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 11 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Daily MoisturizingDIMETHICONEAldi, Inc118a1a07-7283-4353-97b5-6ac3b1cc14302026-05-08Warnings, Adverse reactionsExact identifier
application number: M016
DoveANTIBACTERIAL CARE MOISTURIZING CREAMConopco Inc. d/b/a/ Unilever5150f48c-ff0c-ce39-e063-6394a90ad4242026-05-08WarningsExact identifier
application number: M016
Seedlings Diaper Rash CreamZINC OXIDEYoung Living Essential Oils, LC.4d8aeaba-ddb1-6f74-e054-00144ff88e882026-05-08WarningsExact identifier
application number: M016
Nail Repairs PatchesGLYCERINShantou Ximonth Biotechnology Co., Ltd.5120b708-047a-1182-e063-6394a90a74c32026-05-06WarningsExact identifier
application number: M016
AOAO Acne Buster Salicylic Acid Drying SerumZINC OXIDE,NIACINAMIDE,COLLOIDAL SULFUR,AZELAIC ACID,SALICYLIC ACID.Guangzhou Senmai Biotechnology Co.,Ltd.512185a5-5c1d-ef9f-e063-6394a90a81af2026-05-06WarningsExact identifier
application number: M016
AKOLKOL TOENAIL FUNGUS TREATMENTGLYCERINShantou Ximonth Biotechnology Co., Ltd.5121c341-e5e9-2b36-e063-6394a90a93b82026-05-06WarningsExact identifier
application number: M016
Beyond Good Diaper RashZINC OXIDEBabylist, Inc512b62df-4f08-d839-e063-6294a90ab52f2026-05-06WarningsExact identifier
application number: M016
Acne Buster Salicylic Acid Drying SerumZINC OXIDE,NIACINAMIDE,COLLOIDAL SULFUR,AZELAIC ACID,SALICYLIC ACID.Guangzhou Senmai Biotechnology Co.,Ltd.4c531280-bc5b-1cf2-e063-6394a90a034a2026-05-05WarningsExact identifier
application number: M016
PEGO Acne Buster Salicylic Acid Drying SerumZINC OXIDE,NIACINAMIDE,COLLOIDAL SULFUR,AZELAIC ACID,SALICYLIC ACID.Guangzhou Senmai Biotechnology Co.,Ltd.511eaced-c4d8-ae94-e063-6394a90a320e2026-05-05WarningsExact identifier
application number: M016
Rugby Gas reliefSIMETHICONERugby Laboratories9b84f74f-8609-489d-b411-3103afa1b5c22026-05-04WarningsExact identifier
application number: M016
Vitamin A and DPETROLATUMAldermed Inc.3f13a15c-8b64-48f0-a459-853b9097bc312026-05-04WarningsExact identifier
application number: M016
Zinc Oxide Skin ProtectantZINC OXIDE 20%Aldermed Inc.a55ac5b4-bac7-4d2a-8ac8-c3eaf7e89e522026-05-04WarningsExact identifier
application number: M016
Petroleum JellyWHITE PETROLATUMAldermed Inc.4e02af41-db86-46d8-a97d-332d84eced6f2026-05-04WarningsExact identifier
application number: M016
Daily MoisturizerLOTIONWalgreensfc65f673-b23d-1ffa-e053-6394a90a09662026-05-03WarningsExact identifier
application number: M016
Dry Skin HealingPETROLATUMWalgreen0397507d-4b6e-c679-e063-6294a90a0b332026-05-03WarningsExact identifier
application number: M016
Daily MoisturizerLOTIONWalgreenfc67037a-ed31-f678-e053-6394a90a71752026-05-03WarningsExact identifier
application number: M016
Skin ReliefLOTIONWalgreenfc678e80-e63d-e3fe-e053-6394a90aa7d62026-05-03WarningsExact identifier
application number: M016
Petroleum JellyWHITE PETROLATUMWalmart INCf76ceecc-ef11-3839-e053-6394a90a8d4a2026-05-03WarningsExact identifier
application number: M016
Herpecin LDIMETHICONE AND MERADIMATE AND OCTINOXATE AND OCTISALATE AND OXYBENZONEFocus Consumer Healthcare, LLC5b6ed4e9-3e69-c773-e053-2991aa0a7dfe2026-05-01WarningsExact identifier
application number: M016
CalamineFERRIC OXIDE REDRetail Business Services, LLC7291e175-a9b6-4c47-93ce-227ce11e45992026-04-30Warnings, Adverse reactionsExact 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