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 54 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEStrategic Sourcing Services, LLC1d6c23d7-d1dc-4cba-8600-5762c18a0e272026-01-29WarningsExact identifier
application number: M012
Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLBelmora LLC3622e072-2784-c57e-e063-6394a90a82172026-01-29Warnings, Adverse reactionsExact identifier
application number: M012
Night Time Cold and Flu ReadyInCaseACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEP & L Development, LLCe7dd763b-3005-4723-933b-171eb772afee2026-01-29WarningsExact identifier
application number: M012
Acetaminophen, Guaifenesin, Phenylephrine Hcl and Dextromethorphan HBrACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL AND DEXTROMETHORPHAN HBRSoftgel Healthcare Pvt Ltd24bc9ae6-8e8f-c0a0-e063-6394a90a407f2026-01-28WarningsExact identifier
application number: M012
Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine SuccinateACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATESoftgel Healthcare Private Limited229d1939-84a9-f18e-e063-6394a90aba302026-01-28WarningsExact identifier
application number: M012
Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate and Phenylephrine HydrochlorideACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE AND PHENYLEPHRINE HYDROCHLORIDESOFTGEL HEALTHCARE PRIVATE LIMITED1fcbafaa-c871-db6d-e063-6394a90aab5e2026-01-28WarningsExact identifier
application number: M012
Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine HydrochlorideACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDESOFTGEL HEALTHCARE PRIVATE LIMITED1f7a6375-ab66-9782-e063-6394a90a99f32026-01-28WarningsExact identifier
application number: M012
ONESSIP ADULT NIGHTTIME SEVERE COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCIMEDWISE LIFESCIENCES INC.4970b8bc-3c7b-4b8a-e063-6294a90a7f1b2026-01-28WarningsExact identifier
application number: M012
Daytime Cold and Flu ReliefACETAMINOPHEN DEXTROMETHORPHAN HBRFamily Dollar (FAMILY WELLNESS)fe3e74ba-31d9-4d50-ab61-ffb6aaa660852026-01-28WarningsExact identifier
application number: M012
Leader Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATECardinal Health 110, LLC. dba Leader9b1a5dbe-39dd-4dbb-800c-0cef422ae7c52026-01-28WarningsExact identifier
application number: M012
Cold and Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWalgreen Company93d5b1db-e9ad-4a6a-b869-fd0d1a11df022026-01-27WarningsExact identifier
application number: M012
Childrens Allergy ReliefDIPHENHYDRAMINE HCLWal-Mart Stores Inc53a3e6a7-d625-4393-95eb-bb6f86e86cc12026-01-27WarningsExact identifier
application number: M012
Dextromethorphan Hbr,GuaifenesinDEXTROMETHORPHAN HBR,GUAIFENESINSOFTGEL HEALTHCARE PRIVATE LIMITED2fbbfc7c-81a9-b647-e063-6394a90a55ac2026-01-27WarningsExact identifier
application number: M012
DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDESOFTGEL HEALTHCARE PRIVATE LIMITED32074a31-326b-4aaf-e063-6394a90a0d402026-01-27WarningsExact identifier
application number: M012
DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDESOFTGEL HEALTHCARE PRIVATE LIMITED335b6ddd-fdc8-1120-e063-6394a90add412026-01-27WarningsExact identifier
application number: M012
Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine HydrochlorideACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDESOFTGEL HEALTHCARE PRIVATE LIMITED37e8ccd5-6be1-9aca-e063-6394a90a52632026-01-27WarningsExact identifier
application number: M012
Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine SuccinateACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATESOFTGEL HEALTHCARE PRIVATE LIMITED2f7f078e-de04-9d53-e063-6394a90a409f2026-01-27WarningsExact identifier
application number: M012
Sunscreen SPF50NON NANO ZINC OXIDESBS BILIMSEL BIO COZUMLER SANAYI VE TICARET ANONIM SIRKETI PINAR SUBESIc5d52f13-a649-9579-e053-2a95a90a062c2026-01-27WarningsExact identifier
application number: M012
XL-3 Night TimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATERnv LLC03210929-331e-462d-b566-4e1865f522462026-01-27WarningsExact identifier
application number: M012
XL-3 Day TimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLRnv LLC2381ff41-4584-4b38-839f-f94e733f5bf22026-01-27WarningsExact 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