FDA.reportPublic FDA data

Tylo Extra

Product NDC
49638-110
11-digit product format
496380110
Labeler code
49638
Product ID
49638-110_cacb7047-ecc6-891d-e053-2a95a90a9dae
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
2019-01-17
Marketing end
0000-00-00
Substance
ACETAMINOPHEN
Active strength
500 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 productproduct49638-110DDiscontinued by firm2026-10-05
excluded packagepackage49638-11049638-110-30DDiscontinued 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
49638-110-302024-02-02C16284748780-10191ceaa-71e9-198a-e063-dbdaa90aec3eTylo Extra 500 mg
49638-110-302023-07-28C16284748780-10191ceaa-71e9-198a-e063-dbdaa90aec3eTylo Extra 500 mg

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49638-110TYLO EXTRA (ACETAMINOPHEN) TABLET, DELAYED RELEASE [AMERICA MEDIC & SCIENCE, LLC]8Legacy NDC20240203_dac7c13d-c021-4a6e-9b14-0e312dd0ea2f.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49638-110-30496380110301 BOTTLE in 1 CARTON (49638-110-30) > 30 TABLET, DELAYED RELEASE in 1 BOTTLE1 bottle2019-01-170000-00-00NoNoCurrent