Anorectal

Product NDC: 53329-088
11-digit product format: 533290088
Labeler code: 53329
Product ID: 53329-088_efcefe93-0ec5-2aa1-e053-2995a90a8f22
Type: HUMAN OTC DRUG
Nonproprietary name: zinc oxide, petrolatum
Dosage form: CREAM
Route: TOPICAL
Labeler: Medline Industries, LP
Application: M015
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2010-03-01
Marketing end: 0000-00-00
Substance: PETROLATUM; ZINC OXIDE
Active strength: 800 mg/g; mg/g
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	53329-088		D	Discontinued by firm		2026-10-15
excluded package	package	53329-088	53329-088-14	D	Discontinued by firm		2026-10-15

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 · 32 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53329-088-14	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53329-088-14	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53329-088-14	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53329-088-14	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53329-088-14	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53329-088-14	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53329-088-14	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53329-088-14	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53329-088-14	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	53329-088-14	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	53329-088-14	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	53329-088-14	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	53329-088-14	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	53329-088-14	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	53329-088-14	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	53329-088-14	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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
53329-088-14	2022-10-04	C162847	48780-1	d6a99b39-b972-a426-e053-dadaa90af4c2	088 Curad Zinc Oxide Anorectal Cream
53329-088-14	2022-01-28	C162847	48780-1	d6a99b39-b972-a426-e053-dadaa90af4c2	088 Curad Zinc Oxide Anorectal Cream

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PETROLATUM	ACTIVE INGREDIENT	4T6H12BN9U	ANORECTAL (ZINC OXIDE, PETROLATUM) CREAM [MEDLINE INDUSTRIES, INC.]	2
ZINC OXIDE	ACTIVE INGREDIENT	SOI2LOH54Z	ANORECTAL (ZINC OXIDE, PETROLATUM) CREAM [MEDLINE INDUSTRIES, INC.]	2
PETROLATUM	ACTIVE MOIETY	4T6H12BN9U	ANORECTAL (ZINC OXIDE, PETROLATUM) CREAM [MEDLINE INDUSTRIES, INC.]	2
ZINC OXIDE	ACTIVE MOIETY	SOI2LOH54Z	ANORECTAL (ZINC OXIDE, PETROLATUM) CREAM [MEDLINE INDUSTRIES, INC.]	2

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 6 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PREPARATION H MEDICATED WIPES	WITCH HAZEL	Haleon US Holdings LLC	8d9961f0-1ecf-d7fb-b6b4-856d636d68e1	2026-03-17	Warnings	Exact identifier application number: M015
Crane Safety Burn	LIDOCAINE	Crane Safety LLC	96d81566-6321-731e-e053-2995a90ad07d	2026-03-16	Warnings	Exact identifier application number: M015
Signature Lidocaine Pain Relief Cream	5% LIDOCAINE	Shengnan (Guangzhou) Cosmetics Co., LTD	4c56b3b3-33b3-a50e-e063-6394a90a955f	2026-03-06	Warnings	Exact identifier application number: M015
WowDay Medicated Hemorrhoidal Flushable Wipes	MEDICATED HEMORRHOIDAL FLUSHABLE WIPES	WowDay LLC	4c603b27-4835-bc40-e063-6394a90a8ea2	2026-03-06	Warnings	Exact identifier application number: M015
Numb Fast Hemorrhoidal	LIDOCAINE	Oasis Plus LLC	a00ffed7-8034-4cc0-87c4-3c793c1bcd6e	2026-03-03	Warnings	Exact identifier application number: M015
Curist Lidocaine Relief	LIDOCAINE 5%	Little Pharma, Inc.	f562b57d-6592-93fa-e053-2995a90ae3e0	2026-03-02	Warnings	Exact identifier application number: M015
Therapain Plus	MENTHOL ROLL-ON	Epic Laboratories, LLC	0249cfdf-b7c4-f27d-e063-6294a90aaa26	2026-03-02	Warnings	Exact identifier application number: M015
Liposomal Hemorrhoid Master	LIDOCAINE , PHENYLEPHRINE HCL	Clinical Resolution Laboratory, Inc.	a1e15d2a-44b6-4d9c-89c2-0ff12285724e	2026-03-02	Warnings	Exact identifier application number: M015
Equate Hemorrhoid Relief	LIDOCAINE	Walmart Inc.	48646860-ed5d-62a0-e063-6394a90abb23	2026-03-01	Warnings	Exact identifier application number: M015
Witch Hazel	WITCH HAZEL	The Kroger Co.	bbf2efd7-f181-403b-ac5f-695f7ba15875	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M015
Dermatool Hemorrhoidal	GLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HCL	Papalo Group LLC	4bc06f41-7733-ebd0-e063-6294a90af7a8	2026-02-26	Warnings	Exact identifier application number: M015
Megababe Fun Gal Stuff Antifungal	CLOTRIMAZOLE	Megababe LLC	c599d27b-fdb0-465f-9e43-13d32c520a92	2026-02-25	Warnings	Exact identifier application number: M015
Witch Hazel	WITCH HAZEL	Better Living Brands, LLC	0355edab-b6f7-4e59-bce1-cf6a8897b989	2026-02-24	Warnings, Adverse reactions	Exact identifier application number: M015
Zinc Oxide and Menthol	ZINC OXIDE, MENTHOL	Akron Formulations India Private Limited	4b84556c-521f-eebd-e063-6394a90a8e1e	2026-02-23	Warnings	Exact identifier application number: M015
Calprotect	MENTHOL, ZINC OXIDE	Reliable 1 Laboratories LLC	09fb2810-0cc1-b2e2-e063-6294a90a4576	2026-02-19	Warnings	Exact identifier application number: M015
Oxify	LIDOCAINE 5%	Weeks & Leo Compnay, INC.	41d9d0b4-33e7-7e05-e063-6394a90a1011	2026-02-17	Warnings	Exact identifier application number: M015
WowDay Hemorrhoid and Fissure Cream	HEMORRHOID AND FISSURE CREAM	WowDay LLC	47ba86ad-240a-e733-e063-6394a90a24e3	2026-02-12	Warnings	Exact identifier application number: M015
Gniby - LIDOCAINE ANORECTAL HEMORRHOIDAL	NUMBING	Putian Licheng District Zhijiancheng Trading Co., Ltd.	4a5f59f1-c11a-e2eb-e063-6394a90a3e27	2026-02-10	Warnings	Exact identifier application number: M015
Numb Master	LIDOCAINE	Clinical Resolution Laboratory, Inc.	0921c824-a8a9-4707-a480-c750192983f5	2026-02-09	Warnings	Exact identifier application number: M015
Signature Care Hemorrhoidal	MINERAL OIL, PETROLATUM, AND PHENYLEPHRINE HCI	Better Living Brands, LLC	3c8b43f3-6e1e-499e-ba71-ffdf836f6743	2026-02-05	Warnings	Exact identifier application number: M015

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4T6H12BN9U	PETROLATUM	8009-03-8	PETROLATUM
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53329-088-14	53329008814	1 TUBE in 1 BOX (53329-088-14) > 56.6 g in 1 TUBE	1 tube	2010-03-01	0000-00-00	No	No	Current