FDA.reportPublic FDA data

Benadryl Allergy Liqui-Gels

Product NDC
50580-228
11-digit product format
505800228
Labeler code
50580
Product ID
50580-228_51352d7f-3c17-f0da-e063-6394a90a6be4
Type
HUMAN OTC DRUG
Nonproprietary name
diphenhydramine hydrochloride
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Kenvue Brands LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2009-03-01
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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Benadryl Allergy Liqui-Gels
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
1049909Internal RxNorm lookup
1049910Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
bfeae100-e2d1-4607-be3b-2d9b15cd4f7fAvailable 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
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
50580-228-242024-02-01Benadryl ® Allergy Liqui-Gels ®
50580-228-482024-02-01Benadryl ® Allergy Liqui-Gels ®
50580-228-492024-02-01Benadryl ® Allergy Liqui-Gels ®
50580-228-242024-01-30Benadryl ® Allergy Liqui-Gels ®
50580-228-482024-01-30Benadryl ® Allergy Liqui-Gels ®
50580-228-492024-01-30Benadryl ® Allergy Liqui-Gels ®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50580-228-24Benadryl Allergy Liqui-Gels12 in 1 BLISTER PACKCAPSULE, LIQUID FILLED1210
50580-228-24Benadryl Allergy Liqui-Gels2 in 1 CARTONCAPSULE, LIQUID FILLED210
50580-228-48Benadryl Allergy Liqui-Gels2 in 1 PACKAGECAPSULE, LIQUID FILLED210
50580-228-48Benadryl Allergy Liqui-Gels4 in 1 CARTONCAPSULE, LIQUID FILLED410
50580-228-49Benadryl Allergy Liqui-Gels4 in 1 CARTONCAPSULE, LIQUID FILLED410
50580-228-49Benadryl Allergy Liqui-Gels3 in 1 PACKAGECAPSULE, LIQUID FILLED310

