FDA.reportPublic FDA data

Allergy Relief Antihistamine

Product NDC
63868-474
Requested package NDC
63868-474-24
11-digit product format
638680474
Labeler code
63868
Product ID
63868-474_6c9c7572-01f2-4a08-9332-8f5e39ce7629
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Hydrochloride
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
CDMA Inc
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2021-05-01
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage63868-47463868-474-24IInactivated by FDA2026-10-12

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
63868-474-24Allergy Relief Antihistamine2 in 1 CARTONCAPSULE, LIQUID FILLED24
63868-474-24Allergy Relief Antihistamine12 in 1 BLISTER PACKCAPSULE, LIQUID FILLED124

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-474-24EA - Each63868-4747d6e2855-81f4-4101-b552-ec077ac8978d12022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-474ALLERGY RELIEF ANTIHISTAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [CDMA INC]4Legacy NDC, 2 package rows20250101_c5fdd413-912f-4f80-8376-2dd6c4eabbde.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSNc5fdd413-912f-4f80-8376-2dd6c4eabbde4
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCDc5fdd413-912f-4f80-8376-2dd6c4eabbde4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63868-474-24638680474242 BLISTER PACK in 1 CARTON (63868-474-24) > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK2 blister pack2021-05-010000-00-00NoNoCurrent