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 101 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Giltuss Honey DM CoughDEXTROMETHORPHAN HBRDextrum Laboratories, Inc3f79137f-f0b0-d22c-e063-6394a90a72452025-09-23WarningsExact identifier
application number: M012
GoodSense Medicated Chest RubCAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOLGOOD SENSE240bb6af-9d38-49fe-9011-3016246b09862025-09-23WarningsExact identifier
application number: M012
Xpect Honey Lemon Cough DropsHONEY LEMON COUGH DROPSCintas Corporation79e0b7c1-4acc-41d2-89cd-d075a8bac0c92025-09-23WarningsExact identifier
application number: M012
Topcare NiteTime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATETopco Associates LLCb2b3c450-e988-41d1-9e53-cc8e30d75cb42025-09-23WarningsExact identifier
application number: M012
Xpect Cherry Cough DropsCHERRY COUGH DROPSCintas Corporationd1fd2f23-5435-405d-a7fd-644691f79e802025-09-23WarningsExact identifier
application number: M012
Topcare DayTime NiteTime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATETopco Associates LLC560fb22b-391f-4d7b-a6fd-38d577d404b02025-09-23WarningsExact identifier
application number: M012
Giltuss EX ExpectorantGUAIFENESINDextrum Laboratories Inc.3f67ac3d-1503-3418-e063-6394a90a938f2025-09-22WarningsExact identifier
application number: M012
Giltuss HBP Cough and Chest CongestionDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINDextrum Laboratories Inc.3f68e68a-cf32-9df8-e063-6394a90a30122025-09-22WarningsExact identifier
application number: M012
SUPRESS ADEXBROMOPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLKramer Novisf0bec5f5-4d76-471e-9024-557eba848b932025-09-22WarningsExact identifier
application number: M012
RIGHT REMEDIES NIGHTTIME SEVERE COLD AND FLU softgelACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEStrive Pharmaceuticals Inc.9f050fb0-6100-4b14-b82f-1d5fcbf165402025-09-22WarningsExact identifier
application number: M012
RIGHT REMEDIES DAYTIME SEVERE COLD AND FLU softgelACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEStrive Pharmaceuticals Inc.c6392ace-c7d1-4450-8b71-4dccc60b4f022025-09-22WarningsExact identifier
application number: M012
Giltuss Cough and ColdDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEDextrum Laboratories Inc.3f12ee8f-d1c6-d73a-e063-6394a90a91992025-09-18WarningsExact identifier
application number: M012
CVS Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDECVS Pharmacy3d71d306-893a-e73a-e063-6394a90a0a3b2025-09-18WarningsExact identifier
application number: M012
Giltuss DGILTUSS DDextrum Laboratories Inc.3f17eefb-b625-b0f2-e063-6294a90afd4d2025-09-18WarningsExact identifier
application number: M012
Cold and Flu Relief DaytimeACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLMajor Pharmaceuticals6c11c8c8-b2e1-4b9e-80cf-23247c03dd9b2025-09-17WarningsExact identifier
application number: M012
Childrens Giltuss Honey DM CoughDEXTROMETHORPHAN HBRDextrum Laboratories Inc3effaf4b-28c3-6131-e063-6294a90a17ff2025-09-17WarningsExact identifier
application number: M012
AXIV DayTime - LiquidACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEVIVUNT PHARMA LLC1872e1ff-2e08-c404-e063-6294a90afa142025-09-17WarningsExact identifier
application number: M012
AXIV AllergyDIPHENHYDRAMINE HYDROCHLORIDEVIVUNT PHARMA LLC1323a67c-b9c5-038c-e063-6394a90a5e6b2025-09-17WarningsExact identifier
application number: M012
Giltuss Childrens Cough and ColdDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEDextrum Laboratories Inc.3f025ef6-79e7-e833-e063-6294a90ab5012025-09-17WarningsExact identifier
application number: M012
AXIV Night Time - LiquidACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEVIVUNT PHARMA LLC186f8519-655d-bd21-e063-6294a90a16a82025-09-17WarningsExact 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