FDA.reportPublic FDA data

Childrens Benadryl ALLERGY

Product NDC
50580-534
Requested package NDC
50580-534-04
11-digit product format
505800534
Labeler code
50580
Product ID
50580-534_35026484-5305-5f3d-e063-6294a90a5a50
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

Additional Listing Data#

Finished product
Yes
Brand name base
Childrens Benadryl ALLERGY
Listing expiration
2027-12-31

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
fc9181b9-c92d-493e-8d7c-4a4239c6c092Available 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
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
50580-534-042024-02-01Children's Benadryl ® ALLERGY
50580-534-042024-02-01Children's Benadryl ® ALLERGY
50580-534-082024-02-01Children's Benadryl ® ALLERGY
50580-534-082024-02-01Children's Benadryl ® ALLERGY
50580-534-162024-02-01Children's Benadryl ® ALLERGY
50580-534-162024-02-01Children's Benadryl ® ALLERGY
50580-534-182024-02-01Children's Benadryl ® ALLERGY
50580-534-182024-02-01Children's Benadryl ® ALLERGY
50580-534-042024-01-30Children's Benadryl ® ALLERGY
50580-534-042024-01-30Children's Benadryl ® ALLERGY
50580-534-082024-01-30Children's Benadryl ® ALLERGY
50580-534-082024-01-30Children's Benadryl ® ALLERGY
50580-534-162024-01-30Children's Benadryl ® ALLERGY
50580-534-162024-01-30Children's Benadryl ® ALLERGY
50580-534-182024-01-30Children's Benadryl ® ALLERGY
50580-534-182024-01-30Children's Benadryl ® ALLERGY

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50580-534-04Childrens Benadryl ALLERGY1 in 1 CARTONSOLUTION113
50580-534-04Childrens Benadryl ALLERGY118 mL in 1 BOTTLESOLUTION11813
50580-534-08Childrens Benadryl ALLERGY236 mL in 1 BOTTLESOLUTION23613
50580-534-08Childrens Benadryl ALLERGY1 in 1 CARTONSOLUTION113
50580-534-16Childrens Benadryl ALLERGY2 in 1 PACKAGESOLUTION213
50580-534-16Childrens Benadryl ALLERGY1 in 1 CARTONSOLUTION113
50580-534-18Childrens Benadryl ALLERGY2 in 1 PACKAGESOLUTION213
50580-534-18Childrens Benadryl ALLERGY1 in 1 CARTONSOLUTION113

