Allergy Relief

Product NDC
70000-0492
11-digit product format
700000492
Labeler code
70000
Product ID
70000-0492_3a79fdf6-9c5e-4a15-a35a-50ba8d02fec4
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Hydrochloride
Dosage form
LIQUID
Route
ORAL
Labeler
Cardinal Health (Leader) 70000
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2019-02-28
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 productproduct70000-0492DDiscontinued by firm2026-10-12
excluded packagepackage70000-049270000-0492-1DDiscontinued by firm2026-10-12

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0492-1ML - Milliliter70000-04923f36c24e-ff4e-4c6f-aab1-59a909ff34c012019-10-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0492ALLERGY RELIEF CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [CARDINAL HEALTH (LEADER) 70000]4Legacy NDC20240305_0ca9069c-ca3a-4e67-a5c6-08f9456a1d64.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70000-0492-1700000492011 BOTTLE, PLASTIC in 1 BOX (70000-0492-1) > 118 mL in 1 BOTTLE, PLASTIC2019-02-280000-00-00NoNoCurrent