FDA.reportPublic FDA data

Childrens Benadryl DYE-FREE ALLERGY

Product NDC
50580-535
11-digit product format
505800535
Labeler code
50580
Product ID
50580-535_27d44a57-0879-63ea-e063-6394a90ac4cf
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Kenvue Brands LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2008-07-01
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
12.5 mg/5mL
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 DYE-FREE ALLERGY
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg/5mL

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
1049906Internal RxNorm lookup
1049908Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
10d478ff-ddc6-45da-87ff-cfe1b2b07a8eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
50580-535-012024-02-01Children's Benadryl ® DYE-FREE ALLERGY
50580-535-082024-02-01Children's Benadryl ® DYE-FREE ALLERGY
50580-535-012024-01-30Children's Benadryl ® DYE-FREE ALLERGY
50580-535-082024-01-30Children's Benadryl ® DYE-FREE ALLERGY

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50580-535-01Childrens Benadryl DYE-FREE ALLERGY118 mL in 1 BOTTLESOLUTION11810
50580-535-01Childrens Benadryl DYE-FREE ALLERGY1 in 1 CARTONSOLUTION110
50580-535-02Childrens Benadryl DYE-FREE ALLERGY1 in 1 CARTONSOLUTION110
50580-535-02Childrens Benadryl DYE-FREE ALLERGY2 in 1 PACKAGESOLUTION210
50580-535-08Childrens Benadryl DYE-FREE ALLERGY236 mL in 1 BOTTLESOLUTION23610
50580-535-08Childrens Benadryl DYE-FREE ALLERGY1 in 1 CARTONSOLUTION110

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50580-535-01ML - Milliliter50580-535e7122ba9-fb23-40f7-9eff-7348cc2a793512016-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50580-535CHILDRENS BENADRYL DYE-FREE ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [KENVUE BRANDS LLC]10Current NDC, Legacy NDC, 6 package rows20241204_10d478ff-ddc6-45da-87ff-cfe1b2b07a8e.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 143 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DoloMax Cold CoughACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEBENARD INDUSTRIES INC520aee75-8b9a-4dcc-8970-75e122640e912024-10-31WarningsExact identifier
application number: M012
Good Sense NasalOXYMETAZOLINE HYDROCHLORIDEA-S Medication Solutionsb6fbc0ba-7e88-4ab9-b0fa-1e1e8f9132fe2024-10-31WarningsExact identifier
application number: M012
CareOne Nighttime Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLAmerican Sales Company819d5c82-0240-4013-9904-c335bd65d03e2024-10-30WarningsExact identifier
application number: M012
Signature Care Nighttime Severe Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLSafeway9a0ad5d5-8fd9-468d-be2c-87c14d08b9342024-10-30WarningsExact identifier
application number: M012
Good Sense Severe NightTime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLL. Perrigo Companyf2b77bc3-ba1e-4c3f-bbbd-fa93b2c37dd22024-10-30WarningsExact identifier
application number: M012
dg health cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLDolgencorp, LLC81f3ac36-9bae-4f42-92a0-8a2e4bbd09842024-10-30WarningsExact identifier
application number: M012
severe cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLRite Aid Corporation9a71e8eb-4195-4694-bf3e-44f691ff2cef2024-10-30WarningsExact identifier
application number: M012
nighttime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLH E Bfe4a95d2-6fb3-43fe-baec-6f22d19653232024-10-30WarningsExact identifier
application number: M012
NightTime Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLKroger Company2c9ef0d7-3d5b-494a-8f06-9dd42110d78a2024-10-30WarningsExact identifier
application number: M012
Severe NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLCVS Pharmacyd40d6fd1-3f84-40ae-ab7e-04569eb416172024-10-30WarningsExact identifier
application number: M012
equaline nighttime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLUnited Natural Foods, Inc. dba UNFI4e0c6ad6-81ef-4b0e-b2eb-44256faf73582024-10-30WarningsExact identifier
application number: M012
GOOD REMEDIES Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEStrive Pharmaceuticals Inc.24fbe2c0-7749-4c8a-e063-6394a90a7c6e2024-10-30WarningsExact identifier
application number: M012
basic care nighttime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEAmazon.com Services LLC130e68d1-9048-49c1-beee-490eecaed2d92024-10-30WarningsExact identifier
application number: M012
Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLWalgreen Company02f3e739-3153-412f-b2cd-6f01dcd5875b2024-10-30WarningsExact identifier
application number: M012
HealthWise Medicated Chest RubCAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOLVeridian Healthcare25a19d3e-37b3-50d5-e063-6394a90a97d12024-10-29WarningsExact identifier
application number: M012
Antigrip FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLPharmadel LLC25a23a03-6110-f595-e063-6394a90a70fe2024-10-29WarningsExact identifier
application number: M012
Antigrip Cough and ColdACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLPharmadel LLC25a23e5e-302a-7b7f-e063-6294a90a04632024-10-29WarningsExact identifier
application number: M012
Antigrip Extra StrengthACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLPharmadel LLC25a26adf-fd90-bf57-e063-6294a90a40732024-10-29WarningsExact identifier
application number: M012
Menthol Cough DropsMENTHOLBOSTON NUTRACEUTICAL PRODUCTION, S.Le82dac83-2910-44dc-e053-2995a90a38e12024-10-29WarningsExact identifier
application number: M012
TheraCare Medicated Chest RubCAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOLVeridian Healthcared6e789c7-a55a-dc9a-e053-2a95a90a2bdb2024-10-29WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049908Benadryl Children's Allergy 12.5 MG in 5 mL Oral SolutionPSN10d478ff-ddc6-45da-87ff-cfe1b2b07a8e10
1049906diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSN10d478ff-ddc6-45da-87ff-cfe1b2b07a8e10
1049908diphenhydramine hydrochloride 2.5 MG/ML Oral Solution [Benadryl]SBD10d478ff-ddc6-45da-87ff-cfe1b2b07a8e10
1049906diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCD10d478ff-ddc6-45da-87ff-cfe1b2b07a8e10
1049908Benadryl 2.5 MG/ML Oral SolutionSY10d478ff-ddc6-45da-87ff-cfe1b2b07a8e10
1049908Benadryl Children's Allergy 12.5 MG per 5 ML Oral SolutionSY10d478ff-ddc6-45da-87ff-cfe1b2b07a8e10
1049906diphenhydramine HCl 12.5 MG per 5 ML Oral SolutionSY10d478ff-ddc6-45da-87ff-cfe1b2b07a8e10
1049906diphenhydramine hydrochloride 25 MG per 10 ML Oral SolutionSY10d478ff-ddc6-45da-87ff-cfe1b2b07a8e10
1049906diphenhydramine hydrochloride 50 MG per 20 ML Oral SolutionSY10d478ff-ddc6-45da-87ff-cfe1b2b07a8e10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50580-535-01505800535011 BOTTLE in 1 CARTON (50580-535-01) / 118 mL in 1 BOTTLE1 bottle2015-12-010000-00-00NoNoCurrent
50580-535-02505800535022 CARTON in 1 PACKAGE (50580-535-02) / 1 BOTTLE in 1 CARTON / 236 mL in 1 BOTTLE2 carton2024-11-18NoNoCurrent
50580-535-08505800535081 BOTTLE in 1 CARTON (50580-535-08) / 236 mL in 1 BOTTLE1 bottle2022-06-160000-00-00NoNoCurrent