FDA.reportPublic FDA data

Allergy Relief

Product NDC
55910-222
11-digit product format
559100222
Labeler code
55910
Product ID
55910-222_edc5a7e0-2895-9982-e053-2995a90adcc8
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Dolgencorp, Inc.
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2019-05-17
Marketing end
0000-00-00
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct55910-222IInactivated by FDA2026-10-16
excluded packagepackage55910-22255910-222-24IInactivated by FDA2026-10-16

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55910-222-24Allergy ReliefDye Free2 in 1 BLISTER PACKCAPSULE, LIQUID FILLED26
55910-222-24Allergy ReliefDye Free24 in 1 CARTONCAPSULE, LIQUID FILLED246

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-222ALLERGY RELIEF DYE FREE (DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [DOLGENCORP, INC.]6Legacy NDC, 2 package rows20241222_9660db8e-62ea-411c-ac6a-7c572dec0a72.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSN9660db8e-62ea-411c-ac6a-7c572dec0a726
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCD9660db8e-62ea-411c-ac6a-7c572dec0a726

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55910-222-245591002222424 BLISTER PACK in 1 CARTON (55910-222-24) > 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK24 blister pack2019-05-170000-00-00NoNoCurrent