FDA.reportPublic FDA data

Meclizine HCl

Product NDC
68001-529
11-digit product format
680010529
Labeler code
68001
Product ID
68001-529_11d28658-55a1-ff25-e063-6394a90a7e65
Type
HUMAN OTC DRUG
Nonproprietary name
MECLIZINE HYDROCHLORIDE CHEWABLE
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
BluePoint Laboratories
Application
M009
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-03-14
Substance
MECLIZINE HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Antiemetic [EPC], Emesis Suppression [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Meclizine HCl
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MECLIZINE HYDROCHLORIDE25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
HDP7W44CIOInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
995632Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
d9cc2705-9dcc-0a73-e053-2995a90aafe6Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
95250459-30e4-45c1-b08a-993044f49109Product name220250805
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
ac6963c4-31c6-325f-ee58-83a0a06597adProduct name520221206
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68001-529-00Meclizine HCl100 in 1 BOTTLETABLET, CHEWABLE1002
68001-529-08Meclizine HCl1000 in 1 BOTTLETABLET, CHEWABLE10002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-529-00EA - Each68001-5290e17c453-0e76-44a8-be97-86850ebbce9212022-04-06
68001-529-08EA - Each68001-529392cc8fc-6d12-4f6d-9668-d9477ef4a44912022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68001-529MECLIZINE HCL (MECLIZINE HYDROCHLORIDE CHEWABLE) TABLET, CHEWABLE [BLUEPOINT LABORATORIES]2Current NDC, Legacy NDC, 2 package rows20240222_d9cc2705-9dcc-0a73-e053-2995a90aafe6.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 5 of 6 · 107 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Motion Sickness ReliefDIMENHYDRINATE 50 MGTARGET CORPORATION28586e9b-01e3-0b88-e063-6394a90af7e02025-01-29WarningsExact identifier
application number: M009
MECLIZINEMECLIZINE HCL 12.5MGUlai Health LLCd304e205-85fa-494a-9a68-ae6855b139b12025-01-20WarningsExact identifier
application number: M009
Meclizine HCL 12.5 mgMECLIZINE HCL 12.5 MGReliable 1 Laboratories LLC32832b0f-0b38-27ce-e054-00144ff8d46c2025-01-15WarningsExact identifier
application number: M009
Meclizine HCL 25 mgMECLIZINE HCLReliable 1 Laboratories LLC32bdd802-16b0-184d-e054-00144ff88e882025-01-15WarningsExact identifier
application number: M009
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDEAPNAR PHARMA LPe4d785a7-a688-3acb-e053-2a95a90a6d2e2025-01-09Boxed warning, WarningsExact identifier
application number: M009
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDEAPNAR PHARMA LPed43bf21-f3da-245c-e053-2995a90a504c2025-01-09Boxed warning, WarningsExact identifier
application number: M009
MECLIZINEMECLIZINE HCL 12.5 MGRUGBY LABORATORIES8a234ce3-eb6b-49dd-9d78-7fc7bdd49d352024-12-20WarningsExact identifier
application number: M009
MeclizineMECLIZINE HYDROCHLORIDEAdvanced Rx LLCb0a2a1f7-354e-48bd-9e98-9207bf9f53fd2024-11-27WarningsExact identifier
application number: M009
Dramamine, TRAVEL BASIXDIMENHYDRINATELil' Drug Store Products, Inc.960a642b-ee7c-4e92-9b5f-930425682dac2024-11-26WarningsExact identifier
application number: M009
Dramamine Less Drowsy, Lil Drug StoreMECLAZINE HYDROCHLORIDE TABLETLil' Drug Store Products, Inc.275b3377-9280-c12c-e063-6294a90a54212024-11-20WarningsExact identifier
application number: M009
PhysiciansCare Motion SicknessMECLIZINE HCLAcme United Corporationc4d3ea22-7c22-7311-e053-2a95a90a779c2024-11-12WarningsExact identifier
application number: M009
DRAMAMINE - NMECLIZINE HYDROCHLORIDEMedtech Products Inc.7fec7791-c242-4e43-8184-32820e657afb2024-10-25WarningsExact identifier
application number: M009
DRAMAMINEMECLIZINE HYDROCHLORIDEMedtech Products Inc.f8cf751a-9f19-4744-a350-cd22303435ee2024-10-25WarningsExact identifier
application number: M009
GravolDIMENHYDRINATEChurch & Dwight Co., Inc.d955f612-1265-f1be-e053-2995a90a53452024-07-18WarningsExact identifier
application number: M009
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC199ae195-4556-ee88-e063-6394a90a40d42024-06-10WarningsExact identifier
application number: M009
GravolDIMENHYDRINATEChurch & Dwight Co., Inc.d941705f-12a1-4757-e053-2995a90ad3fa2024-05-13WarningsExact identifier
application number: M009
Kids Gravol Chewables Motion Sickness DimenhydrinateDIMENHYDRINATEChurch & Dwight Co., Inc.cf6de950-a157-4be2-a302-0dc19511d2f22024-03-01WarningsExact identifier
application number: M009
Gravol Chewables Motion Sickness DimenhydrinateDIMENHYDRINATEChurch & Dwight Co., Inc.de5249f7-79fc-4f3c-965a-1e8ec978a0b72024-03-01WarningsExact identifier
application number: M009
Meclizine HClMECLIZINE HYDROCHLORIDE CHEWABLEBluePoint Laboratoriesd9cc2705-9dcc-0a73-e053-2995a90aafe62024-02-21WarningsExact identifier
application number: M009
ndc (product): 68001-529
Childrens AllergyDIPHENHYDRAMINE HYDROCHLORIDEDeMoulas Market Basketfd04fb94-f581-4ca2-b7ac-20359093863e2023-12-29WarningsExact identifier
application number: M009

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995632meclizine HCl 25 MG Chewable TabletPSNd9cc2705-9dcc-0a73-e053-2995a90aafe62
995632meclizine hydrochloride 25 MG Chewable TabletSCDd9cc2705-9dcc-0a73-e053-2995a90aafe62

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68001-529-0068001052900100 TABLET, CHEWABLE in 1 BOTTLE (68001-529-00) 2022-03-140000-00-00NoNoCurrent
68001-529-08680010529081000 TABLET, CHEWABLE in 1 BOTTLE (68001-529-08) 2022-03-140000-00-00NoNoCurrent