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 139 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
basic care tussin dmDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINAmazon.com Services LLC306d5914-03ed-410a-9345-c54ba604e9912024-11-09WarningsExact identifier
application number: M012
care one nasal originalOXYMETAZOLINE HYDROCHLORIDEAmerican Sales Companya0c35e06-c9e9-438e-8224-d4760b6e2aff2024-11-09WarningsExact identifier
application number: M012
adult tussin dmDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINWalgreen Company34174507-cf2e-4ed4-85ec-f915d4b910df2024-11-08WarningsExact identifier
application number: M012
Childrens Benadryl ChewablesDIPHENHYDRAMINE HYDROCHLORIDEKenvue Brands LLCb08f71d8-a06c-41ba-8ed1-fbc41dbc19192024-11-08WarningsExact identifier
application number: M012
SUDAFED PE SINUS CONGESTIONDIPHENHYDRAMINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLCa38fdfb8-db89-487f-9b68-aa9152b91f5f2024-11-08WarningsExact identifier
application number: M012
SUDAFED Sinus CongestionPSEUDOEPHEDRINE HYDROCHLORIDEKenvue Brands LLCc05d7e27-6821-468f-b27d-9c0b02a07b0f2024-11-08WarningsExact identifier
application number: M012
BenadrylDIPHENHYDRAMINE HYDROCHLORIDEKenvue Brands LLC2884d2dc-2d4a-4ca6-ab73-688a80b428eb2024-11-08WarningsExact identifier
application number: M012
Extra Strength TYLENOL Cold plus Flu Multi-Action Day/NightACETAMINOPHEN, PSEUDOEPHEDRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE, AND CHLORPHENIRAMINE MALEATEKenvue Brands LLC712ba011-79aa-469b-9f0f-04a0b4b705bd2024-11-08WarningsExact identifier
application number: M012
SUDAFED PE Pressure Plus PainACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLC8538c291-9ce9-4866-b268-f4cbdb52f5bd2024-11-08WarningsExact identifier
application number: M012
Childrens Sudafed Nasal DecongestantPSEUDOEPHEDRINE HYDROCHLORIDEKenvue Brands LLC52e9307b-ad38-4f65-bb2f-4fa262e820102024-11-08WarningsExact identifier
application number: M012
Benadryl Allergy Plus CongestionDIPHENHYDRAMINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLC685b51d3-cc25-47b2-ac8a-368924f431372024-11-08WarningsExact identifier
application number: M012
Sudafed PE Sinus Pressure Plus PainACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLC60183922-bfd3-4377-884a-51b2f0a4c93a2024-11-08WarningsExact identifier
application number: M012
Sudafed PE Sinus CongestionPHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLC2ca08917-1a75-4365-8520-c083e6a4225a2024-11-08WarningsExact identifier
application number: M012
SUDAFED PE Head Congestion Plus MucusACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLCf0739186-41b9-4761-adf7-08101b30a18e2024-11-08WarningsExact identifier
application number: M012
SUDAFED PE Head Congestion Plus Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLC1e528f78-0ced-4a06-935a-84056c9217272024-11-08WarningsExact identifier
application number: M012
TYLENOL Cold Plus Flu Severe and TYLENOL COLD MAX CoPackACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLC657a1e59-104c-4152-b2c9-00a8b82dc78e2024-11-08WarningsExact identifier
application number: M012
Tylenol Cold plus Flu Severe and Tylenol Cold MaxACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLC47c61858-72ce-409b-a3af-a63620cf7d132024-11-08WarningsExact identifier
application number: M012
Childrens Benadryl Allergy Plus CongestionDIPHENHYDRAMINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLCb8b75904-3806-4258-89c1-d6ff486ed41c2024-11-08WarningsExact identifier
application number: M012
Tylenol Cold Plus Flu Severe Day and Tylenol Cold Plus Flu Plus Cough Night 3-PackACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLC464de5de-0e7a-41d6-875f-dd0e5fe7893c2024-11-08WarningsExact identifier
application number: M012
McKesson Phenylephrine HClPHENYLEPHRINE HCLMcKesson Medical-Surgicale09060f7-ca0b-5f7c-e053-2995a90ab3442024-11-08WarningsExact 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