FDA.reportPublic FDA data

Medline

Product NDC
53329-144
11-digit product format
533290144
Labeler code
53329
Product ID
53329-144_58c68145-e969-316f-e063-6394a90a69df
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 DRUG
Marketing start
2023-09-01
Substance
WHITE PETROLATUM; ZINC OXIDE
Active strength
57; 17 g/100g; g/100g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Medline
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
WHITE PETROLATUM57 g/100g
ZINC OXIDE17 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
B6E5W8RQJ4Internal UNII lookup
SOI2LOH54ZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1494214Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
087d66ff-1a8c-dcb2-e063-6294a90a2f8cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53329-144-14Medline57 g in 1 TUBEPASTE573
53329-144-16Medline4 g in 1 PACKETPASTE43
53329-144-44Medline113 g in 1 TUBEPASTE1133
53329-144-96Medline144 in 1 BOXPASTE1443

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53329-144MEDLINE (WHITE PETROLATUM, ZINC OXIDE) PASTE [MEDLINE INDUSTRIES, LP]2Current NDC, 4 package rows20240130_087d66ff-1a8c-dcb2-e063-6294a90a2f8c.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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1494214petrolatum 57 % / zinc oxide 17 % PastePSN087d66ff-1a8c-dcb2-e063-6294a90a2f8c3
1494214petrolatum 0.57 MG/MG / zinc oxide 0.17 MG/MG PasteSCD087d66ff-1a8c-dcb2-e063-6294a90a2f8c3
1494214Petrolatum 0.57 MG/MG / ZNO 0.17 MG/MG PasteSY087d66ff-1a8c-dcb2-e063-6294a90a2f8c3
1494214petrolatum 57 % / zinc oxide 17 % PasteSY087d66ff-1a8c-dcb2-e063-6294a90a2f8c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
53329-144-145332901441457 g in 1 TUBE (53329-144-14) 57 g2023-09-01NoNoCurrent
53329-144-16533290144164 g in 1 PACKET (53329-144-16) 4 g2023-09-01NoNoCurrent
53329-144-4453329014444113 g in 1 TUBE (53329-144-44) 113 g2023-09-01NoNoCurrent
53329-144-9653329014496144 PACKET in 1 BOX (53329-144-96) / 4 g in 1 PACKET (53329-144-16) 144 packet2023-09-01NoNoCurrent