Home NDC 83650-104 COCOA BUTTER PETROLEUM jelly
Product NDC 83650-104
11-digit product format 836500104
Labeler code 83650
Product ID 83650-104_397d0f9c-63f9-2325-e063-6394a90aa1a4
Type HUMAN OTC DRUG
Nonproprietary name Petrolatum
Dosage form CREAM
Route TOPICAL
Labeler Savvy Care & Cosmetics Pvt. Ltd.
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 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 COCOA BUTTER PETROLEUM jelly
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PETROLATUM 30 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4T6H12BN9U Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1037285 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 83650-104-01 COCOA BUTTER PETROLEUM jelly 133 mL in 1 TUBE CREAM 133 1
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 30 of 68 · 1,357 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 83650-104-01 83650010401 133 mL in 1 TUBE (83650-104-01) 133 ml 2015-07-27 No No Current