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 11 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Medline	MENTHOL, WHITE PETROLATUM, ZINC OXIDE	Medline Industries, LP	006539c9-1982-d6de-e063-6294a90a1a5a	2025-10-17	Warnings	Exact identifier application number: M015
Xesso Strawberry Rear Comfort Glide 4% Lidocaine	LIDOCAINE	Premium Natural Cosmetics Inc	efba09fc-6dd7-0f73-e053-2995a90a628a	2025-10-17	Warnings	Exact identifier application number: M015
medicated pads	WITCH HAZEL	TARGET CORPORATION	acd0d99d-2a77-4227-bebb-c819f4a52666	2025-10-14	Warnings	Exact identifier application number: M015
Acolye Numbing Cream Anorectal(Hemorrhoidal) Cream	LIDOCAINE	Guangzhou Haishi Biological Technology Co., Ltd.	40b0e8d6-4686-960b-e063-6294a90a016e	2025-10-09	Warnings	Exact identifier application number: M015
Acolye Numbing Cream Anorectal(Hemorrhoidal) Cream	LIDOCAINE	Guangzhou Haishi Biological Technology Co., Ltd.	40b452a3-76b7-2433-e063-6294a90ab6b4	2025-10-09	Warnings	Exact identifier application number: M015
EQUATE HEMORRHOID RELIEF	LIDOCAIN 5%	WALMART, INC	d96e8152-e36e-22fc-e053-2995a90a8b2b	2025-10-08	Warnings	Exact identifier application number: M015
Pramoxine Hydrochloride Anorectal	PRAMOXINE HYDROCHLORIDE	Stratus Pharmaceuticals	39a16b66-b0e9-412f-8773-8dec0a1227e0	2025-10-02	Warnings	Exact identifier application number: M015
Doctor Butlers Hemorrhoid and Fissure External Pain Formula	LIDOCAINE 5%	Beyond Health, P.A.	d92f22a7-c0b5-d8b8-e053-2a95a90a2376	2025-09-30	Warnings	Exact identifier application number: M015
RWWXII Deep Numbing Cream(Anorectal Hemorrhoidal Cream)	LIDOCAINE	Guangzhou Haishi Biological Technology Co., Ltd.	3ffc57c7-5bf4-cba8-e063-6394a90a322f	2025-09-29	Warnings	Exact identifier application number: M015
Hemorrhoidal Pain Relief	HEMORRHOIDAL PAIN RELIEF CREAM	Neilmed Pharmaceuticals Inc.	374dc1c0-4243-b272-e063-6394a90a5a6b	2025-09-24	Warnings	Exact identifier application number: M015
Medi-First Burn	LIDOCAINE HYDROCHLORIDE	Unifirst First Aid Corporation	44bb5f25-1114-4bb1-8bcf-40402594abc4	2025-09-09	Warnings	Exact identifier application number: M015
Dr. Care Numbing Cream	5% LIDOCAINE	Shengnan (Guangzhou) Cosmetics Co., LTD	3e456af7-9726-d17e-e063-6394a90ab560	2025-09-08	Warnings	Exact identifier application number: M015
Medi-first Ivy-Rid First Aid	BENZOCAINE AND BENZETHONIUM CHLORIDE	Unifirst First Aid Corporation	905c97ad-0bba-46b1-939c-f16fbdb02818	2025-09-08	Warnings	Exact identifier application number: M015
MediFirst Burn	LIDOCAINE HYDROCHLORIDE	Unifirst First Aid Corporation	9fa5b348-29c2-4cd0-a945-0486bd27f5e0	2025-09-08	Warnings	Exact identifier application number: M015
Medi-First Burn	LIDOCAINE HCL	Unifirst First Aid Corporation	b3ebf104-cc51-0ef5-e053-2a95a90a25c9	2025-09-08	Warnings	Exact identifier application number: M015
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Unifirst First Aid Corporation	4c2e2b91-d2f6-4e41-9a4c-ecabca9830e8	2025-09-08	Warnings	Exact identifier application number: M015
Pain Relief	ANALGESIC MENTHOL	Unifirst First Aid Corporation	8162d22d-04c0-de07-e053-2991aa0a9975	2025-09-08	Warnings	Exact identifier application number: M015
Green Guard Burn	LIDOCAINE HCL	Unifirst First Aid Corporation	b451e96f-fcba-6495-e053-2a95a90a2adf	2025-09-08	Warnings	Exact identifier application number: M015
Lidochill(TM) Gel	LIDOCAINE HCL 4%, MENTHOL 1%	PureTek Corporation	d2a9aeb6-8a94-49e7-ab46-84403560b6c8	2025-09-08	Warnings	Exact identifier application number: M015
Signature numbing cream	5% LIDOCAINE	Shengnan (Guangzhou) Cosmetics Co., LTD	3e1892de-378b-d2d0-e063-6294a90ad7db	2025-09-05	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