FDA.reportPublic FDA data

Benadryl

Product NDC
50580-226
11-digit product format
505800226
Labeler code
50580
Product ID
50580-226_4a24745b-a44e-fbeb-e063-6394a90abd0a
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Kenvue Brands LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2008-09-01
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
Benadryl
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTC2D6JAD40
Rxcui1049630, 1049632

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50580-226-502024-02-06C16284748780-11030e365-46c8-111a-e063-dadaa90a10e2Benadryl ®
50580-226-502024-02-06C16284748780-11030e365-46c8-111a-e063-dadaa90a10e2Benadryl ®
50580-226-512024-02-06C16284748780-11030e365-46c8-111a-e063-dadaa90a10e2Benadryl ®
50580-226-512024-02-06C16284748780-11030e365-46c8-111a-e063-dadaa90a10e2Benadryl ®
50580-226-522024-02-06C16284748780-11030e365-46c8-111a-e063-dadaa90a10e2Benadryl ®
50580-226-522024-02-06C16284748780-11030e365-46c8-111a-e063-dadaa90a10e2Benadryl ®
50580-226-532024-02-06C16284748780-11030e365-46c8-111a-e063-dadaa90a10e2Benadryl ®
50580-226-532024-02-06C16284748780-11030e365-46c8-111a-e063-dadaa90a10e2Benadryl ®
50580-226-542024-02-06C16284748780-11030e365-46c8-111a-e063-dadaa90a10e2Benadryl ®
50580-226-542024-02-06C16284748780-11030e365-46c8-111a-e063-dadaa90a10e2Benadryl ®
50580-226-562024-02-06C16284748780-11030e365-46c8-111a-e063-dadaa90a10e2Benadryl ®
50580-226-562024-02-06C16284748780-11030e365-46c8-111a-e063-dadaa90a10e2Benadryl ®
50580-226-622024-02-06C16284748780-11030e365-46c8-111a-e063-dadaa90a10e2Benadryl ®
50580-226-622024-02-06C16284748780-11030e365-46c8-111a-e063-dadaa90a10e2Benadryl ®
50580-226-502024-01-30C16284748780-11030e365-46c8-111a-e063-dadaa90a10e2Benadryl ®
50580-226-502024-01-30C16284748780-11030e365-46c8-111a-e063-dadaa90a10e2Benadryl ®
50580-226-512024-01-30C16284748780-11030e365-46c8-111a-e063-dadaa90a10e2Benadryl ®
50580-226-512024-01-30C16284748780-11030e365-46c8-111a-e063-dadaa90a10e2Benadryl ®
50580-226-522024-01-30C16284748780-11030e365-46c8-111a-e063-dadaa90a10e2Benadryl ®
50580-226-522024-01-30C16284748780-11030e365-46c8-111a-e063-dadaa90a10e2Benadryl ®
50580-226-532024-01-30C16284748780-11030e365-46c8-111a-e063-dadaa90a10e2Benadryl ®
50580-226-532024-01-30C16284748780-11030e365-46c8-111a-e063-dadaa90a10e2Benadryl ®
50580-226-542024-01-30C16284748780-11030e365-46c8-111a-e063-dadaa90a10e2Benadryl ®
50580-226-542024-01-30C16284748780-11030e365-46c8-111a-e063-dadaa90a10e2Benadryl ®
50580-226-562024-01-30C16284748780-11030e365-46c8-111a-e063-dadaa90a10e2Benadryl ®
50580-226-562024-01-30C16284748780-11030e365-46c8-111a-e063-dadaa90a10e2Benadryl ®
50580-226-622024-01-30C16284748780-11030e365-46c8-111a-e063-dadaa90a10e2Benadryl ®
50580-226-622024-01-30C16284748780-11030e365-46c8-111a-e063-dadaa90a10e2Benadryl ®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50580-226-12Benadryl1 in 1 CARTONTABLET, FILM COATED131
50580-226-12Benadryl12 in 1 BLISTER PACKTABLET, FILM COATED1231
50580-226-20Benadryl1 in 1 CARTONTABLET, FILM COATED131
50580-226-20Benadryl2 in 1 CARTONTABLET, FILM COATED231
50580-226-33Benadryl3 in 1 CARTONTABLET, FILM COATED331
50580-226-33Benadryl1 in 1 CARTONTABLET, FILM COATED131
50580-226-50Benadryl100 in 1 BOTTLETABLET, FILM COATED10031
