FDA.reportPublic FDA data

childrens allergy relief

Product NDC
11673-918
11-digit product format
116730918
Labeler code
11673
Product ID
11673-918_7c10dfc5-4151-4b91-a8a1-9615d3cf46fc
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
SOLUTION
Route
ORAL
Labeler
Target Corporation
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2018-05-20
Marketing end
0000-00-00
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
13 mg/5mL
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 productproduct11673-918DDiscontinued by firm2026-10-16
excluded packagepackage11673-91811673-918-36DDiscontinued by firm2026-10-16

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
11673-918-36childrens allergy reliefdye-free118 mL in 1 BOTTLE, PLASTICSOLUTION11812
11673-918-36childrens allergy reliefdye-free1 in 1 CARTONSOLUTION112

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11673-918CHILDRENS ALLERGY RELIEF DYE-FREE (DIPHENHYDRAMINE HCL) SOLUTION [TARGET CORPORATION]12Legacy NDC, 2 package rows20250429_6cc45cb4-0e48-49ad-829f-b78a4f622ab4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049906diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSN6cc45cb4-0e48-49ad-829f-b78a4f622ab412
1049906diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCD6cc45cb4-0e48-49ad-829f-b78a4f622ab412
1049906diphenhydramine HCl 12.5 MG per 5 ML Oral SolutionSY6cc45cb4-0e48-49ad-829f-b78a4f622ab412
1049906diphenhydramine hydrochloride 25 MG per 10 ML Oral SolutionSY6cc45cb4-0e48-49ad-829f-b78a4f622ab412
1049906diphenhydramine hydrochloride 50 MG per 20 ML Oral SolutionSY6cc45cb4-0e48-49ad-829f-b78a4f622ab412

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11673-918-36116730918361 BOTTLE in 1 CARTON (11673-918-36) > 118 mL in 1 BOTTLE1 bottle2018-05-200000-00-00NoNoCurrent