FDA.reportPublic FDA data

Tylo Night (Acetaminophen)

Product NDC
49638-106
11-digit product format
496380106
Labeler code
49638
Product ID
49638-106_ca763b28-3c99-a5e5-e053-2995a90ab83c
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
America Medic & Science, LLC
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-07-06
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
500 mg/1; mg/1
NDC exclude flag
No
Listing certified through
2022-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct49638-106DDiscontinued by firm2026-10-05
excluded packagepackage49638-10649638-106-30DDiscontinued by firm2026-10-05

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49638-106-302024-02-02C16284748780-10191ceaa-62c5-198a-e063-dbdaa90aec3eTylo Night (Acetaminophen) 500 mg
49638-106-302023-07-28C16284748780-10191ceaa-62c5-198a-e063-dbdaa90aec3eTylo Night (Acetaminophen) 500 mg

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49638-106TYLO NIGHT (ACETAMINOPHEN) (ACETAMINOPHEN) TABLET, DELAYED RELEASE [AMERICA MEDIC & SCIENCE, LLC]8Legacy NDC20240203_709babea-c67a-479b-b47e-18e935de5518.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49638-106-30496380106301 BOTTLE in 1 CARTON (49638-106-30) > 30 TABLET, DELAYED RELEASE in 1 BOTTLE1 bottle2020-07-060000-00-00NoNoCurrent