Allergy Relief

Product NDC
49035-164
Requested package NDC
49035-164-12
11-digit product format
490350164
Labeler code
49035
Product ID
49035-164_964d27e9-3b84-48a8-8670-a6b6e36334c2
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCI
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Wal-Mart Stores Inc
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2018-08-15
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 packagepackage49035-16449035-164-12DDiscontinued by firm2026-10-05

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
49035-164-12Allergy Relief100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10012
49035-164-12Allergy Relief1 in 1 CARTONTABLET, FILM COATED112

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49035-164-12EA - Each49035-16439ac829b-861d-4602-99f3-0e3eeba5449412024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-164ALLERGY RELIEF (DIPHENHYDRAMINE HCI) TABLET, FILM COATED [WAL-MART STORES INC]11Legacy NDC, 2 package rows20240713_ba0fa9f9-7778-4a51-9ad1-fb349ceb8121.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSNba0fa9f9-7778-4a51-9ad1-fb349ceb812112
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCDba0fa9f9-7778-4a51-9ad1-fb349ceb812112

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
49035-164-12490350164121 BOTTLE, PLASTIC in 1 CARTON (49035-164-12) > 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2018-08-150000-00-00NoNoCurrent