50580-226-50Benadryl1 in 1 CARTONTABLET, FILM COATED131
50580-226-51Benadryl12 in 1 BLISTER PACKTABLET, FILM COATED1231
50580-226-51Benadryl2 in 1 CARTONTABLET, FILM COATED231
50580-226-52Benadryl4 in 1 CARTONTABLET, FILM COATED431
50580-226-52Benadryl12 in 1 BLISTER PACKTABLET, FILM COATED1231
50580-226-53Benadryl2 in 1 POUCHTABLET, FILM COATED231
50580-226-54Benadryl60 in 1 CARTONTABLET, FILM COATED6031
50580-226-54Benadryl2 in 1 POUCHTABLET, FILM COATED231
50580-226-56Benadryl3 in 1 PACKAGETABLET, FILM COATED331
50580-226-56Benadryl4 in 1 CARTONTABLET, FILM COATED431
50580-226-62Benadryl2 in 1 POUCHTABLET, FILM COATED231
50580-226-62Benadryl4 in 1 CARTONTABLET, FILM COATED431
50580-226-70Benadryl48 in 1 BOTTLETABLET, FILM COATED4831
50580-226-70Benadryl1 in 1 CARTONTABLET, FILM COATED131

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50580-226-10EA - Each50580-2260e538188-3b26-4cf7-a5d2-7653a4c5807f12012-07-24
50580-226-48EA - Each50580-22630dcc89c-a992-45e8-84cd-964543091fb312012-07-24
50580-226-50EA - Each50580-2260c74e638-fdc6-4e03-aa02-8f64c6b47a2c12017-12-14
50580-226-51EA - Each50580-2264b1c6774-52e1-41f4-bb46-9e341575620012013-04-01
50580-226-52EA - Each50580-22605a4b0af-3905-4b1c-88a4-3fb4f226675b12015-10-02
50580-226-54EA - Each50580-226e04fc601-d017-4bc6-94ae-ecd6715d9b2f12022-02-07
50580-226-62EA - Each50580-226f56d0e68-9dd8-4cf9-b5cd-ac5e7c49552b12019-08-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Diphenhydramine HydrochlorideACTIVE INGREDIENTTC2D6JAD40BENADRYL (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]7
DiphenhydramineACTIVE MOIETY8GTS82S83MBENADRYL (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]7
Aluminum OxideINACTIVE INGREDIENTLMI26O6933BENADRYL (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]7
Calcium Phosphate, Dibasic, DihydrateINACTIVE INGREDIENTO7TSZ97GEPBENADRYL (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]7
Carnauba WaxINACTIVE INGREDIENTR12CBM0EIZBENADRYL (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]7
Cellulose, MicrocrystallineINACTIVE INGREDIENTOP1R32D61UBENADRYL (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]7
Croscarmellose SodiumINACTIVE INGREDIENTM28OL1HH48BENADRYL (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]7
CrospovidoneINACTIVE INGREDIENT68401960MKBENADRYL (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]7
D&C Red no. 27INACTIVE INGREDIENT2LRS185U6KBENADRYL (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]7
HypromellosesINACTIVE INGREDIENT3NXW29V3WOBENADRYL (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]7
Magnesium StearateINACTIVE INGREDIENT70097M6I30BENADRYL (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]7
Polyethylene GlycolsINACTIVE INGREDIENT3WJQ0SDW1ABENADRYL (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]7
Polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HBENADRYL (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]7
Stearic AcidINACTIVE INGREDIENT4ELV7Z65APBENADRYL (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]7
