FDA.reportPublic FDA data

Allergy Relief

Product NDC
50844-329
11-digit product format
508440329
Labeler code
50844
Product ID
50844-329_c32f9c98-7532-4e52-b09d-45534043e8ea
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
L.N.K. International, Inc.
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Allergy Relief
Listing expiration
2027-12-31

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
50844-329-02Allergy Relief12 in 1 BLISTER PACKTABLET, FILM COATED1219
50844-329-02Allergy Relief1 in 1 CARTONTABLET, FILM COATED119
50844-329-07Allergy Relief12 in 1 BLISTER PACKTABLET, FILM COATED1219
50844-329-07Allergy Relief3 in 1 CARTONTABLET, FILM COATED319
50844-329-08Allergy Relief12 in 1 BLISTER PACKTABLET, FILM COATED1219
50844-329-08Allergy Relief2 in 1 CARTONTABLET, FILM COATED219
50844-329-12Allergy Relief100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10019
50844-329-22Allergy Relief4 in 1 CARTONTABLET, FILM COATED419
50844-329-22Allergy Relief12 in 1 BLISTER PACKTABLET, FILM COATED1219
50844-329-51Allergy Relief365 in 1 BOTTLE, PLASTICTABLET, FILM COATED36519
50844-329-78Allergy Relief600 in 1 BOTTLE, PLASTICTABLET, FILM COATED60019
50844-329-82Allergy Relief1 in 1 CARTONTABLET, FILM COATED119
50844-329-82Allergy Relief100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50844-329-07EA - Each50844-3298e1ca771-4325-4b82-80ac-dfa62a1ac88912025-10-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]4
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]4
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]4
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]4
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]4
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]4
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50844-329ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]18Current NDC, Legacy NDC, 13 package rows20250512_db264d2f-bf81-4da2-8595-2bfa1e4ba2f1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSNdb264d2f-bf81-4da2-8595-2bfa1e4ba2f119
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCDdb264d2f-bf81-4da2-8595-2bfa1e4ba2f119

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50844-329-02508440329021 BLISTER PACK in 1 CARTON (50844-329-02) / 12 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack1990-03-020000-00-00NoNoCurrent
50844-329-07508440329073 BLISTER PACK in 1 CARTON (50844-329-07) / 12 TABLET, FILM COATED in 1 BLISTER PACK3 blister pack1990-03-020000-00-00NoNoCurrent
50844-329-08508440329082 BLISTER PACK in 1 CARTON (50844-329-08) / 12 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack1990-03-020000-00-00NoNoCurrent
50844-329-1250844032912100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50844-329-12) 1990-03-02NoNoCurrent
50844-329-22508440329224 BLISTER PACK in 1 CARTON (50844-329-22) / 12 TABLET, FILM COATED in 1 BLISTER PACK4 blister pack1990-03-020000-00-00NoNoCurrent
50844-329-5150844032951365 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50844-329-51) 1990-03-02NoNoCurrent
50844-329-7850844032978600 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50844-329-78) 1990-03-02NoNoCurrent
50844-329-82508440329821 BOTTLE, PLASTIC in 1 CARTON (50844-329-82) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1990-03-02NoNoCurrent