FDA.reportPublic FDA data

Pure petroleum

Product NDC
36800-069
11-digit product format
368000069
Labeler code
36800
Product ID
36800-069_4ab7b9a4-9d02-5d92-e063-6394a90a8588
Type
HUMAN OTC DRUG
Nonproprietary name
White Petrolatum
Dosage form
JELLY
Route
TOPICAL
Labeler
Topco Associates LLC
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1991-08-15
Substance
PETROLATUM
Active strength
1 g/g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage36800-06936800-069-10DDiscontinued by firm2026-10-20

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 · 4 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…

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
Pure petroleum
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PETROLATUM1 g/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4T6H12BN9UInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
204754Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3babe2cf-9e6c-4f22-940f-c1fdf489f1c7Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-069-10Pure petroleum28.3 g in 1 TUBEJELLY28.316
36800-069-27Pure petroleum369 g in 1 JARJELLY36916
36800-069-54Pure petroleum106 g in 1 JARJELLY10616
36800-069-96Pure petroleum213 g in 1 JARJELLY21316

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PETROLATUMACTIVE INGREDIENT4T6H12BN9UPURE PETROLEUM (WHITE PETROLATUM) JELLY [TOPCO ASSOCIATES LLC]1
PETROLATUMACTIVE MOIETY4T6H12BN9UPURE PETROLEUM (WHITE PETROLATUM) JELLY [TOPCO ASSOCIATES LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-069PURE PETROLEUM (WHITE PETROLATUM) JELLY [TOPCO ASSOCIATES LLC]15Current NDC, Legacy NDC, 4 package rows20250322_3babe2cf-9e6c-4f22-940f-c1fdf489f1c7.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
204754petrolatum 100 % Topical JellyPSN3babe2cf-9e6c-4f22-940f-c1fdf489f1c716
204754petrolatum 1 MG/MG Topical OintmentSCD3babe2cf-9e6c-4f22-940f-c1fdf489f1c716
204754petrolatum 100 % Topical JellySY3babe2cf-9e6c-4f22-940f-c1fdf489f1c716

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-069-103680000691028.3 g in 1 TUBE (36800-069-10) 28.3 g1991-08-150000-00-00NoNoCurrent
36800-069-2736800006927369 g in 1 JAR (36800-069-27) 369 g1991-08-150000-00-00NoNoCurrent
36800-069-5436800006954106 g in 1 JAR (36800-069-54) 106 g1991-08-150000-00-00NoNoCurrent
36800-069-9636800006996213 g in 1 JAR (36800-069-96) 213 g1991-08-150000-00-00NoNoCurrent