Benadryl

Product NDC
50580-226
Requested package NDC
50580-226-33
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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
TC2D6JAD40Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1049630Internal RxNorm lookup
1049632Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
702f9786-7ce9-43e4-921d-e1db09612127Available on FDA.report

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#

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 195 · 3,890 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Daytime Nighttime Intense Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEWalgreen Company03aa43fd-4962-4c2c-9edd-e422a629a0e32026-08-06WarningsExact identifier
application number: M012
Allergy Multi-SymptomACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCLARMY AND AIR FORCE EXCHANGE SERVICEf311b56f-b959-4070-9b23-82c642dd98b82026-08-06WarningsExact identifier
application number: M012
Cold Relief Multi-SymptomACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLL.N.K. International, Inc.2ed25f69-89ef-4c50-946a-7e7b9df1ca8a2026-08-06WarningsExact identifier
application number: M012
EucamintMENTHOL, CAMPHORIndiana Botanic Gardensd79bc8de-9efb-4996-a55c-accda0f8edb22026-08-06WarningsExact identifier
application number: M012
DRX CHOICE Daytime and Nighttime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, AND ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATERaritan Pharmaceuticals Incb745f45d-2042-4daa-9932-241836d7734b2026-08-06WarningsExact identifier
application number: M012
Acetaminophen, Dextromethorphan HBrACETAMINOPHEN, DEXTROMETHORPHAN HBRNUVICARE LLC6713fdff-0e4e-4a9d-b218-34f786339c572026-08-06WarningsExact identifier
application number: M012
Daytime Cold, Nighttime Cold multi-symptomACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLUnited Natural Foods, Inc. dba UNFI3b462a5d-d48b-4b73-b5d4-d7944730bbdd2026-08-06WarningsExact identifier
application number: M012
Sinufrin Quick Relief DecongestantSINUFRINNeilmed pharmaceuticals Inc.0c36a34e-462d-713c-e063-6294a90a17762026-08-05WarningsExact identifier
application number: M012
No DripOXYMETAZOLINE HYDROCHLORIDENeilMed Pharmaceuticals Ince9b799ad-9164-7f30-e053-2a95a90a00c52026-08-05WarningsExact identifier
application number: M012
DM MaxDEXTROMETHORPHAN HBR, GUAIFENESINWalgreen Company78edeb7a-4712-4f04-9d76-d5b2d20ce76d2026-08-04WarningsExact identifier
application number: M012
CareOne Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEAmerican Sales Companyc9342ad2-84dc-4f4c-9b05-c6e5c1c7989e2026-08-04WarningsExact identifier
application number: M012
dg health cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEDolgencorp Inc3d8ce88e-9f40-4b58-a811-160ddbfb81122026-08-04WarningsExact identifier
application number: M012
ValuRx Dye Free Allergy ReliefDIPHENHYDRAMINE HCL 25 MGShield Pharmaceuticals Corpca60a413-b02e-48ce-985d-4d415780c6792026-08-04WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLWal-Mart Stores Inc150b68ba-3ed4-4533-9118-74e76eaf6e482026-08-04WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLRite Aid Corporationce393bff-498b-42e6-a41c-bbfbc58fb42c2026-08-04WarningsExact identifier
application number: M012
Sinus and HeadacheACETAMINOPHEN AND PHENYLEPHRINE HCLCardinal Health 110, LLC. DBA Leader3b8662bf-3abb-4e54-af9c-5fa1d2e190032026-08-04WarningsExact identifier
application number: M012
Mucus Relief PEGUAIFENESIN, PHENYLEPHRINE HCLWalgreen Companycb1c1922-5dc6-520d-e77e-e951726d97012026-08-04WarningsExact identifier
application number: M012
Chest Congestion Relief DMDEXTROMETHORPHAN HBR, GUAIFENESINDOLGENCORP, LLCda053bc3-e790-4ae9-a406-2629640e97e72026-08-04WarningsExact identifier
application number: M012
Cold and Flu plus Congestion NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLWALMART INC.1236b463-0073-44b5-a516-5b7c06a408872026-08-04WarningsExact identifier
application number: M012
daytime nitetime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLMeijer Distribution Inc80aae1c3-a616-442b-842e-177db957a69c2026-08-04WarningsExact identifier
application number: M012

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 startSampleExclude flagStatus
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