FDA.reportPublic FDA data

Allergy Relief

Product NDC
46994-660
11-digit product format
469940660
Labeler code
46994
Product ID
46994-660_ee27e29e-e92a-8c75-e053-2a95a90a3152
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
SAVE-A-LOT FOOD STORES, LTD.
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-03-13
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct46994-660IInactivated by FDA2026-10-05
excluded packagepackage46994-66046994-660-24IInactivated by FDA2026-10-05

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
46994-660-24Allergy Relief24 in 1 BOTTLETABLET, FILM COATED247
46994-660-24Allergy Relief1 in 1 CARTONTABLET, FILM COATED17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46994-660ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [SAVE-A-LOT FOOD STORES, LTD.]7Legacy NDC, 2 package rows20241222_2f4071dd-9898-4fa2-9b9f-148d45b9dcdb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN2f4071dd-9898-4fa2-9b9f-148d45b9dcdb7
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD2f4071dd-9898-4fa2-9b9f-148d45b9dcdb7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
46994-660-24469940660241 BOTTLE in 1 CARTON (46994-660-24) > 24 TABLET, FILM COATED in 1 BOTTLE1 bottle2020-03-130000-00-00NoNoCurrent
46994-660-34469940660341 BOTTLE in 1 CARTON (46994-660-34) > 24 TABLET, FILM COATED in 1 BOTTLE1 bottle2020-03-130000-00-00NoNoCurrent