FDA.reportPublic FDA data

Allergy Relief

Product NDC
55910-329
11-digit product format
559100329
Labeler code
55910
Product ID
55910-329_0f869b3c-b39a-4b75-9cf7-6af308fb28b2
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
DOLGENCORP, LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1990-03-02
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Allergy Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTC2D6JAD40
Rxcui1049630

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
55910-329-08Allergy Relief24 in 1 BLISTER PACKTABLET, FILM COATED2415
55910-329-08Allergy Relief1 in 1 CARTONTABLET, FILM COATED115
55910-329-12Allergy Relief100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10015
55910-329-12Allergy Relief1 in 1 CARTONTABLET, FILM COATED115
55910-329-51Allergy Relief365 in 1 BOTTLE, PLASTICTABLET, FILM COATED36515

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET [DOLGENCORP, LLC]1
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET [DOLGENCORP, LLC]1
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET [DOLGENCORP, LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET [DOLGENCORP, LLC]1
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET [DOLGENCORP, LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET [DOLGENCORP, LLC]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET [DOLGENCORP, LLC]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET [DOLGENCORP, LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET [DOLGENCORP, LLC]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET [DOLGENCORP, LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET [DOLGENCORP, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-329ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [DOLGENCORP, LLC]14Current NDC, Legacy NDC, 5 package rows20240623_69af44c2-390c-4223-889a-d5555aef5778.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN69af44c2-390c-4223-889a-d5555aef577815
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD69af44c2-390c-4223-889a-d5555aef577815

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55910-329-085591003290824 in 1 BLISTER PACKHistorical
55910-329-12559100329121 BOTTLE, PLASTIC in 1 CARTON (55910-329-12) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2023-06-27NoNoHistorical
55910-329-5155910032951365 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55910-329-51) 1990-03-020000-00-00NoNoCurrent