FDA.reportPublic FDA data

ProCure Petroleum

Product NDC
55681-049
11-digit product format
556810049
Labeler code
55681
Product ID
55681-049_42c4f1ea-a4a9-2c44-e063-6294a90a18d2
Type
HUMAN OTC DRUG
Nonproprietary name
100% White Petrolatum
Dosage form
JELLY
Route
TOPICAL
Labeler
Twin Med LLC
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-12-01
Substance
WHITE PETROLATUM
Active strength
100 g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
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
ProCure Petroleum
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
WHITE PETROLATUM100 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
B6E5W8RQJ4Internal 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
3eddf0e7-8e9d-a311-e063-6394a90ad156Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55681-049-02ProCure Petroleum56.6 g in 1 TUBEJELLY56.62
55681-049-05ProCure Petroleum5 g in 1 PACKETJELLY52
55681-049-13ProCure Petroleum369 g in 1 JARJELLY3692
55681-049-14ProCure Petroleum144 in 1 CARTONJELLY1442

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 20 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diaper RashZINC OXIDETarget Corporation8059f489-f144-4de5-9454-ac6c1af35dd22026-02-18Warnings, Adverse reactionsExact identifier
application number: M016
Coconut Milk and Shea Petroleum JellyWHITE PETROLATUMTarget Corporationc78d9864-92e0-4ad8-8a9b-9752ac6784e82026-02-18Warnings, Adverse reactionsExact identifier
application number: M016
PetroleumWHITE PETROLATUMStrategic Sourcing Services LLC043375b2-e636-4822-9e05-df2327d299862026-02-17Warnings, Adverse reactionsExact identifier
application number: M016
PetroleumWHITE PETROLATUMStrategic Sourcing Services LLC3ade1f7f-a870-4f77-96b9-f63bf4cdf5ae2026-02-17Warnings, Adverse reactionsExact identifier
application number: M016
Pure petroleumWHITE PETROLATUMValu Merchandisers Company4113bb6e-070a-4116-a8d6-12c6b4475beb2026-02-16Warnings, Adverse reactionsExact identifier
application number: M016
Diaper RashZINC OXIDEValu Merchandisers Companye5465ddd-e38c-44a4-bb9b-3edbc636576d2026-02-16Warnings, Adverse reactionsExact identifier
application number: M016
PetroleumWHITE PETROLATUMValu Merchandisers Company8b8decec-e921-4ff9-bb49-7e38e34724f62026-02-16Warnings, Adverse reactionsExact identifier
application number: M016
Daily MoisturizingDIMETHICONEValu Merchandisers Company0cccadd7-11f3-5d1f-e063-6294a90a55c42026-02-16Warnings, Adverse reactionsExact identifier
application number: M016
Witch HazelWITCH HAZELValu Merchandisers Company7c6fa37f-79b8-4409-b7a9-3f02332f887a2026-02-16Warnings, Adverse reactionsExact identifier
application number: M016
Diaper RashZINC OXIDEUnited Natural Foods, Inc. dba UNFI014d0028-486e-4f1c-a14f-8162e393ebca2026-02-16Warnings, Adverse reactionsExact identifier
application number: M016
PetroleumWHITE PETROLATUMUnited Natural Foods, Inc. dba UNFI29a3a719-5e8b-407d-b9d9-bdba267582922026-02-16Warnings, Adverse reactionsExact identifier
application number: M016
Diaper RashZINC OXIDETopco Associates LLC8acb1b47-70ed-4aa2-a7c0-e807042affc72026-02-13Warnings, Adverse reactionsExact identifier
application number: M016
CalamineFERRIC OXIDE REDTopco Associates LLC2b32e720-ac71-4d60-bc06-e28a00f8a4502026-02-13Warnings, Adverse reactionsExact identifier
application number: M016
Pure petroleumWHITE PETROLATUMTopco Associates LLC3babe2cf-9e6c-4f22-940f-c1fdf489f1c72026-02-13Warnings, Adverse reactionsExact identifier
application number: M016
Clear Anti ItchPRAMOXINE HCL, ZINC ACETATETopco Associates LLC8d3d1ff5-4868-495d-807c-e45aa2176f632026-02-13Warnings, Adverse reactionsExact identifier
application number: M016
HealingPETROLATUMTopco Associates LLCb929b159-4af5-4a03-8e7c-676a6ba2bf552026-02-13Warnings, Adverse reactionsExact identifier
application number: M016
CalamineCALAMINE, PRAMOXINE HCLTopco Associates LLC15d1ae3f-509c-4e6b-8f0c-cf92656803582026-02-13Warnings, Adverse reactionsExact identifier
application number: M016
PetroleumWHITE PETROLATUMTopco Associates LLCcd7f1727-0b6e-4993-9820-43783994efa12026-02-13Warnings, Adverse reactionsExact identifier
application number: M016
DimethiconeDIMETHICONETopco Associates LLCf37f17f7-f084-4b74-8361-178d2315a4762026-02-13Warnings, Adverse reactionsExact identifier
application number: M016
Baby Eczema TherapyCOLLOIDAL OATMEALTopco Associates LLC4f6af42c-f41e-455f-b94b-3793bf0b9a3f2026-02-13Warnings, Adverse reactionsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
204754petrolatum 100 % Topical JellyPSN3eddf0e7-8e9d-a311-e063-6394a90ad1562
204754petrolatum 1 MG/MG Topical OintmentSCD3eddf0e7-8e9d-a311-e063-6394a90ad1562
204754petrolatum 100 % Topical JellySY3eddf0e7-8e9d-a311-e063-6394a90ad1562

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55681-049-025568100490256.6 g in 1 TUBE (55681-049-02) 56.6 g2025-12-01NoNoCurrent
55681-049-05556810049055 g in 1 PACKET5 gHistorical
55681-049-1355681004913369 g in 1 JAR (55681-049-13) 369 g2025-12-01NoNoCurrent
55681-049-1455681004914144 PACKET in 1 CARTON (55681-049-14) / 5 g in 1 PACKET (55681-049-05) 144 packet2025-12-01NoNoCurrent