FDA.reportPublic FDA data

Dye Free Wal Dryl Allergy

Product NDC
0363-0293
11-digit product format
003630293
Labeler code
0363
Product ID
0363-0293_959f4a9a-1539-45a0-b283-37f80b32b0ca
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Hydrochloride
Dosage form
LIQUID
Route
ORAL
Labeler
Walgreens
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-03-31
Marketing end
2027-03-31
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
Dye Free Wal Dryl Allergy
Brand name suffix
childrens

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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1049906Internal RxNorm lookup
1086767Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
53e6f72d-15a4-4efe-8b1f-5753fed53df8Available 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-0293-04Dye Free Wal Dryl Allergychildrens118 mL in 1 BOTTLE, PLASTICLIQUID1188
0363-0293-04Dye Free Wal Dryl Allergychildrens1 in 1 BOXLIQUID18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-0293-04ML - Milliliter0363-0293f6d348e2-7446-455b-8096-a41826ed18fd12022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40DYE FREE WAL DRYL ALLERGY CHILDRENS (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [WALGREENS]2
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MDYE FREE WAL DRYL ALLERGY CHILDRENS (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [WALGREENS]2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLDYE FREE WAL DRYL ALLERGY CHILDRENS (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [WALGREENS]2
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMINACTIVE INGREDIENTK679OBS311DYE FREE WAL DRYL ALLERGY CHILDRENS (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [WALGREENS]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDYE FREE WAL DRYL ALLERGY CHILDRENS (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [WALGREENS]2
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYDYE FREE WAL DRYL ALLERGY CHILDRENS (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [WALGREENS]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUDYE FREE WAL DRYL ALLERGY CHILDRENS (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [WALGREENS]2
SORBITOLINACTIVE INGREDIENT506T60A25RDYE FREE WAL DRYL ALLERGY CHILDRENS (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [WALGREENS]2
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KDYE FREE WAL DRYL ALLERGY CHILDRENS (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [WALGREENS]2
WATERINACTIVE INGREDIENT059QF0KO0RDYE FREE WAL DRYL ALLERGY CHILDRENS (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [WALGREENS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0293DYE FREE WAL DRYL ALLERGY CHILDRENS (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [WALGREENS]7Current NDC, Legacy NDC, 2 package rows20240509_53e6f72d-15a4-4efe-8b1f-5753fed53df8.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 94 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Maximum Strength Mucus Relief DMDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINWal-Mart Stores,Inc.,a748d5ab-901c-47bb-8437-997542ecebfe2025-10-28WarningsExact identifier
application number: M012
Nighttime Childrens Multi Symptoms Cold and Cough Multi-Symptom ReliefCHLORPHENIRAMINE MALEATE AND DEXTROMETHORPHAN HYDROBROMIDEWAL-MART STORES,INC.68a68574-0fcb-4569-be57-d9aee5f62bea2025-10-28WarningsExact identifier
application number: M012
Maximum Strength Mucus Relief Severe Congestion and CoughDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEWal-Mart Stores,Inc.,635009a1-6154-4c62-a4be-d4f32c2cef8d2025-10-28WarningsExact identifier
application number: M012
Publix Maximum StrengthOXYMETAZOLINE HYDROCHLORIDEPUBLIX SUPER MARKETS, INCcf49a06d-f095-48bf-bcd2-a410066ff9af2025-10-28WarningsExact identifier
application number: M012
PublixOXYMETAZOLINE HYDROCHLORIDEPUBLIX SUPER MARKETS, INC283e42b9-173c-4deb-9377-ff649efc177f2025-10-28WarningsExact identifier