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50580-534-04ML - Milliliter50580-5348dc7767c-f723-441f-968d-1619c1aaeb0d12012-07-24
50580-534-08ML - Milliliter50580-534d77ec339-aeee-4272-bab3-be49e308437a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Diphenhydramine hydrochlorideACTIVE INGREDIENTTC2D6JAD40CHILDRENS BENADRYL ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]1
diphenhydramineACTIVE MOIETY8GTS82S83MCHILDRENS BENADRYL ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]1
ammonium glycyrrhizateINACTIVE INGREDIENT3VRD35U26CCHILDRENS BENADRYL ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]1
anhydrous citric acidINACTIVE INGREDIENTXF417D3PSLCHILDRENS BENADRYL ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]1
D&C red no. 33INACTIVE INGREDIENT9DBA0SBB0LCHILDRENS BENADRYL ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]1
FD&C red no. 40INACTIVE INGREDIENTWZB9127XOACHILDRENS BENADRYL ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]1
glycerinINACTIVE INGREDIENTPDC6A3C0OXCHILDRENS BENADRYL ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]1
poloxamer 407INACTIVE INGREDIENTTUF2IVW3M2CHILDRENS BENADRYL ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]1
sodium benzoateINACTIVE INGREDIENTOJ245FE5EUCHILDRENS BENADRYL ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]1
sodium chlorideINACTIVE INGREDIENT451W47IQ8XCHILDRENS BENADRYL ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]1
sodium citrateINACTIVE INGREDIENT1Q73Q2JULRCHILDRENS BENADRYL ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]1
sucroseINACTIVE INGREDIENTC151H8M554CHILDRENS BENADRYL ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]1
waterINACTIVE INGREDIENT059QF0KO0RCHILDRENS BENADRYL ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50580-534CHILDRENS BENADRYL ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [KENVUE BRANDS LLC]13Current NDC, Legacy NDC, 8 package rows20250515_fc9181b9-c92d-493e-8d7c-4a4239c6c092.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 1 of 194 · 3,880 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Severe Congestion and PainACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLFamily Dollar Services Incce590997-3cae-4f22-ac39-2b14d39494bc2026-07-30WarningsExact identifier
application number: M012
Robitussin Direct CoughDEXTROMETHORPHAN HYDROBROMIDEHaleon US Holdings LLC70c9556b-063a-4fb3-96f6-1d4ffa495ed42026-07-30WarningsExact identifier
application number: M012
Major Nasal DecongestantOXYMETAZOLINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.a302e341-1c00-4c3d-b71f-c4c0b307aa672026-07-29WarningsExact identifier
application number: M012
Pain Reliever PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLWalgreens4c737cd6-fe56-4cef-887c-cd6cf83b254c2026-07-29WarningsExact identifier
application number: M012
ROBITUSSIN LONG-ACTING COUGHGELSDEXTROMETHORPHAN HYDROBROMIDEHaleon US Holdings LLC472c5c1f-eb5a-444b-a17e-f0d71007fb152026-07-29WarningsExact identifier
application number: M012
DAYTIME COLD AND FLU NITETIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEMeijer Distribution Inc3a33c6ce-aada-4099-8c61-49c86c0fc1a82026-07-29WarningsExact identifier
application number: M012
Tussin DM Max NighttimeDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEWal-Mart Stores Inc668c92ce-6c1f-4ab3-b0dd-822b0768cb5e2026-07-29WarningsExact identifier
application number: M012
BenadrylDIPHENHYDRAMINE HYDROCHLORIDEKenvue Brands LLC702f9786-7ce9-43e4-921d-e1db096121272026-07-28WarningsExact identifier
application number: M012
LoHist-DCHLORPHENIRAMINE MALEATE / PSEUDOEPHEDRINE HCLLarken Laboratories, Inc.efaa354e-c25c-405b-9d30-001c2796978c2026-07-28WarningsExact identifier
application number: M012
NIGHTTIME SEVERE COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDd1115a55-35cd-4f20-8872-f42983a5ebcd2026-07-28WarningsExact identifier
application number: M012
TUSSINDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINSafewaya5e2bda4-2da6-4c20-855d-2888dadf0c3a2026-07-28WarningsExact identifier
application number: M012
DM MaximumDEXTROMETHORPHAN HBR, GUAIFENESINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDf6029b04-e681-40fc-be4f-14091b76dd4e2026-07-27WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLCVS PHARMACYe958eef1-8aae-4365-ac64-95a9e8e7e0f22026-07-27WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLDOLGENCORP INC38400854-27fa-e291-e063-6294a90a5c4e2026-07-27WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLBetter Living Brands, LLC65802aa7-64e7-4435-ad6b-65895fba17ce2026-07-27WarningsExact identifier
application number: M012
Cold and Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, TRIPROLIDINE HCLWalgreen Company0a48f650-ad2a-4105-9ff4-2bc4d94b46d32026-07-27WarningsExact identifier
application number: M012
Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWalgreen Company84202ebe-97b6-4be2-bb09-7f2729303f962026-07-27WarningsExact identifier
application number: M012
Daytime Severe Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLRite Aid Corporation8d41defe-8120-4cbb-b42e-c805cc5a794b2026-07-24WarningsExact identifier
application number: M012
Childrens Benadryl ALLERGYDIPHENHYDRAMINE HYDROCHLORIDEKenvue Brands LLCfc9181b9-c92d-493e-8d7c-4a4239c6c0922026-07-24WarningsExact identifier
application number: M012
ndc (package): 50580-534-04
ndc (product): 50580-534
ndc11 (package): 50580053404
Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine HydrochlorideACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDEProdose, Inc.3afc88c7-388a-dbd9-e063-6294a90a4faf2026-07-24WarningsExact 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 SolutionPSNfc9181b9-c92d-493e-8d7c-4a4239c6c09213
1049906diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSNfc9181b9-c92d-493e-8d7c-4a4239c6c09213
1049908diphenhydramine hydrochloride 2.5 MG/ML Oral Solution [Benadryl]SBDfc9181b9-c92d-493e-8d7c-4a4239c6c09213
1049906diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCDfc9181b9-c92d-493e-8d7c-4a4239c6c09213
1049908Benadryl 2.5 MG/ML Oral SolutionSYfc9181b9-c92d-493e-8d7c-4a4239c6c09213
1049908Benadryl Children's Allergy 12.5 MG per 5 ML Oral SolutionSYfc9181b9-c92d-493e-8d7c-4a4239c6c09213
1049906diphenhydramine HCl 12.5 MG per 5 ML Oral SolutionSYfc9181b9-c92d-493e-8d7c-4a4239c6c09213
1049906diphenhydramine hydrochloride 25 MG per 10 ML Oral SolutionSYfc9181b9-c92d-493e-8d7c-4a4239c6c09213
1049906diphenhydramine hydrochloride 50 MG per 20 ML Oral SolutionSYfc9181b9-c92d-493e-8d7c-4a4239c6c09213

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50580-534-04505800534041 BOTTLE in 1 CARTON (50580-534-04) / 118 mL in 1 BOTTLE1 bottle2008-07-010000-00-00NoNoCurrent