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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct53329-137DDiscontinued by firm2026-10-15
excluded packagepackage53329-13753329-137-14DDiscontinued by firm2026-10-15
excluded packagepackage53329-13753329-137-16DDiscontinued by firm2026-10-15
excluded packagepackage53329-13753329-137-44DDiscontinued by firm2026-10-15
excluded packagepackage53329-13753329-137-96DDiscontinued by firm2026-10-15

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 · 23 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage53329-137-16d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage53329-137-96d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage53329-137-14d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage53329-137-44d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53329-137-16f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53329-137-96f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage53329-137-162ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage53329-137-962ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage53329-137-16a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage53329-137-96a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage53329-137-16cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage53329-137-96cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage53329-137-16cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage53329-137-96cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53329-137-16302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53329-137-96302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53329-137-16ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53329-137-96ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage53329-137-160efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage53329-137-960efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage53329-137-16ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage53329-137-96ad56d346431e…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 NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53329-137-14GM - Gram53329-137eceba76b-20b4-459e-beca-c2db39be675d12024-04-05
53329-137-44GM - Gram53329-137119ebc1f-0939-4219-bf2e-856d3a8414be12019-06-19
53329-137-96GM - Gram53329-1375eb0cff6-dbc3-4327-9660-676fc2abeb5412024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53329-137Z-GUARD (WHITE PETROLATUM,ZINC OXIDE) PASTE [MEDLINE INDUSTRIES, LP]7Legacy NDC20240130_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 21 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Daily MoisturizingDIMETHICONETopco Associates LLC47e54eee-70e0-4bfa-ae77-d61a6560a9e12026-02-13Warnings, Adverse reactionsExact identifier
application number: M016
Witch HazelWITCH HAZELTopco Associates LLC471a9f8d-ba12-41d3-a510-20c1a13ff8502026-02-13Warnings, Adverse reactionsExact identifier
application number: M016
Skin ProtectantPETROLATUMWakefern Food Corp.b799229b-f7ca-494c-afde-1fd096aef66e2026-02-13Warnings, Adverse reactionsExact identifier
application number: M016
Diaper RashZINC OXIDEWinCo Foods, LLC659cc8c7-6300-41c0-a684-c5fde7f2b1002026-02-12Warnings, Adverse reactionsExact identifier
application number: M016
Zinc OxideZINC OXIDEWalgreen Co.220f70e1-0802-4fe2-92d0-78dec557c9932026-02-12Warnings, Adverse reactionsExact identifier
application number: M016
Witch HazelWITCH HAZELWalgreen Co.417ae199-54bb-420f-a3cf-1c096062d78c2026-02-12Warnings, Adverse reactionsExact identifier
application number: M016
First Aid Beauty Dry Skin Rescue KitCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company4a93d029-d721-0bb5-e063-6294a90a17c42026-02-11WarningsExact identifier
application number: M016
Natouch Eczema WipesECZEMA WIPESNatouch LLC0a9756a4-2fa9-cd19-e063-6294a90a93ad2026-02-10WarningsExact identifier
application number: M016
EARTHS CARE Eczema CreamECZEMADLC Laboratories, Inc.17436fa0-d6c7-1052-e063-6294a90adae42026-02-09WarningsExact identifier
application number: M016
PetrolatumWHITE PETROLATUMRetail Business Services, LLCbf0c9494-0138-4346-9348-e235ca4d9e582026-02-06Warnings, Adverse reactionsExact identifier
application number: M016
Clear Anti-ItchPRAMOXINE HCL, ZINC ACETATERetail Business Services, LLCa80b8fee-2dd9-4640-a4f8-4cf940df85632026-02-06Warnings, Adverse reactionsExact identifier
application number: M016
Advanced HealingPETROLATUMRetail Business Services, LLC6e9121c8-5eb9-4d0b-86c5-b892e14bdab82026-02-06WarningsExact identifier
application number: M016
PetrolatumWHITE PETROLATUMRetail Business Services, LLCbf73c618-ed2f-4468-a51f-ff61c7b1f5062026-02-06Warnings, Adverse reactionsExact identifier
application number: M016
Daily MoisturizingDIMETHICONERetail Business Services, LLCc8a876e2-0a34-4c3d-a0bc-549dd3048e8a2026-02-06Warnings, Adverse reactionsExact identifier
application number: M016
PetroleumWHITE PETROLATUMSalado Sales Inc.f973e3a5-3b45-4842-99ce-dff676ae1f962026-02-06Warnings, Adverse reactionsExact identifier
application number: M016
Petroleum Skin ProtectantWHITE PETROLATUMPharmacy Value Alliance, LLC0ce03cd1-c48d-45cf-b11f-08bade55dcb62026-02-05Warnings, Adverse reactionsExact identifier
application number: M016
Daily MoisturizingDIMETHICONEPublix Super Markets, Inc.28ac9de4-2a63-4839-bed5-9bcc59ebeb2a2026-02-05Warnings, Adverse reactionsExact identifier
application number: M016
Witch HazelWITCH HAZELPublix Super Markets, Inc.0098c983-c518-4a14-8635-c7bdde7bff4f2026-02-05Warnings, Adverse reactionsExact identifier
application number: M016
TN Dickinsons Pain and Itch ReliefPRAMOXINE HYDROCHLORIDE AND ZINC ACETATEDickinson Brands Inc.537c9c27-ee81-4920-8e3f-21edb844c9cf2026-02-05WarningsExact identifier
application number: M016
Aveeno Eczema Therapy Nighttime Itch Relief BalmCOLLOIDAL OATMEALKenvue Brands LLCe3350a8f-b983-7c4d-e053-2a95a90a53f52026-02-04WarningsExact identifier
application number: M016

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53329-137-145332901371457 g in 1 TUBE (53329-137-14) 57 g2016-01-060000-00-00NoNoCurrent
53329-137-16533290137165 g in 1 PACKET (53329-137-16) 5 g2016-01-060000-00-00NoNoCurrent
53329-137-4453329013744113 g in 1 TUBE (53329-137-44) 113 g2016-01-060000-00-00NoNoCurrent
53329-137-9653329013796144 PACKET in 1 BOX (53329-137-96) > 5 g in 1 PACKET (53329-137-16) 144 packet2016-01-060000-00-00NoNoCurrent