FDA.reportPublic FDA data

white rain Cocoa Butter Petroleum Jelly

Product NDC
52862-133
11-digit product format
528620133
Labeler code
52862
Product ID
52862-133_299b6ddb-70cb-a925-e063-6294a90a34ea
Type
HUMAN OTC DRUG
Nonproprietary name
White Petrolatum
Dosage form
JELLY
Route
TOPICAL
Labeler
INTERNATIONAL WHOLESALE INC.
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-01-08
Substance
PETROLATUM
Active strength
99.9 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
white rain Cocoa Butter Petroleum Jelly
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PETROLATUM99.9 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
1148414Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d7068e2b-c3b2-d16d-e053-2a95a90a6dd2Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52862-133-01white rain Cocoa Butter Petroleum Jelly170 g in 1 JARJELLY1702
52862-133-03white rain Cocoa Butter Petroleum Jelly50 g in 1 JARJELLY502
52862-133-04white rain Cocoa Butter Petroleum Jelly113 g in 1 JARJELLY1132
52862-133-05white rain Cocoa Butter Petroleum Jelly226 g in 1 JARJELLY2262
52862-133-06white rain Cocoa Butter Petroleum Jelly283 g in 1 JARJELLY2832
52862-133-07white rain Cocoa Butter Petroleum Jelly100 g in 1 JARJELLY1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52862-133WHITE RAIN COCOA BUTTER PETROLEUM JELLY (WHITE PETROLATUM) JELLY [INTERNATIONAL WHOLESALE INC.]2Current NDC, Legacy NDC, 6 package rows20241222_d7068e2b-c3b2-d16d-e053-2a95a90a6dd2.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 40 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EIGHT HOUR SKIN FRAGRANCE FREEPETROLATUMREVLONb61d6e2e-18dd-37d2-e053-2a95a90af57b2025-08-01WarningsExact identifier
application number: M016
Vigority Wild Yam CreamESTRIOL CREAMFOUNDATION COMMERCE INC39b2bef7-46c5-9ad5-e063-6294a90ae9832025-07-30WarningsExact identifier
application number: M016
Rugby Caldyphen ClearPRAMOXINE HYDROCHLORIDE AND ZINC ACETATE LOTIONRugby Laboratories9af3a740-ef97-26ce-e053-2a95a90a0ee12025-07-28WarningsExact identifier
application number: M016
Aveeno Baby Eczema Therapy Soothing Bath TreatmentOATMEALKenvue Brands LLCe7eb10b7-3950-49cb-ba73-11e7581b6be92025-07-25WarningsExact identifier
application number: M016
ProCure SkinGuardPETROLATUM 49.9%Twin Med LLC3a1721f6-1bb0-cd47-e063-6394a90a148e2025-07-25WarningsExact identifier
application number: M016
ProCure HydroCerinPETROLATUM 33%Twin Med LLC3ab7248d-b914-9fdd-e063-6294a90ac4c82025-07-24WarningsExact identifier
application number: M016
AD PREVENT OriginalAD PREVENT ORIGINALWellSpring Pharmaceutical Corporationcf73246e-81c1-42e9-a107-dc6c99cf7d012025-07-24WarningsExact identifier
application number: M016
Dimethicone 1 Skin ProtectantDIMETHICONEUniversal Distribution Center LLC2c5b96b9-24d6-4223-a63d-fe83d7c023682025-07-24WarningsExact identifier
application number: M016
Dr Butlers Soothing IncontinenceMINERAL OIL 59.8%, PETROLATUM 36.0%Beyond Health PA3a9d3796-fd05-fe57-e063-6294a90a0ac62025-07-23WarningsExact identifier
application number: M016
A and D plus EVITAMIN A, D AND E OINTMENTDerma Sciences Canada Inc.35aca592-bfd0-652f-e063-6394a90ac53e2025-07-22WarningsExact identifier
application number: M016
Petroleum JellyPETROLATUMDerma Sciences Canada Inc.3a895e6c-da8d-db9b-e063-6394a90ace402025-07-22WarningsExact identifier
application number: M016
Petroleum JellyPETROLEUM JELLYNeilMed Pharmaceuticals Inc.36bbbb1e-78e9-98f6-e063-6294a90a66d12025-07-21WarningsExact identifier
application number: M016
Mountain Ice EczemaCOLLOIDAL OATMEALMountainside Medical Equipment, Inc.1a91f33e-dd85-4d5a-b61c-e460a507e2922025-07-21WarningsExact identifier
application number: M016
Our Eczema RemedyCOLLOIDAL OATMEALFewer Better Things3a755b4c-47c8-9ca5-e063-6394a90af84a2025-07-21WarningsExact identifier
application number: M016
Aveeno DAILY MOISTURIZINGDIMETHICONEKenvue Brands LLC54a13b85-32b5-439d-a27a-8fba2cf442512025-07-16WarningsExact identifier
application number: M016
ProCure Moisture Barrier1% DIMETHICONE, 12% ZINC OXIDETwin Med LLC3988c83b-d4eb-1f09-e063-6394a90a45ad2025-07-14WarningsExact identifier
application number: M016
Avalon Organics Antidandruff ConditionerSALICYLIC ACIDThe Hain Celestial Group, Inc.66db1071-022a-aa19-e053-2a91aa0a8e392025-07-11WarningsExact identifier
application number: M016
Avalon Organics AntidandruffSALICYLIC ACIDThe Hain Celestial Group, Inc.66c7f730-64f3-4eef-e053-2a91aa0a42252025-07-11WarningsExact identifier
application number: M016
terrasil Infection Protection Wound Care Maximum StrengthALLANTOINAidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions9e7843e2-ca69-40f5-a4ce-da6b03ebe7f72025-07-11WarningsExact identifier
application number: M016
terrasil Skin RepairALLANTOINAidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions92a23c7f-6b89-49cb-93e2-49ab7a85c86d2025-07-11WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1148414petrolatum 99.9 % Topical GelPSNd7068e2b-c3b2-d16d-e053-2a95a90a6dd22
1148414petrolatum 0.999 MG/MG Topical GelSCDd7068e2b-c3b2-d16d-e053-2a95a90a6dd22
1148414petrolatum 99.9 % Topical JellySYd7068e2b-c3b2-d16d-e053-2a95a90a6dd22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52862-133-0152862013301170 g in 1 JAR (52862-133-01) 170 g2022-01-150000-00-00NoNoCurrent
52862-133-035286201330350 g in 1 JAR (52862-133-03) 50 g2022-01-150000-00-00NoNoCurrent
52862-133-0452862013304113 g in 1 JAR (52862-133-04) 113 g2022-01-150000-00-00NoNoCurrent
52862-133-0552862013305226 g in 1 JAR (52862-133-05) 226 g2022-01-150000-00-00NoNoCurrent
52862-133-0652862013306283 g in 1 JAR (52862-133-06) 283 g2022-01-150000-00-00NoNoCurrent
52862-133-0752862013307100 g in 1 JAR (52862-133-07) 100 g2022-01-150000-00-00NoNoCurrent