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 34 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Kids AllergyDIPHENHYDRAMINE HCLGenexa Inc.a7bc5f7c-eaeb-25d0-e053-2a95a90a9ec42026-05-08WarningsExact identifier
application number: M012
day time non drowsyACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLPublix Super Markets Incf4fd597f-bca2-4ed4-b353-6c734f2f885c2026-05-08WarningsExact identifier
application number: M012
Daytime Non DrowsyACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLCVS Pharmacyd8339bb0-5da3-4f34-a819-339643cf4a972026-05-08WarningsExact identifier
application number: M012
severe tussin cfACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDa26afc33-533e-4dc0-ab25-21be87356e222026-05-08WarningsExact identifier
application number: M012
SEVERE CONGESTION and COUGH MAXDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEDeMoulas Market Basketcdd53eba-1fa2-49c1-b03d-c32f309da7fb2026-05-08WarningsExact identifier
application number: M012
Benadryl Allergy Liqui-GelsDIPHENHYDRAMINE HYDROCHLORIDEKenvue Brands LLCbfeae100-e2d1-4607-be3b-2d9b15cd4f7f2026-05-07WarningsExact identifier
application number: M012
Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLH E B6503761f-37ae-4f39-b727-cb75d4c4a3c92026-05-07Warnings, Adverse reactionsExact identifier
application number: M012
Mucus Relief Severe Congestion and CoughDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLTOPCO ASSOCIATES LLCad199488-a4be-4b6e-b806-67ce8a6e907e2026-05-07WarningsExact identifier
application number: M012
good sense nasalOXYMETAZOLINE HCLL. Perrigo Company5d42adb9-3625-4072-a6b1-29a229f255c82026-05-07WarningsExact identifier
application number: M012
Childrens Allergy ReliefDIPHENHYDRAMINE HCLWalgreen Company4856cd7b-ccdf-4546-9c65-236ebaac3dca2026-05-06WarningsExact identifier
application number: M012
Mucus Relief All in One Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLDolgencorp, Inc. (DOLLAR GENERAL & REXALL)0f8928a1-97ef-4128-b8d2-20bdb6e5b6ac2026-05-06WarningsExact identifier
application number: M012
daytime cough and chest congestion dmDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED175cc2d0-0202-4e38-8af2-9fc126b7412d2026-05-06WarningsExact identifier
application number: M012
Nasal Decongestant PEPHENYLEPHRINE HYDROCHLORIDEHHH Pharmaceuticals90fae0fa-da07-4ea8-bdbd-39c2ed99ae592026-05-06WarningsExact identifier
application number: M012
PHENYLEPHRINE HYDROCHLORIDEPHENYLEPHRINE HYDROCHLORIDEHHH Pharmaceuticals5d8b980f-0011-41e3-a881-ad10fe3990792026-05-06WarningsExact identifier
application number: M012
HALLS MentholyptusMENTHOLMondelez Global LLC38d12374-e2c7-444c-e063-6294a90a42b32026-05-06WarningsExact identifier
application number: M012
HALLS MentholyptusMENTHOLMondelez Global LLC1ab295ff-94b1-c938-e063-6294a90a98fd2026-05-06WarningsExact identifier
application number: M012
ALKA SELTZER COLD Cold and Sinus Maximum Strength Fast GelsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE , PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.512af63d-2f09-4baa-e063-6394a90a86bd2026-05-06WarningsExact identifier
application number: M012
Thieves Chest RubCHEST RUBYoung Living Essential Oils, LC.9b7f125e-6caa-c53e-e053-2a95a90a737e2026-05-06WarningsExact identifier
application number: M012
Maximum Strength Mucus Relief Plus Pain and HeadacheACETAMINOPHEN, GUAIFENESINShield Pharmaceuticals Corpf20c0db1-dcf3-4bfc-b3e4-930398f82dc92026-05-06WarningsExact identifier
application number: M012
NitetimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEPublix Super Markets Inc8aa6492b-1723-4c6b-82ee-4f800301c6ad2026-05-06WarningsExact 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