FDA.reportPublic FDA data

Meclizine HCL

Product NDC
71610-528
11-digit product format
716100528
Labeler code
71610
Product ID
71610-528_2b4cfbd3-496d-100d-e063-6294a90aba52
Type
HUMAN OTC DRUG
Nonproprietary name
Meclizine HCl 25mg Chewable Tablets
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-05-01
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
02d1af4d-d97d-4019-a5bf-3ec391238676Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ac6963c4-31c6-325f-ee58-83a0a06597adProduct name520221206
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71610-528-30Meclizine HCL30 in 1 BOTTLETABLET, CHEWABLE302
71610-528-60Meclizine HCL90 in 1 BOTTLETABLET, CHEWABLE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-528-30EA - Each71610-5282e96690d-35b4-4dc8-ad74-416b6d0fdf5e12021-05-05
71610-528-60EA - Each71610-528cf04b58f-2e24-45dc-a9fa-7480c3765f7212021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-528MECLIZINE HCL (MECLIZINE HCL 25MG CHEWABLE TABLETS) TABLET, CHEWABLE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Current NDC, Legacy NDC, 2 package rows20250112_02d1af4d-d97d-4019-a5bf-3ec391238676.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 167 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Childrens Robitussin Cough Long-ActingDEXTROMETHORPHAN HYDROBROMIDEHaleon US Holdings LLC75bc7827-4439-e6a8-a65c-7154d5592e582024-03-17WarningsExact identifier
application number: M012
Childrens Robitussin Nighttime Cough Long-Acting DMCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDEHaleon US Holdings LLC8a8380f4-fa8a-4cca-8b8f-f8d7c5a33f9c2024-03-17WarningsExact identifier
application number: M012
ANTIGRIP DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLPharmadel LLC12f20aba-f991-bd82-e063-6294a90a4aac2024-03-16WarningsExact identifier
application number: M012
Nighttime Cold and FluACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATEWALGREENSd3053f80-aece-eb50-e053-2a95a90a59452024-03-15WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHINE DEXTROMETHORPHAN HBR PHENYLPHRINE HCLWALGREENSd315bc95-1b46-75df-e053-2a95a90a6c662024-03-15WarningsExact identifier
application number: M012
MAR-COF CG ExpectorantCODEINE PHOSPHATE AND GUAIFENESINMarnel Pharmaceuticals, LLC60a41229-b125-43d8-b2b4-0bf40feed7642024-03-15WarningsExact identifier
application number: M012
Night Time CoughDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATECVS PHARMACY, INC97aa0b90-1230-4143-b5d3-18b96a6b7b4f2024-03-15WarningsExact identifier
application number: M012
Robitussin Sugar-Free Dye-Free Cough Plus Chest Congestion DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINHaleon US Holdings LLC036162c9-f5a6-418e-bd5e-ebd72097d27d2024-03-15WarningsExact identifier
application number: M012
Bronkaid MaxEPHEDRINE SULFATEFoundation Consumer Healthcare LLC9a0b792a-caee-41f6-9400-922a5ebd592f2024-03-14WarningsExact identifier
application number: M012
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEA-S Medication Solutions5f2b16f0-c58b-4e48-ad92-eaab93c6c4b22024-03-12WarningsExact identifier
application number: M012
Coricidin HBP Cough and ColdCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROCHLORIDEA-S Medication Solutionsffcae882-0b19-4219-bbee-a175c63d79c82024-03-11WarningsExact identifier
application number: M012
Theraflu Severe Cold Relief Daytime with Honey Ginger FlavorACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLHaleon US Holdings LLC18dcede2-5a38-40fa-93fe-48acdd6a7cf12024-03-08WarningsExact identifier
application number: M012
Theraflu Severe Cold Relief Nighttime with Honey Elderberry FlavorACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLHaleon US Holdings LLCd4ce06aa-776f-45e4-a1a6-9cf13797048f2024-03-08WarningsExact identifier
application number: M012
Theraflu Severe Cold Relief NighttimeACETAMINOPHEN, DIPHENHYDRAMINE HCLHaleon US Holdings LLC14e38ef0-a5e7-4df7-824f-f27bef664d252024-03-08WarningsExact identifier
application number: M012
Theraflu Flu Relief Maximum Strength Daytime Nighttime Combo PackACETAMINOPHEN, DEXTROMETHORPHAN HBR AND ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRHaleon US Holdings LLC68d3e88a-d1be-410b-92a1-863903b3aa612024-03-08WarningsExact identifier
application number: M012
Theraflu Severe Cold relief NighttimeACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDEHaleon US Holdings LLC0d3b1bea-e2ca-4e07-8ae5-60627d230c962024-03-08WarningsExact identifier
application number: M012
Theraflu PowerPods Daytime Severe ColdACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINEHaleon US Holdings LLCe655c33c-c319-41d9-ae55-cf747242cd102024-03-08WarningsExact identifier
application number: M012
Theraflu Severe Cold Relief Daytime Berry BurstACETAMINOPHEN, DEXTROMETHORPHAN HBRHaleon US Holdings LLCadf33520-4689-4de2-b9d8-c201518e9d262024-03-08WarningsExact identifier
application number: M012
Theraflu ExpressMax Daytime Severe Cold and CoughACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLHaleon US Holdings LLCf6ae9e3a-6bea-40e0-8a6f-45f4be8319e72024-03-07WarningsExact identifier
application number: M012
Theraflu ExpressMax Nighttime Severe Cold and CoughACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLHaleon US Holdings LLCf5a66541-1b15-4dfe-91e0-d8d5f8fdc7fb2024-03-07WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995632meclizine HCl 25 MG Chewable TabletPSN02d1af4d-d97d-4019-a5bf-3ec3912386762
995632meclizine hydrochloride 25 MG Chewable TabletSCD02d1af4d-d97d-4019-a5bf-3ec3912386762

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71610-528-307161005283030 TABLET, CHEWABLE in 1 BOTTLE (71610-528-30) 2021-03-040000-00-00NoNoCurrent
71610-528-607161005286090 TABLET, CHEWABLE in 1 BOTTLE (71610-528-60) 2021-03-040000-00-00NoNoCurrent