FDA.reportPublic FDA data

Rugby Travel Sickness

Product NDC
0536-1018
Requested package NDC
0536-1018-01
11-digit product format
005361018
Labeler code
0536
Product ID
0536-1018_b3db2774-223a-cfdf-e053-2995a90aa68c
Type
HUMAN OTC DRUG
Nonproprietary name
Meclizine HCl
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
RUGBY LABORATORIES
Application
part336
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2014-08-19
Marketing end
2022-09-30
Substance
MECLIZINE HYDROCHLORIDE
Active strength
25 mg/1
NDC exclude flag
No
Listing certified through
0000-00-00
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 packagepackage0536-10180536-1018-01DDiscontinued by firm2026-08-10

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
ac6963c4-31c6-325f-ee58-83a0a06597adProduct name520221206
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1018-01EA - Each0536-101838974734-0ca3-472f-a497-87a548eaec9412014-09-03
0536-1018-10EA - Each0536-1018f375fa7f-4c57-4dd0-8d08-870621e0e1e712014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MECLIZINE HYDROCHLORIDEACTIVE INGREDIENTHDP7W44CIORUGBY TRAVEL SICKNESS MECLIZINE HCL, 25 MG EACH (ANTIEMETIC) (MECLIZINE HCL) TABLET, CHEWABLE [RUGBY LABORATORIES]1
MECLIZINEACTIVE MOIETY3L5TQ84570RUGBY TRAVEL SICKNESS MECLIZINE HCL, 25 MG EACH (ANTIEMETIC) (MECLIZINE HCL) TABLET, CHEWABLE [RUGBY LABORATORIES]1
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1RUGBY TRAVEL SICKNESS MECLIZINE HCL, 25 MG EACH (ANTIEMETIC) (MECLIZINE HCL) TABLET, CHEWABLE [RUGBY LABORATORIES]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61URUGBY TRAVEL SICKNESS MECLIZINE HCL, 25 MG EACH (ANTIEMETIC) (MECLIZINE HCL) TABLET, CHEWABLE [RUGBY LABORATORIES]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48RUGBY TRAVEL SICKNESS MECLIZINE HCL, 25 MG EACH (ANTIEMETIC) (MECLIZINE HCL) TABLET, CHEWABLE [RUGBY LABORATORIES]1
DEXTROSEINACTIVE INGREDIENTIY9XDZ35W2RUGBY TRAVEL SICKNESS MECLIZINE HCL, 25 MG EACH (ANTIEMETIC) (MECLIZINE HCL) TABLET, CHEWABLE [RUGBY LABORATORIES]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOARUGBY TRAVEL SICKNESS MECLIZINE HCL, 25 MG EACH (ANTIEMETIC) (MECLIZINE HCL) TABLET, CHEWABLE [RUGBY LABORATORIES]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30RUGBY TRAVEL SICKNESS MECLIZINE HCL, 25 MG EACH (ANTIEMETIC) (MECLIZINE HCL) TABLET, CHEWABLE [RUGBY LABORATORIES]1
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DRUGBY TRAVEL SICKNESS MECLIZINE HCL, 25 MG EACH (ANTIEMETIC) (MECLIZINE HCL) TABLET, CHEWABLE [RUGBY LABORATORIES]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4RUGBY TRAVEL SICKNESS MECLIZINE HCL, 25 MG EACH (ANTIEMETIC) (MECLIZINE HCL) TABLET, CHEWABLE [RUGBY LABORATORIES]1
SODIUM SULFATEINACTIVE INGREDIENT0YPR65R21JRUGBY TRAVEL SICKNESS MECLIZINE HCL, 25 MG EACH (ANTIEMETIC) (MECLIZINE HCL) TABLET, CHEWABLE [RUGBY LABORATORIES]1
SUCROSEINACTIVE INGREDIENTC151H8M554RUGBY TRAVEL SICKNESS MECLIZINE HCL, 25 MG EACH (ANTIEMETIC) (MECLIZINE HCL) TABLET, CHEWABLE [RUGBY LABORATORIES]1
TRICALCIUM PHOSPHATEINACTIVE INGREDIENTK4C08XP666RUGBY TRAVEL SICKNESS MECLIZINE HCL, 25 MG EACH (ANTIEMETIC) (MECLIZINE HCL) TABLET, CHEWABLE [RUGBY LABORATORIES]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995632meclizine HCl 25 MG Chewable TabletPSN0c871def-c74d-490c-b65b-61883b19bdb78
995632meclizine hydrochloride 25 MG Chewable TabletSCD0c871def-c74d-490c-b65b-61883b19bdb78
995632meclizine HCl 25 MG Chewable TabletPSN19b24b6a-c6e6-4b8e-9f85-25a2ce2746437
995632meclizine hydrochloride 25 MG Chewable TabletSCD19b24b6a-c6e6-4b8e-9f85-25a2ce2746437
995632meclizine HCl 25 MG Chewable TabletPSN4eb556e0-3403-0361-e054-00144ff88e883
995632meclizine hydrochloride 25 MG Chewable TabletSCD4eb556e0-3403-0361-e054-00144ff88e883
995632meclizine HCl 25 MG Chewable TabletPSN280dc4d4-7773-3c13-e054-00144ff8d46c1
995632meclizine HCl 25 MG Chewable TabletPSNb4743896-310d-46be-94f5-61f80e47f6f51
995632meclizine hydrochloride 25 MG Chewable TabletSCD280dc4d4-7773-3c13-e054-00144ff8d46c1
995632meclizine hydrochloride 25 MG Chewable TabletSCDb4743896-310d-46be-94f5-61f80e47f6f51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0536-1018-0100536101801100 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (0536-1018-01) 2014-08-192022-09-30NoNoCurrent