Meclizine HCL 25 mg

Product NDC
71205-606
11-digit product format
712050606
Labeler code
71205
Product ID
71205-606_f7855d32-3393-4704-a412-b978bf4962cf
Type
HUMAN OTC DRUG
Nonproprietary name
Meclizine HCL
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
M009
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-11-01
Substance
MECLIZINE HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Antiemetic [EPC], Emesis Suppression [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
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 25 mg
Listing expiration
2027-12-31

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
d08fa6f5-4293-4468-814e-7dccbd281209Available 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
71205-606-30Meclizine HCL 25 mg30 in 1 BOTTLE, PLASTICTABLET304
71205-606-60Meclizine HCL 25 mg60 in 1 BOTTLE, PLASTICTABLET604
71205-606-90Meclizine HCL 25 mg90 in 1 BOTTLE, PLASTICTABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-606-30EA - Each71205-60689874bdc-fef7-4df4-8aa2-57fac60f86dc12022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-606MECLIZINE HCL 25 MG (MECLIZINE HCL) TABLET [PROFICIENT RX LP]3Current NDC, Legacy NDC, 3 package rows20240125_d08fa6f5-4293-4468-814e-7dccbd281209.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 6 of 6 · 107 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Airmit AceDIMENHYDRINATESato Pharmaceutical Co., Ltd.a98d252d-4cfa-496a-ab2c-627f45f0d7d92023-12-01WarningsExact identifier
application number: M009
Meclizine HClMECLIZINE HYDROCHLORIDEBluePoint Laboratoriesd9cae5a6-8d4b-bdaf-e053-2995a90a7d442023-11-17WarningsExact identifier
application number: M009
ZenTrip Motion SicknessMECLIZINE HYDROCHLORIDESato Pharmaceutical Co., LTDbd86c4c7-b6f0-e3e8-e053-2995a90a44542023-11-03WarningsExact identifier
application number: M009
Travel-EaseMECLIZINE HCLGeri-Care Pharmaceutical Corpe3c64eb9-4972-29d9-e053-2a95a90a2a8a2023-10-25WarningsExact identifier
application number: M009
GravolDIMENHYDRINATEChurch & Dwight Co., Inc.d95240bb-02f2-3226-e053-2995a90afacd2022-03-03WarningsExact identifier
application number: M009
Allergy DyeFreeALLERGY DYEFREEAllegiant Health15736bb8-5a5b-489d-83ad-4cf34ec629562021-04-26WarningsExact identifier
application number: M009
Motion Sickness ReliefDIMENHYDRINATE 50MGAllegiant Health7b0aa993-f08f-4dff-a82d-f35b3ebe3cc12019-12-12WarningsExact identifier
application number: M009

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995632meclizine HCl 25 MG Chewable TabletPSNd08fa6f5-4293-4468-814e-7dccbd2812094
995632meclizine hydrochloride 25 MG Chewable TabletSCDd08fa6f5-4293-4468-814e-7dccbd2812094

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-606-307120506063030 TABLET in 1 BOTTLE, PLASTIC (71205-606-30) 30 tablet2021-09-140000-00-00NoNoCurrent
71205-606-607120506066060 TABLET in 1 BOTTLE, PLASTIC (71205-606-60) 60 tablet2021-09-140000-00-00NoNoCurrent
71205-606-907120506069090 TABLET in 1 BOTTLE, PLASTIC (71205-606-90) 90 tablet2021-09-140000-00-00NoNoCurrent