Medline

Product NDC
53329-153
11-digit product format
533290153
Labeler code
53329
Product ID
53329-153_5996485c-7ed2-ecdb-e063-6294a90ad807
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
2023-05-01
Substance
ZINC OXIDE; WHITE PETROLATUM
Active strength
150; 490 mg/g; mg/g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-08-27 00:01 UTC · source 2025-08-26excluded productproduct53329-153IInactivated by FDAexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53329-15353329-153-44IInactivated by FDAexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

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
ZINC OXIDE150 mg/g
WHITE PETROLATUM490 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1494207Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0073de92-585d-e01a-e063-6394a90a2ec2Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53329-153-44Medline113 g in 1 TUBEPASTE1134

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53329-153-44GM - Gram53329-15377ce5cc5-68f9-4fd8-9316-01c6e06c2d3012024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53329-153MEDLINE (WHITE PETROLATUM, ZINC OXIDE) PASTE [MEDLINE INDUSTRIES, LP]2Current NDC, 1 package rows20231230_0073de92-585d-e01a-e063-6394a90a2ec2.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 36 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
JAFRA Fruteria Coco Fresco Lip BalmDIMETHICONEDistribuidora Comercial Jafra, S.A. de C.V.9895a320-8a74-4b27-9bf1-4b492f89888c2025-10-21WarningsExact identifier
application number: M016
JAFRA Fruteria So CitricoDIMETHICONEDistribuidora Comercial Jafra, S.A. de C.V.a68d6cda-2268-440a-9ca6-677c4e3ea0e72025-10-21WarningsExact identifier
application number: M016
JAFRA Fruteria Very Verde Lip BalmDIMETHICONEDistribuidora Comercial Jafra, S.A. de C.V.4f0de70b-7ebe-4381-9b46-d5b334f426e02025-10-21WarningsExact identifier
application number: M016
Gelmicin Hydrocortisone with AloeHYDROCORTISONEUnited Exchange Corp.bb64eca4-799d-4711-e053-2995a90af4032025-10-21WarningsExact identifier
application number: M016
QuadrydernHYDROCORTISONEProductos Zapotol Corpa087ad4d-9a65-19c3-e053-2995a90ab3412025-10-21WarningsExact identifier
application number: M016
VENROCKROSEMARY OILGuangzhou Oupeng Cosmetics Co., Ltd4156b669-1817-6280-e063-6394a90aaf3a2025-10-17WarningsExact identifier
application number: M016
Gerigentle-Vitamins A and DPETROLATUMGeri-Gentle Corporationc36c74f7-975b-4e4c-99e3-e6921d782c712025-10-17WarningsExact identifier
application number: M016
Seacall Dexamethasone Ointment.DEXAMETHASONE OINTMENTGuangdong Quadrant Ecological Technology Co., Ltd.201adf67-773c-34a2-e063-6394a90ac5252025-10-15WarningsExact identifier
application number: M016
MedlineZINC OXIDEMedline Industries, LPdae45414-7401-9536-e053-2a95a90a0a862025-10-15WarningsExact identifier
application number: M016
Curology Barrier BalmSKIN BARRIER BALMCurology04b2ba38-0f81-be51-e063-6294a90af8212025-10-15WarningsExact identifier
application number: M016
PetroleumWHITE PETROLATUMMedline Industries, LP34f3581f-39ba-4f28-9237-52f3820ab4c02025-10-09WarningsExact identifier
application number: M016
Facial FortressPYRITHIONE ZINCPediatric Solutions, LLCcdd3c52e-4c32-46c1-bdb3-957b164190bb2025-10-08WarningsExact identifier
application number: M016
Happy CappyPYRITHIONE ZINCPediatric Solutions, LLC3d3828d8-ee15-4aff-99d1-a121f0102a002025-10-08WarningsExact identifier
application number: M016
Purforma Advanced Hand Sanitizer 70% AlcoholHAND SANITIZER 70% ALCOHOLSpartan Chemical Company, Inc.06bd825d-914f-5ca7-e063-6394a90aec492025-10-06WarningsExact identifier
application number: M016
Scar Reducer Intensive Herbal and NutrientALLANTOINQuantum, Inc5197f1fa-aae5-406c-97d9-635b8c1a88a82025-10-06WarningsExact identifier
application number: M016
PURE SOL SPF 30 LIP BALM CACOA BUTTERZINC OXIDEBrand 2022b LLC40537561-d334-5859-e063-6394a90a92a72025-10-04WarningsExact identifier
application number: M016
PURE SOL SPF15 Lip Gloss originalZINC OXIDEBrand 2022b LLC4056e49a-2976-38f9-e063-6394a90a786d2025-10-04WarningsExact identifier
application number: M016
PURE SOL SPF15 Lip Gloss Nudie roseZINC OXIDEBrand 2022b LLC4057b0e2-1c31-abae-e063-6294a90a053d2025-10-04WarningsExact identifier
application number: M016
PURE SOL SPF15 Lip Gloss Pink coralZINC OXIDEBrand 2022b LLC405865dd-7d0e-048d-e063-6394a90ab1052025-10-04WarningsExact identifier
application number: M016
HealthWise Medicated Diabetic Foot CreamDIMETHICONE, PETROLATUMVeridian Healthcare164f4cd8-975a-40d5-e063-6394a90ae7d52025-10-02WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1494207petrolatum 49 % / zinc oxide 15 % PastePSN0073de92-585d-e01a-e063-6394a90a2ec24
1494207petrolatum 0.49 MG/MG / zinc oxide 0.15 MG/MG PasteSCD0073de92-585d-e01a-e063-6394a90a2ec24
1494207Petrolatum 0.49 MG/MG / ZNO 0.15 MG/MG PasteSY0073de92-585d-e01a-e063-6394a90a2ec24
1494207petrolatum 49 % / zinc oxide 15 % PasteSY0073de92-585d-e01a-e063-6394a90a2ec24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
53329-153-4453329015344113 g in 1 TUBE (53329-153-44) 113 g2023-05-01NoNoCurrent