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 10 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pranicura 5	GLYCERIN, KAOLIN, CALAMINE, MENTHOL	Pranicura Products LLC	af520a58-3f3c-4d28-a41f-3ed8f74da095	2025-11-04	Warnings	Exact identifier application number: M015
ProCure ClamaPlex	ZINC OXIDE 20.625, MENTHOL 0.44, WHITE PETROLATUM 66.335	Twin Med LLC	3d366857-5178-9032-e063-6294a90a40f3	2025-11-01	Warnings	Exact identifier application number: M015
GNP Hemorrhoidal	MINERAL OIL, PETROLATUM, PHENYLEPHRINE, HCL	Amerisource Bergen	b0f0ef97-9add-717f-e053-2a95a90a0eb0	2025-10-30	Warnings	Exact identifier application number: M015
REMEDY Calazime Skin Protectant	CALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDE	Medline Industries, LP	1295cfcc-5b61-481b-964b-f53ffd0cb58e	2025-10-30	Warnings	Exact identifier application number: M015
Hemorrhoid Anesthetic	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL	Universal Distribution Center LLC	186c2d32-e8c5-d13d-e063-6294a90a2b0e	2025-10-30	Warnings	Exact identifier application number: M015
Workvie	LIDOCAINE HCL, MENTHOL	Marketites LLC	aebaffb5-58dd-ebd5-e053-2a95a90a14ed	2025-10-29	Warnings	Exact identifier application number: M015
hemorrhoidal	GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM	Publix Super Markets Inc	354a640c-bc7e-45c8-9df0-8b5b01767f5c	2025-10-29	Warnings	Exact identifier application number: M015
Hemorrhoidal	COCOA BUTTER, PHENYLEPHRINE HCL	Pharmacy Value Alliance LLC	903b77fc-02bf-73b6-e053-2a95a90ad4cc	2025-10-24	Warnings	Exact identifier application number: M015
Hemorrhoidal	COCOA BUTTER, PHENYLEPHRINE HCL	CVS Pharmacy	845fc11b-707d-2027-e053-2991aa0a1c8a	2025-10-24	Warnings	Exact identifier application number: M015
Calmol 4	ZINC OXIDE AND COCOA BUTTER	Resical Inc.	5516f800-d3fa-4b90-a3eb-c0bdf3183b9b	2025-10-24	Warnings	Exact identifier application number: M015
Hemorrhoidal	COCOA BUTTER, PHENYLEPHRINE HCL	Amerisourcebergen Drug Corporation	231a850a-bad6-9a30-e063-6394a90a0fdc	2025-10-24	Warnings	Exact identifier application number: M015
Signature Care Hemorrhoidal Cream (with applicator)	PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, GLYCERIN, PETROLATUM	BETTER LIVING BRANDS, LLC	b026a386-5e38-52ed-e053-2a95a90a6b0e	2025-10-24	Warnings	Exact identifier application number: M015
Americaine	BENZOCAINE	Insight Pharmaceuticals LLC	d13c022f-2f91-40b4-bd66-0cfc0e147a5f	2025-10-23	Warnings	Exact identifier application number: M015
Winco Hemorrhoidal	MINERAL OIL, PETROLATUM, AND PHENYLEPHRINE HYDROCHLORIDE	Winco Foods, LLC	04ca3ef1-fc6b-4683-b236-a75afc031fb5	2025-10-23	Warnings	Exact identifier application number: M015
Signature Care Medicated Cooling	WITCH HAZEL	Better Living Brands, LLC	b35dc719-a5a2-4839-870d-25313d3f7c9b	2025-10-22	Warnings	Exact identifier application number: M015
Family Care Hemorrhoidal	MINERAL OIL	United Exchange Corp	04375257-f4f3-48c3-a338-de43298b95eb	2025-10-22	Warnings	Exact identifier application number: M015
Family Wellness Hemorrhoidal	MINERAL OIL, PETROLATUM, AND PHENYLEPHRINE HCL	Family Dollar Services, Inc	fe3293bc-80b5-b60a-e053-6394a90a4ede	2025-10-22	Warnings	Exact identifier application number: M015
Xesso Rear Comfort Glide	LIDOCAINE	PREMIUM NATURAL COSMETICS INC	e9eb262e-a1c1-7d5c-e053-2a95a90a7c9f	2025-10-22	Warnings	Exact identifier application number: M015
Adellina Lidocaine Numbing Cream Anorectal(Hemorrhoidal) Cream	LIDOCAINE	Guangzhou Haishi Biological Technology Co., Ltd.	41a6d309-2722-1738-e063-6294a90a8a70	2025-10-21	Warnings	Exact identifier application number: M015
DERMOSCRIBE ICHYBUM	HYDROCORTISONE, CLIOQUINOL, ZINC OXIDE	DERMOSCRIBE PTY LTD	134a88a1-13e5-4da0-8270-c380b57aaeb7	2025-10-17	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