FDA.reportPublic FDA data

Wal-Dryl

Product NDC
0363-0418
Requested package NDC
0363-0418-04
11-digit product format
003630418
Labeler code
0363
Product ID
0363-0418_434438da-c8eb-450a-8520-4a0f2e56633c
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
LIQUID
Route
ORAL
Labeler
Walgreens
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2014-08-31
Marketing end
0000-00-00
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
25 mg/10mL
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0363-04180363-0418-04DDiscontinued by firm2026-10-15

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0363-0418-042023-10-10C16284748780-1f386c649-f48b-0266-e053-dadaa90a7c1aDrug Facts
0363-0418-042023-01-30C16284748780-1f386c649-f48b-0266-e053-dadaa90a7c1aDrug Facts

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-0418-04ML - Milliliter0363-0418039e70a2-4358-4ce2-a631-96294b83dd6f12017-03-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40WAL-DRYL ALLERGY (DIPHENHYDRAMINE HCL) LIQUID [WALGREENS]2
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MWAL-DRYL ALLERGY (DIPHENHYDRAMINE HCL) LIQUID [WALGREENS]2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLWAL-DRYL ALLERGY (DIPHENHYDRAMINE HCL) LIQUID [WALGREENS]2
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LWAL-DRYL ALLERGY (DIPHENHYDRAMINE HCL) LIQUID [WALGREENS]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAWAL-DRYL ALLERGY (DIPHENHYDRAMINE HCL) LIQUID [WALGREENS]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXWAL-DRYL ALLERGY (DIPHENHYDRAMINE HCL) LIQUID [WALGREENS]2
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2WAL-DRYL ALLERGY (DIPHENHYDRAMINE HCL) LIQUID [WALGREENS]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUWAL-DRYL ALLERGY (DIPHENHYDRAMINE HCL) LIQUID [WALGREENS]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XWAL-DRYL ALLERGY (DIPHENHYDRAMINE HCL) LIQUID [WALGREENS]2
SUCROSEINACTIVE INGREDIENTC151H8M554WAL-DRYL ALLERGY (DIPHENHYDRAMINE HCL) LIQUID [WALGREENS]2
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KWAL-DRYL ALLERGY (DIPHENHYDRAMINE HCL) LIQUID [WALGREENS]2
WATERINACTIVE INGREDIENT059QF0KO0RWAL-DRYL ALLERGY (DIPHENHYDRAMINE HCL) LIQUID [WALGREENS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0418WAL-DRYL ALLERGY (DIPHENHYDRAMINE HCL) LIQUID [WALGREENS]8Legacy NDC20250507_42f6b92c-3d05-417e-96b2-22659364c0df.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-0418-04003630418041 BOTTLE in 1 BOX (0363-0418-04) > 118 mL in 1 BOTTLE1 bottle2014-08-310000-00-00NoNoCurrent