FDA.reportPublic FDA data

Childrens Allergy

Product NDC
56062-379
11-digit product format
560620379
Labeler code
56062
Product ID
56062-379_75bffa52-fe5e-4772-bf65-27cad77249fd
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
SOLUTION
Route
ORAL
Labeler
Publix Super Markets Inc
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-02-11
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
Childrens 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 · 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
cc6e4e26-84f5-4003-b1eb-f0e06d3e294eAvailable 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, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
56062-379-262024-01-30C16284748780-11030e365-21ef-111a-e063-dadaa90a10e2Publix Super Markets, Inc. Children’s Allergy Liquid Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
56062-379-26Childrens Allergy1 in 1 CARTONSOLUTION15
56062-379-26Childrens Allergy118 mL in 1 BOTTLESOLUTION1185

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40CHILDRENS ALLERGY (DIPHENHYDRAMINE HCL) SOLUTION [PUBLIX SUPER MARKETS INC]2
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MCHILDRENS ALLERGY (DIPHENHYDRAMINE HCL) SOLUTION [PUBLIX SUPER MARKETS INC]2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLCHILDRENS ALLERGY (DIPHENHYDRAMINE HCL) SOLUTION [PUBLIX SUPER MARKETS INC]2
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LCHILDRENS ALLERGY (DIPHENHYDRAMINE HCL) SOLUTION [PUBLIX SUPER MARKETS INC]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACHILDRENS ALLERGY (DIPHENHYDRAMINE HCL) SOLUTION [PUBLIX SUPER MARKETS INC]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCHILDRENS ALLERGY (DIPHENHYDRAMINE HCL) SOLUTION [PUBLIX SUPER MARKETS INC]2
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SCHILDRENS ALLERGY (DIPHENHYDRAMINE HCL) SOLUTION [PUBLIX SUPER MARKETS INC]2
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2CHILDRENS ALLERGY (DIPHENHYDRAMINE HCL) SOLUTION [PUBLIX SUPER MARKETS INC]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUCHILDRENS ALLERGY (DIPHENHYDRAMINE HCL) SOLUTION [PUBLIX SUPER MARKETS INC]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XCHILDRENS ALLERGY (DIPHENHYDRAMINE HCL) SOLUTION [PUBLIX SUPER MARKETS INC]2
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRCHILDRENS ALLERGY (DIPHENHYDRAMINE HCL) SOLUTION [PUBLIX SUPER MARKETS INC]2
SORBITOLINACTIVE INGREDIENT506T60A25RCHILDRENS ALLERGY (DIPHENHYDRAMINE HCL) SOLUTION [PUBLIX SUPER MARKETS INC]2
WATERINACTIVE INGREDIENT059QF0KO0RCHILDRENS ALLERGY (DIPHENHYDRAMINE HCL) SOLUTION [PUBLIX SUPER MARKETS INC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
56062-379CHILDRENS ALLERGY (DIPHENHYDRAMINE HCL) SOLUTION [PUBLIX SUPER MARKETS INC]5Current NDC, Legacy NDC, 2 package rows20240724_cc6e4e26-84f5-4003-b1eb-f0e06d3e294e.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 104 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Medique Medi-MucusDEXTROMETHORPHAN HBR, GUAIFENESINUnifirst First Aid Corporationf3bb862a-9cb8-f644-e053-2a95a90a5f4f2025-09-08WarningsExact identifier
application number: M012
Physicians Care Cough and Sore ThroatMENTHOLAcme United Corporation4e02223d-f34b-333e-e054-00144ff8d46c2025-09-08WarningsExact identifier
application number: M012
Physicians Care Non-Drowsy Cold and CoughACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEAcme United186ec543-1f23-75d6-e063-6294a90a46b92025-09-08WarningsExact identifier
application number: M012
PhysiciansCare Sinus Non-DrowsyPHENYLEPHRINE HCLAcme United Corporationa6daf3ef-f386-4de4-b38e-d0b90c9ae62b2025-09-08WarningsExact identifier
