Hydrolatum

Product NDC
0295-9011
Requested package NDC
0295-9011-69
11-digit product format
002959011
Labeler code
0295
Product ID
0295-9011_e87d9c37-c508-d9e1-e053-2995a90accba
Type
HUMAN OTC DRUG
Nonproprietary name
White Petrolatum
Dosage form
CREAM
Route
TOPICAL
Labeler
Denison Pharmaceuticals, LLC
Application
part346
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2020-02-19
Marketing end
0000-00-00
Substance
PETROLATUM
Active strength
45 g/100g
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0295-90110295-9011-69IInactivated by FDA2026-08-11

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0295-9011-13Hydrolatum57 g in 1 TUBECREAM574
0295-9011-36Hydrolatum454 g in 1 JARCREAM4544
0295-9011-69Hydrolatum340 g in 1 JARCREAM3404

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0295-9011HYDROLATUM (WHITE PETROLATUM) CREAM [DENISON PHARMACEUTICALS, LLC]4Legacy NDC, 3 package rows20231011_9ef53da4-8f1f-46b0-e053-2995a90aa7a6.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0295-9011-6900295901169340 g in 1 JAR (0295-9011-69) 340 g2022-09-120000-00-00NoNoCurrent