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JPBENADRYL (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50580-226BENADRYL (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [KENVUE BRANDS LLC]28Current NDC, Legacy NDC, 21 package rows20250426_702f9786-7ce9-43e4-921d-e1db09612127.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049632Benadryl 25 MG Oral TabletPSN702f9786-7ce9-43e4-921d-e1db0961212731
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN702f9786-7ce9-43e4-921d-e1db0961212731
1049632diphenhydramine hydrochloride 25 MG Oral Tablet [Benadryl]SBD702f9786-7ce9-43e4-921d-e1db0961212731
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD702f9786-7ce9-43e4-921d-e1db0961212731
1049632Benadryl 25 MG Oral TabletSY702f9786-7ce9-43e4-921d-e1db0961212731
1049632Benadryl Allergy Ultratab 25 MG Oral TabletSY702f9786-7ce9-43e4-921d-e1db0961212731
1049632Benadryl 25 MG Oral TabletPSN17633c87-ff0f-4fde-ab23-bc43bdc3fa8e4
1049632Benadryl 25 MG Oral TabletPSN76433e3c-142c-4704-8b2b-d602f008c3774
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN17633c87-ff0f-4fde-ab23-bc43bdc3fa8e4
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN76433e3c-142c-4704-8b2b-d602f008c3774
1049632diphenhydramine hydrochloride 25 MG Oral Tablet [Benadryl]SBD17633c87-ff0f-4fde-ab23-bc43bdc3fa8e4
1049632diphenhydramine hydrochloride 25 MG Oral Tablet [Benadryl]SBD76433e3c-142c-4704-8b2b-d602f008c3774
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD76433e3c-142c-4704-8b2b-d602f008c3774
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD17633c87-ff0f-4fde-ab23-bc43bdc3fa8e4
1049632Benadryl 25 MG Oral TabletSY17633c87-ff0f-4fde-ab23-bc43bdc3fa8e4
1049632Benadryl 25 MG Oral TabletSY76433e3c-142c-4704-8b2b-d602f008c3774
1049632Benadryl Allergy Ultratab 25 MG Oral TabletSY76433e3c-142c-4704-8b2b-d602f008c3774
1049632Benadryl Allergy Ultratab 25 MG Oral TabletSY17633c87-ff0f-4fde-ab23-bc43bdc3fa8e4
1049632Benadryl 25 MG Oral TabletPSN8d59d121-62a8-c43b-e053-2a95a90a58473
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN8d59d121-62a8-c43b-e053-2a95a90a58473
1049632diphenhydramine hydrochloride 25 MG Oral Tablet [Benadryl]SBD8d59d121-62a8-c43b-e053-2a95a90a58473
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD8d59d121-62a8-c43b-e053-2a95a90a58473
1049632Benadryl 25 MG Oral TabletSY8d59d121-62a8-c43b-e053-2a95a90a58473
1049632Benadryl Allergy Ultratab 25 MG Oral TabletSY8d59d121-62a8-c43b-e053-2a95a90a58473
1049632Benadryl 25 MG Oral TabletPSN37573ee4-4df8-4909-bbaf-9a7dbe336e8e2
1049632Benadryl 25 MG Oral TabletPSNb1c849e5-8003-4fd3-811d-6a927523e3532
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN37573ee4-4df8-4909-bbaf-9a7dbe336e8e2
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSNb1c849e5-8003-4fd3-811d-6a927523e3532
1049632diphenhydramine hydrochloride 25 MG Oral Tablet [Benadryl]SBD37573ee4-4df8-4909-bbaf-9a7dbe336e8e2
1049632diphenhydramine hydrochloride 25 MG Oral Tablet [Benadryl]SBDb1c849e5-8003-4fd3-811d-6a927523e3532
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCDb1c849e5-8003-4fd3-811d-6a927523e3532
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD37573ee4-4df8-4909-bbaf-9a7dbe336e8e2
1049632Benadryl 25 MG Oral TabletSYb1c849e5-8003-4fd3-811d-6a927523e3532
1049632Benadryl 25 MG Oral TabletSY37573ee4-4df8-4909-bbaf-9a7dbe336e8e2
1049632Benadryl Allergy Ultratab 25 MG Oral TabletSYb1c849e5-8003-4fd3-811d-6a927523e3532
