NON ASPIRIN PM

Product NDC
55315-060
11-digit product format
553150060
Labeler code
55315
Product ID
55315-060_c65bec74-3bf5-45d7-b88d-67a8f0e9cac2
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Diphenhydramine HCl
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Freds Inc
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2015-12-17
Marketing end
2025-04-25
Substance
ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
500 mg/1; mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55315-060-502022-10-28C16284748780-1d6a99b39-b99c-a426-e053-dadaa90af4c2487bbddd-87ab-4957-b0ad-f3adbb507f9b
55315-060-502022-01-28C16284748780-1d6a99b39-b99c-a426-e053-dadaa90af4c2487bbddd-87ab-4957-b0ad-f3adbb507f9b

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55315-060-50553150060501 BOTTLE in 1 BOX (55315-060-50) > 50 TABLET, COATED in 1 BOTTLE1 bottle2015-12-170000-00-00NoNoCurrent