FDA.reportPublic FDA data

Wal-Dram 2 Quick-Dissolving

Product NDC
0363-1407
11-digit product format
003631407
Labeler code
0363
Product ID
0363-1407_47396c5d-b8b0-e221-e063-6394a90abe12
Type
HUMAN OTC DRUG
Nonproprietary name
meclizine hydrochloride
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Walgreen Co.
Application
M009
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-03-01
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
Wal-Dram 2 Quick-Dissolving
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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1663815Internal RxNorm lookup
1800794Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f3116203-1b8f-438a-b779-7bdd90eaf79eAvailable 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
0363-1407-01Wal-Dram 2 Quick-Dissolving6 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING610
0363-1407-01Wal-Dram 2 Quick-Dissolving2 in 1 CARTONTABLET, ORALLY DISINTEGRATING210
0363-1407-02Wal-Dram 2 Quick-Dissolving3 in 1 CARTONTABLET, ORALLY DISINTEGRATING310
0363-1407-02Wal-Dram 2 Quick-Dissolving6 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING610

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-1407WAL-DRAM 2 QUICK-DISSOLVING (MECLIZINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [WALGREEN CO.]9Current NDC, Legacy NDC, 4 package rows20231104_f3116203-1b8f-438a-b779-7bdd90eaf79e.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 6 of 6 · 107 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Airmit AceDIMENHYDRINATESato Pharmaceutical Co., Ltd.a98d252d-4cfa-496a-ab2c-627f45f0d7d92023-12-01WarningsExact identifier
application number: M009
Meclizine HClMECLIZINE HYDROCHLORIDEBluePoint Laboratoriesd9cae5a6-8d4b-bdaf-e053-2995a90a7d442023-11-17WarningsExact identifier
application number: M009
ZenTrip Motion SicknessMECLIZINE HYDROCHLORIDESato Pharmaceutical Co., LTDbd86c4c7-b6f0-e3e8-e053-2995a90a44542023-11-03WarningsExact identifier
application number: M009
Travel-EaseMECLIZINE HCLGeri-Care Pharmaceutical Corpe3c64eb9-4972-29d9-e053-2a95a90a2a8a2023-10-25WarningsExact identifier
application number: M009
GravolDIMENHYDRINATEChurch & Dwight Co., Inc.d95240bb-02f2-3226-e053-2995a90afacd2022-03-03WarningsExact identifier
application number: M009
Allergy DyeFreeALLERGY DYEFREEAllegiant Health15736bb8-5a5b-489d-83ad-4cf34ec629562021-04-26WarningsExact identifier
application number: M009
Motion Sickness ReliefDIMENHYDRINATE 50MGAllegiant Health7b0aa993-f08f-4dff-a82d-f35b3ebe3cc12019-12-12WarningsExact identifier
application number: M009

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1663815meclizine HCl 25 MG Disintegrating Oral TabletPSNf3116203-1b8f-438a-b779-7bdd90eaf79e10
1800794Wal-Dram 2 25 MG Disintegrating Oral TabletPSNf3116203-1b8f-438a-b779-7bdd90eaf79e10
1800794meclizine hydrochloride 25 MG Disintegrating Oral Tablet [Wal-Dram 2]SBDf3116203-1b8f-438a-b779-7bdd90eaf79e10
1663815meclizine hydrochloride 25 MG Disintegrating Oral TabletSCDf3116203-1b8f-438a-b779-7bdd90eaf79e10
1663815meclizine HCl 25 MG Disintegrating Oral TabletSYf3116203-1b8f-438a-b779-7bdd90eaf79e10
1800794Wal-Dram 2 25 MG Disintegrating Oral TabletSYf3116203-1b8f-438a-b779-7bdd90eaf79e10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-1407-01003631407012 BLISTER PACK in 1 CARTON (0363-1407-01) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK2 blister pack2016-03-010000-00-00NoNoCurrent
0363-1407-02003631407023 BLISTER PACK in 1 CARTON (0363-1407-02) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK3 blister pack2018-10-230000-00-00NoNoCurrent