FDA.reportPublic FDA data

allergy

Product NDC
41250-379
11-digit product format
412500379
Labeler code
41250
Product ID
41250-379_0fa13b75-38d3-486d-b12d-4054c9861b06
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Meijer Distribution Inc
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1987-11-15
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
allergy
Brand name suffix
childrens
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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1049906Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
622b12fa-455c-4432-a9a2-698a929bbd68Available 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, Related label table
NDCRelated label
41250-379-26Meijer Distribution, Inc. Children’s Allergy Liquid Drug Facts
41250-379-26Meijer Distribution, Inc. Children’s Allergy Liquid Drug Facts
41250-379-34Meijer Distribution, Inc. Children’s Allergy Liquid Drug Facts
41250-379-34Meijer Distribution, Inc. Children’s Allergy Liquid Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41250-379-26allergychildrens118 mL in 1 BOTTLESOLUTION1187
41250-379-26allergychildrens1 in 1 CARTONSOLUTION17
41250-379-34allergychildrens1 in 1 CARTONSOLUTION17
41250-379-34allergychildrens237 mL in 1 BOTTLESOLUTION2377

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
41250-379-26ML - Milliliter41250-379c5fe9355-0212-47a1-b68e-bb2b50b0c74212012-07-24
41250-379-34ML - Milliliter41250-37924fe83bc-4b83-4539-9705-13a2df19e55312013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40ALLERGY CHILDRENS (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [MEIJER DISTRIBUTION INC]3
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MALLERGY CHILDRENS (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [MEIJER DISTRIBUTION INC]3
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLALLERGY CHILDRENS (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [MEIJER DISTRIBUTION INC]3
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LALLERGY CHILDRENS (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [MEIJER DISTRIBUTION INC]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAALLERGY CHILDRENS (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [MEIJER DISTRIBUTION INC]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXALLERGY CHILDRENS (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [MEIJER DISTRIBUTION INC]3
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SALLERGY CHILDRENS (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [MEIJER DISTRIBUTION INC]3
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2ALLERGY CHILDRENS (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [MEIJER DISTRIBUTION INC]3
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUALLERGY CHILDRENS (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [MEIJER DISTRIBUTION INC]3
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XALLERGY CHILDRENS (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [MEIJER DISTRIBUTION INC]3
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRALLERGY CHILDRENS (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [MEIJER DISTRIBUTION INC]3
SORBITOLINACTIVE INGREDIENT506T60A25RALLERGY CHILDRENS (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [MEIJER DISTRIBUTION INC]3
WATERINACTIVE INGREDIENT059QF0KO0RALLERGY CHILDRENS (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [MEIJER DISTRIBUTION INC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41250-379ALLERGY CHILDRENS (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [MEIJER DISTRIBUTION INC]6Current NDC, Legacy NDC, 4 package rows20240712_622b12fa-455c-4432-a9a2-698a929bbd68.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 22 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
foster and thrive daytime cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLStrategic Sourcing Services LLC067ce5de-dbb4-4b65-8ec0-f4aacbe5e0a62026-06-16WarningsExact identifier
application number: M012
