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 63 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydro GelGLYCERIN 20%Trifecta Pharmaceuticals USA LLC02e8e5d0-7844-39fe-e063-6394a90a57e12024-01-19WarningsExact identifier
application number: M016
White PetrolatumWHITE PETROLATUMSled Distribution, LLCe73a4b7a-7b27-abfc-e053-2995a90a35c22024-01-15WarningsExact identifier
application number: M016
Sunmark CaldiphenCALAMINE AND PRAMOXINE HYDROCHLORIDEStrategic Sourcing Services4f4d4c54-64b5-4e20-bed0-c7fb470b84342024-01-12WarningsExact identifier
application number: M016
EIGHT HOUR NIGHTDIMETHICONEREVLONb3b277f9-565a-636c-e053-2995a90a94d22024-01-12WarningsExact identifier
application number: M016
CeraVe Developed with Dermatologists Eczema Relief CreamyOATMEALL'Oreal USA Products Incbcf7b985-6875-4033-a412-1bb6d3afa6d82024-01-01WarningsExact identifier
application number: M016
CeraVe Developed with Dermatologists HealingPETROLATUML'Oreal USA Products Inc.1b3ad3e8-cbac-4a92-84e2-4f3ab4512d952023-12-31WarningsExact identifier
application number: M016
CeraVe Developed with Dermatologists Baby HealingPETROLATUML'Oreal USA Products Inc.fe665bbc-1172-4f59-acc6-8d5c179693b62023-12-31WarningsExact identifier
application number: M016
Quality Choice Anti-Itch ClearZINC ACETATE AND PRAMOXINE HYDROCHLORIDEChain Drug Market Associatione3c0c46d-3d85-411d-a543-009064cdd19e2023-12-28WarningsExact identifier
application number: M016
CeraVe Developed with Dermatologists Therapeutic HandDIMETHICONEL'Oreal USA Products Inc7fe49112-4180-415c-a380-768a8d6b21852023-12-28WarningsExact identifier
application number: M016
CalaclearPRAMOXINE HYDROCHLORIDE AND ZINC ACETATEPharma Nobis, LLCe42fccc2-1b4e-e7f3-e053-2a95a90aef392023-12-26WarningsExact identifier
application number: M016
Calamine Phenolated Topical SuspensionCALAMINE AND ZINC OXIDE AND PHENOLPharma Nobis, LLCe42fbdcc-3291-7761-e053-2995a90a71722023-12-26WarningsExact identifier
application number: M016
Humco CalagesicCALAMINE AND PRAMOXINE HYDROCHLORIDEPharma Nobis, LLCe42fb807-8cb4-ed25-e053-2995a90a67802023-12-26WarningsExact identifier
application number: M016
Leader Calamine PlusZINC OXIDE LOTIONCardinal Health, 110 dba Leader81f29789-f794-1e64-e053-2a91aa0ac85e2023-12-22WarningsExact identifier
application number: M016
CVS Calamine PlusZINC OXIDECVS Pharmacyb90cd214-d44a-4458-876d-59cc0795226d2023-12-22WarningsExact identifier
application number: M016
CalamineCALAMINE 8% AND ZINC OXIDE 8%Pharma Nobis, LLCe42f0bd6-3ad3-7e07-e053-2995a90a564a2023-12-22WarningsExact identifier
application number: M016
DDM CalamineCALAMINE 8% AND ZINC OXIDE 8%Discount Drug Mart5d53685b-ca4c-35c1-e053-2a91aa0aff6e2023-12-20WarningsExact identifier
application number: M016
DDM CalagesicZINC ACETATE AND PRAMOXINE HYDROCHLORIDEDiscount Drug Mart5d537a11-049e-0a8d-e053-2a91aa0aa0c32023-12-20WarningsExact identifier
application number: M016
Health Mart CalamineCALAMINE 8% AND ZINC OXIDE 8%Strategic Sourcing Services LLC349ea07d-79bc-46f3-9d60-85b40db51bbb2023-12-20WarningsExact identifier
application number: M016
Health Mart Witch HazelWITCH HAZELStrategic Sourcing Services LLC2a1d9b27-0bd4-4475-8218-ba0f5560a9692023-12-20WarningsExact identifier
application number: M016
Quality Choice CalamineCALAMINE 8% AND ZINC OXIDE 8%Chain Drug Market Association62fe653f-e861-472b-b193-4fdd9d25de8d2023-12-20WarningsExact 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