1049632Benadryl Allergy Ultratab 25 MG Oral TabletSY37573ee4-4df8-4909-bbaf-9a7dbe336e8e2
1049632Benadryl 25 MG Oral TabletPSNd3f44425-db82-4569-8ed0-2fe990b233841
1049632Benadryl 25 MG Oral TabletPSN7c8b3e05-bdd5-46d3-8ff4-ea6e1f1885491
1049632Benadryl 25 MG Oral TabletPSNf4ff84b3-bb0c-4900-8ba4-6d1b903947821
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSNd3f44425-db82-4569-8ed0-2fe990b233841
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN7c8b3e05-bdd5-46d3-8ff4-ea6e1f1885491
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSNf4ff84b3-bb0c-4900-8ba4-6d1b903947821
1049632diphenhydramine hydrochloride 25 MG Oral Tablet [Benadryl]SBD7c8b3e05-bdd5-46d3-8ff4-ea6e1f1885491
1049632diphenhydramine hydrochloride 25 MG Oral Tablet [Benadryl]SBDd3f44425-db82-4569-8ed0-2fe990b233841
1049632diphenhydramine hydrochloride 25 MG Oral Tablet [Benadryl]SBDf4ff84b3-bb0c-4900-8ba4-6d1b903947821
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCDd3f44425-db82-4569-8ed0-2fe990b233841
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD7c8b3e05-bdd5-46d3-8ff4-ea6e1f1885491
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCDf4ff84b3-bb0c-4900-8ba4-6d1b903947821
1049632Benadryl 25 MG Oral TabletSY7c8b3e05-bdd5-46d3-8ff4-ea6e1f1885491
1049632Benadryl 25 MG Oral TabletSYd3f44425-db82-4569-8ed0-2fe990b233841
1049632Benadryl 25 MG Oral TabletSYf4ff84b3-bb0c-4900-8ba4-6d1b903947821
1049632Benadryl Allergy Ultratab 25 MG Oral TabletSYd3f44425-db82-4569-8ed0-2fe990b233841
1049632Benadryl Allergy Ultratab 25 MG Oral TabletSYf4ff84b3-bb0c-4900-8ba4-6d1b903947821
1049632Benadryl Allergy Ultratab 25 MG Oral TabletSY7c8b3e05-bdd5-46d3-8ff4-ea6e1f1885491

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50580-226-12505800226121 BLISTER PACK in 1 CARTON (50580-226-12) / 12 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2025-06-11NoNoCurrent
50580-226-20505800226202 CARTON in 1 CARTON (50580-226-20) / 1 BOTTLE in 1 CARTON / 100 TABLET, FILM COATED in 1 BOTTLE2 carton2024-01-15NoNoCurrent
50580-226-33505800226333 CARTON in 1 CARTON (50580-226-33) / 1 BOTTLE in 1 CARTON / 48 TABLET, FILM COATED in 1 BOTTLE3 carton2025-07-28NoNoCurrent
50580-226-50505800226501 BOTTLE in 1 CARTON (50580-226-50) / 100 TABLET, FILM COATED in 1 BOTTLE1 bottle2012-06-040000-00-00NoNoCurrent
50580-226-51505800226512 BLISTER PACK in 1 CARTON (50580-226-51) / 12 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack2012-06-040000-00-00NoNoCurrent
50580-226-52505800226524 BLISTER PACK in 1 CARTON (50580-226-52) / 12 TABLET, FILM COATED in 1 BLISTER PACK4 blister pack2012-06-040000-00-00NoNoCurrent
50580-226-53505800226532 TABLET, FILM COATED in 1 POUCH (50580-226-53) 2012-06-040000-00-00NoNoCurrent
50580-226-545058002265460 POUCH in 1 CARTON (50580-226-54) / 2 TABLET, FILM COATED in 1 POUCH60 pouch2015-07-270000-00-00NoNoCurrent
50580-226-56505800226563 CARTON in 1 PACKAGE (50580-226-56) / 4 BLISTER PACK in 1 CARTON / 12 TABLET, FILM COATED in 1 BLISTER PACK3 carton2013-02-010000-00-00NoNoCurrent
50580-226-62505800226624 POUCH in 1 CARTON (50580-226-62) / 2 TABLET, FILM COATED in 1 POUCH4 pouch2017-01-020000-00-00NoNoCurrent
50580-226-70505800226701 BOTTLE in 1 CARTON (50580-226-70) / 48 TABLET, FILM COATED in 1 BOTTLE1 bottle2025-06-02NoNoCurrent