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 33 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mucinex Childrens Cough and Chest Congestion Mini-Melts Orange CremeDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINReckitt Benckiser LLC66543190-1d3d-4259-ae73-d366ecbf9e522026-05-12WarningsExact identifier
application number: M012
basic care daytime nighttime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLAmazon.com Services LLC612719a9-fa2e-4c40-8f35-a399aeaafecc2026-05-12WarningsExact identifier
application number: M012
Sinus Pressure and Pain Daytime Nighttime Maximum StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCL, GUAIFENESIN, PHENYLEPHRINE HCLWalgreen Company3cac44ad-1835-487e-b6d0-1483d724bb5e2026-05-12WarningsExact identifier
application number: M012
GUAIFENESIN DMGUAIFENESIN AND DEXTROMETHORPHANCardinal Health 107, LLC9cfb1abb-98c4-4e90-8dd7-fcffc112f9882026-05-12WarningsExact identifier
application number: M012
Nasal Decongestant PE and Pain Relief Maximum StrengthACETAMINOPHEN, PHENYLEPHRINE HCLWinCo Foods, LLCfab51b36-1c2e-4c97-932c-dacfaf55935a2026-05-11WarningsExact identifier
application number: M012
Mucus Relief DMDEXTROMETHORPHAN HBR, GUAIFENESINWalgreen Companycad5da8c-65a6-44c4-a4c7-38f2c7fe43aa2026-05-11WarningsExact identifier
application number: M012
NebuClear MDSALINEBlue Echo Care LLC3f85fe62-230f-b0f1-e063-6394a90a5cb82026-05-11WarningsExact identifier
application number: M012
Device - NebuClear MD Hand-held Rubber Bulb NebulizerDEVICE - HAND-HELD RUBBER BULB NEBULIZERBlue Echo Care LLC43e0a646-be57-1024-e063-6394a90a43e42026-05-11WarningsExact identifier
application number: M012
Severe Congestion and CoughDEXTROMETHORPHAN HBR, GUAIFENESINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED1efd1778-7ab1-4797-98c5-4637940ee3ec2026-05-11WarningsExact identifier
application number: M012
DayTime High Blood Pressure Cold and Flu Relief Liquid filled SoftgelsACETAMINOPHEN,DEXTROMETHROPHAN HBRAptaPharma Inc.0380035e-44d5-44ea-9d1c-d57a1de651882026-05-10WarningsExact identifier
application number: M012
Night Time Cold and Flu relief liquid filled softgelsACETAMINOPHEN,DEXTROMETHROPHAN HBR,DOXYLAMINE SUCCINATEAptaPharma Inc.d61e2186-8b59-45f9-96ec-83430a0fe0cb2026-05-10WarningsExact identifier
application number: M012
Maximum Strength Tussin DM Liquid filled SoftgelsDEXTROMETHORPHAN HBR, GUAIFENESINAptaPharma Inc.39ad6cc9-d2b0-4b4a-8aa3-977905c9e6f12026-05-10WarningsExact identifier
application number: M012
Day-Time Cold/Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLAptaPharma Inc.c0dc613c-7f4e-4733-b2b6-6ba20e8fb83c2026-05-10WarningsExact identifier
application number: M012
Daytime Cold and Flu Relief Liquid Filled SoftgelsACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLAptaPharma Inc.c078efb5-d30e-4dd1-a600-6e827390df762026-05-10WarningsExact identifier
application number: M012
DM Max CONGESTION and COUGHDEXTROMETHORPHAN HBR, GUAIFENESINDeMoulas Market Basketb12e26b2-79e4-45a5-9a90-4630f92457d02026-05-09WarningsExact identifier
application number: M012
Flu HBP Maximum StrengthACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRWalgreen Companyfac55d76-457f-4258-9cc8-6edae539cada2026-05-08WarningsExact identifier
application number: M012
Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLHyVee Inc5a0ef8ae-f6d5-4388-b4da-6b7f025160b22026-05-08WarningsExact identifier
application number: M012
Halls Variety Pack Mentholyptus Honey Lemon CherryMENTHOLMondelez Global LLC512a9a2e-6160-80d1-e063-6394a90aeff02026-05-08WarningsExact identifier
application number: M012
ALKA SELTZER COLD Cold Flu and Congestion Severe Night Fast GelsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.5150ff85-85bb-9cd9-e063-6294a90a11442026-05-08WarningsExact identifier
application number: M012
Dr. Simi Children s CoughDEXTROMETHORPHAN HBR, GUAIFENESINFarmacias De Similares TX LLC5151740a-8270-7bb5-e063-6294a90ae3872026-05-08WarningsExact 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