FDA.reportPublic FDA data

Meclizine HCL 25 mg

Product NDC
69618-028
11-digit product format
696180028
Labeler code
69618
Product ID
69618-028_2bc84375-4d37-4be4-e063-6394a90a63f6
Type
HUMAN OTC DRUG
Nonproprietary name
Meclizine HCL
Dosage form
TABLET
Route
ORAL
Labeler
Reliable 1 Laboratories LLC
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
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 25 mg
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
32bdd802-16b0-184d-e054-00144ff88e88Available 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
69618-028-012023-03-29Meclizine HCL 25 mg
69618-028-102023-03-29Meclizine HCL 25 mg
69618-028-012023-01-30Meclizine HCL 25 mg
69618-028-102023-01-30Meclizine HCL 25 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69618-028-01Meclizine HCL 25 mg100 in 1 BOTTLE, PLASTICTABLET1006
69618-028-10Meclizine HCL 25 mg1000 in 1 BOTTLE, PLASTICTABLET10006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69618-028-01EA - Each69618-02805854f16-ef26-4281-a82d-55afaf652f5212016-05-16
69618-028-10EA - Each69618-02834099ed8-cfa9-415b-92f0-ce00963c6a3612016-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69618-028MECLIZINE HCL 25 MG (MECLIZINE HCL) TABLET [RELIABLE 1 LABORATORIES LLC]6Current NDC, Legacy NDC, 2 package rows20250117_32bdd802-16b0-184d-e054-00144ff88e88.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 4 of 6 · 112 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDECVS Pharmacy, Incb57fc6c2-fbfc-24c3-e053-2995a90a33892025-10-16WarningsExact identifier
application number: M009
Motion Sickness ReliefMECLIZINE HCLAmerisource Bergen503f62e7-8ec8-4409-9697-4efef4ff7b152025-10-08WarningsExact identifier
application number: M009
Meclizine HCL 25 mgMECLIZINE HCLProficient Rx LPd08fa6f5-4293-4468-814e-7dccbd2812092025-10-01WarningsExact identifier
application number: M009
Dramamine for KidsDIMENHYDRINATEMedtech Products Inc.12bc3f17-ed62-4d0d-9b1e-3835579e711b2025-09-10WarningsExact identifier
application number: M009
Medique Medi-MeclizineMECLIZINE HCLUnifirst First Aid Corporationb3fec2df-c41d-0b56-e053-2995a90a35e82025-09-09WarningsExact identifier
application number: M009
Motion Sickness ReliefMECLIZINE HYDROCHLORIDETARGET CORPORATION36ba2950-4a09-e5de-e063-6394a90a17712025-09-04WarningsExact identifier
application number: M009
MECLIZINEMECLIZINE HCL 12.5 MGAdvanced Rx LLC032a89f2-17e7-45d2-94a1-cc7a601ebdee2025-09-01WarningsExact identifier
application number: M009
DimenhydrinateDIMENHYDRINATEMajor Pharmaceuticals78d22836-a442-7c0c-e053-2991aa0a62f32025-08-13WarningsExact identifier
application number: M009
MQ Motion PatchMOTION PATCHZhengzhou Miaoqi Medical Technology Co., Ltd.3a70bc22-8e31-2d4c-e063-6394a90a3b242025-07-21WarningsExact identifier
application number: M009
Bangbrek Bee Venom Wart Corn Callus RemoverSALICYLIC ACID 17%Brilliance Trade LLC377946a0-0e8c-70f4-e063-6294a90a1d852025-06-20WarningsExact identifier
application number: M009
Dramamine for KidsDIMENHYDRINATEMedtech Products Inc.48e2e9ef-4c88-42ef-b825-d1b0074752752025-05-06WarningsExact identifier
application number: M009
BONINE MAXMECLIZINE HYDROCHLORIDEWellSpring Pharmaceutical Corporation7326a47e-284e-4b6f-8eb0-7933dc1e3f0d2025-04-11WarningsExact identifier
application number: M009
Meclizine HCL 25 mgMECLIZINE HCLBryant Ranch Prepackd1c58a74-5455-4a07-bcb6-cc114032ed122025-03-31WarningsExact identifier
application number: M009
BONINEMECLIZINE HYDROCHLORIDEWellSpring Pharmaceutical Corporationad3d66ca-a52c-43ba-b9e2-6269b8a413a92025-03-21WarningsExact identifier
application number: M009
BONINEMECLIZINE HYDROCHLORIDEWellSpring Pharmaceutical Corporation0b2ea6b8-b342-4940-8922-898758fbeb312025-03-21WarningsExact identifier
application number: M009
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDEWalgreen Companyecf8d05e-0e77-f3e8-e053-2a95a90a66042025-03-11WarningsExact identifier
application number: M009
MECLIZINEMECLIZINE HCL 25MGPD-Rx Pharmaceuticals, Inc.cf79ac74-017e-4fb4-85d3-4ea944080e892025-03-06WarningsExact identifier
application number: M009
Bedy Motion Sickness PatchesMOTION SICKNESS RELIEF PATCHES, NAUSEA RELIEF PATCHES, SEA SICKNESS PATCHESHenan Hengchuntang Pharmaceutical Co., Ltd2e57d2b7-875e-4e20-e063-6394a90acab62025-02-17WarningsExact identifier
application number: M009
HIONFURT Motion SicknessMOTION SICKNESS NATURAL HERBAL PLANTPuning Huiyu E-Commerce Co., Ltd.2e2c9073-1dcf-a3e8-e063-6394a90a6ee32025-02-15WarningsExact identifier
application number: M009
HIONFURT Motion SicknessMOTION SICKNESS NATURAL HERBAL PLANT LEMONPuning Huiyu E-Commerce Co., Ltd.2e2b3729-f8b0-605f-e063-6294a90a90c82025-02-15WarningsExact identifier
application number: M009

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995632meclizine HCl 25 MG Chewable TabletPSN32bdd802-16b0-184d-e054-00144ff88e886
995632meclizine hydrochloride 25 MG Chewable TabletSCD32bdd802-16b0-184d-e054-00144ff88e886
995632meclizine HCl 25 MG Chewable TabletPSNd1c58a74-5455-4a07-bcb6-cc114032ed125
995632meclizine HCl 25 MG Chewable TabletPSNe4201bdc-18b4-4229-a7c0-300c5d5ad8db5
995632meclizine hydrochloride 25 MG Chewable TabletSCDd1c58a74-5455-4a07-bcb6-cc114032ed125
995632meclizine hydrochloride 25 MG Chewable TabletSCDe4201bdc-18b4-4229-a7c0-300c5d5ad8db5
995632meclizine HCl 25 MG Chewable TabletPSNd08fa6f5-4293-4468-814e-7dccbd2812094
995632meclizine hydrochloride 25 MG Chewable TabletSCDd08fa6f5-4293-4468-814e-7dccbd2812094
995632meclizine HCl 25 MG Chewable TabletPSNa58d13fe-2920-3b43-e053-2a95a90a5b941
995632meclizine hydrochloride 25 MG Chewable TabletSCDa58d13fe-2920-3b43-e053-2a95a90a5b941

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69618-028-0169618002801100 TABLET in 1 BOTTLE, PLASTIC (69618-028-01) 100 tablet2015-11-010000-00-00NoNoCurrent
69618-028-10696180028101000 TABLET in 1 BOTTLE, PLASTIC (69618-028-10) 1000 tablet2015-11-010000-00-00NoNoCurrent