FDA.reportPublic FDA data

Rugby Travel Sickness

Product NDC
71610-245
Requested package NDC
71610-245-60
11-digit product format
716100245
Labeler code
71610
Product ID
71610-245_4c668824-7502-4799-8efc-e93581cd75d0
Type
HUMAN OTC DRUG
Nonproprietary name
Meclizine HCl
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
part336
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2014-08-19
Marketing end
0000-00-00
Substance
MECLIZINE HYDROCHLORIDE
Active strength
25 mg/1
NDC exclude flag
No
Listing certified through
2020-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage71610-24571610-245-60DDiscontinued by firm2026-10-15

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71610-24571610-245-60DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71610-24571610-245-60DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-245-30EA - Each71610-24530b13301-712d-414a-aa7c-38862996393012020-07-13
71610-245-60EA - Each71610-245949c69a8-84f3-40f0-898d-614a3f599df912020-07-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-245RUGBY TRAVEL SICKNESS MECLIZINE HCL, 25 MG EACH (ANTIEMETIC) (MECLIZINE HCL) TABLET, CHEWABLE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC20190322_099d75cc-a2c7-4140-9884-b45010aaf2b5.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71610-245-607161002456090 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (71610-245-60) 2019-02-280000-00-00NoNoCurrent