FDA.reportPublic FDA data

PURE PETROLATUM

Product NDC
51628-5600
11-digit product format
516285600
Labeler code
51628
Product ID
51628-5600_4fba8bc7-590e-f621-e063-6294a90ad8c9
Type
HUMAN OTC DRUG
Nonproprietary name
PETROLATUM
Dosage form
JELLY
Route
TOPICAL
Labeler
MY IMPORTS USA LLC
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-04-18
Substance
PETROLATUM
Active strength
100 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
PURE PETROLATUM
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PETROLATUM100 g/100g

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
4fba8bc7-590d-f621-e063-6294a90ad8c9Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51628-5600-1PURE PETROLATUM170 g in 1 JARJELLY1701

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 42 of 68 · 1,343 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Witch HazelWITCH HAZELTOP CARE (Topco Associates LLC)23b592f7-3af3-45ef-897a-fe33ab518b6d2025-04-14WarningsExact identifier
application number: M016
Witch HazelWITCH HAZELStrategic Sourcing Services LLCef3408db-de98-4a43-9215-f80fed14815c2025-04-14WarningsExact identifier
application number: M016
Petroleum JellyPETROLATUMWalgreens69bdd508-7c33-42c5-9a08-e56cf3eaebf32025-04-11WarningsExact identifier
application number: M016
4% 10gTATTOO Numb Cream4% LIDOCAINEShengnan (Guangzhou) Cosmetics Co., LTD322daa32-a74e-1fee-e063-6294a90a37aa2025-04-07WarningsExact identifier
application number: M016
Aluroderm ScarALLANTOINAsclemed USA, Inc.60656ca1-5218-4595-854e-19f1061def1e2025-04-01WarningsExact identifier
application number: M016
Dr. Maxs DiaperZINC OXIDEDr. Maxs LLC31bfa962-5e3b-c5d2-e063-6294a90ac1772025-04-01WarningsExact identifier
application number: M016
VaselineBABY HEALING JELLYConopco Inc. d/b/a Unileverbca3176f-86fe-5969-e053-2995a90a24192025-03-31WarningsExact identifier
application number: M016
4% TATTOO Numb Cream4% LIDOCAINEShengnan (Guangzhou) Cosmetics Co., LTD31646815-f591-c560-e063-6294a90ad11a2025-03-28WarningsExact identifier
application number: M016
Face Saver GelSKIN PROTECTANT GELNeat Feat Products Limited31563dd7-9f58-80f6-e063-6294a90a55712025-03-27WarningsExact identifier
application number: M016
PorphoseCOLLOIDAL OATMEAL TOPICAL SPRAYPorphose315951e0-899f-c968-e063-6294a90abe612025-03-27WarningsExact identifier
application number: M016
Petroleum JellyWHITE PETROLATUM JELLYWALGREENS1fc9eecd-fd25-827c-e063-6394a90a26a52025-03-26WarningsExact identifier
application number: M016
Cocoa Butter Petroleum JellyWHITE PETROLATUM JELLYWALGREENS1fcc9626-6058-e9b3-e063-6394a90ab5252025-03-26WarningsExact identifier
application number: M016
Nicotine PatchesNICOTINE PATCHESZhejiang FTA Shengzuozhi Biotechnology Co., LTD313b08e2-d764-96da-e063-6294a90ab7052025-03-25WarningsExact identifier
application number: M016
Eczema CreamECZEMA CREAMKyte Baby LLC30c943aa-d9dc-5c16-e063-6294a90a3c582025-03-20WarningsExact identifier
application number: M016
Koala Kubs Diaper Rash CreamDIAPER RASH CREAMMelaleuca, Inc.c6b3b0dd-22a8-16f7-e053-2a95a90a51ea2025-03-20WarningsExact identifier
application number: M016
Gold Bond Eczema Relief Medicated Skin Protectant CreamCOLLOIDAL OATMEALChattem, Inc.2b6b8342-878d-4588-8b24-6746d35d319d2025-03-19WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Cream Intense Hydration Skin Protectant Juicy PeachCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company30b20bd5-3b4f-8cc7-e063-6394a90a91062025-03-19WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Cream Intense Hydration Skin Protectant Fresh StrawberryCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company30b2744d-fb59-f383-e063-6294a90abd2a2025-03-19WarningsExact identifier
application number: M016
Dr. Butler Hemorrhoid and PerinealMINERAL OIL 59.8%,PETROLATUM 36%Beyond Health P.A.d17b6f16-6893-ce0a-e053-2a95a90aa23a2025-03-19WarningsExact identifier
application number: M016
Gold Bond Diabetics Medicated Dry Skin Relief Foot CreamDIMETHICONE, WHITE PETROLATUMChattem, Inc.b951d1cb-b81e-4d7f-9a67-8405daa896672025-03-19WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
204754petrolatum 100 % Topical JellyPSN4fba8bc7-590d-f621-e063-6294a90ad8c91
204754petrolatum 1 MG/MG Topical OintmentSCD4fba8bc7-590d-f621-e063-6294a90ad8c91
204754petrolatum 100 % Topical JellySY4fba8bc7-590d-f621-e063-6294a90ad8c91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51628-5600-151628560001170 g in 1 JAR (51628-5600-1) 170 g2026-04-18NoNoCurrent