetics Co., LTD	4805ba4e-45d3-bf0a-e063-6294a90a6eef	2026-01-10	Warnings	Exact identifier application number: M015
THE SOLUTION 2.0	LIDOCAINE	SCALP TECH INC	0fa423b6-cc0f-b569-e063-6294a90a239e	2026-01-09	Warnings	Exact identifier application number: M015
BLACK LABEL B NUMB	LIDOCAINE HYDROCHLORIDE	SCALP TECH INC	11fcf401-0891-04bc-e063-6294a90a8ad5	2026-01-09	Warnings	Exact identifier application number: M015
GOLD LABEL B NUMB	LIDOCAINE HYDROCHLORIDE, EPINEPHRINE HYDROCHLORIDE	SCALP TECH INC	1211590a-13b5-2e75-e063-6394a90a0f86	2026-01-09	Warnings	Exact identifier application number: M015
0.25 % PHENYLEPHRINE HCl HEMORRHOIDAL	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE	Universal Distribution Center LLC	90844919-f16a-4390-9dca-b0405b501445	2026-01-08	Warnings	Exact identifier application number: M015
Signature numbing cream	5% LIDOCAINE	Shengnan (Guangzhou) Cosmetics Co., LTD	47dda425-86d8-441e-e063-6294a90a0f9a	2026-01-08	Warnings	Exact identifier application number: M015
AER Traveler Towelette	AER TRAVELER	Birchwood Laboratories LLC	26556b9b-1c3a-6cf5-e063-6394a90ab26c	2026-01-08	Warnings	Exact identifier application number: M015
Preparation H Rapid Relief	GLYCERIN, LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE	Haleon US Holdings LLC	49a93cfc-4ccd-4ef3-928f-901b9926f794	2026-01-08	Warnings	Exact identifier application number: M015
PREPARATION H FOR WOMEN	WITCH HAZEL	Haleon US Holdings LLC	a9099cf4-4e2e-4cf1-a52f-48f8e174cb15	2026-01-08	Warnings	Exact identifier application number: M015
LIPOCAINE 5	LIDOCAINE 5%	ESBA LABORATORIES INC.	849d6e28-a6b8-7f49-e053-2a91aa0a497d	2026-01-08	Warnings	Exact identifier application number: M015
TOPICAINE 5	LIDOCAINE 5%	ESBA LABORATORIES INC.	15d33ff7-34ed-253d-e054-00144ff88e88	2026-01-08	Warnings	Exact identifier application number: M015
Dr Wellskin Numbing Cream	5% LIDOCAINE	Shengnan (Guangzhou) Cosmetics Co., LTD	47ebedc5-caf1-a774-e063-6394a90ae14d	2026-01-08	Warnings	Exact identifier application number: M015
Dr. Care Numbing Cream	LIDOCAINE	Shengnan (Guangzhou) Cosmetics Co., LTD	47c94198-7718-bbc2-e063-6294a90a48f1	2026-01-07	Warnings	Exact identifier application number: M015
Healthwise Anorectal Pain Relief	LIDOCAINE 5%	Veridian Healthcare	19c24e1b-a31b-478b-a48b-c39bb4753ca7	2026-01-06	Warnings	Exact identifier application number: M015
Good Sense Hemorrhoidal Maximum Strength Pain Relief	GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM	L. Perrigo Company	1d6142b6-3746-46f1-99ec-4b19d26f056e	2026-01-06	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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
72188-076-59	72188007659	59 mL in 1 JAR (72188-076-59)	59 ml	2025-05-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
MAXOCAINE Topical Anesthetic Anorectal	PRIME COMMERCE, LLC \| Pure Source, LLC	2025-05-27	HUMAN OTC DRUG LABEL	4