FDA.reportPublic FDA data

Shea Butter Petroleum Jelly

Product NDC
30400-501
11-digit product format
304000501
Labeler code
30400
Product ID
30400-501_29768db2-7b93-f182-e063-6394a90a0ad3
Type
HUMAN OTC DRUG
Nonproprietary name
Petrolatum Jelly
Dosage form
JELLY
Route
TOPICAL
Labeler
Jell Pharmaceuticals Pvt. Ltd.
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-05-10
Substance
PETROLATUM
Active strength
99.6 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
Shea Butter Petroleum Jelly
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PETROLATUM99.6 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
1252009Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
cd848f33-e863-d3af-e053-2a95a90a45b1Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
30400-501-01Shea Butter Petroleum Jelly368 g in 1 JARJELLY3682
30400-501-02Shea Butter Petroleum Jelly49 g in 1 JARJELLY492
30400-501-03Shea Butter Petroleum Jelly100 g in 1 JARJELLY1002
30400-501-04Shea Butter Petroleum Jelly113 g in 1 JARJELLY1132
30400-501-05Shea Butter Petroleum Jelly170 g in 1 JARJELLY1702
30400-501-06Shea Butter Petroleum Jelly425 g in 1 JARJELLY4252
30400-501-07Shea Butter Petroleum Jelly226 g in 1 JARJELLY2262
30400-501-08Shea Butter Petroleum Jelly283 g in 1 JARJELLY2832

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
30400-501SHEA BUTTER PETROLEUM JELLY (PETROLATUM JELLY) JELLY [JELL PHARMACEUTICALS PVT. LTD.]2Current NDC, Legacy NDC, 8 package rows20241219_cd848f33-e863-d3af-e053-2a95a90a45b1.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 43 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
Gold Bond Eczema Relief Medicated Hand CreamCOLLOIDAL OATMEALChattem, Inc.27457bc5-3edc-4c8b-b8a2-eaf09b511cf82025-03-19WarningsExact identifier
application number: M016
Nicotine PatchesNICOTINE PATCHESZhejiang FTA Shengzuozhi Biotechnology Co., LTD30a977c3-6862-670e-e063-6294a90aeb2f2025-03-18WarningsExact identifier
application number: M016
YVTYVT Copper Peptides Face SerumCOPPER TRIPEPTIDE-1Beijing JUNGE Technology Co., Ltd.306f2d48-43b8-359a-e063-6394a90a06dc2025-03-16Boxed warning, WarningsExact identifier
application number: M016
Dr Talbots Cooling Perineal PadWATER, ALOE BARBADENSIS LEAF JUICE, BIOFLAVONOIDS, CALENDULA OFFICINALIS FLOWER EXTRACT, CHAMOMILLA RECUTITA FLOWER EXTRACT, CITRIC ACID, DECYL GLUCOSIDE, GLYCERIN, LACTIC ACID, LEVULINIC ACID, MENTHA PIPERITA (PEPPERMINT) OIL, SODIUM COCOAMPHOACETATE, POTASSIUM SORBATETalbot's Pharmaceuticals family Products, LLC.242277e2-ff26-ad4e-e063-6394a90ab3172025-03-14WarningsExact identifier
application number: M016
RID Poison Ivy Rash ReliefCALAMINE AND ZINC OXIDEOystershell Consumer Health Inc.36c3af9a-2646-4427-e063-6394a90a2c5e2025-03-13WarningsExact identifier
application number: M016
Aavini Double Layer Brightening Spot Correcting Essence OilAAVINI DOUBLE LAYER BRIGHTENING SPOT CORRECTING ESSENCE OILQingyuan Moksha Biotechnology Co., Ltd.2ff89a13-3969-2df1-e063-6394a90ac0d32025-03-10WarningsExact identifier
application number: M016
5% Signature Numb cream5% LIDOCAINEShengnan (Guangzhou) Cosmetics Co., LTD3008bbeb-abba-5cdb-e063-6294a90ae4832025-03-10WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Cream Intense Hydration Skin Protectant Cucumber MelonCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company2fc4745c-fac9-7861-e063-6294a90a3f142025-03-07WarningsExact identifier
application number: M016
AD Skin ProtectantAD SKIN PROTECTANTWellSpring Pharmaceutical Corporationd26f1312-2e1b-4106-bc48-a336d4e034ad2025-03-07WarningsExact identifier
application number: M016
Aveeno Baby Eczema Therapy Nighttime BalmOATMEALKenvue Brands LLC04d90e45-c2ee-4122-b919-a0eb6d11b59a2025-03-04WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1252009petrolatum 99.6 % Topical GelPSNcd848f33-e863-d3af-e053-2a95a90a45b12
1252009petrolatum 0.996 MG/MG Topical GelSCDcd848f33-e863-d3af-e053-2a95a90a45b12
1252009white petrolatum 99.6 % Topical GelSYcd848f33-e863-d3af-e053-2a95a90a45b12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
30400-501-0130400050101368 g in 1 JAR (30400-501-01) 368 g2021-10-110000-00-00NoNoCurrent
30400-501-023040005010249 g in 1 JAR (30400-501-02) 49 g2021-10-110000-00-00NoNoCurrent
30400-501-0330400050103100 g in 1 JAR (30400-501-03) 100 g2021-10-110000-00-00NoNoCurrent
30400-501-0430400050104113 g in 1 JAR (30400-501-04) 113 g2021-10-110000-00-00NoNoCurrent
30400-501-0530400050105170 g in 1 JAR (30400-501-05) 170 g2021-10-110000-00-00NoNoCurrent
30400-501-0630400050106425 g in 1 JAR (30400-501-06) 425 g2021-10-110000-00-00NoNoCurrent
30400-501-0730400050107226 g in 1 JAR (30400-501-07) 226 g2021-10-110000-00-00NoNoCurrent
30400-501-0830400050108283 g in 1 JAR (30400-501-08) 283 g2021-10-110000-00-00NoNoCurrent