FDA.reportPublic FDA data

Childrens Allergy

Product NDC
63868-370
11-digit product format
638680370
Labeler code
63868
Product ID
63868-370_efac59d9-21aa-4627-876f-12a5fe16165b
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Hydrochloride
Dosage form
LIQUID
Route
ORAL
Labeler
QUALITY CHOICE (Chain Drug Marketing Association)
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-05-30
Marketing end
2026-12-28
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
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

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-370-04Childrens Allergy1 in 1 BOXLIQUID17
63868-370-04Childrens Allergy118 mL in 1 BOTTLELIQUID1187

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-370-04ML - Milliliter63868-37033df79f1-77ca-40ba-9508-19cfff3b1f2a12021-04-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MCHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLCHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LCHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUCHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XCHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRCHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1
SUCROSEINACTIVE INGREDIENTC151H8M554CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1
WATERINACTIVE INGREDIENT059QF0KO0RCHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-370CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]7Current NDC, Legacy NDC, 2 package rows20240423_9bddedbb-40a2-47d3-be35-7b6fce4f755d.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 85 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Allergy ReliefDIPHENHYDRAMINE HCLBIONPHARMA INC.323347c3-d51a-4976-e063-6294a90a952e2025-12-01WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLWALGREEN COMPANY2969ba8f-c477-222a-e063-6394a90af7032025-12-01WarningsExact identifier
application number: M012
CareAll Medicated Chest RubCAMPHOR, MENTHOL, EUCALYPTUSNew World Imports, Inc4cd2f751-e072-4f4e-b059-ed1dfcc60c6b2025-12-01WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLCVS PHARMACY, INCbbb1b395-48d9-4859-ad52-6650961089d92025-12-01WarningsExact identifier
application number: M012
Severe Sinus Pain and CongestionACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDfbc541ac-9465-4296-bb1e-811b9d811f402025-11-26WarningsExact identifier
application number: M012
Daytime Severe and Nighttime Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLGrocery Outlet, Inc.447951e6-459d-0a52-e063-6294a90a62262025-11-26WarningsExact identifier
application number: M012
Daytime Cold and Flu ReliefACETAMINOHPEN, DEXTROMETHORPHAN HBR, GUAIFENESIN PHENYLEPHRINE HCLWALGREENS CO.bfc58cd5-9815-43af-895d-ec6cbd10937e2025-11-26WarningsExact identifier
application number: M012
Walgreen Cough and Chest CongestionDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINWALGREEN COMPANY40c038a3-91c7-4ed0-8210-65d58b82ca2b2025-11-26WarningsExact identifier
application number: M012
Mucus Relief DM Maximum StrengthDEXTROMETHORPHAN HBR AND GUAIFENESINWALGREENS CO724554ab-60b8-46c8-96a8-a98242604e3b2025-11-26WarningsExact identifier
application number: M012
Walgreens Grape FlavorCHILDREN COUGH AND CHEST CONGESTIONWALGREENS795cf1af-3847-46bc-b605-64a38e57cca22025-11-26WarningsExact identifier
application number: M012
WalgreensCHILDRENS STUFFY NOSE AND COLDWALGREENS CO.7ac3de2d-1d10-49ec-a2da-da46977684ad2025-11-26WarningsExact identifier
application number: M012
Childrens Chest Congestion ReliefGUAIFENESINWALGREENS COMPANYc1382512-e6f3-4bdf-a9e6-4f68dd5ea5532025-11-26WarningsExact identifier
application number: M012
Dye Free Wal Sleep ZDIPHENHYDRAMINE HYDROCHLORIDEWALGREEN CO.96948973-09e3-4c05-8982-0494ebeaac4b2025-11-26WarningsExact identifier
application number: M012
WALGREEN ADULT COUGH PLUS CHEST CONGESTION DMDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINWALGREEN COMPANY02ad9f98-07ad-4786-a1ab-169b870fec012025-11-26WarningsExact identifier
application number: M012
Walgreen CherryGUAIFENESINWALGREEN COMPANY1f1cb4a5-1ebd-483c-bf82-16931da00e052025-11-26WarningsExact identifier
application number: M012
Walgreen Childrens COLD PLUS COUGH PLUS SORE THROATACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDEWALGREENS CO.801880b2-6116-4d26-a7bf-a669eef6ad8b2025-11-26WarningsExact identifier
application number: M012
Walgreen Daytimel Kids Cold Cough plus MucusGUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDEWALGREENS CO.452159e0-1204-460c-981f-cace4e815c6f2025-11-26WarningsExact identifier
application number: M012
Multi Symptom Wal Flu Severe ColdACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLWALGREEN CO.9c0f3f1e-25d1-4d73-9cd7-42708aa66dcb2025-11-25WarningsExact identifier
application number: M012
WALGREEN Daytime Multi Symptom Flu Relief Max StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBRWALGREENS CO.c92a0f47-0b7c-4034-83d1-b7d2ed8022fc2025-11-25WarningsExact identifier
application number: M012
Mucus Relief DM Honey and Berry FlavorDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINWALGREENS CO.428081f5-b7eb-42da-963c-a587a44b2a792025-11-25WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049906diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSN9bddedbb-40a2-47d3-be35-7b6fce4f755d7
1049906diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCD9bddedbb-40a2-47d3-be35-7b6fce4f755d7
1049906diphenhydramine HCl 12.5 MG per 5 ML Oral SolutionSY9bddedbb-40a2-47d3-be35-7b6fce4f755d7
1049906diphenhydramine hydrochloride 25 MG per 10 ML Oral SolutionSY9bddedbb-40a2-47d3-be35-7b6fce4f755d7
1049906diphenhydramine hydrochloride 50 MG per 20 ML Oral SolutionSY9bddedbb-40a2-47d3-be35-7b6fce4f755d7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63868-370-04638680370041 BOTTLE in 1 BOX (63868-370-04) / 118 mL in 1 BOTTLE1 bottle2014-05-302026-12-28NoNoCurrent