FDA.reportPublic FDA data

Childrens Benadryl Chewables

Product NDC
50580-232
11-digit product format
505800232
Labeler code
50580
Product ID
50580-232_215db1b4-b8fb-90be-e063-6294a90a6353
Type
HUMAN OTC DRUG
Nonproprietary name
diphenhydramine hydrochloride
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Kenvue Brands LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-07-11
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
12.5 mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
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
Childrens Benadryl Chewables
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE12.5 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
1049900Internal RxNorm lookup
1049901Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b08f71d8-a06c-41ba-8ed1-fbc41dbc1919Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50580-232-012024-02-01C16284748780-11030e364-fd97-111a-e063-dadaa90a10e2Children's Benadryl ® Chewables
50580-232-012024-01-30C16284748780-11030e364-fd97-111a-e063-dadaa90a10e2Children's Benadryl ® Chewables

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50580-232-01Childrens Benadryl Chewables10 in 1 BLISTER PACKTABLET, CHEWABLE107
50580-232-01Childrens Benadryl Chewables2 in 1 CARTONTABLET, CHEWABLE27

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50580-232-01EA - Each50580-2324445c856-b1ee-4622-8a5b-446f41f6230012016-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50580-232CHILDRENS BENADRYL CHEWABLES (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, CHEWABLE [KENVUE BRANDS LLC]7Current NDC, Legacy NDC, 2 package rows20241109_b08f71d8-a06c-41ba-8ed1-fbc41dbc1919.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 118 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nighttime Ultra Concentrated Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE SOFTGELSWALGREENS2be0a699-e6ad-ef56-e063-6394a90aaca52025-04-03WarningsExact identifier
application number: M012
Cough and CongestionDEXTROMETHORPHAN HBR, GUAIFENESINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED44fb27d3-5125-4511-84d2-76555bc46e662025-04-03WarningsExact identifier
application number: M012
GuaifenesinGUAIFENESINKESIN PHARMA CORPORATION31b8ad0a-3637-03db-e063-6394a90acdc32025-04-01WarningsExact identifier
application number: M012
Pharmacys Prescription Vapor RubMENTHOLAmerican Consumer Products Corp31aa54d8-df8d-f1ae-e063-6294a90a96222025-03-31WarningsExact identifier
application number: M012
GuaifenesinGUAIFENESINBryant Ranch Prepack570a71eb-2d19-4c7b-8c00-e1524bfa38442025-03-31WarningsExact identifier
application number: M012
GuaifenesinGUAIFENESINKESIN PHARMA CORPORATION365c01b7-a197-4876-85fc-42204f787e3a2025-03-28WarningsExact identifier
application number: M012
Diphenhydramine HCLDIPHENHYDRAMINE HCLBryant Ranch Prepack59aeb692-2f79-45aa-8e6a-dab77cd3b2f92025-03-28WarningsExact identifier
application number: M012
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEOncor Pharmaceuticals06ecba97-c790-4672-a8c3-f9caf6272d262025-03-27WarningsExact identifier
application number: M012
Sugar Free Honey-Lemon Fishermans Friend Menthol Cough SuppressantMENTHOLLofthouse of Fleetwood, Ltd.87ebb4d9-78d7-1c87-e053-2a95a90adb7d2025-03-27WarningsExact identifier
application number: M012
REVASOL CHILDRENS ALLERGYDIPHENHYDRAMINE HCLRnv LLC3143137f-ef42-5358-e063-6394a90a8ed12025-03-26WarningsExact identifier
application number: M012
Rompe Pecho SF FLUDEXTROMETHORPHAN, BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDEEfficient Laboratories Incbc10695a-9664-4ce3-82bb-820da06129fa2025-03-26WarningsExact identifier
application number: M012
SUPRESS-PE PediatricGUIAFENESIN, PHENYLEPHRINE HCLKramer Novisa474171d-5c29-4a80-9d37-00613796211a2025-03-26WarningsExact identifier
application number: M012
Guaifenesin DMDEXTROMETHORPHAN HYDROBROMIDE,GUAIFENESINInnovida Pharmaeutique Corporationdd3f806b-2470-4055-94e1-18adac8110252025-03-25WarningsExact identifier
application number: M012
Foster and Thrive childrens cold cough relief dmBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDEStrategic Sourcing Services LLC38b710e3-1d01-4ff4-a6b6-44936f277f492025-03-25WarningsExact identifier
application number: M012
Revasol Tussin DM Max with HoneyDEXTROMETHORPHAN HBR AND GUAIFENESINRnv LLC30da9255-c93a-84d6-e063-6394a90a7c2a2025-03-21WarningsExact identifier
application number: M012
REVASOL NIGHTTIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATERnv LLC30dfd8f7-4cc6-d4f2-e063-6394a90aa9c92025-03-21WarningsExact identifier
application number: M012
Chest Congestion ReliefGUAIFENESINMeijer, Inc.261a79b3-5704-76f2-e063-6394a90a5ac62025-03-20WarningsExact identifier
application number: M012
Rompe Tos X ChildrenACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLOPMX LLC05cc932d-b412-0710-e063-6394a90a87f62025-03-19WarningsExact identifier
application number: M012
Rompe Tos X AdultsACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLOPMX LLC05abb2db-d22e-90b5-e063-6294a90ace3f2025-03-19WarningsExact identifier
application number: M012
Sinus Head CongestionACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDEVIVUNT PHARMA LLC30a07773-bd6f-b9f2-e063-6394a90ab8aa2025-03-18WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049901Benadryl Allergy 12.5 MG Chewable TabletPSNb08f71d8-a06c-41ba-8ed1-fbc41dbc19197
1049900diphenhydrAMINE HCl 12.5 MG Chewable TabletPSNb08f71d8-a06c-41ba-8ed1-fbc41dbc19197
1049901diphenhydramine hydrochloride 12.5 MG Chewable Tablet [Benadryl]SBDb08f71d8-a06c-41ba-8ed1-fbc41dbc19197
1049900diphenhydramine hydrochloride 12.5 MG Chewable TabletSCDb08f71d8-a06c-41ba-8ed1-fbc41dbc19197
1049901Benadryl 12.5 MG Chewable TabletSYb08f71d8-a06c-41ba-8ed1-fbc41dbc19197

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50580-232-01505800232012 BLISTER PACK in 1 CARTON (50580-232-01) / 10 TABLET, CHEWABLE in 1 BLISTER PACK2 blister pack2016-07-110000-00-00NoNoCurrent