Childrens Allergy Relief

Product NDC
73282-0012
Requested package NDC
73282-0012-1
11-digit product format
732820012
Labeler code
73282
Product ID
73282-0012_f089f40e-5ed4-ca95-e053-2995a90a145f
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
CalmCo LLC
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2021-08-06
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage73282-001273282-0012-1DDiscontinued by firm2026-10-12

Reported adverse events (FAERS/openFDA)#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73282-0012CHILDRENS ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [CALMCO LLC]5Legacy NDC20240526_c8ea4c6d-19c7-894f-e053-2a95a90a30af.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
73282-0012-17328200120120 VIAL in 1 CARTON (73282-0012-1) > 5 mL in 1 VIAL20 vial2021-08-060000-00-00NoNoCurrent