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50580-228-24EA - Each50580-22800a84415-c75c-4e95-872c-4e52da22ede112013-10-17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
diphenhydramine hydrochlorideACTIVE INGREDIENTTC2D6JAD40BENADRYL ALLERGY LIQUI-GELS (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]2
diphenhydramineACTIVE MOIETY8GTS82S83MBENADRYL ALLERGY LIQUI-GELS (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]2
gelatinINACTIVE INGREDIENT2G86QN327LBENADRYL ALLERGY LIQUI-GELS (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]2
glycerinINACTIVE INGREDIENTPDC6A3C0OXBENADRYL ALLERGY LIQUI-GELS (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]2
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1ABENADRYL ALLERGY LIQUI-GELS (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]2
sorbitolINACTIVE INGREDIENT506T60A25RBENADRYL ALLERGY LIQUI-GELS (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]2
waterINACTIVE INGREDIENT059QF0KO0RBENADRYL ALLERGY LIQUI-GELS (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50580-228BENADRYL ALLERGY LIQUI-GELS (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [KENVUE BRANDS LLC]9Current NDC, Legacy NDC, 6 package rows20241109_bfeae100-e2d1-4607-be3b-2d9b15cd4f7f.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 85 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Allergy ReliefDIPHENHYDRAMINE HCLBIONPHARMA INC.323347c3-d51a-4976-e063-6294a90a952e2025-12-01WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLWALGREEN COMPANY2969ba8f-c477-222a-e063-6394a90af7032025-12-01WarningsExact identifier
application number: M012
CareAll Medicated Chest RubCAMPHOR, MENTHOL, EUCALYPTUSNew World Imports, Inc4cd2f751-e072-4f4e-b059-ed1dfcc60c6b2025-12-01WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLCVS PHARMACY, INCbbb1b395-48d9-4859-ad52-6650961089d92025-12-01WarningsExact identifier
application number: M012
Severe Sinus Pain and CongestionACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDfbc541ac-9465-4296-bb1e-811b9d811f402025-11-26WarningsExact identifier
application number: M012
Daytime Severe and Nighttime Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLGrocery Outlet, Inc.447951e6-459d-0a52-e063-6294a90a62262025-11-26WarningsExact identifier
application number: M012
Daytime Cold and Flu ReliefACETAMINOHPEN, DEXTROMETHORPHAN HBR, GUAIFENESIN PHENYLEPHRINE HCLWALGREENS CO.bfc58cd5-9815-43af-895d-ec6cbd10937e2025-11-26WarningsExact identifier
application number: M012
Walgreen Cough and Chest CongestionDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINWALGREEN COMPANY40c038a3-91c7-4ed0-8210-65d58b82ca2b2025-11-26WarningsExact identifier
application number: M012
Mucus Relief DM Maximum StrengthDEXTROMETHORPHAN HBR AND GUAIFENESINWALGREENS CO724554ab-60b8-46c8-96a8-a98242604e3b2025-11-26WarningsExact identifier
application number: M012
Walgreens Grape FlavorCHILDREN COUGH AND CHEST CONGESTIONWALGREENS795cf1af-3847-46bc-b605-64a38e57cca22025-11-26WarningsExact identifier
application number: M012
WalgreensCHILDRENS STUFFY NOSE AND COLDWALGREENS CO.7ac3de2d-1d10-49ec-a2da-da46977684ad2025-11-26WarningsExact identifier
application number: M012
Childrens Chest Congestion ReliefGUAIFENESINWALGREENS COMPANYc1382512-e6f3-4bdf-a9e6-4f68dd5ea5532025-11-26WarningsExact identifier
application number: M012
Dye Free Wal Sleep ZDIPHENHYDRAMINE HYDROCHLORIDEWALGREEN CO.96948973-09e3-4c05-8982-0494ebeaac4b2025-11-26WarningsExact identifier
application number: M012
WALGREEN ADULT COUGH PLUS CHEST CONGESTION DMDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINWALGREEN COMPANY02ad9f98-07ad-4786-a1ab-169b870fec012025-11-26WarningsExact identifier
application number: M012
Walgreen CherryGUAIFENESINWALGREEN COMPANY1f1cb4a5-1ebd-483c-bf82-16931da00e052025-11-26WarningsExact identifier
application number: M012
Walgreen Childrens COLD PLUS COUGH PLUS SORE THROATACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDEWALGREENS CO.801880b2-6116-4d26-a7bf-a669eef6ad8b2025-11-26WarningsExact identifier
application number: M012
Walgreen Daytimel Kids Cold Cough plus MucusGUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDEWALGREENS CO.452159e0-1204-460c-981f-cace4e815c6f2025-11-26WarningsExact identifier
application number: M012
Multi Symptom Wal Flu Severe ColdACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLWALGREEN CO.9c0f3f1e-25d1-4d73-9cd7-42708aa66dcb2025-11-25WarningsExact identifier
application number: M012
WALGREEN Daytime Multi Symptom Flu Relief Max StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBRWALGREENS CO.c92a0f47-0b7c-4034-83d1-b7d2ed8022fc2025-11-25WarningsExact identifier
application number: M012
Mucus Relief DM Honey and Berry FlavorDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINWALGREENS CO.428081f5-b7eb-42da-963c-a587a44b2a792025-11-25WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049910Benadryl Allergy Liqui-Gel 25 MG Oral CapsulePSNbfeae100-e2d1-4607-be3b-2d9b15cd4f7f10
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSNbfeae100-e2d1-4607-be3b-2d9b15cd4f7f10
1049910diphenhydramine hydrochloride 25 MG Oral Capsule [Benadryl]SBDbfeae100-e2d1-4607-be3b-2d9b15cd4f7f10
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCDbfeae100-e2d1-4607-be3b-2d9b15cd4f7f10
1049910Benadryl 25 MG Oral CapsuleSYbfeae100-e2d1-4607-be3b-2d9b15cd4f7f10
1049910Benadryl Dye-Free Allergy 25 MG Oral CapsuleSYbfeae100-e2d1-4607-be3b-2d9b15cd4f7f10
1049910Benadryl Allergy Liqui-Gel 25 MG Oral CapsulePSN0bbc8617-3833-4a97-9749-7c0e793fc9c51
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSN0bbc8617-3833-4a97-9749-7c0e793fc9c51
1049910diphenhydramine hydrochloride 25 MG Oral Capsule [Benadryl]SBD0bbc8617-3833-4a97-9749-7c0e793fc9c51
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCD0bbc8617-3833-4a97-9749-7c0e793fc9c51
1049910Benadryl 25 MG Oral CapsuleSY0bbc8617-3833-4a97-9749-7c0e793fc9c51
1049910Benadryl Dye-Free Allergy 25 MG Oral CapsuleSY0bbc8617-3833-4a97-9749-7c0e793fc9c51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50580-228-24505800228242 BLISTER PACK in 1 CARTON (50580-228-24) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK2 blister pack2009-03-010000-00-00NoNoCurrent
50580-228-48505800228482 CARTON in 1 PACKAGE (50580-228-48) / 4 BLISTER PACK in 1 CARTON / 6 CAPSULE, LIQUID FILLED in 1 BLISTER PACK2 carton2023-02-01NoNoCurrent
50580-228-49505800228493 CARTON in 1 PACKAGE (50580-228-49) / 4 BLISTER PACK in 1 CARTON / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK3 carton2023-06-19NoNoCurrent