Sha-lem

Product NDC
59862-100
11-digit product format
598620100
Labeler code
59862
Product ID
59862-100_af476c82-6637-431f-8ba3-e2816cc19135
Type
HUMAN OTC DRUG
Nonproprietary name
Palmitic Acid, Stearic Acid, Oleic Acid, Bismuth Subcarbonate, Boric Acid
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Shalem Products, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
1992-05-08
Marketing end
0000-00-00
Substance
PALMITIC ACID; STEARIC ACID; OLEIC ACID; BISMUTH SUBCARBONATE; BORIC ACID
Active strength
7 g/30mL; g/30mL; g/30mL; g/30mL; g/30mL
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0be8e4ae-4d57-49f3-b3a9-e4728b4e8d15Product name120240313

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59862-100-112020-09-27C16284748780-1ab0e2407-3214-f274-e053-dbdaa90a6471Sha'-lem TM OINTMENT
59862-100-112020-09-25C16284748780-1ab0e2407-3214-f274-e053-dbdaa90a6471Sha'-lem TM OINTMENT
59862-100-112020-07-22C16284748780-1ab0e2407-3214-f274-e053-dbdaa90a6471Sha'-lem TM OINTMENT

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59862-100-11Sha-lem30 mL in 1 JAROINTMENT301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59862-100SHA-LEM (PALMITIC ACID, STEARIC ACID, OLEIC ACID, BISMUTH SUBCARBONATE, BORIC ACID) OINTMENT [SHALEM PRODUCTS, INC.]1Legacy NDC, 1 package rows20151224_e10d94eb-b1cf-4995-81ca-88322a01c37f.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
59862-100-115986201001130 mL in 1 JAR30 mlHistorical