FDA.reportPublic FDA data

Meclizine Hydrochloride

Product NDC
71610-836
Requested package NDC
71610-836-60
11-digit product format
716100836
Labeler code
71610
Product ID
71610-836_1a8bdae4-1b42-0a1c-e063-6294a90a49aa
Type
HUMAN OTC DRUG
Nonproprietary name
Meclizine Hydrochloride
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
M009
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-10-30
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 Hydrochloride
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
199ae195-4556-ee88-e063-6394a90a40d4Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ac6963c4-31c6-325f-ee58-83a0a06597adProduct name520221206

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71610-836-30Meclizine Hydrochloride30 in 1 BOTTLETABLET, CHEWABLE302
71610-836-53Meclizine Hydrochloride60 in 1 BOTTLETABLET, CHEWABLE602
71610-836-60Meclizine Hydrochloride90 in 1 BOTTLETABLET, CHEWABLE902
71610-836-80Meclizine Hydrochloride180 in 1 BOTTLETABLET, CHEWABLE1802

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-836-30EA - Each71610-8366c74f4d3-9da3-4ed6-9a3b-56c62592e90312024-07-12
71610-836-53EA - Each71610-8362ebc9656-05b7-405e-bf8a-1c4d2b87e2d312024-07-12
71610-836-60EA - Each71610-8365ccb775c-4eb5-40c2-827c-5089f8a00b3012024-07-12
71610-836-80EA - Each71610-836f0411068-d435-4330-b5e5-f7068cf5b59212024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-836MECLIZINE HYDROCHLORIDE TABLET, CHEWABLE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC ]2Current NDC, 4 package rows20240612_199ae195-4556-ee88-e063-6394a90a40d4.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 1 of 6 · 112 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dramamine OrangeDIMENHYDRINATEMedtech Products Inc.76166156-bce1-492f-833e-6bbd07859c3f2026-09-17WarningsExact identifier
application number: M009
Pepto Nausea Motion SicknessMECLIZINE HCLTHE PROCTER & GAMBLE MANUFACTURING COMPANY29a1bd1e-d0e0-478f-e063-6394a90ab0aa2026-09-10WarningsExact identifier
application number: M009
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDEA-S Medication Solutions2518b0b6-35ab-49f4-936c-1eafea04b4662026-09-09WarningsExact identifier
application number: M009
Dramamine Less DrowsyMECLIZINE HYDROCHLORIDEMedtech Products Inc.fa6a0969-7427-4b87-bc04-a2792665c2182026-09-04WarningsExact identifier
application number: M009
Less Drowsy Motion Sickness ReliefMECLIZINE HCLWal-Mart Stores Inc277a6266-e641-4621-bbb9-64195d51b66a2026-08-28WarningsExact identifier
application number: M009
Nausea ReliefMECLIZINE HCLWALMART INC.8010741e-61b2-4c1f-9f0e-21612878fa0e2026-08-28WarningsExact identifier
application number: M009
Motion SicknessMECLIZINE HCLH E B9837e9af-c542-4c0f-be33-94927d67c6a72026-08-21WarningsExact identifier
application number: M009
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDEBryant Ranch Prepackcd82fca9-a8dc-4545-8e64-b67d644832e72026-08-20WarningsExact identifier
application number: M009
Motion SicknessDIMENHYDRINATEStrategic Sourcing Services LLCbe8f91d4-6e4f-4d47-93e9-7fb91160b7df2026-08-17WarningsExact identifier
application number: M009
Motion Sickness ReliefDIMENHYDRINATEWalgreen Companyace7eba4-e033-48f5-8533-c3ea9dfc32b02026-08-12WarningsExact identifier
application number: M009
Motion SicknessMECLIZINE HCLStrategic Sourcing Services LLC76fb6471-09b0-4c51-bacc-b3533b6aa9712026-08-07WarningsExact identifier
application number: M009
Motion Sickness ReliefDIMENHYDRINATECardinal Health 110, LLC. DBA Leaderce83a868-bdd8-4c77-9bc0-664133028f752026-08-06WarningsExact identifier
application number: M009
Less Drowsy Formula Motion Sickness ReliefMECLIZINE HCLSalado Sales, Inc.273235b0-dacc-4a95-91be-91e13a2c6d102026-08-05WarningsExact identifier
application number: M009
Motion Sickness ReliefMECLIZINE HCLL.N.K. International, Inc.8e1889de-fbef-44f1-bbfb-c68a78e6330c2026-07-30WarningsExact identifier
application number: M009
Motion Sickness ReliefDIMENHYDRINATEChain Drug Marketing Association, Inc.00a327c6-6b86-4702-8c04-55c405c1404c2026-07-23WarningsExact identifier
application number: M009
Pepto Motion SicknessMECLIZINE HCLTHE PROCTER & GAMBLE MANUFACTURING COMPANY571e3eeb-ae9e-7054-e063-6394a90a26342026-07-21WarningsExact identifier
application number: M009
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDERugby Laboratoriesb57f14a7-3852-03db-e053-2a95a90a80d62026-07-16WarningsExact identifier
application number: M009
Motion SicknessDIMENHYDRINATECVS Pharmacy0998947c-cfba-497e-bf7a-9c7f8fff17642026-07-16WarningsExact identifier
application number: M009
Motion Sickness ReliefMECLIZINE HCLTopco Associates, LLC307e3144-3b01-4bd0-9155-6b58fc4cab922026-07-09WarningsExact identifier
application number: M009
Motion Sickness ReliefDIMENHYDRINATEL.N.K. International, Inc.95aae32f-6b3f-469d-86a5-c201a53f862a2026-06-29WarningsExact identifier
application number: M009

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995632meclizine HCl 25 MG Chewable TabletPSN199ae195-4556-ee88-e063-6394a90a40d42
995632meclizine hydrochloride 25 MG Chewable TabletSCD199ae195-4556-ee88-e063-6394a90a40d42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71610-836-607161008366090 TABLET, CHEWABLE in 1 BOTTLE (71610-836-60) 2024-05-24NoNoCurrent