application number: M012
PhysiciansCare Allergy Multi-Symptom ReliefACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDEAcme United Corporationfd101c27-6ba9-4cd3-baec-a354504c37a02025-09-08WarningsExact identifier
application number: M012
Green Guard Honey Lemon Cough DropMENTHOL 8.6 MGUnifirst First Aid Corporation8a94f090-61d6-4909-e053-2995a90aee382025-09-08WarningsExact identifier
application number: M012
Green Guard Cough Drop ReliefMENTHOLUnifirst First Aid Corporation0fc4cb11-8ff9-4eff-9588-c73eef4e01372025-09-08WarningsExact identifier
application number: M012
Multi-Symptom Cold ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL , GUAIFENESIN, ,Unifirst First Aid Corporatione6ea6faf-baff-a130-e053-2a95a90a085a2025-09-08WarningsExact identifier
application number: M012
MEDIQUE Medikoff DropsMENTHOLUnifirst First Aid Corporation0d6b4443-16a1-4851-bb03-d7407167551d2025-09-08WarningsExact identifier
application number: M012
Medique Sugar Free Medikoff DropsMENTHOLUnifirst First Aid Corporation92d13e19-4e7b-4565-970e-504abf02579a2025-09-08WarningsExact identifier
application number: M012
Medique at Home DiphenDIPHENHYDRAMINE HCLUnifirst First Aid Corporationb56d1966-efd7-56eb-e053-2995a90a89b52025-09-08WarningsExact identifier
application number: M012
Medique ChlorphenCHLORPHENIRAMINE MALEATEUnifirst First Aid Corporationb3d5d161-8d4c-f1bb-e053-2a95a90a5bc52025-09-08WarningsExact identifier
application number: M012
Crane Safety Sinus DecongestantPHENYLEPHRINE HYDROCHLORIDECrane Safety LLC968baa85-ce0e-0c3d-e053-2995a90ac03a2025-09-08WarningsExact identifier
application number: M012
Thompson Cherry Cough DropsMENTHOLThompson Safety LLCc948f5b0-8491-6f9f-e053-2995a90a55fa2025-09-08WarningsExact identifier
application number: M012
Medique Decorel ForteACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEUnifirst First Aid Corporatione64c283b-0efa-0bfd-e053-2a95a90ab71d2025-09-08WarningsExact identifier
application number: M012
Daytime Nighttime Cold and CoughACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DOXYLAMINE SUCCINATEWalgreensa99fdd49-0160-4a82-983b-fa56ab38ae762025-09-08WarningsExact identifier
application number: M012
Dye Free Wal Dryl Allergy childrensDIPHENHYDRAMINE HYDROCHLORIDEWalgreens53e6f72d-15a4-4efe-8b1f-5753fed53df82025-09-08WarningsExact identifier
application number: M012
Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEWalgreens40bfd631-51a4-4684-9ba0-a365d61da9bc2025-09-08WarningsExact identifier
application number: M012
Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEWalgreensf796ce1f-3077-4a0d-a41a-249c345ddb5f2025-09-08WarningsExact identifier
application number: M012
equate nighttime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEWal-Mart Stores Inc6ccbd537-2264-4b3c-804e-3d3ea5368a5f2025-09-05WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049906diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSNcc6e4e26-84f5-4003-b1eb-f0e06d3e294e5
1049906diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCDcc6e4e26-84f5-4003-b1eb-f0e06d3e294e5
1049906diphenhydramine HCl 12.5 MG per 5 ML Oral SolutionSYcc6e4e26-84f5-4003-b1eb-f0e06d3e294e5
1049906diphenhydramine hydrochloride 25 MG per 10 ML Oral SolutionSYcc6e4e26-84f5-4003-b1eb-f0e06d3e294e5
1049906diphenhydramine hydrochloride 50 MG per 20 ML Oral SolutionSYcc6e4e26-84f5-4003-b1eb-f0e06d3e294e5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
56062-379-26560620379261 BOTTLE in 1 CARTON (56062-379-26) / 118 mL in 1 BOTTLE1 bottle2014-02-110000-00-00NoNoCurrent