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 5 of 6 · 112 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HIONFURT Motion SicknessMOTION SICKNESS NATURAL HERBAL PLANT LAVENDERPuning Huiyu E-Commerce Co., Ltd.2e30b09d-838d-59fb-e063-6394a90aa9842025-02-15WarningsExact identifier
application number: M009
HIONFURT Motion SicknessMOTION SICKNESS PREVENT NAUSEA,DIZZINESS VOMITINGPuning Huiyu E-Commerce Co., Ltd.2e31419e-3ccd-d7b5-e063-6394a90ac7652025-02-15WarningsExact identifier
application number: M009
Bedy motion sicknessMOTION SICKNESS RELIEF , NAUSEA RELIEF , SEA SICKNESSHenan Hengchuntang Pharmaceutical Co., Ltd2e3bf94c-4e60-7f78-e063-6394a90a70212025-02-15WarningsExact identifier
application number: M009
Dramamine for KidsDIMENHYDRINATEMedtech Products Inc.3ccd6eb4-ba7e-4a6a-abb9-a6ef3196240c2025-02-12WarningsExact identifier
application number: M009
Motion SicknessMOTION SICKNESS NATURAL HERBAL PLANTPuning Huiyu E-Commerce Co., Ltd.2db09ade-c94b-5f5f-e063-6394a90af9dc2025-02-09WarningsExact identifier
application number: M009
Motion Sickness ReliefDIMENHYDRINATE 50 MGTARGET CORPORATION28586e9b-01e3-0b88-e063-6394a90af7e02025-01-29WarningsExact identifier
application number: M009
MECLIZINEMECLIZINE HCL 12.5MGUlai Health LLCd304e205-85fa-494a-9a68-ae6855b139b12025-01-20WarningsExact identifier
application number: M009
Meclizine HCL 12.5 mgMECLIZINE HCL 12.5 MGReliable 1 Laboratories LLC32832b0f-0b38-27ce-e054-00144ff8d46c2025-01-15WarningsExact identifier
application number: M009
Meclizine HCL 25 mgMECLIZINE HCLReliable 1 Laboratories LLC32bdd802-16b0-184d-e054-00144ff88e882025-01-15WarningsExact identifier
application number: M009
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDEAPNAR PHARMA LPe4d785a7-a688-3acb-e053-2a95a90a6d2e2025-01-09Boxed warning, WarningsExact identifier
application number: M009
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDEAPNAR PHARMA LPed43bf21-f3da-245c-e053-2995a90a504c2025-01-09Boxed warning, WarningsExact identifier
application number: M009
MECLIZINEMECLIZINE HCL 12.5 MGRUGBY LABORATORIES8a234ce3-eb6b-49dd-9d78-7fc7bdd49d352024-12-20WarningsExact identifier
application number: M009
MeclizineMECLIZINE HYDROCHLORIDEAdvanced Rx LLCb0a2a1f7-354e-48bd-9e98-9207bf9f53fd2024-11-27WarningsExact identifier
application number: M009
Dramamine, TRAVEL BASIXDIMENHYDRINATELil' Drug Store Products, Inc.960a642b-ee7c-4e92-9b5f-930425682dac2024-11-26WarningsExact identifier
application number: M009
Dramamine Less Drowsy, Lil Drug StoreMECLAZINE HYDROCHLORIDE TABLETLil' Drug Store Products, Inc.275b3377-9280-c12c-e063-6294a90a54212024-11-20WarningsExact identifier
application number: M009
PhysiciansCare Motion SicknessMECLIZINE HCLAcme United Corporationc4d3ea22-7c22-7311-e053-2a95a90a779c2024-11-12WarningsExact identifier
application number: M009
DRAMAMINE - NMECLIZINE HYDROCHLORIDEMedtech Products Inc.7fec7791-c242-4e43-8184-32820e657afb2024-10-25WarningsExact identifier
application number: M009
DRAMAMINEMECLIZINE HYDROCHLORIDEMedtech Products Inc.f8cf751a-9f19-4744-a350-cd22303435ee2024-10-25WarningsExact identifier
application number: M009
GravolDIMENHYDRINATEChurch & Dwight Co., Inc.d955f612-1265-f1be-e053-2995a90a53452024-07-18WarningsExact identifier
application number: M009
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC199ae195-4556-ee88-e063-6394a90a40d42024-06-10WarningsExact 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