FDA.reportPublic FDA data

Benadryl Allergy Extra Strength Liqui-Gels

Product NDC
50580-322
11-digit product format
505800322
Labeler code
50580
Product ID
50580-322_451a21a1-4357-d575-e063-6394a90a900a
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
2025-05-15
Marketing end
2027-04-30
Substance
DIPHENHYDRAMINE HCL
Active strength
50 mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
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 Extra Strength Liqui-Gels

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HCL50 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
1020477Internal RxNorm lookup
1050076Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
30aca3ab-b091-3939-e063-6294a90a9819Available 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50580-322-20Benadryl Allergy Extra Strength Liqui-Gels2 in 1 CARTONCAPSULE, LIQUID FILLED23
50580-322-20Benadryl Allergy Extra Strength Liqui-Gels10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50580-322BENADRYL ALLERGY EXTRA STRENGTH LIQUI-GELS (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [KENVUE BRANDS LLC]2Current NDC, 2 package rows20250523_30aca3ab-b091-3939-e063-6294a90a9819.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 107 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ACTIDOGESICDEXBROMPHENIRAMINE MALEATE, ACETAMINOPHENACTIPHARMA, LLC697da3f9-9888-4d41-ba83-87ca9bf1e54b2025-08-18WarningsExact identifier
application number: M012
Night Time Cold and Flu Relief Multi SymptomACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATERite Aid Corporation5f9c9c48-4e8f-4ace-a6fb-1c1bccaf02a02025-08-18WarningsExact identifier
application number: M012
MAJOR NASAL DECONGESTANTOXYMETAZOLINE HYDROCHLORIDEA-S Medication Solutions4b78b9af-0975-43f8-8b44-daddef0478be2025-08-15WarningsExact identifier
application number: M012
Dr Simi Mucus Relief ExpectorantGUAIFENESINFarmacias De Similares TX LLC3c6d0e75-a685-6020-e063-6294a90a5c1b2025-08-15WarningsExact identifier
application number: M012
Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATERite Aid Corporation25bf4390-23f7-4bb6-b86e-c40eaf8d92da2025-08-15WarningsExact identifier
application number: M012
Childrens Chewable Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEKROGER COMPANY2cac72be-4830-ad49-e063-6394a90a78322025-08-14WarningsExact identifier
application number: M012
GOOD NEIGHBOR PHARMACY MUCUS RELIEF DM MAXIMUM STRENGTHDEXTROMETHORPHAN HBR AND GUAIFENESINAMERISOURCE BERGEN2ea1e7bf-1bb9-4627-bbd4-4a78920a8b6e2025-08-12WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLWalmart Inc.16fae164-28db-8ef1-e063-6294a90ab5da2025-08-12WarningsExact identifier
application number: M012
Exchange Select Cough Drops Original HerbMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.fbece335-a7e5-4732-a086-561b237415792025-08-12WarningsExact identifier
application number: M012
MGC Health Cough Drops Original HerbMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.779ddb89-b6e2-4bfb-bcb5-8c7ec916675a2025-08-12WarningsExact identifier
application number: M012
Equaline NasalOXYMETAZOLINE HYDROCHLORIDEUnited Natural Foods, Inc. dba UNFId7fa1720-eac4-4e82-9401-77215ce4f5452025-08-12WarningsExact identifier
application number: M012
Diabetic Tussin DM Maximum StrengthDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINMEDTECH PRODUCTS INCa10a3b33-7503-4334-8ed7-2bb881df43272025-08-08WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDECabinet Health, Inc26a55d74-f772-5d17-e063-6394a90a55832025-08-07WarningsExact identifier
application number: M012
Daytime SevereACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEH E Bb7434978-44a8-4c51-979d-0bc446461e432025-08-06WarningsExact identifier
application number: M012
Tussin DMDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATECVS Pharmacyfc1e224c-5c57-43fc-ae6e-36aa0a4ae4392025-08-06WarningsExact identifier
application number: M012
childrens cold cough dmBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDEPublix Super Markets Inc6efe7097-2a99-4654-9d94-b47f2e64d19d2025-08-05WarningsExact identifier
application number: M012
Quality Choice Throat Soothing Drops Creamy StrawberryPECTINChain Drug Marketing Association, Inc.3b7548ee-7cd3-62c3-e063-6294a90a06122025-08-03WarningsExact identifier
application number: M012
Vaporizing chest rubCAMPHOR, EUCALYPTUS OIL, MENTHOLLJ Pharma065bb666-e482-4e96-ac75-c6577dcc5b482025-08-01WarningsExact identifier
application number: M012
Nighttime Cough-KidsCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRGenexa024bb864-4214-1d8b-e063-6394a90aa5732025-08-01WarningsExact identifier
application number: M012
Antigrip Cough and ColdACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRPharmadel LLC3b53e5fc-f258-c2b9-e063-6394a90ab5002025-08-01WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1050076Benadryl Allergy 50 MG Oral CapsulePSN30aca3ab-b091-3939-e063-6294a90a98193
1020477diphenhydrAMINE HCl 50 MG Oral CapsulePSN30aca3ab-b091-3939-e063-6294a90a98193
1050076diphenhydramine hydrochloride 50 MG Oral Capsule [Benadryl]SBD30aca3ab-b091-3939-e063-6294a90a98193
1020477diphenhydramine hydrochloride 50 MG Oral CapsuleSCD30aca3ab-b091-3939-e063-6294a90a98193
1050076Benadryl 50 MG Oral CapsuleSY30aca3ab-b091-3939-e063-6294a90a98193
1020477diphenhydramine HCl 50 MG Oral CapsuleSY30aca3ab-b091-3939-e063-6294a90a98193

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50580-322-20505800322202 BLISTER PACK in 1 CARTON (50580-322-20) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK2 blister pack2025-05-152027-04-30NoNoHistorical