Home NDC 0496-0590 Dr. Mom Butt Balm
Product NDC 0496-0590
11-digit product format 004960590
Labeler code 0496
Product ID 0496-0590_1ac7d69c-9d20-26ff-e063-6394a90a2aa6
Type HUMAN OTC DRUG
Nonproprietary name dimethicone petrolatum
Dosage form OINTMENT
Route TOPICAL
Labeler Ferndale Laboratories, Inc.
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-11-07
Substance DIMETHICONE; WHITE PETROLATUM
Active strength .28; .48 g/g; g/g
Pharmacologic classes Skin Barrier Activity [PE]
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 Dr. Mom Butt Balm
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIMETHICONE .28 g/g WHITE PETROLATUM .48 g/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 92RU3N3Y1O Internal UNII lookup B6E5W8RQJ4 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2627302 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 0496-0590-02 Dr. Mom Butt Balm 70 g in 1 TUBE OINTMENT 70 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0496-0590 DR. MOM BUTT BALM (DIMETHICONE PETROLATUM) OINTMENT [FERNDALE LABORATORIES, INC.] 2 Current NDC, Legacy NDC, 1 package rows 20240616_ec06f1fd-c3e1-5dfc-e053-2a95a90a7cdd.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 55 of 68 · 1,350 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0496-0590-02 00496059002 70 g in 1 TUBE (0496-0590-02) 70 g 2022-11-07 0000-00-00 No No Current