Z-Guard

Product NDC: 53329-137
11-digit product format: 533290137
Labeler code: 53329
Product ID: 53329-137_e9b198d3-31ae-4b43-e053-2995a90a900c
Type: HUMAN OTC DRUG
Nonproprietary name: White Petrolatum,Zinc Oxide
Dosage form: PASTE
Route: TOPICAL
Labeler: Medline Industries, LP
Application: M016
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2016-01-06
Marketing end: 0000-00-00
Substance: PETROLATUM; ZINC OXIDE
Active strength: 57 g/100g; g/100g
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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	53329-137		D	Discontinued by firm	2026-10-16
excluded package	package	53329-137	53329-137-14	D	Discontinued by firm	2026-10-16
excluded package	package	53329-137	53329-137-16	D	Discontinued by firm	2026-10-16
excluded package	package	53329-137	53329-137-44	D	Discontinued by firm	2026-10-16
excluded package	package	53329-137	53329-137-96	D	Discontinued by firm	2026-10-16

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 · 23 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
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53329-137-16	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53329-137-96	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53329-137-14	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53329-137-44	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53329-137-16	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53329-137-96	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53329-137-16	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53329-137-96	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53329-137-16	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53329-137-96	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53329-137-16	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53329-137-96	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53329-137-16	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53329-137-96	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53329-137-16	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53329-137-96	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53329-137-16	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53329-137-96	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53329-137-16	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53329-137-96	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	53329-137-16	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	53329-137-96	`ad56d346431e…`	`cc804d4bbf1e…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
53329-137-14	GM - Gram	53329-137	eceba76b-20b4-459e-beca-c2db39be675d	1	2024-04-05
53329-137-44	GM - Gram	53329-137	119ebc1f-0939-4219-bf2e-856d3a8414be	1	2019-06-19
53329-137-96	GM - Gram	53329-137	5eb0cff6-dbc3-4327-9660-676fc2abeb54	1	2024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53329-137	Z-GUARD (WHITE PETROLATUM,ZINC OXIDE) PASTE [MEDLINE INDUSTRIES, LP]	7	Legacy NDC	20240130_2b70b8c7-d6d5-4bd3-e054-00144ff88e88.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 35 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Witch Hazel	WITCH HAZEL	Meijer Distribution Inc	03f23b04-e7f7-49b7-e063-6294a90ad58a	2025-10-31	Warnings	Exact identifier application number: M016
Diaper Rash skin protectant	LANOLIN AND PETROLATUM	Universal Distribution Centre LLC	1852246a-6a1c-49ab-e063-6294a90a9048	2025-10-30	Warnings	Exact identifier application number: M016
FB HYDRATING HAND SANITIZER	FB HYDRATING HAND SANITIZER	FAMILY DOLLAR SERVICES, LLC	20b531c1-9ab0-5ff1-e063-6394a90a2975	2025-10-30	Warnings	Exact identifier application number: M016
FB HYDRATING HAND SANITIZER	FB HYDRATING HAND SANITIZER	FAMILY DOLLAR SERVICES, LLC	20b650bd-18fe-8696-e063-6394a90aa9a2	2025-10-30	Warnings	Exact identifier application number: M016
FB HYDRATING HAND SANITIZER	FB HYDRATING HAND SANITIZER	FAMILY DOLLAR SERVICES, LLC	20b5f354-3379-3d9f-e063-6294a90ae817	2025-10-30	Warnings	Exact identifier application number: M016
Boudreauxs	ZINC OXIDE	C.B. Fleet Company, Inc.	59d90652-a471-4f77-a3d5-88aad9dc9e13	2025-10-30	Warnings	Exact identifier application number: M016
CVS Cools Itch Fast	HYDROCORTISONE	CVS Pharmacy, Inc.	8a4544df-bbba-47d2-ada0-352757abc91f	2025-10-29	Warnings	Exact identifier application number: M016
Winco Maximum Strength Hydrocortisone	HYDROCORTISONE	WINCO FOODS, LLC	b1812ea3-78cc-607a-e053-2a95a90a0a10	2025-10-29	Warnings	Exact identifier application number: M016
Good Neighbor Pharmacy Skin Protectant	ZINC OXIDE	AMERISOURCE BERGEN	c28e63f1-34be-9206-e053-2995a90accf6	2025-10-29	Warnings	Exact identifier application number: M016
Remedy Nutrashield	DIMETHICONE	Medline Industries, LP	ed8a08a7-594c-46e2-b70f-b75b2960141f	2025-10-28	Warnings	Exact identifier application number: M016
American Red Cross Anti-Itch	HYDROCORTISONE 1.0%(W/W)	MY IMPORTS USA LLC	421da126-a1c4-54d7-e063-6394a90ac401	2025-10-27	Warnings	Exact identifier application number: M016
GeriGard	ZINC OXIDE	Geri-Gentle Corporation	05b67830-adc8-46b1-b0a0-a6cd2875e80c	2025-10-27	Warnings	Exact identifier application number: M016
Boudreauxs Butt Barrier	DIMETHICONE	C.B. Fleet Company, Inc.	06a5af4d-40dd-42a4-8368-4d6a772d1b3a	2025-10-27	Warnings	Exact identifier application number: M016
Boudreauxs Baby Shower Bundle	ZINC OXIDE	C.B. Fleet Company, Inc.	a289ed3c-3c7a-4eda-bf5e-139203d2e17e	2025-10-27	Warnings	Exact identifier application number: M016
WinCo Original Strength Anti-Itch	DIPHENHYDRAMINE HYDROCHLORIDE, AND ZINC ACETATE	WinCo Foods, LLC	ae74e163-ba1a-4d1e-aaeb-9976bd202674	2025-10-24	Warnings	Exact identifier application number: M016
Maximum Strength Moisture Barrier	PETROLATUM AND ZINC OXIDE	Derma Sciences Canada Inc.	41ee91c0-d196-cc0f-e063-6394a90a7b97	2025-10-24	Warnings	Exact identifier application number: M016
Tenderphor	SKIN PROTECTANT	GERI-GENTLE CORPORATION	e6763da3-cbd1-7a86-e053-2995a90a26c1	2025-10-23	Warnings	Exact identifier application number: M016
Boudreauxs	ZINC OXIDE	C.B. Fleet Company, Inc.	262278f6-7e4c-44ee-b40d-39662a239d73	2025-10-23	Warnings	Exact identifier application number: M016
American Red Cross Anti-Itch	HYDROCORTISONE 1.0%(W/W)	Zhejiang Guoyao Jingyue Aerosol Co., Ltd.	41b8cb00-a04e-52f0-e063-6294a90aabf7	2025-10-22	Warnings	Exact identifier application number: M016
WinCo Foods Hydrocortisone Cream Intensive Healing	HYDROCORTISONE	WINCO FOODS, LLC	ac4e0e24-9295-b83b-e053-2995a90a996f	2025-10-22	Warnings	Exact identifier application number: M016

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
53329-137-14	53329013714	57 g in 1 TUBE (53329-137-14)	57 g	2016-01-06	0000-00-00	No	No	Current
53329-137-16	53329013716	5 g in 1 PACKET (53329-137-16)	5 g	2016-01-06	0000-00-00	No	No	Current
53329-137-44	53329013744	113 g in 1 TUBE (53329-137-44)	113 g	2016-01-06	0000-00-00	No	No	Current
53329-137-96	53329013796	144 PACKET in 1 BOX (53329-137-96) > 5 g in 1 PACKET (53329-137-16)	144 packet	2016-01-06	0000-00-00	No	No	Current