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 12 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Signature Numb cream	5% LIDOCAINE	Shengnan (Guangzhou) Cosmetics Co., LTD	3d2ecb86-6bb1-2528-e063-6394a90a8d89	2025-08-25	Warnings	Exact identifier application number: M015
Cooling Perineal Pad Liners	COOLING PERINEAL	ELEEO BRANDS LLC	29a433bc-a833-ffc7-e063-6294a90a465a	2025-08-25	Warnings	Exact identifier application number: M015
Signature numbing cream	5% LIDOCAINE	Shengnan (Guangzhou) Cosmetics Co., LTD	3d3b771f-5e30-b23e-e063-6294a90a3fb2	2025-08-25	Warnings	Exact identifier application number: M015
Exchange Select Hemorrhoidal	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL	Army & Air Force Exchange Service	6c32af3e-5b60-4e3e-95c2-ada37a7d3b2a	2025-08-22	Warnings	Exact identifier application number: M015
Hemorrhoidal	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL	Padagis Israel Pharmaceuticals Ltd	43826c68-0a20-460d-a7b5-f3e12395a7d0	2025-08-22	Warnings	Exact identifier application number: M015
Barrier Protectant Cream	BARRIER CREAM	Cardinal Health	539d9aac-75cf-4efd-bb3e-b465563304ca	2025-08-21	Warnings	Exact identifier application number: M015
Lidocaine Patch	LIDOCAINE 4%	SLV PHARMACEUTICALS LLC DBA AUM PHARMACEUTICALS	0a31ba9a-8283-4bf8-b6c6-6e331465622f	2025-08-20	Warnings	Exact identifier application number: M015
VBBV Anorectal(Hemorrhoidal) Creams	LIDOCAINE	Jiashen International Trading Co., Ltd.	3cba84ea-5ee0-7ee3-e063-6294a90af11b	2025-08-19	Warnings	Exact identifier application number: M015
Hemorrhoidal	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL	Publix Super Markets Inc	7b360d3b-fb2b-4f35-a04d-203dd352933d	2025-08-19	Warnings	Exact identifier application number: M015
Good Sense Hemorrhoidal	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL	L. Perrigo Company	2492ee1b-01f1-46e7-8790-b6ebc48f2aff	2025-08-19	Warnings	Exact identifier application number: M015
Norms Hemorrhoid	PHENYLEPHRINE HYDROCHLORIDE, WITCH HAZEL	Totally Normal Company	3c98cc12-2476-9f73-e063-6394a90a6f23	2025-08-17	Warnings	Exact identifier application number: M015
Upside Down Pain Relief	BENZOCAINE, GLYCERIN	Fridababy, LLC	31c2cd25-1fec-5ec5-e063-6394a90a24b4	2025-08-15	Warnings	Exact identifier application number: M015
DG Health Hemorrhoidal	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL	Dolgencorp, LLC	d9f12a34-7bd1-4ba5-b34b-1b641f58271a	2025-08-12	Warnings	Exact identifier application number: M015
Norms Hemorrhoid	GLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HCL	Totally Normal Company	3bdf8c74-3db6-1805-e063-6394a90aaba0	2025-08-08	Warnings	Exact identifier application number: M015
Asteroid	MENTHOL, PETROLATUM, ZINC OXIDE	HEALTHTEX LIMITED	29d1e46d-0189-4f9e-9963-8a9de2757f28	2025-07-30	Warnings	Exact identifier application number: M015
Comfort Candy Hemorrhoidal	LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE	BOWLER ESTHETICS, INC	4951d984-3e86-4eb6-9505-2c506e22fda2	2025-07-23	Warnings	Exact identifier application number: M015
Doctor Butler Hemorrhoid and Fissure Advanced Formula	GLYCERIN 37.5%, LANOLIN 12.5%, LIDOCAINE 4%, ZINC OXIDE 5%	Beyond Health, PA	d2a769e2-afd0-aed2-e053-2995a90ad429	2025-07-23	Warnings	Exact identifier application number: M015
Dr Butlers Hemorrhoid	WITCH HAZEL 50%	Beyond Health, PA	3a9fea0c-b189-c77e-e063-6294a90a0583	2025-07-23	Warnings	Exact identifier application number: M015
Dr Butlers Advanced Hemorrhoid Relief	LIDOCAINE HCL 5%, PHENYLEPHRINE HCL 0.25%, WITCH HAZEL 50%	Beyond Health. PA	3aa0ee7a-3863-254d-e063-6394a90ad40e	2025-07-23	Warnings	Exact identifier application number: M015
Dr. Butler Hemorrhoid Treatment	PHENYLEPHRINE HYDROCHLORIDE 0.25%, WITCH HAZEL 50%	Beyond Health P.A.	d2d1c81c-6443-c4b7-e053-2995a90a14d7	2025-07-22	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