Equate Severe Cold Cough and FluACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDEWALMART INC.a35531d7-1a96-45cb-922f-61db085cde1f2026-06-16WarningsExact identifier
application number: M012
Cold and Flu Daytime, Nighttime, Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCLWalgreen Company5fe9f313-d6e7-41f5-abfc-e4c72b7089612026-06-15WarningsExact identifier
application number: M012
Pain Relief Sinus CongestionACETAMINOPHEN, PHENYLEPHRINE HCLBetter Living Brands, LLC1d3d6397-0d92-4145-9a70-8bcc45bd03222026-06-15WarningsExact identifier
application number: M012
Goodmeds Allergy Relief Diphenhydramine HClDIPHENHYDRAMINE HYDROCHLORIDECabinet Health P.B.C.c1cc40f4-9bbb-47f2-ba3b-a5c46ec10f112026-06-15WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLRite Aid Corporationd5d9334d-3db6-4f45-ab84-3e1ec5a752c62026-06-15WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLGeiss, Destin & Dunn Inc.fac64ddc-a89b-4d73-b9e5-edc4e5cc3c4b2026-06-15WarningsExact identifier
application number: M012
equate daytime cold and flu nighttime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLWal-Mart Stores Inc983a4783-d826-41b6-8087-ca66bcd5b6ca2026-06-12WarningsExact identifier
application number: M012
Equate Daytime Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEWal-Mart Stores Inc4173ecde-a2d7-4836-a6e9-fef2270d1b4e2026-06-12WarningsExact identifier
application number: M012
PAIN RELIEVER PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLBest Choice (Valu Merchandisers Company)cf370a59-42d5-42fe-882f-09885c55f5702026-06-11WarningsExact identifier
application number: M012
Sudafed Sinus Congestion Plus Cold Severe DayACETAMINOPHEN, PSEUDOEPHEDRINEKenvue Brands LLC537e1a0d-820d-c3f7-e063-6294a90a56ea2026-06-10WarningsExact identifier
application number: M012
Sudafed Sinus Congestion plus Cold Severe Day and NightACETAMINOPHEN, DIPHENHYDRAMINE, PSEUDOEPHEDRINEKenvue Brands LLC5382dcad-0337-4440-e063-6394a90a706e2026-06-10WarningsExact identifier
application number: M012
good neighbor pharmacy nasalOXYMETAZOLINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.21cfa71c-7a8f-4100-a42e-9190260653d12026-06-09WarningsExact identifier
application number: M012
Daytime NighttimeACETAMINOPHEN DEXTROMETHORPHAN HBR, ACETAMINOPHEN DEXTROMETHORPHAN HBR TRIPROLIDINE HCLWALGREENS47f1d92f-cb4b-1635-e063-6294a90a2c712026-06-09WarningsExact identifier
application number: M012
HALLS HoneyMENTHOLMondelez Global LLC837f5ded-8efb-402b-a1bc-b5c1427556602026-06-09WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLMeijer Distribution Inc932b11b1-f4a0-417a-bfa1-05261a1721552026-06-08WarningsExact identifier
application number: M012
NO DRIP NASAL MISTOXYMETAZOLINE HYDROCHLORIDEKroger Company957efbcf-b6d3-4793-bb6e-27e99c9be9052026-06-08WarningsExact identifier
application number: M012
DAYTIME SEVERE COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED493caecb-e687-49ea-b7a1-2a5b9376896d2026-06-08WarningsExact identifier
application number: M012
Severe Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCVS PHARMACY4ad10fd7-c088-4356-9d34-a95cfe3a41332026-06-08WarningsExact identifier
application number: M012
Theraflu Severe Congestion Relief Nasal MistOXYMETAZOLINE HCLHaleon US Holdings LLC4ec42064-7390-4137-a93e-57343c3c76a72026-06-08WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049906diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSN622b12fa-455c-4432-a9a2-698a929bbd687
1049906diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCD622b12fa-455c-4432-a9a2-698a929bbd687
1049906diphenhydramine HCl 12.5 MG per 5 ML Oral SolutionSY622b12fa-455c-4432-a9a2-698a929bbd687
1049906diphenhydramine hydrochloride 25 MG per 10 ML Oral SolutionSY622b12fa-455c-4432-a9a2-698a929bbd687
1049906diphenhydramine hydrochloride 50 MG per 20 ML Oral SolutionSY622b12fa-455c-4432-a9a2-698a929bbd687

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41250-379-26412500379261 BOTTLE in 1 CARTON (41250-379-26) / 118 mL in 1 BOTTLE1 bottle1987-11-150000-00-00NoNoCurrent
41250-379-34412500379341 BOTTLE in 1 CARTON (41250-379-34) / 237 mL in 1 BOTTLE1 bottle1995-12-120000-00-00NoNoCurrent