FDA.reportPublic FDA data

COCOA BUTTER PETROLEUM jelly

Product NDC
52000-124
11-digit product format
520000124
Labeler code
52000
Product ID
52000-124_ffe3f8cb-02cc-44e8-9b37-4db81fde2b04
Type
HUMAN OTC DRUG
Nonproprietary name
Petrolatum
Dosage form
CREAM
Route
TOPICAL
Labeler
Universal Distribution Center LLC
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-07-27
Substance
PETROLATUM
Active strength
30 g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
COCOA BUTTER PETROLEUM jelly
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PETROLATUM30 g/100mL

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
1037285Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c1b10d34-2905-4ad6-8f90-7f9800de2b46Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52000-124-35COCOA BUTTER PETROLEUM jelly133 mL in 1 TUBECREAM1332

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52000-124COCOA BUTTER PETROLEUM JELLY (PETROLATUM) CREAM [UNIVERSAL DISTRIBUTION CENTER LLC]2Current NDC, Legacy NDC, 1 package rows20241212_c1b10d34-2905-4ad6-8f90-7f9800de2b46.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 1 of 70 · 1,385 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hair Regrowth FoamGLYCERINShantou Ouhoe Technology Co., Ltd.59ef5953-e96f-5707-e063-6294a90a30942026-08-26WarningsExact identifier
application number: M016
Acne ReliefSALICYLIC ACID,NIACINAMIDE,PANTHENOL.Guangzhou Senmai Biotechnology Co.,Ltd.59db0143-de57-59d2-e063-6294a90a32a82026-08-25WarningsExact identifier
application number: M016
Witch HazelWITCH HAZELYour Military Exchanges4079fd56-55f3-4e69-93e0-7590c07fb7942026-08-25Warnings, Adverse reactionsExact identifier
application number: M016
Salicylic Acid Acne Gel CleanserSALICYLIC ACID,PANTHENOLGuangzhou Senmai Biotechnology Co.,Ltd.59eb395b-493b-efc9-e063-6294a90aa8912026-08-25WarningsExact identifier
application number: M016
ClaravieDIMETHICONEGentell LLC59c6da39-b5f1-8253-e063-6394a90a0e8f2026-08-24WarningsExact identifier
application number: M016
MUSTELA Diaper Rash 1 2 3ZINC OXIDEExpanscience Laboratories d/b/a Mustela59cf1d1e-e951-9d58-e063-6394a90af0f32026-08-24WarningsExact identifier
application number: M016
ClaravieZINC OXIDE, DIMETHICONEGentell LLC598a5c0b-1e2f-1335-e063-6394a90ac4f42026-08-21WarningsExact identifier
application number: M016
MUSTELA Diaper Rash 1 2 3ZINC OXIDEExpanscience Laboratories d/b/a Mustela163f388e-849d-4b7e-93c1-9045d77a9ec22026-08-21WarningsExact identifier
application number: M016
MedlineWHITE PETROLATUM, ZINC OXIDEMedline Industries, LP0073de92-585d-e01a-e063-6394a90a2ec22026-08-21WarningsExact identifier
application number: M016
Mederma PMDIMETHICONEL Perrigo Company8c728904-28f4-4333-a9ea-20996fd1b0072026-08-21WarningsExact identifier
application number: M016
Earths Care Hemorrhoid ReliefWITCH HAZEL AND MENTHOL, UNSPECIFIED FORMDLC Laboratories, Inc.e860d65b-126d-4d77-8003-9d1381849ab52026-08-20WarningsExact identifier
application number: M016
ClaraViePETROLATUMGentell LLC596987e4-4205-b911-e063-6294a90aa5702026-08-19WarningsExact identifier
application number: M016
ClaraVieZINC OXIDEGentell LLC596abd98-17d7-2a22-e063-6294a90af57d2026-08-19WarningsExact identifier
application number: M016
Claravie Skin Repair CreamDIMETHICONEGentell LLC596ae269-172e-aef5-e063-6394a90a4e2a2026-08-19WarningsExact identifier
application number: M016
ClaravieLANOLINGentell LLC596c1b73-e34d-c97d-e063-6394a90ada1b2026-08-19WarningsExact identifier
application number: M016
ClaraVieMENTHOL, ZINC OXIDEGentell LLC596c467f-a056-ea78-e063-6394a90a79f22026-08-19WarningsExact identifier
application number: M016
ClaraVieLANOLINGentell LLC596fe32d-be34-0635-e063-6394a90a2fc02026-08-19WarningsExact identifier
application number: M016
MedprideZINC OXIDEShield Line LLCe2689cae-e347-4c0b-825b-6281a0b7c2f12026-08-18WarningsExact identifier
application number: M016
Eczema Skin Relief CreamCOLLOIDAL OATMEALCVS Health98fac854-f7b0-4c6e-888d-1bdc6b9323b92026-08-17WarningsExact identifier
application number: M016
Zinc OxideZINC OXIDEADUSA Distribution, LLC5940399c-31e3-6d51-e063-6294a90a8e7c2026-08-17Warnings, Adverse reactionsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1037285petrolatum 30 % Topical GelPSNc1b10d34-2905-4ad6-8f90-7f9800de2b462
1037285petrolatum 0.3 MG/MG Topical GelSCDc1b10d34-2905-4ad6-8f90-7f9800de2b462
1037285petrolatum 30 % Topical GelSYc1b10d34-2905-4ad6-8f90-7f9800de2b462
1037285petrolatum 30 % Topical JellySYc1b10d34-2905-4ad6-8f90-7f9800de2b462

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52000-124-3552000012435133 mL in 1 TUBE (52000-124-35) 133 ml2015-07-270000-00-00NoNoCurrent