application number: M012
Publix Extra MoisturizingOXYMETAZOLINE HYDROCHLORIDEPUBLIX SUPER MARKETS, INCeae83b75-9d5a-4100-9304-629e54ef77522025-10-28WarningsExact identifier
application number: M012
PublixPHENYLEPHRINE HYDROCHLORIDEPUBLIX SUPER MARKETS, INCf10e120d-f0b7-4c51-b29b-e8cdbb1456f32025-10-28WarningsExact identifier
application number: M012
Family Care Nasal ReliefOXYMETAZOLINE HYDROCHLORIDEUnited Exchange Corp6d0f8e9e-0503-522b-e053-2a91aa0aca352025-10-28WarningsExact identifier
application number: M012
Family Care Nasal ReliefOXYMETAZOLINE HYDROCHLORIDEUnited Exchange Corp6d0eef2f-f546-d769-e053-2991aa0a8fe42025-10-28WarningsExact identifier
application number: M012
Sinus Plus HeadacheACETAMINOPHEN, PHENYLEPHRINE HCLKroger Companyb622b6cb-f756-439e-8684-d45ee1ea75ab2025-10-28WarningsExact identifier
application number: M012
Tussin DM Cough and Chest Congestion AdultDEXTROMETHORPHAN HBR, GUAIFENESINP & L Development, LLC4af67ba7-8892-442c-b9fb-80aba9140e052025-10-28WarningsExact identifier
application number: M012
No Drip Nasal Mist Nasal Decongestant Severe CongestionOXYMETAZOLINE HYDROCHLORIDEWal-Mart Stores,Inc.,994fa270-65bb-4097-b88a-d5ce3c0e1c792025-10-27WarningsExact identifier
application number: M012
Dye Free Childrens Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEWAL-MART STORES INC.3652ee94-b762-4100-a305-5acbec5f795a2025-10-27WarningsExact identifier
application number: M012
Maximum Strength Mucus Relief Cold,Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN ,PHENYLEPHRINE HCLWal-Mart Stores,Inc.,2fd5be4f-2bb6-4241-9e0f-be7610ae2fdc2025-10-27WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLUnited Natural Foods, Inc. dba UNFI4517c7ef-156c-42b8-a2da-165e936f08372025-10-27WarningsExact identifier
application number: M012
Allergies MY CHILD NEEDS HELP WITHDIPHENHYDRAMINE HCLUnconditional Love5ad293e9-0a4b-4923-8a91-f014507268282025-10-27WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLCardinal Health 110, LLC. DBA Leader933a54d3-196d-4c5d-b26f-d18b2d2ba1df2025-10-27WarningsExact identifier
application number: M012
BanophenDIPHENHYDRAMINE HCLMajor Pharmaceuticals69b7f7ca-7a3a-4fe6-a9bb-90b0e6ad62c12025-10-27WarningsExact identifier
application number: M012
basic care daytime severe cold and flu nighttime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCLAmazon.com Services LLC4a9fd615-b7d3-452c-ac40-d9189124faaa2025-10-24WarningsExact identifier
application number: M012
allergy childrensDIPHENHYDRAMINE HYDROCHLORIDEMeijer Distribution Inc622b12fa-455c-4432-a9a2-698a929bbd682025-10-24WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049906diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSN53e6f72d-15a4-4efe-8b1f-5753fed53df88
1086767Wal-Dryl Children's Allergy 12.5 MG in 5 mL Oral SolutionPSN53e6f72d-15a4-4efe-8b1f-5753fed53df88
1086767diphenhydramine hydrochloride 2.5 MG/ML Oral Solution [Wal-Dryl Childrens]SBD53e6f72d-15a4-4efe-8b1f-5753fed53df88
1049906diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCD53e6f72d-15a4-4efe-8b1f-5753fed53df88
1049906diphenhydramine HCl 12.5 MG per 5 ML Oral SolutionSY53e6f72d-15a4-4efe-8b1f-5753fed53df88
1049906diphenhydramine hydrochloride 25 MG per 10 ML Oral SolutionSY53e6f72d-15a4-4efe-8b1f-5753fed53df88
1049906diphenhydramine hydrochloride 50 MG per 20 ML Oral SolutionSY53e6f72d-15a4-4efe-8b1f-5753fed53df88
1086767Wal-Dryl Children's 12.5 MG per 5 ML Oral SolutionSY53e6f72d-15a4-4efe-8b1f-5753fed53df88
1086767Wal-Dryl Children's 12.5 MG per 5 ML Prefilled SpoonSY53e6f72d-15a4-4efe-8b1f-5753fed53df88
1086767Wal-Dryl Children's Allergy 12.5 MG per 5 ML Oral SolutionSY53e6f72d-15a4-4efe-8b1f-5753fed53df88
1086767Wal-Dryl Childrens 2.5 MG/ML Oral SolutionSY53e6f72d-15a4-4efe-8b1f-5753fed53df88

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0363-0293-04003630293041 BOTTLE, PLASTIC in 1 BOX (0363-0293-04) / 118 mL in 1 BOTTLE, PLASTIC2015-03-312027-03-31NoNoCurrent