FDA.reportPublic FDA data

Pepto Nausea

Product NDC
84126-340
11-digit product format
841260340
Labeler code
84126
Product ID
84126-340_5b226063-f2f3-f101-e063-6394a90aa7a0
Type
HUMAN OTC DRUG
Nonproprietary name
Meclizine HCl
Dosage form
TABLET
Route
ORAL
Labeler
THE PROCTER & GAMBLE MANUFACTURING COMPANY
Application
M009
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-03-03
Marketing end
2028-09-01
Substance
MECLIZINE HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Antiemetic [EPC], Emesis Suppression [PE]
NDC exclude flag
No
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
Pepto Nausea
Brand name suffix
Motion Sickness

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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
995666Internal RxNorm lookup
2706368Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
29a1bd1e-d0e0-478f-e063-6394a90ab0aaAvailable 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
84126-340-01Pepto NauseaMotion Sickness1 in 1 CARTONTABLET13
84126-340-01Pepto NauseaMotion Sickness10 in 1 VIAL, PLASTICTABLET103
84126-340-03Pepto NauseaMotion Sickness3 in 1 CELLO PACKTABLET33
84126-340-03Pepto NauseaMotion Sickness10 in 1 VIAL, PLASTICTABLET103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84126-340PEPTO NAUSEA MOTION SICKNESS (MECLIZINE HCL) TABLET [THE PROCTER & GAMBLE MANUFACTURING COMPANY]1Current NDC, 4 package rows20250304_29a1bd1e-d0e0-478f-e063-6394a90ab0aa.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 3 of 6 · 112 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DimenhydrinateDIMENHYDRINATELEADER/ Cardinal Health 110, Inc.7c4adbdb-9bce-0c9c-e053-2a91aa0a81072026-02-20WarningsExact identifier
application number: M009
Dramamine Less DrowsyMECLIZINE HYDROCHLORIDENavajo Manufacturing Company Inc.4b203479-ba8d-7237-e063-6294a90ae6cb2026-02-18WarningsExact identifier
application number: M009
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.d0d8b376-8fe9-8776-e053-2a95a90ae6512026-01-27WarningsExact identifier
application number: M009
Motion Sickness ReliefMECLIZINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED4f806804-48c7-414e-a177-5d3daf5b22e32026-01-20WarningsExact identifier
application number: M009
MECLIZINEMECLIZINE HCL 25 MGBi-Mart2e2c8189-c026-48f8-bbc6-371498ccf4442026-01-13WarningsExact identifier
application number: M009
Motion Sickness ReliefMECLIZINE HCLUnited Natural Foods, Inc. dba UNFI108bb943-529f-4510-b770-b54eca493ae02026-01-12WarningsExact identifier
application number: M009
Less Drowsy Motion Sickness ReliefMECLIZINE HCLRite Aid Corporation2f9ebe6b-ffde-41de-9eaa-b03d87d330052026-01-09WarningsExact identifier
application number: M009
Motion Sickness ReliefDIMENHYDRINATERite Aid Corporation4f532984-aeee-4dde-972c-742bdf12868f2026-01-07WarningsExact identifier
application number: M009
Motion Sickness ReliefMECLIZINE HCLFamily Dollar Services Ince34126e3-52ef-4999-bf61-cba9b18182592026-01-05WarningsExact identifier
application number: M009
CVS Motion Sickness Fast MeltingMECLIZINE HYDROCHLORIDECVS Pharmacy, Inc.2a723bce-a581-4558-b028-22f1f9125dd52025-12-30WarningsExact identifier
application number: M009
Wal-Dram 2 Quick-DissolvingMECLIZINE HYDROCHLORIDEWalgreen Co.f3116203-1b8f-438a-b779-7bdd90eaf79e2025-12-30WarningsExact identifier
application number: M009
MECLIZINEMECLIZINE HCL 12.5 MGPharbest Pharmaceuticals, Inc.8b3c9283-b618-4d57-9f15-7cf73e8737f52025-12-24WarningsExact identifier
application number: M009
MECLIZINEMECLIZINE HCL 25MGPharbest Pharmaceuticals, Inc.4bac2765-045c-405e-8006-8c5cfdfa89bc2025-12-24WarningsExact identifier
application number: M009
DRAMAMINEMECLIZINE HYDROCHLORIDEMedtech Products Inc.fdcbcc4e-9370-4975-8905-1f12c73fdc8c2025-12-23WarningsExact identifier
application number: M009
DRAMAMINEMECLIZINE HYDROCHLORIDEMedtech Products Inc.3a960d43-62aa-464e-92b9-d83042ba02bf2025-12-23WarningsExact identifier
application number: M009
DRAMAMINEMECLIZINE HYDROCHLORIDEMedtech Products Inc.6efd3473-ee14-4ee0-8a58-d15a64a9224a2025-12-18WarningsExact identifier
application number: M009
Motion Sickness ReliefMECLIZINE HCLRite Aid Corporatione599dc64-ac10-4f4e-9318-e9fab05264882025-11-15WarningsExact identifier
application number: M009
Motion Sickness ReliefMECLIZINE HCLKroger Company64e0496c-5e09-46e9-94b9-624163d71b602025-11-05WarningsExact identifier
application number: M009
Motion Sickness ReliefMECLIZINE HCLWalgreen Company27bd9c74-c85e-4eeb-9e43-4120f90011872025-11-05WarningsExact identifier
application number: M009
Dramamine Original FormulaDIMENHYDRINATEMedtech Products Inc.f9302a5a-295a-4501-9332-e3f5eb3873622025-10-23WarningsExact identifier
application number: M009

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995666meclizine HCl 25 MG Oral TabletPSN29a1bd1e-d0e0-478f-e063-6394a90ab0aa3
2706368Pepto Nausea 25 MG Oral TabletPSN29a1bd1e-d0e0-478f-e063-6394a90ab0aa3
2706368meclizine hydrochloride 25 MG Oral Tablet [Pepto Nausea]SBD29a1bd1e-d0e0-478f-e063-6394a90ab0aa3
995666meclizine hydrochloride 25 MG Oral TabletSCD29a1bd1e-d0e0-478f-e063-6394a90ab0aa3
2706368Pepto Nausea 25 MG Oral TabletSY29a1bd1e-d0e0-478f-e063-6394a90ab0aa3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
84126-340-01841260340011 VIAL, PLASTIC in 1 CARTON (84126-340-01) / 10 TABLET in 1 VIAL, PLASTIC2025-03-032028-09-01NoNoHistorical
84126-340-03841260340033 VIAL, PLASTIC in 1 CELLO PACK (84126-340-03) / 10 TABLET in 1 VIAL, PLASTIC2026-03-032028-09-01NoNoHistorical