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 38 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ProCure LanaCare	LANOLIN 30%	Twin Med LLC	3aad8395-6dc2-f600-e063-6294a90a6e9a	2025-09-15	Warnings	Exact identifier application number: M016
ProCure DryDrox	ALUMINUM HYDROXIDE GEL 2%	Twin Med LLC	3ab4efb6-bd31-2583-e063-6294a90a415b	2025-09-15	Warnings	Exact identifier application number: M016
ProCure Petroleum	100% WHITE PETROLATUM	Twin Med LLC	3eddf0e7-8e9d-a311-e063-6394a90ad156	2025-09-15	Warnings	Exact identifier application number: M016
NOURISHING HAND SANITIZER SPRAYS	CHLORHEXIDINE DIGLUCONATE	GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD	3e95a30c-8ed3-30ed-e063-6294a90a2417	2025-09-12	Warnings	Exact identifier application number: M016
I.C. Ivy Block	ZINC ACETATE	R & R Lotion, Inc	db263f4a-56a1-432c-b2e8-2a9bdd3ff129	2025-09-10	Warnings	Exact identifier application number: M016
RoyceDerm Eczema Relief Cream	COLLOIDAL OATMEAL 1%	RoyceDerm LLC	3e09f000-01d2-0d21-e063-6294a90ac548	2025-09-05	Warnings	Exact identifier application number: M016
Healing Hand Cream	ALLANTOIN	Carolina Cannabis Creations LLC	3dd5887f-a26b-01ef-e063-6394a90a0c52	2025-09-02	Warnings	Exact identifier application number: M016
OKeeffes Skin Repair Body Cream Eczema Relief	COLLOIDAL OATMEAL	The Gorilla Glue Company/O'Keeffe's Company	39e9ca98-d0e6-6b8f-e063-6394a90aa366	2025-09-01	Warnings	Exact identifier application number: M016
ProCure HydroCerin	PETROLATUM 33%	Twin Med LLC	3d379d5b-e939-9391-e063-6294a90a375c	2025-08-25	Warnings	Exact identifier application number: M016
Pure Petrolatum Jelly	PETROLATUM	MY IMPORTS USA LLC	3d1fd588-8d16-509c-e063-6394a90ad025	2025-08-24	Warnings	Exact identifier application number: M016
Kidgets Baby Petroleum Jelly	BABY PETROLEUM JELLY	MY IMPORTS USA LLC	3d2000da-a173-1fc3-e063-6294a90ad3a9	2025-08-24	Warnings	Exact identifier application number: M016
Foaming Facial Cleanser	GLYCERIN, NIACINAMIDE	Guangzhou Danting Bath&Body Care Industry Co. Ltd	396c1db9-a5d3-cc82-e063-6294a90a90bb	2025-08-23	Warnings	Exact identifier application number: M016
Pure Petrolatum Jelly	PETROLATUM	MY IMPORTS USA LLC	3cf22c5a-f9a0-4bfb-e063-6394a90af8dd	2025-08-22	Warnings	Exact identifier application number: M016
Kidgets Baby Petroleum Jelly with Vitamin A D	LANOLIN, PETROLATUM	MY IMPORTS USA LLC	3cf37fa7-6be4-b835-e063-6394a90ad406	2025-08-22	Warnings	Exact identifier application number: M016
Awaken Moisturizing Cream	DIMETHICONE	Guangzhou Danting Bath&Body Care Industry Co. Ltd	486c7f05-708a-44a1-8fc0-78344f5018db	2025-08-21	Warnings	Exact identifier application number: M016
Zinc Oxide 40%	DIAPER RASH SKIN PROTECTENT	ELEEO BRANDS LLC	2992285b-bcdb-c0da-e063-6294a90ac650	2025-08-19	Warnings	Exact identifier application number: M016
MedPride Vitamin A and D	WHITE PETROLATUM	Shield Line LLC	360085ae-29fc-41c9-9875-c902f197a871	2025-08-18	Warnings	Exact identifier application number: M016
Novita Petrolatum with Cocoa Butter	PETROLATUM	Shield line LLC	3e9c68e5-8983-1a18-e054-00144ff8d46c	2025-08-18	Warnings	Exact identifier application number: M016
Medpride	WHITE PETROLATUM	Shield Line LLC	0c4201e1-54f5-4d44-a31a-89aaa511d6b5	2025-08-18	Warnings	Exact identifier application number: M016
Novita Baby Petrolatum Jelly	PETROLATUM	Shield Line LLC	3e9cf8bf-929b-45bf-e054-00144ff8d46c	2025-08-18	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