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
2027-12-31
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
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 · 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 166 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DEXTROMETHORPHAN HBR, GUAIFENESINDEXTROMETHORPHAN HBR, GUAIFENESINOPMX LLC9a16e7f3-78aa-0b01-e053-2a95a90ab19c2024-04-05WarningsExact identifier
application number: M012
Theraflu Severe Cold Relief Daytime Honey GingerACETAMINOPHEN, DEXTROMETHORPHAN HBRHaleon US Holdings LLC44404c6a-8031-4f4b-a48e-3739a11a0d2c2024-04-05WarningsExact identifier
application number: M012
ActivcinACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEOPMX LLC.e06a4d72-cc8d-fd9d-e053-2995a90a7a762024-04-05WarningsExact identifier
application number: M012
Coldtac Plus SoftgelsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEOPMX LLC.ff5ce5c6-a03f-2ad3-e053-6394a90a99f62024-04-05WarningsExact identifier
application number: M012
Desresfriol-DX SoftgelsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEOPMX LLC.ff5e0e0f-bfd2-b02b-e053-6394a90afe8a2024-04-05WarningsExact identifier
application number: M012
Leader Nasal DecongestantOXYMETAZOLINE HYDROCHLORIDECardinal Health 110,Inc98bf8e84-b555-4b5a-90a0-7837a55602892024-04-03WarningsExact identifier
application number: M012
DAYTIME COLD AND FLU RELIEFACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEAdvanced Rx LLC38299cf3-e884-4676-8cc4-6dd64e7d023c2024-03-30WarningsExact identifier
application number: M012
NIGHTTIME COLD AND FLU RELIEFACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATEAdvanced Rx LLCd1542362-19c5-4470-89e8-87d26e2ca8ed2024-03-30WarningsExact identifier
application number: M012
ANTIGRIP NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLPharmadel LLC12de30fd-95b6-f16d-e063-6294a90aeba22024-03-27WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLFamily Dollar (FAMILY WELLNESS)0044c53c-11dd-41a9-a5d9-622dd8b1c1442024-03-27WarningsExact identifier
application number: M012
Codeine-GuaifenesinCODEINE PHOSPHATE AND GUAIFENESINBryant Ranch Prepack9812056b-736e-40c5-ae60-21dd9221397c2024-03-22WarningsExact identifier
application number: M012
Tussin CFDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLBest Choice (Valu Merchandisers Company)1b7b5811-722e-4c4a-844d-c05fa5cfb2e52024-03-21WarningsExact identifier
application number: M012
Daytime and Nighttime Cold and Flu Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR,GUAIFENESIN, PHENYLEPHRINE HCL / ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLWalgreensda2a77c3-7d0f-157b-e053-2995a90a951a2024-03-19WarningsExact identifier
application number: M012
Robitussin Medi-SoothersDEXTROMETHORPHAN HYDROBROMIDE, MENTHOLHaleon US Holdings LLC6bec225e-a203-4866-b0db-b76f73a6ae252024-03-19WarningsExact identifier
application number: M012
Cold and Flu Relief NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEDolgencorp, Inc. (DOLLAR GENERAL & REXALL)06d47104-a8ca-48cc-b27e-08c9d018c37b2024-03-19WarningsExact identifier
application number: M012
Cold and Flu NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEDolgencorp, Inc. (DOLLAR GENERAL & REXALL)b80dae7f-ed2d-4a9e-bef9-f1ed8add01742024-03-19WarningsExact identifier
application number: M012
Daytime Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEWALGREENSc945c35e-de0d-0fd6-e053-2995a90a1fbf2024-03-19WarningsExact identifier
application number: M012
Daytime Nighttime Sinus Relief Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL/ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE,PHENYLEPHRINE HCLWalgreensda046b01-707c-326a-e053-2995a90a09272024-03-19WarningsExact identifier
application number: M012
DAYTIME NIGHTTIME SEVERE COLD AND FLU Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR,GUAIFENESIN, PHENYLEPHRINE HCL / ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLWalgreensda2b0276-9ab0-38e6-e053-2a95a90a54d82024-03-19WarningsExact identifier
application number: M012
Childrens Robitussin Cough and Chest Congestion DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINHaleon US Holdings LLCb9772292-9eb6-47cf-abb8-007c254780902024-03-17WarningsExact 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