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 38 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Vicks Sinex Severe OriginalOXYMETAZOLINE HYDROCHLORIDEProcter & Gamble Manufacturing GmbHcfd048c9-2f33-101d-e053-2995a90ad8542026-04-22WarningsExact identifier
application number: M012
Vicks Sinex SEVERE VapoCOOL ULTRA FINE MISTOXYMETAZOLINE HYDROCHLORIDEProcter & Gamble Manufacturing GmbHd0768332-7c24-7c30-e053-2a95a90a26d42026-04-22WarningsExact identifier
application number: M012
HistanazPSEUDOEPHEDRINE HCL, PYRILAMINE MALEATECapital Pharmaceutical, LLC3e87d0f3-f16c-5972-e063-6294a90acc8a2026-04-22WarningsExact identifier
application number: M012
Good Sense Severe Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLL. Perrigo Companyd5faf89f-3641-4be1-8d43-35504f12fe8d2026-04-22WarningsExact identifier
application number: M012
Multi-Symptom Cold childrensDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWALMART INC.5ee5eb75-fc56-42a1-bf2c-b9c10ea8bfd42026-04-22WarningsExact identifier
application number: M012
good sense nasalOXYMETAZOLINE HYDROCHLORIDEL. Perrigo Company95f23049-e523-4c59-904c-b8e9ae82602c2026-04-22WarningsExact identifier
application number: M012
Mucinex Childrens FreeFrom Multi-Symptom Cold and Stuffy NoseDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLCc07dad99-87b0-419b-9230-7c22a77ecf9e2026-04-21WarningsExact identifier
application number: M012
Cough and Cold HBPCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRValu Merchandisers Company83db90da-9155-4f6a-8209-44c87d14b6962026-04-21WarningsExact identifier
application number: M012
Pain, Headache and CoughACETAMINOPHEN, DEXTROMETHORPHAN HBRCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED613a2516-fc61-4bb4-bd44-ca60045481932026-04-21WarningsExact identifier
application number: M012
Dr. Simi Allergy ReliefDIPHENHYDRAMINE HCLFarmacias De Similares TX LLC4fe8bbe3-13c9-5458-e063-6294a90a90642026-04-20WarningsExact identifier
application number: M012
Cold and Flu Day and Night, SevereACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLARMY AND AIR FORCE EXCHANGE SERVICE58d722ef-db67-44ac-a295-dd10e1f5ca1d2026-04-20WarningsExact identifier
application number: M012
Loratadine 10mgLORATADINEBETTER LIVING BRANDS, LLC46d615dd-45d5-2dfc-e063-6394a90a5d422026-04-18WarningsExact identifier
application number: M012
Multi-Symptom Cold DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLValu Merchandisers Companyd0f896a6-5637-45ef-bf60-b343cbcdcf7e2026-04-17WarningsExact identifier
application number: M012
MUCUS RELIEFGUAIFENESINBryant Ranch Prepack9ed5611f-4e1d-4f71-b430-a2a949bf7fe52026-04-17WarningsExact identifier
application number: M012
Multi-Symptom ColdACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLValu Merchandisers Companybf3158af-89ab-4b7c-9f39-0f316fbe90562026-04-17WarningsExact identifier
application number: M012
MUCUS RELIEFGUAIFENESINBryant Ranch Prepack761825bc-f835-4947-bfa0-2940f1dff5fb2026-04-17WarningsExact identifier
application number: M012
equate cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEWALMART INC.e83d14cc-9b90-40ce-a00a-2702d8a8968f2026-04-17WarningsExact identifier
application number: M012
Childrens Allergy ReliefDIPHENHYDRAMINE HCLWalgreen Company0b34b5a3-98a2-4096-9d95-071bb5a63c862026-04-17WarningsExact identifier
application number: M012
Mucus ReliefGUAIFENESINWalgreen Company1cd69ede-29c6-4216-95b7-b58fc96c084b2026-04-16WarningsExact identifier
application number: M012
Sinus SevereACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLValu Merchandisers Companycdcb8e0d-7847-4f28-bb09-7dc7b5d35c132026-04-16WarningsExact 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