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 2 of 6 · 112 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DRAMAMINE CHEWABLE ORANGEMECLIZINE HYDROCHLORIDEMedtech Products Inc.30387e63-278d-412a-bcad-7965c7c0aea72026-06-23WarningsExact identifier
application number: M009
Motion Sickness ReliefDIMENHYDRINATEWal-Mart Stores Incc25a7f2b-0f01-4ec0-8849-f08c23608d1d2026-06-22WarningsExact identifier
application number: M009
Motion Sickness ReliefMECLIZINE HCLCardinal Health 110, LLC. DBA Leader69099658-a584-49a9-8a95-de258a697c4f2026-06-16WarningsExact identifier
application number: M009
Motion Sickness ReliefDIMENHYDRINATETopco Associates, LLC503a70db-d564-4ea0-851e-8ff617e707282026-06-16WarningsExact identifier
application number: M009
Motion SicknessMECLIZINE HCLARMY AND AIR FORCE EXCHANGE SERVICE20229ad5-cb28-4667-ab70-97a1102873a22026-06-16WarningsExact identifier
application number: M009
Motion SicknessDIMENHYDRINATEGeiss, Destin & Dunn Inc.fdb683c5-ff7f-4b93-9892-670cf1f29f2a2026-06-15WarningsExact identifier
application number: M009
DimenhydrinateDIMENHYDRINATECVS Pharmacy, Inc.6dfc5cb4-af0c-56c9-e053-2a91aa0a5d562026-06-12WarningsExact identifier
application number: M009
DriminateDIMENHYDRINATEMajor Pharmaceuticalsd2967f78-41ee-4c30-8b47-0757df9f3d912026-06-10WarningsExact identifier
application number: M009
Motion Sickness ReliefDIMENHYDRINATEAmerisource Bergenc4077301-db6c-473d-beb3-232d7134a13a2026-06-03WarningsExact identifier
application number: M009
Motion Sickness ReliefMECLIZINE HCLWalgreen Company761b7f9d-eaa1-47f0-89d9-c2da0e364a8b2026-05-18WarningsExact identifier
application number: M009
Motion SicknessMECLIZINE HCLStrategic Sourcing Services LLC550b803c-a038-455c-908a-a6244c0952ba2026-05-12WarningsExact identifier
application number: M009
Motion Sickness ReliefDIMENHYDRINATEValu Merchandisers Company56c26102-8d39-458e-b076-3fe67456a4c02026-04-16WarningsExact identifier
application number: M009
Motion Sickness ReliefMECLIZINE HCLDOLGENCORP, LLC1616c540-dcd9-46f1-823f-27b67ef488d22026-04-16WarningsExact identifier
application number: M009
Meclizine HCL 12.5 mgMECLIZINE HCL 12.5 MGProficient Rx LP3ffa63f2-ea06-4be0-9f59-162c2a9604fc2026-04-01WarningsExact identifier
application number: M009
Motion Sickness ReliefMECLIZINE HCLMeijer Distribution Inc1ac451c4-2467-46d6-bc0d-f6368699d1682026-03-23WarningsExact identifier
application number: M009
Travel easeMECLIZINE HCLChain Drug Marketing Association, Inc.c1345a46-51f4-4a6e-aa55-05d221e328372026-03-10WarningsExact identifier
application number: M009
Motion Sickness ReliefMECLIZINE HCLAmerisource Bergen71654e2b-a4db-4131-8c51-bedb3995784c2026-03-10WarningsExact identifier
application number: M009
Medique Medi-MeclizineMECLIZINE HCLSportpharm LLC95da2a1e-354c-4851-b147-cf6ee52e14e32026-03-03WarningsExact identifier
application number: M009
Motion SicknessDIMENHYDRINATETarget Corporation3fd4a96f-8f69-42bf-b777-6e3a2bfea2752026-03-03WarningsExact identifier
application number: M009
Motion Sickness Relief Less DrowsyMECLIZINE HCLBetter Living Brands, LLCeff22da8-63b2-47b7-8cfc-e8251029ee442026-02-27WarningsExact 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