FDA.reportPublic FDA data

Childrens Benadryl ALLERGY

Product NDC
50580-534
11-digit product format
505800534
Labeler code
50580
Product ID
50580-534_5b322e17-68d7-7008-e063-6394a90a36c9
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
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50580-53450580-534-16DDiscontinued by firm2026-10-23

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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 ALLERGY
Listing expiration
2027-12-31

Active Ingredients#

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

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
50580-534-042024-02-01Children's Benadryl ® ALLERGY
50580-534-082024-02-01Children'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
50580-534-162024-02-01Children's Benadryl ® ALLERGY
50580-534-182024-02-01Children'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
50580-534-042024-01-30Children's Benadryl ® ALLERGY
50580-534-082024-01-30Children'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
50580-534-162024-01-30Children's Benadryl ® ALLERGY
50580-534-182024-01-30Children'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 108 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diphenhydramine HClDIPHENHYDRAMINE HYDROCHLORIDEMajor Pharmaceuticals1b591e27-b00b-41c8-9fe9-c633aba091342025-08-01WarningsExact identifier
application number: M012
meijer Nighttime Cold and Flu SOFTGELACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEMeijer, Inc.377248b6-d64d-8dff-e063-6394a90a43f62025-07-31WarningsExact identifier
application number: M012
meijer Daytime Cold and Flu SOFTGELACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEMeijer, Inc.3771f778-7ac9-7108-e063-6394a90a11052025-07-31WarningsExact identifier
application number: M012
tussin dmDEXTROMETHORPHAN HBR, GUAIFENESINCVS Pharmacy087d7774-9b0f-44f6-bc1b-4dfbd2f2f6ca2025-07-31WarningsExact identifier
application number: M012
Equate NasalOXYMETAZOLINE HCLWal-Mart Stores Incc38a2783-aed9-466d-8976-59d03a792c042025-07-30WarningsExact identifier
application number: M012
Quality Choice Throat Soothing Drops Creamy StrawberryPECTINXiamen Kang Zhongyuan Biotechnology Co., Ltd.3b15d2ea-f784-275d-e063-6394a90a800c2025-07-29WarningsExact identifier
application number: M012
Respiratory ReliefGUAIFENESINSchwabe North America, Incf683041a-4ff9-42a5-9047-a9a3140a87582025-07-29WarningsExact identifier
application number: M012
Childrens Robitussin Honey Cough and Chest Congestion DMDEXTROMETHORPHAN HBR, GUAIFENESINHaleon US Holdings LLCb87f700e-3414-463c-80d4-c3dbca89a4882025-07-29WarningsExact identifier
application number: M012
Tussin DMTUSSIN DMAllegiant Health7a2f8d48-3123-4c37-b238-bd7cc4242bb72025-07-23WarningsExact identifier
application number: M012
Dr. SANA COUGH AND CHEST CONGESTION DM SUGAR FREEDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINGADAL Laboratories, Inc5fb2438b-8f2d-4af2-9981-42d278d268002025-07-23WarningsExact identifier
application number: M012
DR. SANA COUGH AND CHEST CONGESTION DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINGADAL Laboratories, Incbaca0580-4c30-4b94-89fa-a7cf06d4ff252025-07-22WarningsExact identifier
application number: M012
Defensol DACETAMINOPHEN, CHLORPHERINAMINE MALEATE, PHENYLEPHRINE HCIMenper Distributors, Inc.f466c660-69eb-4581-81ff-1499fa421d8b2025-07-22WarningsExact identifier
application number: M012
Defensol D Blister PackACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCIMenper Distributors, Inc.0dfcc977-6101-4536-e063-6294a90a7a482025-07-22WarningsExact identifier
application number: M012
BroncofinDEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLMenper Distributors, Inc.fdf67382-1692-485b-92f1-2cbb8be4fb702025-07-22WarningsExact identifier
application number: M012
Defensol Adult SyrupGUAIFENESIN, DEXTROMETHORPHAN HBRMenper Distributors, Inc.62acff69-8c40-4a0e-8d56-be2cc14e3d452025-07-22WarningsExact identifier
application number: M012
Cosedal DropsDEXTROMETHORPHAN HBR, GUAIFENESINMenper Distributors, Inc.1241d249-ea3b-4d2b-87ed-835d6a2d286a2025-07-22WarningsExact identifier
application number: M012
Berro y Cebolla DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINMenper Distributors, Inc.20107bd9-6d84-4ab5-a0d9-966f1f11d9192025-07-22WarningsExact identifier
application number: M012
Defensol-itoDEXTROMETHORPHAN, GUIAFENESIN, PHENYLEPHRINEMenper Distributors, Inca7c7a60d-d49f-4239-92f7-714eac7eb0c52025-07-22WarningsExact identifier
application number: M012
Bisolvine ChildrenGUAIFENESIN, DEXTROMETHORPHANMENPER DISTRIBUTORS INC.896a5443-e3d2-4af7-9e27-f1c1899ce0382025-07-22WarningsExact identifier
application number: M012
Bisolvine Aloe-MielDEXTROMETHORPHAN, GUAIFENESINMENPER DISTRIBUTORS INC.34801c79-ce88-492f-808e-b639e86016072025-07-22WarningsExact 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
50580-534-08505800534081 BOTTLE in 1 CARTON (50580-534-08) / 236 mL in 1 BOTTLE1 bottle2008-07-010000-00-00NoNoCurrent
50580-534-16505800534162 CARTON in 1 PACKAGE (50580-534-16) > 1 BOTTLE in 1 CARTON > 236 mL in 1 BOTTLE2 carton2009-01-280000-00-00NoNoCurrent
50580-534-18505800534182 CARTON in 1 PACKAGE (50580-534-18) / 1 BOTTLE in 1 CARTON / 236 mL in 1 BOTTLE2 carton2021-04-120000-00-00NoNoCurrent