FDA.reportPublic FDA data

ULTRACIN M

Product NDC
55628-9107
11-digit product format
556289107
Labeler code
55628
Product ID
55628-9107_77087b7e-0a55-4aad-8c55-a2bac2398835
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL
Dosage form
GEL
Route
TOPICAL
Labeler
Cal Pharma
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2016-01-24
Marketing end
0000-00-00
Substance
MENTHOL
Active strength
5 g/100mL
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55628-9107-42024-04-01C16284748780-1d6a99b39-9c04-a426-e053-dadaa90af4c206f84b11-579b-4c9c-a5ad-e3f3a59b98c7
55628-9107-42022-01-28C16284748780-1d6a99b39-9c04-a426-e053-dadaa90af4c206f84b11-579b-4c9c-a5ad-e3f3a59b98c7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55628-9107-4ML - Milliliter55628-910737f6bf04-90e7-48e5-88e3-a7ff2bafc04812016-02-04

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55628-9107-455628910704120 mL in 1 TUBE (55628-9107-4) 120 ml2016-01-240000-00-00NoNoCurrent